HIV Biobehavioral Survey and
Population Size Estimation among Men
Who Have Sex with Other Men and
People Who Inject Drugs in the Kyrgyz
Republic
SURVEY OVERVIEW
Project name
HIV Biobehavioral Survey and Population Size Estimates among
Men Who Have Sex with Other Men and People Who Inject Drugs
in the Kyrgyz Republic
Funder
U.S. Centers for Disease Control and Prevention
Key contacts
Dr. Nazira Usmanova; Dr. Patrick Nadol; Dr. Joyce Neal
Collaborating
Republican AIDS Center of the Kyrgyz Republic
agencies
ICAP, Columbia University
This protocol is the key guidance document for the study entitled, “HIV Biobehavioral Survey and
Population Size Estimates among Men Who Have Sex with Other Men and People Who Inject
Drugs in the Kyrgyz Republic” (BBS 2020). This study will conduct a behavioral and biological
survey of men who have sex with men (MSM) and people who inject drugs (PWID) in selected
survey cities/districts in the Kyrgyz Republic. The primary objectives of this project are to estimate
the viral load suppression, prevalence of HIV, and population size of MSM and PWID in each of
the selected survey sites. The cities/districts in the study are considered to have the largest
populations of PWID and MSM in the Kyrgyz Republic, based on previous surveys of both
populations conducted throughout the Kyrgyz Republic. The prior surveys were conducted in 2016
and updated information is required to: inform the HIV programmatic response led by the
government of the Kyrgyz Republic, assess the HIV prevention needs of these key populations,
allocate resources appropriately, and inform advocacy efforts. The study will utilize respondentdriven sampling which has been used in previous surveys and is a proven method for recruiting
key populations in locations where legal issues, stigma and discrimination prevent MSM and
PWID from disclosing their risk behavior.
Funding: This study is funded by the Centers for Disease Control and Prevention: Cooperative
Agreements awarded to the Republican AIDS center of the Kyrgyz Republic
GH002048 “Strengthening the Capacity of the Republican AIDS Center to implement HIV programs
in the Kyrgyz Republic under PEPFAR” and awarded to ICAP 17565 “Technical Assistance
Services to Countries Supported by PEPFAR and Global Fund”.
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TABLE OF CONTENTS
1 INVESTIGATORS AND ROLES ......................................................................................... 8
2 Overview............................................................................................................................. 12
3 Background........................................................................................................................ 13
3.1
Epidemiology of HIV in the Kyrgyz Republic ............................................................... 13
4 Rationale ............................................................................................................................ 15
5 PURPOSE AND OBJECTIVES .......................................................................................... 16
5.1
PURPOSE ................................................................................................................... 16
5.2
OBJECTIVES .............................................................................................................. 16
6 Methodology ...................................................................................................................... 17
6.1
Scope .......................................................................................................................... 17
6.1.1 Populations ........................................................................................................ 17
6.1.2 Study Locations ...................................................................................... 18
6.1.3 Biomarkers ............................................................................................ 18
6.2
Survey design and sampling methods ........................................................................ 19
6.2.1 Respondent-driven sampling (RDS) .................................................................. 19
6.3
Sample size calculations ............................................................................................. 20
6.4
Population size estimation .......................................................................................... 23
6.4.1 Service multipliers ............................................................................................. 24
6.4.2 3-Source Capture-Recapture ................................................................... 25
6.4.3 Sequential Sampling PSE (SS-PSE) ......................................................... 27
6.4.4 Finalization of PSE for national use and global reporting ............................. 29
6.5
Data collection tools .................................................................................................... 29
6.5.1 Pre-testing of questionnaire ..................................................................... 30
6.6
Study procedures ........................................................................................................ 30
6.6.1 Participant Enrolment & Data collection ............................................................ 30
6.6.2 Recruitment and screening .................................................................... 303
6.6.3 Informed consent and withdrawal ..................................................................... 39
6.6.4 Compensation ................................................................................................... 41
6.6.5 Questionnaire administration ............................................................................ 42
6.6.6 Pre- and post-test counseling ........................................................................... 43
6.6.7 Testing procedures ........................................................................................... 45
Linkage to Services ..................................................................................................... 51
6.7
6.8
Confidentiality and anonymity ..................................................................................... 53
6.8.1 Complaints ........................................................................................................ 53
6.8.2 Field staff security and safety ........................................................................... 53
6.9 Field staff recruitment and training .......................................................................... 54
6.9.1 Recruitment ....................................................................................................... 54
6.9.2 Training ............................................................................................................. 56
6.10 Data ownership, storage, sharing and release ............................................................... 58
6.11 Data analysis .................................................................................................................. 59
6.12 Variables ......................................................................................................................... 64
6.13 Ethics
.......................................................................................................................... 64
6.13.1 Potential Risks ...................................................................................... 65
6.13.2 Response to New or Unexpected Findings and Changest .......................... 66
6.13.3 Adverse Events .................................................................................... 66
6.13.4 Potential Benefits .................................................................................. 66
6.14
Monitoring and quality control .................................................................................... 66
6.14.1 Periodic monitoring .......................................................................................... 67
6.14.2 Ongoing oversight from investigators ....................................................... 68
6.15
Reporting, dissemination of results and publication .................................................. 69
7 CAPACITY BUILDING PLAN ............................................................................................. 69
8 TIMELINE ............................................................................................................................ 70
9 REFERENCES .................................................................................................................... 73
10 APPENDICES .................................................................................................................... 74
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ACRONYMS AND ABBREVIATIONS
4
ADS
Associate Director of Science
AIDS
Acquired Immune Deficiency Syndrome
ART
Anti-retroviral therapy
BBS
Biobehavioral Survey
CDC
Center for Disease Control and Prevention
DAA
Direct acting antiviral
DEFF
Design Effect
EECA
Eastern Europe and Central Asia
EHCMS
Electronic HIV Case Management System
EIA
Enzyme Immunoassay
FSW
Female sex workers
GFATM
The Global Fund to Fight AIDS, Tuberculosis and Malaria
HCV
Hepatitis C Virus
HIV
Human Immunodeficiency Virus
IRB
Institutional Review Board
KP
Key Population
MAT
Medication Assisted Therapy
MCMC
Markov chain Monte Carlo
MSM
Men who have sex with men
NAT
Nucleic Acid Test
NGO
Non-Governmental Organization
NR
Non-Response rate
PCR
Polymerase Chain Reaction
PEPFAR
US President’s Emergency Plan for AIDS Relief
PPT
Plasma Preparation Tubes
PrEP
Pre-exposure Prophylaxis
PWID
People who inject drugs
BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
5
RAC
Republican AIDS Center
RDS
Respondent-driven Sampling
RDT
Rapid Diagnostic Test
RITA
Recency Infection Testing Algorithm
RTRI
Rapid Test for Recent Infection
SOP
Standard Operating Procedures
SS-PSE
Successive sampling population size estimation
STI
Sexually Transmitted Infections
TP
Trust point
TWG
Technical Working Group
UIC
Unique Identity Code
UNAIDS
Joint United Nations Program on HIV and AIDS
VCT
Voluntary Counseling and Testing
VL
Viral Load
WHO
World Health Organization
BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
DEFINITIONS
TERM
DEFINITION
Equilibrium
A sample has reached “equilibrium” if the observed sample composition
matches the expected long-run sample composition assuming a specific model
of the sampling process.
MSM
A biological male 18 and above, who has oral or anal sexual intercourse with
other men in the 12 months preceding the survey.
People who inject drugs
A men or women 18 and above, who has injected drugs for non-medical
purposes at least once in the 60 days preceding the survey.
Study participants
Members of the target population who have provided consent, completed the
study interview, and testing. These people could have been recruited by
researchers (in which case these study participants are known as “seeds”) or by
peers (known as “peer-recruited participants”).
Peer-recruited
A participant that is recruited by a member of the target population.
participant
Coupon recipient
A person who receives a coupon. Not all coupon recipients are members of the
target population and not all coupon recipients become study participants.
Convergence
The point at which the sample characteristics no longer change, no matter how
many more individuals enter the sample. Convergence is an indication of seed
dependence, like equilibrium, but is based on the population estimate for a given
variable. Whereas equilibrium is based on the wave, convergence is based on
the order of enrolment into the survey.
Homophily
The ratio of number of recruits that have the same characteristic (e.g. HIV
positive vs. HIV negative) as their recruiter to the number we would expect by
chance, for the recruitment chain.
Candidate participant
A coupon recipient who attempts to enroll in the study. Not all candidate
participants will be members of the target population, eligible or consent to be
interviewed, and thus not all candidate participants will become study
participants.
Recruiter
A study participant who has completed the interview process and has received
coupons with which to recruit peers.
Recruitment chain
The set of all participants linked to a specific seed. In respondent-driven
sampling, several waves of recruitment make up a recruitment chain.
Respondent-driven
Sampling methodology used for hard-to-reach population.
Sampling (RDS)
6
Recent Infection
A laboratory test or combination of tests, or a combination of tests and
Testing Algorithm
supplementary laboratory and clinical information, used to classify an HIV
(RITA)
infection as recent or not recent.
Seeds
A participant recruited non-randomly by survey staff, rather than a peer.
BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
7
Successful/completed
A participant who completed the interview, HIV rapid testing (and referral if
participation
positive), HCV and syphilis rapid testing.
Viral load suppression
A viral load below < 1000 copies/mL using viral load assays.
BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
1 INVESTIGATORS AND ROLES
Republican AIDS Center (RAC), Ministry of Health, the Kyrgyz Republic: RAC is the direct
award recipient from the CDC. RAC has overall responsibility for the study and its implementation,
including but not limited to, protocol development, forming a technical working group (TWG) to
inform study implementation, coordinating study preparation with all stakeholders, study
implementation, data collection, supervision and monitoring, data analysis, development of the final
report and data dissemination.
Local non-governmental organizations working with PWID and MSM: A number of nongovernmental organizations (NGO) who provide services to PWID and MSM in survey sites have
established good relationship with target groups of population and are familiar with local context and
thus will facilitate the study. These NGOs also participated in the formative qualitative assessment
among PWID and MSM in the Kyrgyz Republic to inform methods for this biobehavioral survey. The
NGOs will provide technical assistance in protocol development, assist in identification of seeds for
RDS implementation, and monitor implementation through their role on the TWG. They will also
actively participate in the dissemination of results. Table 1 provides information on the NGOs that
will facilitate study implementation by survey sites and groups.
Table 1. List of facilitating NGOs, by survey sites and groups.
#
Survey site
NGOs which will take part in the study by survey groups
PWID
NGO
MSM
NGO
“Kyrgyz Indigo”,
1 Bishkek
+
“Rans Plus”
+
“Anti-SPID”
2 Kara-Balta
+
“Rans Plus”
3 Karasuu
+
“Parents Against Drugs”
“Kyrgyz Indigo”,
4 Osh
+
“Parents Against Drugs”
+
“Musaada”
“Rans
Plus”
5 Sokuluk
+
6 Tokmok
+
“Rans Plus”
“+” - site where survey will take place
“-” - site where survey will not take place
ICAP at Columbia University: ICAP will provide technical assistance to the RAC on protocol
development and study implementation including training of study staff in protocol implementation
and data handling procedures, development of study specific e-BBS systems, study monitoring,
data analysis, and dissemination. ICAP employees will have no contact with study participants, and
no access to individually identifiable information.
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U.S. Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA, and CDC
Central Asia Region: The CDC is the sponsor and advisory institution for this study. CDC will not
be directly engaged with data collection. CDC will provide technical leadership and oversight on
protocol development, data collection procedures, data analysis as well as results and publications
dissemination. CDC employees and agents consequently will have no contact with study
participants and will have no access to individually identifiable information.
As the survey sponsor, the Centers for Disease Control and Prevention (CDC) may conduct
monitoring or auditing of survey activities to ensure the scientific integrity of the survey and to
ensure the rights and protection of survey participants. Monitoring and auditing activities may be
conducted by:
•
CDC staff (“internal”)
•
Authorized representatives of CDC (e.g., a contracted party considered to be “external”)
•
Both internal and external parties
Monitoring or auditing may be performed by means of on-site visits to the Investigator’s facilities or
remotely through digital platforms or other communications such as telephone calls or written
correspondence. The visits will be scheduled at mutually agreeable times, and the frequency of
visits will be at the discretion of CDC. During the visit, any survey-related materials may be
reviewed and the investigator along with the survey staff should be available for discussion of
findings.
The survey may also be subject to inspection by regulatory authorities (national or foreign) as well
as the Institutional Ethics Committees (IEC)/Institutional Review Boards (IRB) to review compliance
and regulatory requirements.
SPONSORING INSTITUTION
U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through the Centers for Disease
Control and Prevention (CDC) under the terms of the cooperative agreements GH002048
“Strengthening the Capacity of the Republican AIDS Center to implement HIV programs in the
Kyrgyz Republic under PEPFAR” awarded to the Republican AIDS Center of the Kyrgyz Republic
and 17565 “Technical Assistance Services to Countries Supported by PEPFAR and Global Fund”
awarded to ICAP.
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List of investigators and institutional affiliations.
Organization, address
Name, contact information
Role
Republican AIDS Center of the Kyrgyz
Dr. Chokmorova Umutkan
Principal
Republic
Director
Investigator
8, Logvinenko Street, 720005, Bishkek,
E-mail: chokmorovakg@mail.ru
the Kyrgyz Republic
Phone: +996 312 301 082
FWA: 00023982
Dr. Aygul Solpueva
Study
Study Coordinator
Coordinator
E-mail: solpuevaigul@mail.ru
Phone: +996 552 455 696
Dr. Dilyayim Yismailova
Co-Principal
Deputy Coordinator
Investigator
E-mail: dilya-9393kg@mail.ru
Phone: +996 707 302 125
Dr. Bubusara Sheralieva
Deputy Coordinator
E-mail: bisara@mail.ru
Phone: +996 999 111 980
NGO “Kyrgyz Indigo”
Mr. Amir Mukambetov
475, Frunze str., Bishkek, the Kyrgyz
Director
Republic
E-mail:
Collaborator
a.mukambetov@gmail.com
kyrgyz.indigo@gmail.com
Phone: +996 555 333 770
+996 555 231 215
Association of Legal Entities “Anti SPID
Mrs. Chynara Bakirova
Association”
Director
7, Maldybaev str., Bishkek, the Kyrgyz
E-mail: chbakirova@gmail.com
Republic
Phone: +996 555 337 412
Public Fund “Musaada”
Mr. Nurmamatov Isa
12, Zinabiddinova str., Osh city, the
Director
Kyrgyz Republic
E-mail: musaada@rambler.ru
Collaborator
Collaborator
Phone: +996 550 000 358
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PF “Parents Against Drugs”
Mr. Mamasobir Burkhanov
19, Shakirova str., Osh city, the Kyrgyz
Director
Republic
E-mail: rpn_osh@mail.ru
Collaborator
Phone: +996 555 810 762
PF “Healthy Generation”
Ms. Kannazarova Aisuluu
2, Frunze str., Jalalabat city, the Kyrgyz
Director
Republic
Phone: +996 559 234 300
PH “Rans Plus”
Mr. Ibragim Lebuzov
55, Er Tabaldy str., Bishkek, the Kyrgyz
President
Republic
E-mail: rans_plus@list.ru
Collaborator
Collaborator
Phone: +996 555 357 050
CDC Central Asia Region
Dr. Patrick Nadol
Co-Investigator
U.S. Embassy, Bishkek
Director
171, Chyngyz Aitmatov Avenue
E-mail: pen5@cdc.gov
Bishkek, the Kyrgyz Republic 720005
(CITI ID: 7374866)
CDC the Kyrgyz Republic
Dr. Nazira Usmanova
U.S. Embassy, Bishkek
HIV Clinical Advisor
171, Chyngyz Aitmatov Avenue
E-mail: hnv9@cdc.gov
Bishkek, the Kyrgyz Republic 720005
(CITI ID: 7424312)
CDC the Kyrgyz Republic
Dr. Bolot Kalmyrzaev
U.S. Embassy, Bishkek
HIV Laboratory Advisor
171, Chyngyz Aitmatov Avenue
E-mail: och1@cdc.gov
Bishkek, the Kyrgyz Republic 720005
(CITI ID: 7511161)
CDC Atlanta
Dr. Joyce Neal
Technical
1600 Clifton Rd. NE
Epidemiologist
Advisor
Atlanta, GA 30329
E-mail: jxn4@cdc.gov
Co-Investigator
Co-Investigator
(CITI ID: 7385257)
ICAP at Columbia University
Dr. Anna Deryabina
Co-Investigator
Director for Central Asia
FWA 00002636
E-mail:
ad2906@cumc.columbia.edu
Co-Investigator
Dr. Ainagul Isakova
Country Coordinator
E-mail: a.isakova@icap.kg
Co-Investigator
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Dr. Maria Lahuerta
Deputy Director
Strategic Information Unit
E-mail:
ml2842@cumc.columbia.edu
Co-Investigator
Mr. Viktor Ivakin
Deputy Director for Strategic
Information for Central Asia
E-mail:
vi2117@cumc.columbia.edu
2 OVERVIEW
This protocol is the key guidance document for the study entitled ‘HIV Biobehavioral Survey and
Population Size Estimates among Men Who Have Sex with Other Men and People Who Inject
Drugs in the Kyrgyz Republic’ (‘BBS 2021’). The study will conduct a behavioral and biological
survey of two key populations at increased risk of HIV in the Kyrgyz Republic: men who have sex
with other men (MSM) and people who inject drugs (PWID).
•
The study will be implemented in six districts/cities of the Kyrgyz Republic’ with the highest
relative concentration of PWID (6 sites) and MSM (2 sites).
•
The study will increase the sample sizes of MSM and PWID compared to the previous
surveys conducted in 2013 and 2016 in order to provide accurate and precise estimates as
defined by the study objectives.
•
Respondent-driven sampling (RDS) for study participant enrolment will be utilized for both
target populations with post-hoc weighting to provide estimations that approximate simple
random sampling.
•
Participation in the study includes completing the survey questionnaire and providing a blood
specimen for defined biological testing; there will be primary compensation for completing
the survey and biological testing and secondary compensation for successfully recruiting
peers as per the protocol.
•
Multiple empirical methods will be used to estimate the size of PWID and MSM populations
in each location.
•
Data collection is anticipated to commence in the second quarter of 2021 and last
approximately three months.
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This document details the study objectives, design and methodology, implementation plan and
capacity-building plan. It is based on the Global HIV Strategic Information Working Group
Biobehavioral Survey Guidelines for Populations at Risk for HIV
(http://www.who.int/hiv/pub/guidelines/biobehavioral-hiv-survey/en/) also known as “The Blue Book”.
It is informed by desk review of available HIV surveillance literature in the Kyrgyz Republic,
including: previous BBS studies, previous population size estimation results, mapping and social
research exercises, formative qualitative assessment among PWID and MSM in the Kyrgyz
Republic to inform methods for a biobehavioral survey and population size estimates that was
conducted from September-October 2020, and HIV notification and survey surveillance data.
3
BACKGROUND
•
Epidemiology of HIV in the Kyrgyz Republic
The Kyrgyz Republic, with a population of 6.5 million, is one of eight countries in Eastern Europe
and Central Asia (EECA), with a growing HIV epidemic. Estimates suggest that there are an
estimated 9,200 people living with HIV (SPECTRUM, 2018) in The Kyrgyz Republic. In 2019, 57%
of newly diagnosed HIV cases among adults were registered as men and 43% as women. An
estimated 3.5% of the total new HIV cases in 2019 were registered among children (Statistical
report of the Republican AIDS Center, January 2020). Sexual contact is the primarily reported route
of HIV transmission (72%), followed by injection drug use (14%), vertical (14%), and unknown (2%)
(Statistical RAC report, January 2020).
The HIV epidemic in the Kyrgyz Republic remains concentrated among key populations (KPs),
including people who inject drugs (PWID), men who have sex with other men (MSM), female sex
workers (FSWs) and their sexual partners. There is also risk of HIV transmission from KPs to the
general population which requires strengthening prevention programs. Despite recent programmatic
investments and implementation by government agencies, non-government organizations and
international society, the number of officially registered HIV cases in the country has increased from
4,819 in 2013 to 9,136 to 2019 (Statistical report of the Republican AIDS Center, January 2020).
Recent studies suggest that people who inject drugs are 24 times more likely to acquire HIV than
adults in the general population; sex workers are 10 times more likely to acquire HIV; (UNAIDS,
2016; Baral et al. The Lancet Infectious Disease, 2013). PWID accounted for almost 14% of new
HIV infections among adults in 2019 despite accounting for just 0.4% of the total country’s
population (Statistical report of the Republican AIDS Center, January 2020). Many KPs do not
access prevention services to lack of availability as well as stigma and discrimination. During 2019,
an estimated 68% of PWID and 66% of MSM were covered by HIV prevention services, however,
these coverage rates are based on official population size estimates that are widely considered to
be low (Program report of the Republican AIDS Center, January 2020) so the actual prevention
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program coverage among these KPs may actually be lower. Policy makers are concerned that
prevention services are not reaching KPs, who are at the highest risk of acquiring and transmitting
HIV.
The country needs substantial support to reduce risk behavior, improve knowledge, and enhance
HIV prevention, care, and treatment. Among the 9,200 estimated PWID (Key Population size
estimation report, Republican AIDS Center, 2018), HIV prevalence ranges from 1.5% to 10.1%
among MSM (Republican AIDS Center, BBS among MSM, 2016). An estimated 14% of total HIV
transmission among adults has occurred from unsafe drug injection (Statistical report of the
Republican AIDS Center, January 2017). HIV is officially recorded as sexually transmitted in 72%
cases, however, there is some concern these infections are linked to other risk behaviors (Statistical
report of the Republican AIDS Center, January 2020). Sexual (heterosexual, homosexual)
transmission as the documented route of transmission has increased from 27% in 2007 to 72% in
2019. The majority of sexually transmitted cases are from male PWID to their sexual partners.
Homosexual route also contributes to the HIV transmission. From 2013 to 2018, HIV infection
among MSM has grown, as a proportion of reported cases from 2.5% to 5.5%.
Even though harm reduction programs, including needle–syringe exchanges, are available in most
locations in the country, program uptake is low. Only 37.9% of the participants of the BBS
implemented among PWID in 2016 reported that they have received an HIV test in the past 12
months and knew their HIV status, whereas this indicator was even lower for MSM – 25.3%
(Republican AIDS Center, BBS among PWID, MSM, 2016). There is low coverage with HIV testing
and antiretroviral therapy, and only 55% of the MSM participants and 59% of the PWID participants
of BBS in 2016 reported use of a condom at the last sexual intercourse (Republican AIDS Center,
BBS among PWID, 2016).
Coverage of medicated assisted therapy (MAT), another evidence-informed intervention to reduce
vulnerability to infectious diseases among PWID, and improve uptake of health and social services,
remains inadequate to reduce HIV transmission in the country. By the end of 2019, MAT was
offered in 24 sites country-wide, and 915 clients of the currently available MAT clinics serve 3.7% of
the estimated number of PWID in the country (Republican Clinical-Narcology Center, January
2020).
Kyrgyzstan is considered hyperendemic for viral hepatitis. Anti-HCV prevalence among the general
population is 2.6% (95%CI 1.7-3.6%) [8]. BBS conducted in 2016 showed 60.9% anti-HCV
prevalence among PWID and 1.6% among MSM. DAA treatment is available for free from state
budget in the Kyrgyz Republic only for PLHIV co-infected with HCV; the cost of the 3-months
treatment course is $250. In 2020, RAC was able to procure DAA for 200 patients. In 2020, RAC
covered 108 HCV-coinfected PLHIV with HCV treatment.
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4 RATIONALE
The Kyrgyzstan HIV epidemic is primarily driven by transmission among people who inject drugs
(PWID), men who have sex with men (MSM), and female sex workers (FSW). These key
populations (KP) tend to be at higher risk of HIV, and many countries across Asia have experienced
escalating epidemics among these groups (UNAIDS, 2013). These population groups are often
hard-to-reach, often because of laws prohibiting the very practices that define these groups.
Intended use of study findings: Regular biological and behavioral surveillance of key populations is
essential in providing an evidence base for the design, planning, implementation and performance
monitoring of targeted HIV and sexually transmitted infections (STIs) programs. Gaining an
understanding of HIV (prevalence, recent infection, viral suppression), HCV and STIs prevalence for
key populations across time enables us to know the scale of an epidemic and how an epidemic may
be changing over time. Similarly, measuring risk-related behavior and changes over time allows
programs to monitor progress, refine programs, and direct resources to where they are most
needed. Likewise, BBS provides the evidence base for setting and revising performance indicators
and targets for programs targeting the various population groups.
Data from a second round of this survey will contribute to evidence-informed design and
enhancements of HIV/AIDS policies and interventions for PWID and MSM in The Kyrgyz Republic.
The survey is intended to strengthen the overall approach to targeting key populations at high risk
for HIV. This will be achieved in part by producing reliable data on the health and social welfare
needs of PWID MSM in The Kyrgyz Republic.
Data from the survey’s formative assessment and mapping phases, as well as the survey itself and
its associated population size estimation methods, will enrich the understanding of the PWID and
MSM population in The Kyrgyz Republic context. This includes information on HIV prevalence, viral
load suppression, utilization of available HIV prevention and treatment programs, and related socioecological factors that affect HIV and STI transmission. Population size estimates will help
stakeholders advocate for the appropriate resources, levels of funding and types of interventions for
PWID and MSM.
See Appendix X (Formative Assessment among MSM—Brief Report), Appendix Y (Formative
Assessment among PWID—Brief Report), Appendix HH (Approved formative assessment protocol),
Appendix II (CDC/CGH formative assessment protocol approval), Appendix JJ (local approval of
formative assessment protocol).
Study locations: Listed below in section 6.1.2 and Table 3.
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5
PURPOSE AND OBJECTIVES
5..1 PURPOSE
The overall purpose of this survey being conducted among MSM and PWID in the Kyrgyz Republic
is to estimate the prevalence of HIV, HCV, syphilis, and risk behavior; estimate viral load
suppression among those with HIV; estimate the population size of MSM and PWD; and assess
progress toward reaching UNAIDS 95-95-95 targets.
5..2 OBJECTIVES
The primary objectives of this BBS and PSE project are:
1) To estimate the prevalence of HIV viral load suppression among HIV- infected MSM and
PWID in selected survey sites.
2) To estimate the prevalence of HIV, HCV and syphilis and associated risk behaviors among
the MSM and PWID population in selected survey sites.
3) To estimate the size of MSM and PWID population in selected survey sites in the Kyrgyz
Republic.
4) To determine the proportion of individuals with recent HIV infection, as evaluated by Rapid
Test for Recent Infection (RTRI), among newly diagnosed HIV-positive persons in participating
health facilities.
5) To monitor key characteristics in the proportion testing recent on the RTRI and/or Recent
Infection Testing Algorithm (RITA):
a. Among newly diagnosed PLHIV by select demographic and HIV risk variables
b. Among proxy population at risk of HIV infection, calculated as the number of clients
testing recent (RTRI or RITA) divided by the number of clients testing HIV negative
plus clients testing recent
6) To estimate access to and uptake of HIV-related services among MSM and PWID in
selected survey sites in the Kyrgyz Republic.
7) Translate surveillance findings into recommendations for policy and program development.
8) Strengthen capacity of the RAC to conduct biobehavioral surveys and population size
estimation using respondent-driven sampling.
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6 METHODOLOGY
6..1 Scope
6..1.1 Populations
The survey populations will be:
•
Men who have sex with other men (MSM), defined as a biological male, aged 18 or older,
who has had insertive or receptive sexual intercourse (oral, anal) with other men at least
once during the last 12 months preceding enrolment in the survey.
People who inject drugs (PWID), defined as persons, aged 18 or older, who have injected
drugs for non-medical purposes within the 60 days preceding enrolment in the survey.
Inclusion criteria
The study population inclusion criteria are outlined in Table 2 below. It is possible that individuals
will fall into more than one category (for instance, participants who were recruited as MSM but
report injecting drugs could be asked to answer additional PWID questions; a man recruited into the
PWID survey who reports having sex with other men could be asked to answer additional MSMspecific questions). Such individuals would be documented as such and would not be required to
complete two separate interviews rather would complete a single interview as per their preferred
designation.
Table 2. Proposed BBS population inclusion criteria.
Population
Inclusion criteria
MSM
•
•
•
•
•
•
•
Biologically male
Practiced oral or anal sex with other men at least once during last 12 months
Age ≥ 18 years old
Resided in survey city/district for the past six months
Speaks Kyrgyz or Russian
Able to provide verbal informed consent for all study procedures
In possession of a valid recruitment coupon
PWID
•
•
•
•
•
•
Injected drugs for non-medical purposes at least once in the last 60 days
Age ≥ 18 years old
Resided in survey city/district for the past six months
Speaks Kyrgyz or Russian
Able to provide verbal informed consent for all study procedures
In possession of a valid recruitment coupon
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
Exclusion criteria
Any person who does not meet the inclusion criteria will be excluded. Any person who meets the
inclusion criteria but who fits any of the following exclusion criteria will not be able to participate in
the study:
•
Participant not able to give informed consent
•
Participant aggressive, violent, or intoxicated, or the data collector feels otherwise unsafe in
administering the questionnaire
•
Participant has already participated in the survey (same population)
6..1.2 Study Locations
The study cities/districts by populations are summarized in Table 3. Further information on these
choices is contained below.
Table 3. Proposed BBS study survey cities/districts by survey groups (confirmed after Formative
Assessment results).
District
MSM
PWID
Bishkek
Yes
Yes
Karabalta
No
Yes
Karasuu
No
Yes
Osh
Yes
Yes
Sokuluk
No
Yes
Tokmok
No
Yes
Rationale for Survey Site Selection
Two (for MSM) and six (for PWID) cities/districts were purposively selected as survey sites as these
areas have the largest concentration of PWID and MSM based on findings from earlier rounds of
surveillance and expert opinion from the Republican AIDS Center, the Republican Narcology Center
and respective NGOs. The list of survey sites was confirmed based on Formative Assessment
results. The survey sites include at least one site in each region of the Kyrgyz Republic.
6..1.3 Biomarkers
Survey participants will be tested for biomarkers of:
•
HIV
o
o
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HIV Infection
Recency of infection
BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
o
Viral Suppression
•
Hepatitis C virus (HCV)
•
Syphilis
6..2 Survey design and sampling methods
The study will utilize a cross-sectional survey design and respondent-driven sampling (RDS).
6..2.1 Respondent-driven sampling (RDS)
Respondent-driven sampling (RDS) (Handcock, Gile, & Mar, 2012; Heckathorn, 1997), a peerdriven, recruitment-chain referral method used to recruit members of hidden population groups, will
be used to sample MSM and PWID in each survey site in the Kyrgyz Republic. The RDS method
starts by choosing ‘seed’ participants who are often well-known and respected individuals within
their communities. The initial seeds participate in the survey process and are then trained to recruit
up to a designated number e.g. three, of their peers using uniquely identified coupons. Recruited
peers enroll in the survey and subsequently recruit their peers, with the process continuing until the
calculated sample size is reached. A primary and secondary compensation system is used to
remunerate participants for their time (primary) and then for successfully recruiting eligible
participants (secondary). Pre-screening to assess eligibility of participants will include asking those
presenting at the interview/study site to describe details about injection drug practices, price of
drugs, and to show their track marks.
RDS is a probability-based sampling method which includes an analysis process to adjust for social
network sizes (number of peers known to participants) and differential recruitment (Heckathorn,
1997) and to provides empirical estimates that approximate a simple random sample. This
advantage over ‘snowball’ and other non-probability sampling methods enables population
inferences to be made about the estimate of interest. However, RDS relies on the population group
being well networked to allow participants to recruit peers and is therefore not suitable for groups
whose members are not socially connected. Formative assessment results informed BBS
investigators about how well networked potential survey participants are in each location; what
proportion of the PWID/MSM peers reside within the boundaries of the same survey site; and what
proportion of their PWID/MSM peers they may have seen within 30 days preceding the formative
assessment. The results of the formative assessment confirmed that RDS is an appropriate
sampling method to use.
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6..3
Sample size calculations
Sample size calculations are based on one of the primary objectives of the survey, i.e., to estimate
the percent of virally suppressed HIV-infected MSM and PWID in each study location. The
investigators calculated target sample sizes (SS) needed for each location based on expected viral
load suppression (VLS). Investigators accepted 70% VLS levels based on a review of program
coverage and discussions with key stakeholder’s vis-a-via survey feasibility. A baseline estimate of
70% VLS was used with a target 95% Confidence Interval 1/2 Width of 20-percentage points (so
VLS would range from 50 to 90%). Percent non-response of 2.0 for viral load testing was assumed.
This implies that 21 HIV-positives are needed prior to accounting for the design effect, based on the
asymptotic binomial sample size formula (see Appendix Y). Adjusting for a design effect of 2.0,
based on evidence in the literature for RDS surveys (Salganik, 2006), 42 HIV-positives are needed.
Please refer to Appendix Y. Sampling based on VLS Among MSM and PWID, the Excel-based
sample size calculator (source: Appendix I-2 of Biobehavioral Survey Guidelines For Populations At
Risk For HIV6) for survey-based viral load suppression, which shows detailed sample size
calculations for each key population by location. For calculating target sample sizes, estimates of
KP HIV prevalence in each study location was derived from previous round of BBS where available.
For sites without previous results, HIV prevalence estimates from sites with similar characteristics
(e.g., size, urbanicity, entertainment venues, transportation routes, etc.) were used. Tables 4 and 5
below summarize results of sample size calculations derived using the sample size calculator.
Table 4. Summary of sample size calculations for MSM, by location.
Sample size needed (number of
Number* of HIV-positives
Assumed HIV
needed to estimate VLS
prevalence
Bishkek
42
0.101
416
Osh
42
0.015
2800
Location
TOTAL
HIV-positives needed/assumed
HIV prevalence)
3216
*Accounting for design effect of 2.0
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Table 5. Summary of sample size calculations for PWID, by location.
Sample size needed
Number* of HIV-positives
Assumed HIV
needed to estimate VLS
prevalence
Bishkek
42
0.191
220
Karabalta
42
0.200
210
Karasuu
42
0.129
326
Osh
42
0.191
220
Sokuluk
42
0.240
175
Tokmok
42
0.095
442
Location
TOTAL
(Number of HIV-positives
needed /HIV prevalence)
1592
*Accounting for design effect of 2.0.
To compare these target sample sizes with a reasonable estimate of the number of key population
members in the catchment area (pool of potential participants from which to sample), we multiplied
the general population of men and women aged 18-64 years in each survey location (vital statistics
census data for 2020) by the estimated percent of the population that engage in the behavior (e.g.,
male-to-male sex or injection of drugs). These percentages were based on generally accepted
thresholds (UNAIDS, CDC) and published estimates for Central Asia. For MSM in non-urban area
we assume 1% of the adult male population practice male-to male sex and for urban areas we used
2%; for areas which may catch participants from urban areas and outskirts we used 1.5%. For
example, if a city had 100,000 men aged 18-64 and an estimated 2% of them were MSM, the
estimated number of MSM in that location would be 2,000 (Table6). Because Bishkek and Osh are
considered urban, we used 2.0% to estimate the possible total number of MSM in both survey
locations.
A systematic review published by Louisa Degenhardt in 2017 estimated a population prevalence of
injection drug use (IDU) in Central Asia among persons aged 15-64 years of 0.63% (0.43%-1.1%
uncertainty interval [UI]). Among women this was 0.16% (0.09%-0.24%) and among men, 1.13%
(0.7%-1.61%). Based on these parameters, we generated an estimate of the possible total number
of PWID in each proposed survey location (Table 7).
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Table 6. Possible total number of MSM aged 18-64 years, based on census data and estimated
proportion of general male population who are MSM, by location, 2020.
Location
General population
men aged 18-64
Example
Bishkek
Osh
100,000
296,109
87,081
Estimated
population
prevalence of MSM
0.02
0.02
0.02
Possible total
number of MSM
2,000
5,922
1,742
Table 7. Possible total number of PWID aged 18-64 years, based on census data and estimated
proportion of general population who are PWID, by location and sex, 2020.
Location
General
population
aged 18-64
Men
Estimated
population
prevalence
of PWID
Possible
number
of PWID
General
population
aged 18-64
Women
Estimated
population
prevalence
of PWID
Possible
number
of PWID
Total
Possible
total
number of
PWID
Bishkek
296,109
0.0113
3346
349,274
0.0016
559
3905
Karabalta
10,652
0.0113
120
13,469
0.0016
22
142
Karasuu
123,025
0.0113
1390
122,884
0.0016
197
1587
Osh
87,081
0.0113
984
97,969
0.0016
157
1141
Sokuluk
55,615
0.0113
628
57,254
0.0016
92
720
Tokmok
16,299
0.0113
184
19,544
0.0016
31
215
The last step in calculating the final target sample size for each survey location was the application
of the finite population correction factor (FPC). This factor is applied to the sample size in a “withoutreplacement” design and is important when sample size is an appreciable proportion (>5%) of the
estimated total population and allows for a smaller sample size as the proportion increases.
Comparison of target sample sizes (Tables 4 and 5) with possible number of key population
members in each survey location (Tables 6 and 7) suggest that use of FPC to adjust sample sizes
is a reasonable approach. FPC calculation is performed using the formula: FPC = ((N-n)/(N-1))1/2.
The FPC-adjusted target sample sizes for MSM are presented in Table 8 and for PWID in Table 9.
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Table 8. FPC-adjusted target sample sizes for MSM.
Possible total number of
MSM (Pop)
5922
Target sample size
(SS) without FPC
416
FPC* adjusted target
sample size (SS)
389
Osh
1742
2800
1074
TOTAL
7664
3216
1463
Location
Bishkek
*FPC = SS/ [1 + {(SS − 1)/Pop}]
Table 9. FPC-adjusted target sample sizes for PWID.
Possible total number of
PWID (Pop)
3905
Target sample size (SS)
without FPC
220
FPC* adjusted
target SS
208
Karabalta
142
210
85
Karasu
1587
326
270
Osh
1141
220
184
Sokuluk
720
175
141
Tokmok
215
442
145
TOTAL
7710
1592
1034
Location
Bishkek
*FPC = SS/ [1 + {(SS − 1)/Pop}]
6..4 Population size estimation
One of the objectives of this survey is to estimate the size of PWID and MSM in each of the survey
locations. The purpose of size estimation is to determine the scale and size of the population of
PWID and MSM in selected locations in the Kyrgyz Republic. Size estimates help policy makers and
program staff understand the scope of the HIV problem, plan appropriate interventions, and allocate
sufficient resources as well as inform various modeling efforts. As population sizes change over
time, particularly in mobile populations, refreshing existing size estimates in the present survey will
aid in understanding these fluctuations and ensure the most recent data is availed to key
stakeholders.
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Because there is no gold standard method for population size estimation (PSE), multiple empirical
methods will be employed to strengthen confidence in the estimates, provide upper and lower
plausibility bounds, and reduce the likelihood that biases of any single method will substantially alter
results.
Multiple size estimation methods are necessary to arrive at an accurate estimate of population size
through triangulation of multiple results. The adequacy of these methods in producing reliable
estimates was assessed and confirmed during the formative assessment.
This protocol proposes a combined approach to produce multiple MSM and PWID population size
estimates embedded within the BBS. The following size estimation methods will be adopted in
consultation with the KP community and stakeholders: service multiplier, 3-source capturerecapture, and successive sampling – as described in the Global HIV Strategic Information Working
Group’s Biobehavioral Survey Guidelines for Populations at Risk for HIV6
(http://www.who.int/hiv/pub/guidelines/biobehavioral-hiv-survey/en/) also known as “The Blue Book.”
6..4.1
Service multipliers
The survey allows for the integration of several related PSE methods, collectively known as
“multiplier methods”. The first part of this multiplier approach gathers de-identified counts of visits by
population members to specific programs or services, such as utilization of HIV Testing Services
(HTS) by the target population at a specific site. The second part of the multiplier will be to inquire in
the BBS survey about prior participation in HTS during a specified period. Based on those who
complete the survey and report participating in HTS, we will be able to estimate the size of the
PWID and MSM population. With reference to the formula presented below, n is the total number of
PWID or MSM who access a given service in a given time period, and p is the proportion of BBS
participants who report accessing the service.
Of note, the program data need to de-duplicate individual contacts and ascertain PWID or MSM
status among their clients for the estimate to be unbiased. During preparations for implementation,
the investigators will convene a meeting to determine which sources of data may be appropriate
and available for size estimation through the multiplier method, including potential sources used in
this survey.
Procedures entail determining the overlap in two independent data sources with the following steps:
1. Obtaining the unduplicated counts of the PWID and MSM population using the below
services or facilities, membership lists, or participating in a research study.
2. Adding questions to the MSM and PWID RDS survey instruments that ask about the use of
specific services or facilities,
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Using these two data sources, the multiplier method provides a population size estimate by the
formula:
•
N=n/p
Where N is the MSM or PWID population size, given by n as the number of the key population using
a particular service in a specified period and p as the proportion of the survey participants who
reported using the particular service during the same period. For example, if an outreach program
reached 1,000 PWID in Bishkek in 2020 and 10% of RDS survey respondents reported meeting one
of the program’s outreach workers in 2020, then there are an estimated 10,000 (1,000 / 0.10) PWID
in Bishkek.
Several multipliers can be collected simultaneously to minimize the potential influence of biases of
any one multiplier and to help produce upper and lower plausible bounds. Of note, the program data
staff need to de-duplicate individual contacts and ascertain MSM and PWID status among their
clients for the estimate to be unbiased. Service multiplier methods work best using records from
service providers that maintain line-listed registers and can distinguish between individuals and
encounters (because one individual may account for several visits or encounters and should only be
included once in the PSE formula).
Potential sources of multipliers include:
a) Programmatic data from non-governmental organizations providing outreach services to
MSM and PWID.
b) Programmatic data counting MSM and PWID for outreach education, VCT, and condom
distribution via government-led HIV prevention services.
c) Programmatic data from HIV prevention needle exchanges for PWID.
d) The register that lists all PWID who have received clinical Narcology services.
6..4.2 3-Source Capture-Recapture
Three-source capture-recapture (3S-CRC) will be another method used to estimate MSM and PWID
population size. MSM and PWID will be “sampled” during three independent captures. Unique
objects will be offered in captures (i.e. rounds) 1 and 2. BBS enrollment will constitute capture 3
(see Figure 1 below and standard operating procedures, appendices KK and LL).
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
Figure 1: Overview of 3S-CRC for Enumerating Population Sizes.
A fixed number of unique objects (e.g., a distinct key chain or bracelet) will be distributed to PWID
and MSM populations in each survey site (Capture 1). The goal will be to distribute twice as many of
the unique objects as the sample size in each city for each capture. Distribution sites, including
locations where PWID/MSM congregate (i.e., streets, bars, clubs, restaurants), and distribution
times was identified during the formative assessment and through consultations with KP
organizations. To ensure adequate recall, the distributed objects will be distinctive and not
something found in the survey sites unless distributed as part of the survey. Selection of the objects
for distribution was determined during formative assessment and through conversations with key
population members and stakeholders. The objects offered in Capture 2 will be different from the
objects offered in Capture 1 to distinguish the two captures from each other. The goal will be to
distribute as many of the unique objects as the sample size in each city for each capture. For
example, if the survey sample size (number of people we want to enroll in the survey) for survey
location in Osh is 200, then we would try to distribute 400 objects for capture 1 and 400 different
objects (several days or a week later) for capture 2.
To reduce dependence between captures, different unique object distributors will be used for each
capture. All distributors will receive training prior to distribution of the unique objects. Training will
include the following: assessment of eligibility prior to giving out unique objects, guidance on what to
say about the unique objects, instructions on how to maintain anonymity and confidentiality,
instructions on how to maintain safety in the field, and instructions on how to complete the
distributor’s log. During this training session, staff and volunteers will sign a confidentiality
agreement.
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Survey investigators will identify 10-30 members (who are not and will not become seeds) of the
respective key populations in each city to serve as volunteer object distributors. The number of
volunteer distributors will depend on the number of objects being distributed in each city. Having
more distributors is ideal. Distributors will record the number of objects distributed and the number
refused in the distributor’s log. In each capture, distributors will give only one object per person and
only to a member of the key population. Each person encountered by distributors will receive only
one unique object each capture and will be instructed to keep the unique object because they may
be asked about it the near future by survey staff. Distributors will wear something distinctive
(perhaps a tee shirt or hat with a unique logo or bracelet) so that they can be recalled by survey
participants.
Distributors will ask KP members sampled during Capture 2 whether they received the object
distributed in Capture 1. The information will be recorded in the distributor’s log. Questions will be
included in the RDS survey instrument that ask participants whether they received a “gift” (without
specifying the object) during a certain time period from a certain individual (e.g., person wearing a
hat with the survey logo) and to identify that object from different photos presented in the tablet.
Those sampled in Capture 3 (the survey) will be asked if they had received either or both objects
distributed in captures 1 and 2.
Captures 1 and 2 will be conducted no more than one week apart. Capture 2 will be conducted no
more than one week before the survey is launched. Population size estimates and credibility
intervals will be derived using a Bayesian nonparametric latent-class model for 3-source capturerecapture. Analysis will be performed using the ‘EpiApps’ shiny app (CDC Atlanta
https://epiapps.com/shiny/app_direct/shinyproxy_popsize_estimation/) developed for the R-software
package for analyzing 3S-CRC data.
6..4.3 Sequential Sampling PSE (SS-PSE)
Successive sampling-population size estimation (SS-PSE) along with network size imputation
allows population size estimates to be made without relying on separate studies or additional data
(unlike network scale-up, multiplier and capture-recapture methods), which may in themselves be
biased. 1 SS-PSE is a relatively new method and a potential alternative to estimate the size of hardto-reach populations. It relies primarily on data collected within the RDS survey (participant’s
1
Johnston LG, McLaughlin KR, El Rhilani H, Latifi A, Toufik A, et al. (2015) Estimating the size of hidden populations using respondentdriven sampling data: case examples from Morocco. Epidemiology (Cambridge, Mass) 26: 846
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
personal network size or degree, recruitment patterns, and date of survey participation). In addition,
it relies upon prior beliefs about the population size.
The statistical methodology for SS-PSE assumes individuals with higher social visibility are more
likely to be recruited earlier in the RDS process. 2 By this logic, fewer high reported degrees in later
waves of RDS recruitment represents a depletion of those population members with higher visibility.
In this case, the sample represent a substantial portion of the population. Notably this assumes
visibility and reported degree are positively associated, that is the size of individual’s personal
network with respect to the target population influences the probability that an individual will be
observed during the RDS process. However, if the reported personal network sizes or degrees
remain approximately constant throughout the recruitment waves, the sample size is likely to
represent a smaller portion of the population. If reported degrees increase across waves, this could
indicate that RDS recruitment is not operating as expected and would serve as a warning when
interpreting the results.
SS-PSE method uses a Bayesian approach2 to estimate the probable size of the target population.
The prior population size estimates used to represent previous knowledge about the target
population, and, if necessary, establish bounds on the population size estimate. The prior estimate,
expressed as a measure of central tendency, is combined with a specific shape of the distribution to
calculate the prior distribution of the population size.
SS-PSE method uses the prior estimate in combination with the specified distribution and
participant’s self-reported network size to calculate the posterior population size estimate. Markov
chain Monte Carlo (MCMC) simulations are used to compute the posterior distribution. MCMC
simulations use a directed random-walk algorithm to sample possible values of the parameter of
interest. 3 While this process of sampling from the parameter space is random, some values will
have a higher probability of being drawn than others, because the Markov chain is sampling from
the more likely regions of the parameter space. The differential probability of sampling from the
parameter space is determined by the information in the data (in this case, the network size) and
the prior estimate for the population size. The entire distribution of the parameter of interest is then
constructed from this (directed) random sampling. Consistently estimating the posterior distribution
can be improved by increasing the MCMC settings, such as the number of samples taken from the
parameter space. Additionally, the burn-in period may also be increased; the burn-in period refers to
2
Handcock MS, Gile KJ, Mar CM (2014) Estimating hidden population size using respondent-driven sampling data. Electronic journal of
statistics 8: 1491.
3
Hamra G, MacLehose R, Richardson D (2013) Markov chain Monte Carlo: an introduction for epidemiologists. International journal of
epidemiology 42: 627-634.
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
the number of samples initially taken to begin the Markov chain, but these samples do not
contribute to the estimation of the posterior distribution. Any measure of central tendency can then
be calculated to summarize the probability distribution of the population size. For this method, we
will follow the full description of the SS-PSE method as described elsewhere.2
6..4.4 Finalization of PSE for national use and global reporting
Data from each of the above methods will be compiled using tables and figures, then presented to
and reviewed with national and local stakeholders. Data will be compared and considered with
programmatic PSE results of the National HIV Program, UNAIDS data for the last year PSE
exercise and the results of the previous BBS survey to explore differences.
The survey team will discuss the results with the RAC and the MOH in the context of the relative
strengths and limitations of each method and the establishment of upper and lower plausibility
bounds. This discussion will culminate in setting PSE figures for national use and global reporting.
This will involve extrapolating the results from survey sites to non-survey sites, in consultation with
statisticians with expertise in extrapolation (e.g. local experience, or from ICAP or CDC HQ), to
derive the national estimates.
6..5 Data collection tools
Questionnaires (Appendices C & D) for each KP for this BBS have been developed based on
standardized behavioral surveys from other settings, incorporating global indicators and referencing
previous behavioral surveys used in the Kyrgyz Republic. The tools will measure key measures to
address study objectives and will comprise questions from the following topic areas: demographics
and knowledge, sexual practices, attitudes, and other behaviors connected with HIV and other STIs,
and access to and uptake of health services. Attention has been paid to standardized questions and
reference periods to ensure comparability of the variables from one period to another and to other
geographies. Note that all relevant national indicators contained in the Global AIDS Monitoring 2020
guidelines will be calculated and reported. The consent forms and the questionnaires were
developed in English and will be translated and back translated into Russian and Kyrgyz by a
certified translator. Translations will be carried out using a contextual approach, where questions
and phrases will be translated according to the meaning rather than a direct word-for-word
translation, including back-translation to English to verify accuracy of translation.
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6..5.1 Pretesting of questionnaire
After translation, the questionnaire will be pretested in two stages. The first will involve liaising with
TWG members to review the questionnaires for content, clarity and appropriateness of question
wording and translation. The second stage will involve pre-testing the questionnaires with members
of the respective communities for which the questionnaires will be administered. Selection of
questionnaire piloting participants will be done in consultation with local stakeholders to get broad
representation of the key population.
Pre-test participants will be asked to comment on any aspect of the questionnaire or how it was
administered that did not work well. These comments will be documented and used to improve the
questionnaires and their administration prior to the survey implementation. Consent for piloting
questionnaires for MSM and PWID will be obtained orally (Appendices AA and BB) and
interviewees will be compensated for their time using mobile ‘top-up’ cards equal to 500 kg soms
(~5.90 USD). Survey staff will record disbursement on logs (Appendices CC and DD) to document
compensation and track expenditures.
6..6 Study procedures
6..6.1 Participant Enrolment & Data collection
The list of survey sites, days of operation, and opening hours was finalized based on results of
formative assessment conducted in potential survey locations (for brief reports of formative
assessment findings see Appendices W and X). MSM and PWID survey participants prefer
separate survey sites (i.e., the location where interviews, specimen collection, and biomarker rapid
testing will occur). Investigators decided to organize separate sites for the two groups based on
formative assessment results. They will also take into consideration the logistical challenges (e.g.,
screening, managing enrollment, crowd size) that collocation and simultaneous implementation of
two separate enrolment sites may present.
A flowchart depicting the data collection process in each study site is contained in Figure 2 and
Figure 3.
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Figure 2. Data collection process flowchart (RDS first visit).
Enrollment
(coupon
validation,
screening,
consent)
Interview
Return of
rapid test
results, posttest
counseling,
referral for
confirmatory
testing,
linkage to
care, as
needed
Pre-test
counseling and
biological
testing for HIV,
HCV and
syphilis, RTRI
if HIV positive
Coupon
explanation,
provision of
coupons,
primary
compensation
Figure 3. Data collection process flowchart (RDS second visit).
Verification screening,
follow-up questions
Secondary compensation for
each eligible recruit who
enrolled in and completed
survey
First visit to the study site (Figure 2)
A standardized participant checklist form (Appendices A or B) will be used to help survey staff
ensure that each participant has completed each step of the process. All staff members who interact
with the participant will write their initials on the checklist at their respective sections to indicate
completion of the task before escorting the participant to the next stage or to the reception area to
await the next task. The checklist is presented either to the survey staff responsible for the next
stage of the survey or to the receptionist. After the participant leaves the office, the coupon manager
will collect, sign, and file the checklist.
The receptionist will greet the candidates (potential survey participants) to ensure they have a
coupon for the survey. The receptionist will prepare a participant checklist and escort the candidate
to the coupon manager who will conduct coupon verification. If the candidate is eligible after the
coupon verification stage, the coupon manager will initial the checklist and present it to the screener
(or receptionist if the screener is occupied), and personally escort the participant to see the
screener (or receptionist).
The screener will assess the candidate’s eligibility to participate in the survey using the criteria in
the eligibility form in the tablet. The screener will be a member of the target population. All the study
staff, including coupon manager, screener, interviewer, and HTC specialist will be trained on how to
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assess mental and physical abilities of the potential participants to take part in the study. If the
candidate meets all the survey inclusion criteria, the screener will initial the checklist and proceed
with obtaining verbal informed consent using the script in Appendices E or F. The coupon manager
or interviewer (depending on availability) will serve as a witness during the process of obtaining the
informed consent and initial the consent form for documentation. When verbal informed consent is
obtained, the screener will initial the checklist and present it to the interviewer (or receptionist if the
interviewer is occupied), and personally escort the participant to see the interviewer (or
receptionist).
The interviewer will administer the survey questionnaire (Appendices C or D), including ask the
participants questions to determine their social network size, a variable required for proper analysis
and weighting of the RDS data. If the participant has successfully completed the interview, the
interviewer will initial the checklist and present it to the HIV Testing and Counselling (HTC)
specialist (or the receptionist if the HTC specialist is occupied), and personally escort the participant
to see the HTC specialist (or receptionist).
The HTC specialist will conduct pre-test counselling; specimen collection; rapid testing for HIV, HCV
and syphilis; return of results; post-test counseling; psychosocial needs assessment, and referral to
the appropriate services. The HTC specialist will also supply participants with HIV prevention
commodities, including needles, syringes, and condoms as applicable. When all of their assigned
procedures have been completed the HCT specialist will initial the checklist and present it to the
coupon manager (or the receptionist if the coupon manager is occupied), and personally escort the
participant to see the coupon manager (or receptionist).
The coupon manager will verify that the participant successfully completed all the procedures
required for participation to be considered valid and will issue primary compensation and record
issuance. The coupon manager will ask the participant if he/she would be willing to recruit his/her
peers to participate in the survey. If the participant agrees, he/she will be issued up to five
recruitment coupons and will be trained on the recruitment process and coupon management. The
number of coupons may be reduced (if recruitment is too fast) or increased (if recruitment is too
slow) based on survey site attendance and recruitment monitoring. In places with low recruitment
(unproductive seeds) or if bottlenecks are identified we may introduce new seeds. The coupon
manager will tell the participant the date (approximately 2 weeks after the first visit) when he/she
can come to pick up compensation for successful recruitment of his/her peers for survey
participation.
If the participant’s HIV test result is positive, the HTC specialist will walk the participant to the
screener for referral to the AIDS center or Family Medicine Center (FMC) for confirmatory
diagnosis/diagnosis verification.
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Second visit to the study site (Figure 3)
During the second visit, participants will be interviewed about their recruitment efforts and will
receive their secondary compensation. Participants will be allowed to attend the second visit before
or after the scheduled appointment date. The survey staff will ask participants about their network
size to validate the information provided during the first visit using the second visit form (Appendix U
or V). Participants will be asked about their success in handing out coupons and information on
those who did not accept coupons. This information may be discussed during meetings with the
primary investigator(s) and used to improve recruitment procedures.
The coupon is essential to link the recruiters to their recruits and is necessary for the analysis of
RDS data. Issuance and receipt of coupons will be monitored using an electronic RDS Coupon
Manager Software (Excel file), identify duplicate recruits, confirm correct ownership of a recruit’s
coupon, and re-establish the participant ID of participants who present themselves at the follow-up
visit without a coupon.
During the second visit, the participant will present to the coupon manager the compensation part of
the recruitment coupon he/she used to recruit peers. Using the survey registration number from that
coupon, the coupon manager will check the RDS Coupon Manager file to determine if the returning
participant is eligible for the secondary compensation based on their successful recruitment of
peers. Successful recruitment requires that referred peers were eligible to participate, enrolled, and
completed their first visit. Depending on the number of successful recruits, secondary compensation
will be issued, and the issuance recorded. If one or more of the participant’s peers have not
redeemed their coupons, the participant may return later for secondary compensation. If any of the
referred peers were deemed ineligible for the survey, the coupons they received were collected,
marked void, and recorded as such in the RDS Coupon Manager file.
6..6.2 Recruitment and screening
Recruitment of seeds and peers
Seeds are the initial PWID or MSM who start the chains of recruitment among their social networks.
Seeds are purposely selected to reflect the diversity of social networks in the location to reach
equilibrium. In theory, the characteristics of the starting seeds are irrelevant if chains progress long
enough. However, in practice, time constraints dictate that seeds should be selected from each of
the major sub-populations identified in the formative assessment (i.e., to avoid “bottlenecks”
between distinct groups or areas). Upon verifying salient sociodemographic and network
characteristics of the PWID and MSM populations in each site (e.g., geographic spread), we will
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develop a “seed tool” in Microsoft Excel that will allow us to strategically select and plant seeds
consistent with achieving as representative a sample as possible. Additionally, we will be monitoring
recruitment weekly to understand the characteristics of the sample and to know when to plant new
seeds (e.g., if the sample seems to be characterized by downtown-central business district (CBD)
located MSM to the exclusion of more suburban-based MSM).
Persons who meet the requirements of a seed (i.e. socioeconomics, large social networks, well
connected peers, trusted and well-liked, communicates well verbally) will be identified through NGO
and key-informant interviews. Contact details of these persons will be obtained. After compiling the
list of potential seeds – the survey coordinator will use contact details provided from the interviews
to contact the potential seed and invite them to participate in the survey as a seed. Seeds will have
to be eligible for and enrolled as survey participants. They will be given coupons and instructions on
peer referral. Seeds will be oriented and motivated at the survey start to promote a feeling of survey
ownership and enthusiasm about the project. NGO partners currently providing services to PWID
and MSM at each site will play an integral role in the identification and recruitment of seed
participants—for example, they are likely to know those whose social and sexual networks are large
and diverse with respect to key demographic and geographic variables, and who are likely to be
successful recruiters of other PWID or MSM.
During implementation of RDS, we will also track crude sample stability on these characteristics.
Additional seeds may be identified and launched as needed, based on the investigators’ weekly and
ongoing monitoring of sample composition and recruitment patterns.
In each survey location, to initiate recruitment process, up to five seeds (initial recruits) will be
recruited from the population groups based on the size and diversity of their social networks and
ability to recruit diverse peers from their social networks. Depending on the rate of recruitment the
investigators may introduce additional seeds. Seeds will be recruited through the organization/s
working with or representing the respective communities. The coupon manager will provide seeds
information on how to recruit their peers. If, during survey implementation, recruitment monitoring
identifies bottlenecks, seeds will be added. Diversity of seeds should include the characteristics
mentioned in the Table 10:
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Table 10. Diversity in selecting seeds.
PWID
Type of drugs injected, if applicable
MSM
Type of MSM (locations where clients are
solicited, locations of providing sex)
Geography (residing different parts of the
Geography (residing different parts of the
city/district)
city/district)
Different sex, education levels, ages,
Different marital statuses, education levels,
ethnicities
ages, ethnicities
Length of time injecting drugs
Selling sex if any (yes/no)
Injection practices (inject alone vs. with others,
location and method of obtaining drugs, etc.)
Degree of engagement with NGO services
High and low risk (use drugs vs. not using
drugs, HIV positive vs. not HIV positive,
unprotected sex vs. protected sex, etc.)
Degree of engagement with NGO services
Seeds, along with subsequent participants, will receive up to five referral coupons (Appendix H is an
example of coupons given to seeds for recruitment; Appendix I is an example of coupons given to
subsequent participants. Each coupon has a unique number (coupon identification number) that will
allow for tracking of recruitment chains (see ‘Coupon Management’ section below). The linkage
between enrolled participants and those they refer is preserved for statistical analysis.
Individuals who come to the survey site will present a valid referral coupon and undergo a screening
process administered by the screener, as described above. This screening will include a standard
set of questions to determine eligibility. MSM and PWID will be asked to describe some details
about sex with other men (for MSM) and injection drug use (for PWID).
Survey ID Codes
The proposed survey will be confidential and anonymous. Non-identifying survey codes will be used
for all data components pertaining to the survey. Multiple codes will be used for different purposes:
a) Coupon ID: Each recruit must present with a coupon in order to enroll in the survey. Each
coupon presented by a recruit will include a unique coupon ID. Coupon IDs will be auto
generated by the electronic biobehavioral survey software (e-BBS) and manually transcribed
on to the paper coupon. All coupon codes will be tracked by the Coupon Manager in the
RDS Coupon Management (RDSCM) Spreadsheet. In addition to their own coupon ID, each
participant will be given three uniquely numbered coupons to refer others to the survey. The
linkage between enrolled participants and those that they refer to the survey will be
preserved for statistical analysis in the RDSCM. The coupon identification number (coupon
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ID) format will be sequential numbering based on the coupon ID number of a seed, coupon
ID number of the recruitment, which may be from 1 to 5, and number of waves of the RDS
chain. For example, the first participant recruited by the third participant from those recruited
by the seed number 2, would have the following coupon ID: 231.
b) Participant ID number (PIN): A PIN will be used to identify participant questionnaire data and
results from rapid tests. PINs will be assigned sequentially after enrolment at each survey
site. All specimens for laboratory testing will be labeled with the PIN. Each PIN will be linked
to a participant’s coupon code, in order to link behavioral and biological data to network
data. The five-digit participant ID number (PIN) is composed of three parts.
Figure 4. Participant ID composition.
•
The first digit indicates the survey group (1 for MSM and 2 for PWID).
•
The second digit indicates the survey site (see Table 11 for the survey site codes).
•
The last three digits indicate the sequential number of study participants at a given
survey site, such that the last three digits of the first respondent’s PIN will be 001, the
second PIN is 002, and so forth.
As an example, the twelfth PWID participant who enrolled in the survey in Bishkek, will have
the PIN 2-1-012. The PIN is assigned to a participant when he/she comes to the study site
and must correspond to the number specified in the BBS Participation Registration Logbook
(Appendix G), electronic questionnaire (appendices C and D), lab (RT) log (Appendix Q),
survey participant registration card (Appendix J), and in the logbook report of the previous
registration as HIV-positive in EHCMS or HIV confirmatory tests results (Appendix K).
c) Unique identification code: The unique identification code (UIC) is an alphanumeric code
used in the Kyrgyz Republic to identify PLHIV and participants of prevention program. The
survey will use this UIC for identification purposes, to prevent duplicate participation and to
link the data with the EHCMS. Participants will be asked to give their UIC for identification at
each follow-up contact or survey visit. The UIC consists of the first two letters of
respondent’s mother’s first name, first two letter of respondent’s father first name, gender
code (1 for male and 2 for female) and the last two digits of year birth. Each part of the UIC
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will be separated by dash. For example, for a participant, whose mother’s first name is Anna
and father’s first name is Boris, who is a male, and born in 1985, the code would be AN-BO1-85.
Coupon Management
A coupon is essential to link the recruiter to their recruits (referred peers) and is necessary for the
analysis of RDS data to adjust for network size and homogeneity within social circles and weight the
data to make inferences about the population. Being in possession of a valid coupon is an eligibility
criterion. Issuance and receipt of coupons will be monitored using an Excel RDS Coupon Manager
spreadsheet. Coupon numbers will be generated within the e-BBS software on the data collection
tablets (see below). Coupon management is used to track recruit processing and coupons, to
identify duplicate recruits, to confirm correct ownership of a recruit’s coupon, and to re-establish the
registration number of participants who present themselves at the follow-up visit without a coupon.
Initially, each participant, including seeds, will be given three coupons each. This number may be
reduced to two and thereafter one as sampling progresses and recruitment needs to be slowed and
stopped as the sample size is reached. The number of coupons given could also increase if
recruitment is too slow. Once the sample size approaches the target, no coupons will be handed out
to remaining participants. No information that identifies the survey with the key population will
appear on the coupons. The coupons were designed based on the recommendations from the
formative assessment among MSM and PWID. The coupon format will be different for primary
respondents/seeds (Appendix H) and for the recruitment and compensation purposes (Appendix I).
For recruitment and compensation, the double-sided coupon will be used (Appendix I), which will
consist of the compensation coupon and recruitment coupon, divided by a detachment line. The
recruiter will give the recruitment part of the coupon to the peer (representative of the key population
group) from his/her social network. The referred peer (recruit) will use the recruitment coupon to
visit the survey site and enrol in the survey. The recruiter will retain the compensation coupon to
collect compensation for their successful recruitment efforts. Both recruitment and compensation
coupons will be in Kyrgyz and Russian.
The recruitment coupon will have information that the potential survey participant will need to enroll
in the survey, including:
•
The survey name:
o
o
•
37
For MSM: Kyrgyzstan Men’s Health Survey.
For PWID: Kyrgyzstan Behavioral Health Study.
Coupon identification number.
BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
•
Survey registration number.
•
Information about compensation for participation in the study.
•
Address of the study site, its operation hours and days as well as contact phone number.
•
Brief information about when and during which period the potential participant can use this
coupon to take part in the study.
•
Expiration date.
The compensation coupon will have information for recruiters to receive secondary compensation
(for recruitment efforts), including:
•
Coupon identification number.
•
Survey registration number.
•
Brief information about secondary compensation, address and operation hours and days of
the place where compensation can be received.
•
Contact phone number to get additional information about compensation.
•
Brief information on when the recruiter may not be eligible for the secondary compensation.
•
Expiration date.
The target group and exact purpose will not be mentioned in the coupons to protect potential
recruits and minimize any possible risks associated with participating in the BBS. A coupon may be
invalid if tampered with, unreadable, or already used. Invalid coupons will be retained and stamped
“VOID”. Valid coupons of candidate participants undergoing screening for eligibility will be retained
and stamped “USED”. Depending on labeling, coupons will be stored in different folders with
respective names: “Void recruitment coupons”, “Void compensation coupons”, “Used recruitment
coupons” and “Used compensation coupons.”
Table 11. Survey site codes.
Code
MSM (1)
PWID (2)
Bishkek
1
+
+
Kara-Balta
2
-
+
Karasuu
3
-
+
Osh
4
+
+
Sokuluk
5
-
+
Tokmok
6
-
+
6 survey sites
Manager spreadsheet.
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6..6.3 Informed consent and withdrawal
Upon recruitment and screening, individuals will be provided with an informed consent form
(Appendices E or F) which will outline the following: study purpose; why the respondents were
selected; risks and benefits; privacy protocol; that respondents may be asked to recruit their peers
to take part in the study; compensation for participation and recruiting peers to participate in the
survey; complaints and feedback process; and consent process. Data will be collected anonymously
to encourage participation and protect participants from any undue risk. To minimize the risk of a
confidentiality breach, the investigators request a waiver of the requirement of written informed
consent as per 45CFR46.117(c) 2. The survey and biomarker screening do not involve the
collection of individually link, identifiable information and present no more than minimal risk of harm
to participants. The informed consent process will be witnessed and documented by trained survey
staff. All potential participants are anticipated to speak either Kyrgyz or Russian, and in most cases
both languages. Eligible candidate participants will be able to read the consent form in Kyrgyz or
Russian or may choose to have it read to them by trained study staff. For illiterate participants, the
consent form will be read in presence of a witness. If the participant prefers, non-survey site staff
chosen by the candidate may serve as a witness during the reading of the informed consent form to
illiterate candidates.
To minimize risk (or perception of risk) to participants, study personnel will thoroughly explain the
purpose and procedures of the study to candidates with an emphasis on the voluntary nature of the
study. Candidates will be given extensive information regarding their role, potential risks and
benefits, and their rights as a survey participant. As above, they will be advised of the purpose of
the survey, and receive details of the relevant survey procedures, potential risks and benefits, and
whom to contact at the Bioethics committee and RAC to report complaints or concerns. They will
also be informed that in addition to the blood collected for biomarker screening, a small amount of
that specimen may be stored and used for other future unspecified testing to help provide
information to the RAC that may be used to improve the health of people in Kyrgyzstan, including
their community. Participants will be informed that participation is confidential and voluntary and that
they can withdraw from participation at any time without giving an explanation and can always
refuse to answer specific questions during the interview. After all questions have been answered by
the interviewer, candidate participants will be asked to provide oral consent to participate in the
study, which includes completion of the questionnaire and provision of a blood specimen for testing,
and optionally, storage and future testing of additionally collected blood specimens. If the candidate
chooses not to participate in the questionnaire or biological testing, the person obtaining informed
consent will hand the checklist to the coupon manager, who will enter these data in the BBS
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participation rejection and criteria ineligibility logbook (Appendix L), indicating the reason why the
participant did not participate in the survey.
Participants must also agree to receive the results of their HIV test. If they do not agree to receive
the results of the test, they will not be tested and therefore will not be allowed to enroll in the survey.
Completion of the interview and biomarker testing is required to receive primary compensation and
coupons to subsequently recruit peers. Participants may withdraw from the study at any time during
the first visit and at any later date. The informed consent will provide detailed contact information to
participants on whom to contact if they decide to withdraw later.
There is a small likelihood the study may identify minor MSM or PWID who are less than 18 years
old. If this occurs, they will not be enrolled but provided MSM and PWID referrals to the NGO
“Kyrgyz Indigo” or NGO “Anti-SPID” or their affiliated NGOs in the survey sites who offer counselling
for MSM, STIs screening, and social support and PWID referrals to narcology services. A module
on how to complete these referrals will be included in the mandatory study personnel training. A
copy of the completed referral forms (Appendix M Referral form for MSM, who are less than 18
years old and Appendix M1 Referral from for PWID, who are less than 18 years old) will be retained
with the other study materials for a period of 1 year following the completion of the study and then
destroyed.
Special considerations apply to candidates under 18 years of age who state being or having been:
1) engaged in sex work; 2) trafficked; or 3) subjected to violence.
•
Referral criteria. Such participants will be referred for support services (see table 12 below
under service provision) regardless of their eligibility for survey participation and, therefore, also
includes children encountered in screening but not eligible to enroll.
•
Host country requirements. No additional reporting is mandated by The Kyrgyz Republic
requirements.
•
Staff training. Survey staff who may encounter these individuals will be trained and
knowledgeable of the need to make referrals for such children identified as engaged in sex
work, trafficked, or being victims of violence. SOPs that guide staff for spotting such individuals
and referring them will be developed shortly after approval of this protocol.
•
Emergency response plan. For individuals indicating to staff that she/he/they is in imminent
danger, internal procedures and points of contacts are in place for an immediate response plan
such that a service provider can reach such participants in a minimal amount of time.
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
•
Service provision. The following service providers were contacted, were found to meet local
standards for social sensitivity and technical capacity to deliver these services and have agreed
to see such participants.
Table 12. List of Support Service Providers.
Agency
Address and Phone no.
Days open
Services offered
Violence against children
Republican
Narcology
Center (RNC)
3, Suyerkolova str., Bishkek, the Kyrgyz
Republic
Monday Friday
NGO “Kyrgyz
Indigo”
513, Frunze str., the Kyrgyz Republic
Monday Friday
Elvira Telek, Phone: +996 777 548 005
Elena Tkacheva, Phone: +996 555 900 698
Sexual violence,
psychosocial support, legal
assistance
Nestan Ismailova, Phone: +996 772 252 628
Documentation for such referrals include date of referral, age of participant, type of referral, and
referral agency. No identifiable information will be included. This documentation and other survey
records will be retained for a minimum of one year and up to five years.
6..6.4 Compensation
The participants who successfully completed the survey, biomarker testing, and receipt of their
results, will receive in-kind compensation (primary compensation) which will appropriately
compensate their time, transport and other costs associated with participation. Those respondents,
who will recruit their peers to take part in the survey, will also be eligible for in- kind secondary
compensation for successful recruitment of their peers as described above.
The formative assessment preceding the BBS took place in fall 2020 among PWID and MSM and
informed that PWID and MSM would prefer to receive as a primary and a secondary compensation
will consist of ‘top-up’ phone cards for talk and data. The actual amount of compensation will be
large enough to be considered fair compensation for participants time and effort but not too large to
be considered coercive or to attract money-making schemes. MSM and PWID seeds and
subsequent participants recruited through RDS successfully completed both interview and testing,
will receive primary compensation valued at 6.25 USD. The cost of the compensation, to be given
as secondary compensation to those who will recruit their peers to take part in the study, will be
3.75 USD for each successfully recruited peer.
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6..6.5 Questionnaire administration
The questionnaire instruments will be administered by the designated study interviewer using
electronic tablets. Based on our experience of using electronic tablets successfully in pilot sites in
the 2016 BBS and in full scale in several countries, and is consistent with literature (Jaspan et al.,
2007). These electronic devices provide several advantages over paper and pencil questionnaires,
including: ease and cost of transportation, data management and security from collection and field
transmission, improved data quality by reducing potential data-entry errors, enabling interim and
real-time data analysis and RDS recruitment monitoring, reducing the duration of the questionnaire
through automatic skip patterns, and increasing the sense of participant confidentiality and
anonymity.
This software ensures that participants will not be asked questions that contradict prior answers
unless they are asked deliberately to validate the accuracy of responses. If tablets are used in study
sites without an available power source, tablets will be recharged overnight, and external battery
packs will be available if required. A limited number of hard copy versions of the questionnaire will
be available as a backup in the unlikely event that a tablet is lost, stolen or malfunctions. Each hard
copy version will reflect the electronic version and will contain easy-to-follow detail of all the routing
to assist in interviewer administration.
The survey data management system consists of two components – a web-based system housed
on a server and a mobile application for data collection that could be run onto tablets in the offline
mode.
Trained field-based staff will be responsible for entering survey data into the tablets from their
respective sites that will be transmitted via the internet to the central study database immediately
after completing interview in case the internet is available at the survey site. If the internet is not
available, the survey data could be transmitted later but on the same day at the place with access to
the internet. All the tablets will be encrypted and password-protected. Access to the application onto
the tablet will be granted by the data manager to trained staff responsible for interviews. The
database restricts access by user ensuring that each site only has access to their site’s data.
Access to the database for data entry, query resolution, and reporting is controlled by the Data
Manager and tracked by the system. Survey personnel requiring access to the database will be
required to complete training prior to receiving the necessary username and password. The interim
and final analytical datasets will be stored on password-protected, encrypted computers housed at
the RAC with technical support provided by CDC and ICAP. Scheduled backups of the system will
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
be performed automatically daily. Data will be validated on entry, using range and consistency
checks.
Quality control procedures will include review of survey questionnaires for completion and
correctness. Logical data and completeness/correctness checks will also be performed on the data
and resolved during the interview. In addition to system checks, the data are also routinely reviewed
by data management and statistics staff for continuity and longitudinal integrity. The survey will be
monitored by internal monitors.
Any paper-based forms will be entered (electronically transformed) daily at the survey office by the
site coordinator, checked by another member of survey staff, and the corresponding file will be
uploaded to the local data warehouse. This will be done along with all other electronic surveys for
the day and uploaded to a private folder on a secure (encrypted) server made available to the data
manager. Any paper-based form will be kept in a secure locked cabinet at the survey office and
brought to the central survey office by way of secure courier service at the end of the survey. Forms
will not contain identifiable information, only unique survey ID numbers as described above.
Continuous quality checks will be performed throughout the survey to assure data quality. These
include programming error checks within the questionnaire and other databases (coupon manager,
testing database, etc.), daily monitoring of participant IDs to ensure that code numbers are recorded
properly for each participant, and weekly monitoring of key indicators. Merging of data sources (i.e.,
the laboratory and survey responses) will be conducted under the supervision of the investigators
and lead data manager. All databases will be encrypted and password protected.
6..6.6 Pre- and post-test counselling
Pre-test counselling
After completing the questionnaire, participants will see an HTC specialist to discuss the rationale
and value of HIV, HCV, recency testing and syphilis testing as well as the process involved at the
study site, what it might mean for them as well as implications of testing. No blood specimens will
be collected without the HTC specialist providing pre-test counselling. However, consent for testing
will have already been obtained during the informed consent procedure. The HTC specialist will
review the participant checklist to ensure that consent has been obtained. HTC specialists will
answer any participant questions regarding testing and reinforce the non-invasiveness, speed, and
benefits of undergoing the testing, as well as testing confidentiality (see Appendix N for guidance on
pre- and post-test counselling).
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Return of results and post-test counselling
During post -counseling, safe sex and other health promotion messages will be reinforced by the
HTC specialist. Since this type of education can influence participant responses to sexual behavior
questions (social desirability bias), the behavioral questionnaire will always be administered before
counseling. No matter what the test result will be, the participant will receive it both orally and in
writing along with health-related messages (Appendices EE – script for HIV test results, FF- for
HCV test results and GG – for returning syphilis test results).
Additional testing for viral load suppression (VLS) will be done for participants found to be HIV
infected at the local AIDS Center/FMC regardless of the date of last VL testing in case if participant
already on ART. All participants will receive their VL test result at the local AIDS Center/FMC (see
Linkage section below for a full description of VL testing and return of results) The HTC specialist
will provide tailored counselling to those with HIV-positive test results to respond to questions or
distress. Emphasis will be given to providing empathetic counseling that emphasizes that the
infections are treatable, provision of information about treatment options, and immediate referral to
appropriate services.
Participants will be escorted and/or electronic HIV case registration look-up to confirm previously
diagnosed and registered HIV cases.
Participants with a positive HIV test as well as those already aware of their HIV-positive status will
be escorted by an NGO representative to the local AIDS Center/FMC for confirmation of HIV result
and viral load testing (See Linkage section for details). The AIDS Center will provide a weekly line
paper listing (Appendix K) of HIV-positive participants by PIN and UIC, indicating if the infection was
previously registered in the Electronic HIV Case Management System (EHCMS); and if not, the
confirmatory HIV test results per the national HIV diagnostic algorithm. Confirmation result will be
ready to inform the participant the same day if blood is collected in the morning, and the next day if
blood is collected in the afternoon. If blood is collected on Friday afternoon, the result will be
available the following Monday. Based on these test results, a final determination of HIV status will
be used for the BBS HIV testing result. The confirmatory test result and post-test counselling will be
provided by AIDS center/FMC personnel. No patient-level identifiable data will be accessed by BBS
study staff or included within BBS study records. In the same form (Appendix K), the AIDS Center
will also indicate whether HIV-positive BBS participants (both previously known and newly identified
cases) were previously or newly enrolled (column 8 of Appendix K) on antiretroviral therapy (ART),
if will provide the reason why if they were not enrolled (column 9 of Appendix K).
For positive HCV results, participants will receive post-test counselling and direct referral to HCV
treatment services using referral coupon with no identifying information (Appendix O). Direct referral
will occur only with full consent from the participant. Participants will not be required to provide
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
identifying details to community support group/s and/or treatment service providers, though they
may opt to do so for purposes of counselling and treatment follow-up. In case if participant is also
positive for HIV, there is possibility to link this person to free HCV treatment if he meets eligibility
criteria (stable PLHIV, adherence to ART).
For positive syphilis results, participants will receive post-test counselling about the importance of
seeking immediate treatment and direct referral to free syphilis treatment services using referral
coupon with no identifying information (Appendix P). Direct referral will occur only with full consent
from the participant. Participants will not be required to provide identifying details to community
support group/s and/or treatment service providers, though will be offered to do for purposes of
counselling and treatment follow-up.
6..6.7 Testing procedures
Testing procedures will be implemented in-line with national testing algorithms and international
standards. The study team has worked to avoid the need for more invasive procedures such as full
blood-draw on testing sites and instead will utilize finger prick blood samples, to conduct rapid tests
for HIV, HCV, RTRI and syphilis; for HIV viral load testing venous blood specimens will be collected
in AIDS centers/FMC; for anti-HCV positives venous blood specimens will be collected in AIDS
centers/FMCs for RNA HCV testing. BBS Biomarker Testing Flowchart described in Appendix Z
(Excel spreadsheet).
Testing sites and staff
A strong emphasis will be placed on ensuring testing sites and staff make participants feel welcome
and respected, reduce discomfort, and maintain confidentiality. The site will be laid out to ensure
confidentiality and reduce discomfort, for instance by ensuring testing occurs in a private room. All
study staff, including the HTC specialist, will be trained, and monitored on issues including stigma
and discrimination, ethics of research with affected communities, confidentiality and privacy.
Participant identification
Each participant’s survey ID will be used to anonymously link laboratory test results to their
behavioral questionnaire data. As described elsewhere, all data including biological data will be
anonymized to protect participants’ identities and participation will be voluntary.
Serological testing procedures
A table of all tests, where they are performed, in which sequence, and on which specimens is
provided in Appendix Z.
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
HIV and Viral Load Testing
Serological testing for HIV will follow national serology laboratory standard operating procedures
(SOPs) in Kyrgyzstan. All rapid tests will be conducted using aliquots from whole blood specimen
collected from finger prick into a single microtainer tube (500 uL) at the study site after completion of
standard of care pre-test counselling using the Kyrgyzstan national HIV testing algorithm. Determine
HIV-1/2 (Abbott Diagnostic Medical Co. Ltd, Japan) rapid test will be used as the first-line screening
test. The HTC specialist will record the result of the rapid test in the participant checklist and in the
BBS rapid testing log (Appendix Q) using the survey PIN and UIC as identification. Non-reactive
results will be considered negative.
If a participant’s HIV test is positive at the survey site, the participant will be issued a referral coupon
(Appendix R) and a guided referral (see above) to visit the local AIDS Center/FMC for confirmation
testing as per national guidelines. The referral coupon is needed to track referrals to the AIDS
Center/FMC. The coupon will be double-sided coupon, two parts of which will be divided by a
detachment line. One part will be given to the participants to bring to AIDS Center/FMC testing
facility. Another part will be retained by the survey site HTC specialist and will be used to track
whether AIDS Center lab returned results for all the referred clients. The referral coupon will have
no identifying information. The referral will be tracked using the PINs and the UICs. Participants
whose survey-site HIV test was positive will be escorted with assistance from a community-based
partner to the AIDS Center/FMC for either confirmatory HIV testing or confirmation of previous HIV
case registration within the Electronic HIV Case Management System (EHCMS). Those not
registered in EHCMS will need to have their survey-site HIV screening test confirmed per the
standard-of-care diagnostic algorithm in Kyrgyzstan. The national HIV standard-of-care confirmatory
diagnostic algorithm is two consecutive confirmatory HIV diagnostic tests differing from each other
and from the screening test (an EIA followed by a more specific RDT) (The national HIV standardof-care diagnostic algorithm, Figure 5). Participation will be considered complete and eligible for
primary compensation when participants with a positive HIV screening test at the survey site receive
post-test counselling and referral to AIDS Center/FMC regardless of his decision to visit or not the
AIDS center/FMC to check if they are registered as HIV+ or to confirm their diagnosis.
The local AIDS Center testing facility will provide the BBS HTC specialist a line listing (Appendix K)
of results by PIN and UIC indicating if the reactive result is already registered in EHCMS HIV case
or, if not, the results of the confirmatory testing using the national algorithm.
Among those who screen HIV positive either their diagnosis confirmed in EHCMS or they start the
diagnostic algorithm (Appendix T), the survey will also collect data on patient viral load regardless of
history of previous VL testing (Appendix K).
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
Figure 5. The national HIV standard-of-care diagnostic algorithm.
Whole blood will be collected by the AIDS center/FMC phlebotomist to the plastic, 5-ml-drawvolume, Vacutainer Plasma Preparation Tubes (PPT) with a Hemogard closure containing spraydried K2 EDTA and a separator gel. Within an hour of collection, the PPT tubes will be centrifuged at
1,100 × g for 10 minutes and plasma separated from venous whole blood will be stored at 4°C in
the lab refrigerator in the local AIDS center. The VL test will be run on plasma samples within 72
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
hours of phlebotomy. For the HIV viral load testing the GeneXpert testing platforms (Cepheid, USA)
will be used together with Cepheid Xpert HIV-1 VL assay. Samples will be analyzed according to
manufacture instructions and standard internal quality control procedure are currently implemented
as part of routine laboratory procedures. Quantitative results will be recorded in the EHCMS to be
returned to the patient at their next clinical visit as well as entered into Appendix K (Previous
registration as HIV positive in EHCMS or HIV confirmatory tests and viral load results report and
enrollment in ART(to be completed by the AIDS Center)).
Syphilis
Syphilis rapid testing on consenting participants will be conducted using an aliquot from the same
finger stick whole blood specimen collected into a single microtainer tube (500 uL) for all rapid tests
at the study site after completion of standard of care pre-test counselling. SD BIOLINE HIV/Syphilis
Duo (Abbott Diagnostics Korea Inc., Korea) rapid test kit will be used. The lab specialist will record
the syphilis test result in the participant checklist and in the BBS rapid testing log (Appendix Q)
using the PIN and UIC as identification. All participants will receive results and post-test counselling
regardless of the biomarker status. Non-reactive syphilis test results will be considered negative.
Reactive results for rapid syphilis tests will be considered positive for presence of antibodies to
Treponema Pallidum in whole blood, serum, or plasma samples, and respondents will be referred to
free specialized care and treatment. With the support from GFATM, there is a network of STIs
physicians providing free STI counseling, diagnosis, and treatment to key populations following
national guidelines. If a participant has syphilis, he/she will get referral coupon (Appendix P) and
with this coupon they will be treated by an STI physician.
Hepatitis C
Hepatitis C rapid testing will be performed at the survey site using an aliquot from the same finger
stick whole blood specimen collected into a single microtainer tube (500 uL) for all rapid testings
after completion of standard-of-care pre-test counselling. Rapid HCV antibody (anti-HCV) screening
will be conducted using SD BIOLINE HCV (Abbott Diagnostics Korea Inc., Korea) rapid test kit, and
those persons with reactive anti-HCV screening tests will be referred to the AIDS center or FMC to
have blood drawn for confirmatory testing (see below). The HTC specialist will record the HCV test
result in the participant checklist and in the BBS rapid testing log (Appendix Q) using the PIN and
UIC as identification. All participants regardless of test result will receive post-test counselling. Nonreactive anti-HCV results will be considered negative. Reactive results for anti-HCV tests indicate
that the participant will need a second test to determine if they have HCV infection, participant will
be given a referral coupon to infection disease specialist/hepatologist (Appendix O) and the HTC
specialist will walk the participant to the screener for referral to the AIDS center/FMC for venous
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
blood sample collection. The collected blood sample will be used for confirmatory PCR testing at the
RAC to detect HCV RNA, which distinguishes those with current infection from those whose
infection has resolved. Testing done on GeneXpert platform using Xpert HCV Viral Load tests
(Cepheid, USA)). Although it is quantitative test it is approved for and commonly used as a
qualitative test to detect HCV infection (see
https://www.who.int/diagnostics_laboratoy/evaluations/pqlist/hcv/170404_final_pg_report_pqdx_0260-070-00.pdf?ua=1).
HIV Recency Testing
An HIV recency test will be performed on all HIV-positive specimens. Recency testing will be
conducted on site using an aliquot from the same finger stick whole blood specimen collected into a
single microtainer tube (500 uL) for all rapid tests. Recency testing is used primarily for surveillance
and not individual-level results. Test results will not be returned to participant. Participants will be
informed that the rapid test will be conducted to test for recent infection. Recognizing that an
individual has a right to know test results about themselves, individual test results of approved HIVrelated tests are typically returned. Because the HIV rapid test for recent infection is currently under
evaluation, not yet pre-qualified by the World Health Organization, and results will be used for
surveillance purposes only, the survey will not return the results of recency testing. The proportion
of individuals with recent HIV infection will be calculated among those participants confirmed as
newly diagnosed HIV-positive.
HIV recency is an important estimate in tracking the recent spread of HIV and in identifying specific
areas where more infections are currently being acquired to inform HIV prevention and control
strategies. For this reason, specimens from all HIV+ participants will be subjected to the Asanté™
HIV-1 Rapid Recency™ Assay (Sedia Biosciences Corporation, USA), an experimental point-ofcare (POC) rapid test, which is CDC approved, used to differentiate recent from long-term HIV-1
infections in combination with viral load testing (Image 1). The HIV recency rapid test will be used
following counselling and consent process.
Image 1. Rapid Test for Recent Infection Illustration.
Long-term infection
Recent infection
Recency status unknown
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
According to CDC recommended Recent Infection Testing Algorithm (RITA, Figure 6), participants
will be classified as having a recent infection if the result of the rapid test indicates recent infection
and VL ≥ 1000 copies/ml. Those identified by the rapid test as recent infection and with a VL <1000
copies/mL may represent elite controllers or individuals on ART and will be classified as long-term
infections. Results will be registered in the BBS rapid testing log (Appendix Q) and HIV+ registration
log (Appendix K).
Figure 6. Interpretation of a Recent Infection Testing Algorithm (RITA) Using a POC Test for
Recent Infection and Viral Load Testing.
HIV+
Test for Recent Infection
[Recency status: preliminary
classification Results not shared]
Viral load
[Recency status: final classification
Results not shared]
Test RECENT
Test NONRECENT
VL ≥1000
copies/mL
VL <1000
copies/mL
RITA RECENT
infection
LONG-TERM
infection
Testing quality assurance
Quality control will strictly be maintained throughout the process of the collection of the specimen,
handling and testing stages. All test devices will be used according to manufacturer’s specifications
and undertaken by trained laboratory staff with regular onsite supervision, with all test kits stored in
temperature-controlled spaces prior to use.
In case of HIV rapid testing all newly positive participants will be offered two rounds of confirmatory
testing (in accordance with the national HIV diagnostic testing algorithm) and HIV VL testing. These
additional rounds of confirmatory testing with different test systems and VL testing using new whole
blood samples collected additionally will serve as a quality assurance.
Ten percent randomly identified (every tenth) of all non-reactive participants will be selected for
quality assurance testing. HTC specialist will make a second finger prick blood collection and use
the new blood specimen with another different HIV rapid test - SD BIOLINE HIV 1/2, 3.0 (Abbott
Diagnostics Korea Inc., Korea). Discordance between the quality assurance testing and the screen
rapid testing results above 2% threshold will trigger an investigation into testing procedures. In case
of any of primarily non-reactive participant produces reactive result after QA testing this participant
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should be accepted as a primarily reactive and follow the same algorithm as defined for all primarily
positives including reactive result confirmation according to the national HIV testing algorithm, HIV
recency testing, HIV VL testing and linked to treatment.
Waste management
All laboratory waste coming from HIV, HCV and Syphilis testing and sample collection, such as
gloves, test devices, capillary tube, antiseptic wipes, sterile gauze pad will be collected, stored and
disposed as per nationally approved infectious waste disposal guidance.
Management and storage of specimens
Participants will be informed during the informed consent process that further tests may be
conducted on the samples and will be asked for their consent to store the specimens for potential
future use. We anticipate long-term storage of at least five years. Specimens collected from the
survey will be owned by the Government of Kyrgyzstan and stored until all survey procedures
described in this protocol are complete. Any future use of specimens beyond the procedures
described in this protocol will require a protocol amendment, review, and written approval by the coprincipal investigators and the ethics committees, which approved this protocol. Participants are
informed during the consent process that it will not be possible to withdraw stored specimens at a
later date.
Results
As described above, test results will be recorded into the participant checklist and transcribed to the
BBS database using a tablet device by the site testing staff. HIV, HCV, and Syphilis rapid test
results will be available on the day of testing from the HTC specialist.
6..7 Linkage to Services
During interviews within formative assessment, KP informants expressed preference for having
survey sites work in the afternoon until late evening. For this reason, RAC will establish agreement
with AIDS centers/FMCs to extend working hours for the survey period until 19h (7pm).
An NGO representative will escort participants with a positive HIV rapid test to the AIDS center/FMC
with a referral form. The referral form will include the PIN and UIC for the survey staff to link key
data collected at the AIDS center/FMC with the rest of the survey data for analysis.
1. If participants were already aware of their HIV status prior to the survey, medical staff
(doctor) of AIDS Center/FMC will verify that the person is registered in EHCMS. Those not
registered will be entered in EHCMS. Then, the medical staff will verify treatment status:
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
i.
If the participant had never initiated ART, comprehensive counseling will be provided
for same day ART initiation.
j.
If the participant is currently on ART, no additional action will be needed.
k. If the participant had discontinued ART, comprehensive counseling will be conducted
to reinitiate ART the same day.
2. If participants were newly diagnosed (i.e., received a positive HIV rapid test at the survey
site), medical staff (doctor or nurse) in AIDS Center/FMC will perform confirmatory HIV
testing according to national HIV testing algorithm. Confirmation will be performed the same
day if participant will show up in the HCF morning time, in case if afternoon result will be
available next day and if confirmatory test will be done Friday afternoon result will be
available on Monday next week.
a) If the participant has a confirmatory HIV test result, comprehensive counselling will be
provided for same day ART initiation and they will be registered in EHCMS.
b) If confirmatory test result is uncertain, participant will be invited to come back to the AIDS
Center/FMC in 2 weeks for an additional confirmatory test. If confirmatory test is
negative, result will be recorded, post-counselling will be performed, and the participant
will be referred to prevention services.
All HIV-positive participants, regardless of whether HIV infection was newly diagnosed or EHCMS
registry was verified, will be tested for VL at that visit. Venous blood will be collected at the day of
referral at the AIDS Center/FMC. Testing will be performed within local schedule. Result will be
returned by healthcare staff during next appointment visit.
All results (HIV status verification, HIV confirmation result, ART regimen, and VL test results) will be
reported back to survey site using PINs and UICs on paper. No PII information will be available to
survey team.
All HCV positive in rapid test post-counselled participants will receive referral coupon and will be
escorted to AIDS Center/FMC for blood collection. Further samples will be sent to National Ref Lab
for PCR testing. Participants will be asked to call back AIDS Center/FMC after certain time to know
test results.
Real-time monitoring of linkage rates will be conducted; and if survey team identifies any problems
with linkage to treatment, survey procedures will be revisited to improve linkage rates.
We will seek collaboration with health care providers willing to accept these referral letters and
provide further care and treatment as necessary to key populations. Health care providers will store
the referral forms from the survey and include on the form the date a survey participant accesses
treatment for the first time to be able to document linkage to care. Survey staff will visit the provider
periodically to pick up the forms and check against the testing database. This will occur from the
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start of the survey to two months after the end of the survey. Participants will be able to seek
treatment at any time, but referral facilities will track the arrival of survey participants only until the
end of data collection.
Participants with a reactive syphilis test will be referred for treatment to STI doctor at a nearby
health facility. The healthcare worker will ask any female PWID participant whether she is pregnant
before administering any treatment.
6..8 Confidentiality and anonymity
As with all studies involving participant specific data, there is a slight risk of loss of privacy for study
participants. In order to minimize this, all study staff will be trained on confidentiality procedures and
will sign a confidentiality agreement (Appendix S). No identifying information will be collected nor
linked with data. Data management procedures ensuring safety of collected data are outlined in the
Data management section. Additionally, particular care will be taken to select the study sites so that
eavesdropping and speculation by outsiders is minimized and confidentiality is ensured.
6..8.1 Complaints
Participants will be provided with an informed consent form (Appendices E and F) which will advise
them to direct any complaints to the National Bioethics Committee of Kyrgyzstan. Contact
information of the in-country Research Coordinator will also be provided on the Participant
Information Statement. If complaints are made directly to data collectors, data collectors will be
trained to document complaints and report all complaints promptly to the Survey Coordinator who
will communicate them to Principal Investigators for any necessary action.
6..8.2 Field staff security and safety
In all settings, data will be collected in a way that maximizes privacy, while also ensuring adherence
to risk mitigation measures for COVID-19.
For the safety of survey staff and participants, COVID mitigation efforts will be in place as outlined in
the SOP presented in Appendix MM: BBS – SOP – SARS-cOv-2 Universal Precautions. The SOP
may be adapted in adherence to any revisions of US CDC and Government of Kyrgyz Republic
guidelines. All participants will be screened for symptoms of COVID-19 and their temperatures
taken prior to screening and enrollment. Symptomatic participants e.g. temperature >37.5C, will be
immediately referred to the in-country health facility for testing and diagnosis as per national
guidelines. Information collected related to these symptoms will not be used for survey purposes but
as part of the national public health response mechanism for COVID-19.
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Participants will not be excluded from participation if they report COVID-19-related symptoms, but
they can only return for enrolment after being non-symptomatic for at least two days. Additional PPE
and mitigation measures will be taken, as per country guidelines and study SOPs (Appendix MM).
While the project team does not foresee that this project will put data collectors in any contexts with
significantly heightened security and safety risks, precautions will be made to minimize any
possibility of such risks. Data collection will occur in a secure building with multiple researchers
onsite. Any injuries, accidents and incidents will be logged and assessed by the Survey
Coordinator, which may include a reassessment of field procedures if warranted.
6..9 Field staff recruitment and training
6..9.1 Recruitment
Staff qualifications and responsibilities are outlined in the matrix below (Table 13). To meet the
needs of the study, data collectors will be a mix of qualified researchers and peers (i.e. members of
the hidden populations covered by the study) with appropriate research skills. Job advertisements
for data collectors will be placed through appropriate channels (e.g. at university public health
schools; NGOs working with key population groups, etc.). Key informants (e.g. management of
NGOs working with key population groups) may provide recommendations as to candidates with
appropriate skills and work interest. All study staff will receive comprehensive training on study
procedures, ethics, stigma and discrimination sensitization, and other topics as applicable for their
role.
Table 13. Study team members, required qualifications and responsibilities.
Title
Qualifications
Responsibilities
Study coordinator (1)
•
Masters of Public Health or
Epidemiology
•
At least 3-5 years’ experience
in research and related study
involving RDS is an added
advantage
•
•
•
•
Good management skills and
attention to details
•
Fluent in Kyrgyz and Russian
•
•
•
•
•
54
Assist in survey preparation
Liaise with Principal Investigators
Oversee day-to-day adherence with
study protocol
Supervise site supervisors
Monitor recruitment and sampling
for homophily, equilibrium, and other
characteristics of recruitment and
participants
Monitor data quality, completeness,
and initiate any corrective action
required
Study
Recommend decreases in coupon
distribution and end of recruitment
BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
Title
Qualifications
Responsibilities
Site supervisors (8)
•
A certified degree
•
•
Previous experience in work
that covers sensitive topics
•
•
Fluent in Russian and Kyrgyz
•
•
•
•
Diploma certificate
Previous experience in work
that covers sensitive topics
Fluent in Russian and Kyrgyz
•
•
Receptionists/screeners
(16)
•
•
•
•
Interviewers (16)
HTC specialists (8)
•
•
•
•
•
•
Diploma certificate
Previous experience as
interviewers in work that covers
sensitive topics
Fluent in Russian and Kyrgyz
Diploma certificate
Fluent in Russian and Kyrgyz
Certified in Kyrgyzstan to
provide HTC and STI
testing/screening and
treatment
•
•
•
•
•
•
•
•
Coupon and data
managers (8, depending
on number of sites)
•
•
•
•
Diploma certificate
Experience with information
technology
Previous experience as
interviewers in work that covers
sensitive topics
Fluent in Russian or Kyrgyz
•
•
•
•
•
•
•
•
55
Oversee day-to-day activities of
study site
Ensure adherence with the study
protocol
Supervise study site personnel
Ensure data handling according to
the protocol
Receive participants at study site
Verify that participant has a valid
coupon/appointment card
Maintain participant flow
Make appointments using
appointment voucher
Initiate participant checklist and
verify its completeness before
participant leaves study site
Assist coupon/data manager
Conduct interviews
Primarily responsible for initial data
quality reviews and completeness
checks
Conduct pre- and post-HIV, HCV
and syphilis testing counseling
Conduct HIV, HCV and Syphilis
testing
Collect, storage, and referring DBS
for QA and future testing to RAC
lab.
Record results of testing
Provide and document referrals to
HIV, HCV and syphilis-positive
participants
Obtain verbal informed consent
Register coupon information in
database
Instruct participants on participant
recruitment and issue coupons
Provide participant reimbursements
Label coupons (e.g., invalid, used)
and ensure correct coupon IDs are
used
Ensure data security, storage and
back-up
Manage study tablets and other data
management issues
Conduct network size questionnaire
BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
HTC specialists
HTC specialists will be trained medical professionals with experience working with key populations
and/or the areas of sexual health, who are knowledgeable about HIV, HCV and STI testing,
treatment options and access to treatment services, stigma/discrimination, and confidentiality
issues. All HTC specialists will be required to undergo training for the study provided by the study
team, including training on specimen collection procedures in accordance with testing protocols in
Kyrgyzstan. Each interview site will have one HTC specialist responsible for conducting HIV, HCV,
and syphilis rapid testing, conducting a short interview on HIV testing experience, and assessing
HIV prevention, care, and treatment needs of participants.
Screeners
Screeners will be members of the respective target populations, who are trained to administer the
standard screening criteria and checklist, create a welcoming environment for prospective
participants, and provide guided referrals to local AIDS centers as needed for HIV rapid test reactive
participants. Each interview site is anticipated to have two screeners.
Interviewers
Interviewers will be selected from the local AIDS centers and neighboring medical facilities. Many, if
not most, will be healthcare providers with experiencing working with patients and handling and
communicating sensitive information.
Site Manager
The site manager will be the district-level HIV epidemiologist currently employed by the RAC. They
will likely have experience implementing RDS surveys and expertise in other epidemiological
methods. Similarly, they will be extremely knowledgeable about key populations within the district
and attending micro-epidemiology.
6..9.2 Training
Once field staff have been recruited, they will receive the tools and training to perform their roles
effectively. A core-training module will be delivered for both data collectors and field supervisors.
This training will occur over five days. It will be informal and facilitatory in style to build an open
forum for participation questions, discussion and to build team cohesion, cooperation and ways of
problem solving. Training will occur over five days with the following structure:
Day 1 morning – overview
56
•
Project overview
•
Roles, responsibilities, and expectations (ours and yours)
•
Lines of communication
•
Protocols: reporting and debriefing
BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
•
Safety procedures
•
Salary and per diems
•
Housekeeping and logistics
Day 1 afternoon – Working with affected communities
•
Stigma and discrimination
•
Ethics of research with affected communities
•
Good clinical practices certification
•
Confidentiality and privacy
•
Roleplaying
Day 2 – Data collection
•
Overview of sampling methods (RDS )
•
Procedures:
o
o
o
Sampling
Recruitment
Screening
o
Consent
o
Anonymous identifier codes
o
o
o
o
o
Questionnaire administration
Pre-test counselling
Testing procedures
Post-test counselling
Compensation
Day 3 – Data collection – roleplaying
•
Survey forms: run through, role-play and final piloting
•
Data safety
•
Coupon management
Days 4 & 5 – E-BBS intensive workshop
•
Data management
•
Data quality assurance
Additional training for lab specialists
A counselling specialist will deliver an additional one-day module for lab specialists. As they will be
recruited with prior experience, the module will refresh counselling staff on principles of
confidentiality, respect, and non-discrimination, as well as communication skills. The module will be
a mix of lecture- and role play-based activities. They will also undergo training to be fully proficient
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in helping participants to feel at ease, in explaining the processes involved in providing biological
data, in administering finger prick, conducting HIV, HCV, recency and syphilis rapid testing.
6..10 Data ownership, storage, sharing and release
Questionnaire data will be collected on password-protected electronic tablets with a mobile
application “e- BBS app” developed by ICAP in 2014 and adapted to this survey. The application
can be downloaded onto any Android-based mobile devices from Google Play Market and allows
input of data in offline mode. It has built-in data entry checks and skip patterns that help reduce data
entry mistakes and significantly decrease the time of interview. Before the survey, all interviewers
will be trained on how to collect data with hand-held devices.
Then data will be uploaded to a secure electronic BBS web-based platform (e-BBS system) at least
once-daily using encrypted SSL (https) connection and afterwards automatically deleted from the
data collection device. The e-BBS system - a unified online database to enter, process, store and
extract BBS data that allows to monitor BBS sampling processes and get dataset in Excel format to
be opened in RDS Analyst for further RDS diagnostics at the various sites in real-time. The system
is accessible on the Internet through an administrator-authorized password. Republican AIDS
center will be administrator of the system and owner of data. After extracting from the e-BBS system
all electronic datasets will be stored on password-protected computers of AIDS centers staff
computers for a period of five years.
All paper forms will be kept in portable locked files during data collection and after completion of
data, collection and analysis will be handed to the RAC in Bishkek, where they will be kept in a
locked cabinet. All electronic data will be saved on password-protected computers. Access to paper
forms and electronic files will be restricted to study investigators. Paper forms and electronic files
will be stored for up to three years after data collection and will then be destroyed.
Data governance
A data governance document will be developed to define the rights each investigating institution has
with regards to data, the roles and responsibilities of each partner for data stewardship, the
membership of the RAC, and the process by which RAC will make and communicate decisions on
data handling and access. RAC will be responsible for approving the data management plan,
granting release of data, and certifying finalization of data at the end of the survey. The data
governance agreement covers the time period from start of survey data collection to the release of
the survey report and dataset-associated documentation.
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Data ownership
RAC is the primary owner of the data. CDC and ICAP will also have real-time, unimpeded access to
the de-identified data for the purpose of data monitoring, data analysis, and report/manuscript
development. Any outside requests for the data will require a signed data use agreement.
Data and specimen storage
Any left-over whole blood/serum/plasma specimens should be frozen at -20C or below immediately
after use in a study testing and stored in such conditions for 5 years. Questionnaires will be
collected as electronic data using password protected computers or tablets using with a mobile
application “e- BBS app” developed by ICAP in 2014. The e-BBS system - a unified online database
to enter, process, store and extract BBS data that allows to monitor BBS sampling processes and
get dataset in Excel format to be opened in RDS Analyst for further RDS diagnostics at the various
sites in real-time. The system is accessible on the Internet through an administrator-authorized
password. At the conclusion of data collection, the data will be retained at RAC on a passwordprotected computer or tablet. Survey staff will be trained to send encrypted data files and ensure
that encryption with password protection is performed prior to transmission of files. The data will be
stored for up to five years after data collection, on the network share drive, which only authorized
project staff can access, after which it will be destroyed.
Public access
Data are owned by RAC. CDC and ICAP have unrestricted access to de-identified data. The RAC
will be responsible for the release the de-identified survey database, summary sheet(s), and the
final report without delay regarding the timeline for the summary sheet within 30 days after data
collection completion, final report, and manuscript within 1 year after survey completion. Costs are
budgeted within the survey budget to prepare data for public use without restriction. Data will be
available to researchers, in accordance with CDC policy, subject to an approved concept sheet that
has been reviewed and cleared by the local ethical committee. The released de-identified data will
include all lab and data variables. Researchers who are not participating in the survey will have
access to data sets, survey documentation, code books, and questionnaires on the RAC website:
(http://www.aidscenter.kg). When downloading the database, they must agree to the terms and
conditions described.
6..11 Data analysis
To ensure an approximation of a randomized sample, the analysis of RDS data requires adjustment
for social network size and homophily within networks. Specialized analyses will be conducted to
produce adjusted population prevalence estimates and confidence intervals of variables adjusting
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for unequal probabilities of inclusion due to varying social network sizes and the similarities in
characteristics of persons within their social networks. Advanced aspects of the analysis of RDS
data, such as adjusted multivariate analysis, are currently under research and we will keep abreast
of the most up to date accepted standards during the analysis phase.
At present, we will use RDS-Analyst (RDS-A) available from
http://wiki.stat.ucla.edu/hpmrg/index.php/RDS_Analyst_Install, SAS (Version 9.2, Cary, NC), Stata,
(Version 15, College Station, TX), SPSS (version 22. New York, NY) or R for analyses. RDS-A is
software developed for analysis of RDS data that produces population point prevalence and 95%
confidence intervals for key indicator variables. RDS-A also produces survey weights. These data
can then be exported into standard statistical packages (e.g., SAS, Stata, or R) for more complex
analysis as appropriate.
The primary analyses will include the adjusted population estimate of HIV prevalence by location,
90-90-90 cascade for HIV+ individuals, key risk behaviors (e.g., condom use with partners) and
access to and use of HIV prevention programs - including exposure to HIV prevention and treatment
programs and other services by each location (i.e., data will not be aggregated across locations).
Standard errors and confidence intervals will be adjusted based on the RDS design effects. Both
weighted and unweighted analyses will be completed and presented.
To determine the proportion of recent infection, the number of clients with recent HIV infection will
be divided by the total number of clients that are new HIV diagnosed cases to calculate the
proportion testing recent on the RITA among newly diagnosed PLHIV. This calculation will be
conducted by select demographic and behavioral characteristics, including age, sex, risk behavior,
and access to health services. The number and proportion of eligible persons who choose not to
participate in or decline testing for recent infection will be calculated. Where possible, comparisons
of demographic and behavioral characteristics of persons who did not receive testing for recent
infection to those who were tested will be made. Further, more advanced statistical analyses may be
conducted to identify demographic, behavioral, and health service-related factors associated with testing
recent versus long-term on the RITA. Demographic and behavioral characteristics of persons with
recent infection and long-term infection can be compared using a 2-sided Pearson chi-square or
fisher exact test to assess for statistical significance. Continuous variables can be compared using
the Wilcoxon rank sum test. Regression analysis can be conducted to identify independent factors
associated with recent infection. Where appropriate, analyses will account for site clustering and/or
include examination of differences across sites.
Refer to Table 14 for data analysis table shells. Stratified analyses will also be performed within
locations to identify sub-populations at higher risk. Using exported weights, conventional analyses
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of association (e.g., logistic regression) will be done to identify significant predictors of HIV and risk
behaviors as appropriate.
Table 14. Outline of minimum analysis output for survey.
Variable
Population n
Age
All
Crude % (95%
CI)
RDS Weighted %
(95% CI)
15-19
20-24
25-29
30-34
35-39
>40
Area of town population can be found by
outreach workers
All
Area A
Area B
Area C
Number of children living with
All
0
1
>2
Used a condom at last sex with another man
MSM
Used a condom at last sex
All
Experienced physical violence in the last 12
months
All
Experienced sexual violence in the last 12
months
All
Arrested because of KP status in last 12
months
All
Treated unfairly or denied healthcare because
of KP status in last 12 months
All
Among those with symptoms of a sexually
transmitted infection in the last 12 months,
sought screening
All
Among those with an STI, received treatment
for a sexually transmitted infection in the last
12 months
All
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Time since last engagement with an outreach
worker
All
0-3 months
4-6 months
7-12 months
>12 months (one year)
Never
Received free lubricants in the last 12 months
MSM
Received clean needles or syringes in the last
6 months
PWID
Shared injection equipment in the last 6
months
PWID
Shared drug preparation equipment in the last
6 months
PWID
Received medication for drug dependency in
the last 6 months
PWID
Tested for hepatitis B in the last 12 months
All
Tested for hepatitis C in the last 12 months
PWID
Ever tested for HIV
All
Reason for never testing for HIV
All
Reason A
Reason B
Discussed pre-exposure prophylaxis in the last
12 months with a healthcare provider
All
Taken pre-exposure prophylaxis in the last 12
months
All
Time since last HIV test
All
0-3 months
4-6 months
7-9 months
10-12 months
>12 months (one year)
Source of last HIV test
All
KP facility
KP community provider
MOH clinic
Private clinic
Self-test
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ART provider
All
MOH clinic (name)
Private clinic
Reason for not taking ART
All
Reason A
Reason B
Reason C
Started ART but no longer taking ART
All
Had HIV viral load measured in last 12 months
All
HIV prevalence
All
Aware of HIV-positive status (1st 90)
All
Aware of HIV-positive status and on ART (2nd
90)
All
On ART and virally suppressed (3rd 90)
All
Viral suppression among all PLHIV
All
Syphilis prevalence
All
Hepatitis C prevalence
PWID
Other STI prevalence
All
TB prevalence
All
HIV and other co-infection prevalence
All
Proportion of HIV recent infection (by location)
All
Population size estimate (by location)
Service Multiplier
All
3-Source-Capture-Recapture
All
RDS-A/Sequential Sample
All
RDS survey weights: The analysis of RDS data requires adjustment for social network size of each
participant to approximate a simple random sample. We plan to use the Gile Successive Sampling
estimator in RDSA post-hoc to weight the data, unless we determine that homophily (which refers to
the measurement of contact between people based on characteristics) is high. In that case, we will
use another estimator such as RDS-I or RDS-II to weight the data.
Intermediate reviews and analyses: RDSA will be used every week to analyze the sample for each
site and key population. Specifically, the software will be used once per week to conduct the
following analyses:
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
1.
Recruitment homophily: The ratio of number of recruits that have the same characteristic
(e.g. HIV positive vs. HIV negative) as their recruiter to the number we would expect by chance, for
that recruitment chain.
2.
Recruitment plots: Stratified by HIV, the recruitment plots will show whether the average
personal network size differs by wave, which can indicate when a substantial proportion of the
population has been sampled. The plots will also indicate if recruitment chains are biased in terms
of recruitment according to certain characteristics, such as HIV.
3.
Convergence and bottleneck plots: These plots can indicate if the sample has reached
convergence on HIV and other variables, and whether the population contains distinct subcommunities that could bias the RDS estimate. These recruitment diagnostics will help investigators
determine if they need to modify recruitment training, to determine if more sampling is required to
reach equilibrium, or if more seeds need to be added.
6..12 Variables
HIV prevalence and risk behaviors: The primary analyses will be the adjusted (RDS-weighted)
population point estimates of HIV, HCV and Syphilis prevalence, viral load suppression, key risk
behaviors, and access to services. Where feasible, stratified analyses will also be done to identify
sub-populations at higher risk. Using the RDS- specific weights, regression analyses (e.g., logistic
regression) will be done to identify significant predictors of HIV infection. Bivariable and
multivariable analysis with odds ratios and 95% confidence intervals will also be included in the final
report. Both weighted and unweighted values, and their associated 95% confidence intervals (95%
CI) will be calculated and presented.
6..13 Ethics
The study team has developed procedures to ensure ethical practices concerning recruitment,
consent, revocation of consent, participant complaints, confidentiality, anonymity, community
consultation, data collection, data management and storage, data analysis, reporting and
dissemination. Data will be collected according to international ethical standards. Protocols,
procedures, and data collection forms will be subject to review, approval, and oversight by both
local and international ethics review committees. Individual participation in the study will be
voluntary and all data collection will be anonymous and confidential. Prior to participation in the
survey and testing individuals will give witnessed verbal informed consent. Participants will be
informed of the purpose of the data collection, and if requested, data collectors will provide details
for the data collection agency, the funding agency, and the contact details of an appropriate person
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to whom enquiries and concerns can be addressed. Immediately following the survey component of
the study and prior to testing, participants will meet with a pre-test counsellor to be fully informed of
the testing procedure and testing implications particularly in the case of receiving a positive result.
Testing protocols adhering to national algorithms will be developed and all staff involved in the
collection of sample specimens will receive full training and oversight. All supervisors, coordinators,
recruiters, and interviewers will sign strict confidentiality and procedural agreements at the outset.
All data tabulation and information disseminated will be based on groups rather than individuals,
thus keeping anonymous individual identity. Completed data forms and data collection schedules
will stored securely in locked file cabinets. Resulting datasets will be handled securely, with
attention to fail-safe back-ups.
The protocol will be reviewed by the CDC Associate Director of Science (ADS), Columbia
University’s Medical Center (CUMC) Institutional Review Board (IRB), and Bioethics Committee
under Academy of Medical Sciences of the Ministry of Health and Social protection of the
Population of the Kyrgyz Republic.
6..13.1 Potential Risks
As with all studies involving participant specific data, there is a slight risk of loss of privacy for study
participants. In order to minimize this, all study staff will be trained in Good Clinical Practices and
will sign a confidentiality agreement (Appendix S). Additionally, particular care will be taken to select
the interview locations so that eavesdropping and speculation by outsiders is minimized and
confidentiality is ensured. Participants might experience discomfort or distress because of
discussion of behaviors that are sensitive or highly stigmatized. In order to avoid this risk,
interviewers will take particular care to explain that participants can withdraw from the study at any
time without any explanation or risk of impeded future access to services in the government or NGO
sector and that it acceptable to provide no answer to specific questions and continue the survey.
Participants identified as in need of mental health or other health services during the interviews will
be referred for appropriate services, as available.
There is a small likelihood that during the participant screening process investigators may identify
MSM who are less than 18 years old. If this occurs, these individuals will be referred to the NGO
“Kyrgyz Indigo” or “Anti-SPID” or their affiliated NGO in the survey sites who offer counselling for
MSM, STI screening, and social support. A module on how to complete these referrals will be
included in the mandatory study personnel training. A copy of the completed referral forms
(Appendix M) will be retained with the other study materials for a period of 1 year following the
completion of the study and then destroyed.
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6..13.2 Response to New or Unexpected Findings and Changes
in Survey Environment
Any changes to the survey environment will be reported to the survey coordinator, who will inform
the investigators immediately. The survey principal investigators will have the responsibility of
suspending survey enrollment and temporary closing survey site if a perceived danger to the survey
staff or participants is found, and they will also immediately inform the Bioethics Committee under
Scientific Production Center “Preventive Medicine” of the Ministry of Health of the Kyrgyz Republic
and to the CDC DGHT ADS in the event of suspension of enrollment or if they determine that a
change in the protocol is needed.
6..13.3 Adverse Events
Should any adverse events occur, these events will be immediately reported to the Bioethics
Committee under Scientific Production Center “Preventive Medicine” of the Ministry of Health of the
Kyrgyz Republic, CUMC IRB, and CDC ADS as per their standard procedures. Potential incidents
may include protocol violations, security incidents harming recruits, participants or staff, or breach of
confidentiality. Any unexpected or adverse events will immediately be reported by the survey team
to the principal investigators within 24 hours of discovering the adverse event via the field incident
report and to all relevant ethical review committees within 5 to 10 days (depending on severity and
needed information collection), with follow-up reporting of any pending information, action or followup.
6..13.4 Potential Benefits
Direct benefits to participants include free HIV, HCV and syphilis testing and counselling, HIV
prevention commodities (condoms, needles, and syringes), and referrals for HIV prevention
services. In addition, if, during the survey, the participants are diagnosed with HIV, such
respondents will be enrolled in HIV care and treatment programs. Those found to have syphilis will
be referred to free syphilis treatment. Those found to have HCV will be referred to free HCV
treatment.
Indirectly, the assessment of HIV risk among MSM/PWID and estimation the size of the MSM/PWID
population in study locations and in Kyrgyzstan as a whole, will produce reliable data on the health
and social welfare needs of MSM/PWID in Kyrgyzstan which will be used to optimize the HIV, HCV,
STI, and harm reduction responses in Kyrgyzstan and plan future surveillance activities.
6..14 Monitoring and quality control
As the study sponsor, the CDC may conduct monitoring or auditing of study activities to ensure the
scientific integrity of the study and to ensure the rights and protection of study participants.
Monitoring and auditing activities may be conducted by:
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
•
CDC staff (“internal”)
•
authorized representatives of CDC (e.g., a contracted party considered to be “external”)
•
both internal and external parties
Monitoring or auditing may be performed by means of on-site visits to the study sites or through
other communications such as telephone calls or written correspondence. The visits will be
scheduled at mutually agreeable times, and the frequency of visits will be at the discretion of
CDC. During the visit, any study-related materials may be reviewed and the Investigator along with
study staff should be available for discussion of findings.
The study may also be subject to inspection by regulatory authorities (national or foreign) as well as
the International Ethics Committees/Institutional Review Boards to review compliance and
regulatory requirements.
Monitoring and quality control will occur through the following mechanisms:
•
Periodic monitoring from:
o
o
•
ICAP specialists
RAC laboratory and surveillance specialists
Ongoing oversight of data collection staff from senior members of project team (Project
Manager, Deputy Project Manager, Research Coordinator)
•
CDC staff
•
Financial monitoring and risk management by the business unit of the RAC
6..14.1 Periodic monitoring
ICAP and RAC Surveillance Specialists
ICAP and RAC will provide external monitoring and verification during the data collection phase.
This will help to ensure all aspects of data collection occurs accurately and according to the data
collection procedure and ethics protocol.
They will:
•
Receive a full project briefing from the project management team
•
During the data collection phase, conduct random quality checks of electronic data collection
forms from all city/districts
•
Conduct weekly recruitment diagnostics and analysis
•
Conduct on-site monitoring of data collection at a random selection of 2 city/districts to
determine if appropriate data collection and ethics procedures are being adhered to during
field data collection
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•
Conduct on-site monitoring of data collection at a targeted selection of 2 city/districts to
provide remediation technical assistance based on quality checks of electronic data
collection
•
Conduct telephone discussions with member/s of the data collection team during data
collection to discuss adherence to data collection and ethics procedures
Laboratory personnel from the Republican AIDS Center
Laboratory personnel will provide oversight of testing procedures to ensure adherence to the study
protocol.
They will:
•
Conduct telephone discussions with member/s of the data collection team during data
collection to discuss adherence to test protocols, specimen collection and ethics procedures
•
Provide on-site monitoring of data collection a targeted selection of city/districts to provide
remediation technical assistance based on requests from the members of the data
collection team
6..14.2 Ongoing oversight from investigators
The undersigned investigators have extensive experience in project management and project
monitoring. Additionally, they each have significant professional interest in ensuring accurate and
ethical collection of data. Parallel to the periodic monitoring outlined above, they will be conducting
ongoing monitoring of the data collection team, both onsite and remotely. During onsite monitoring,
along with the Research Coordinator they will observe and provide feedback on data collection
activities; perform checks of and provide feedback on electronic data collection forms; and
undertake routine team debriefs to discuss and work through issues encountered. During offsite
monitoring they will liaise weekly with the Research Coordinator and member/s of the research
team to debrief; discuss and work through issues encountered; conduct random checks of data
entry forms; and verify electronic data entry.
As the study sponsor, CDC may conduct monitoring or auditing of study activities to ensure the
scientific integrity of the study and to ensure the rights and protection of study participants.
Monitoring and auditing activities may be conducted by:
•
CDC staff (“internal”)
•
Authorized representatives of CDC (e.g., a contracted party)
•
Both internal and external parties
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Monitoring or auditing may be performed by means of on-site visits to the Investigator’s facilities or
through other communications such as telephone calls or written correspondence. The visits will be
scheduled at mutually agreeable times, and the frequency of visits will be at the discretion of CDC.
During the visit, any study-related materials may be reviewed and the Investigator along with the
study staff should be available for discussion of findings.
6..15 Reporting, dissemination of results and publication
A draft report will be completed approximately six weeks after the completion of data collection
alongside a presentation of findings to stakeholders with a final report planned for submission and
dissemination in late 2021. The report will include conclusions, recommendations, and potential
programming considerations to ensure the results are used for action and reflected in tailored
program design. In addition, and where possible, we anticipate publishing the overall findings in
peer reviewed journal/s subject to approval from the Ministry of Health, Kyrgyzstan. In any
dissemination context and/or publication, data will only ever be presented in the aggregate form for
the key population in question so that no individual will be identifiable. Reporting on sexual behavior
(e.g. condom use during sexual intercourse in MSM) will only ever be done at a population level
(e.g. ‘X% of MSM in city/district Y’). We will never mention specific landmark that could identify any
individual and only report on generic location types (for example, MSM reported finding clients in
hotels/bars, through existing clients in case if these will be MSM/SWs, etc.). In addition, all data
collected will be anonymous. A summary of key findings in readily understood form will be
disseminated through 1) relevant websites, including those of local NGOs, RAC, etc.; and 2) a
dissemination workshop in Bishkek tailored for members of the key populations. The project team
acknowledges that any form of dissemination or publication first requires approval of the MOH and
the Centers for Disease Control and Prevention, Division of Global HIV and Tuberculosis Associate
Director for Science.
7
CAPACITY BUILDING PLAN
Capacity building activities for the BBS will seek to:
1. Build capacity of a team of motivated and engaged researchers, including peer-based
researchers, to undertake high-quality social research among marginalized and hidden
population groups using a defined study protocol while maintaining the dignity and human
rights of all participants;
2. Build capacity of key individuals from the RAC to develop a core understanding of the design
and implementation of integrated biological and behavioral surveillance;
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3. Build capacity of a broad range of stakeholders (government, NGOs, and others) to develop
an understanding of the BBS process and the implications of BBS findings for health policy,
strategy, and program design, planning, delivery, monitoring and evaluation; and
4. Build capacity of stakeholders to interpret and use final results for program improvement.
Capacitating researchers
For the BBS, the investigators will be working alongside a locally recruited data collection team that
will include an BBS coordinator; study site coordinators; peer- and non-peer data collectors; testing
and laboratory staff; and other research support staff. The data collection team will undergo formal
training upon recruitment providing a core understanding of the implementation of a study of this
nature among key population groups. The team will receive ongoing ‘on-the-job’ mentoring and
participate daily team debriefs to discuss and work through issues encountered.
Capacitating stakeholders
The study’s consultation process will focus on ensuring a broad range of relevant stakeholders –
particularly organizations and networks working with or representing key population groups – have
1) a strong understanding of and involvement in the BBS process; and 2) an understanding of the
implications and importance of BBS findings for HIV and related programs. In addition to formal
stakeholder consultation prior to the commencement of the study and dissemination at its
conclusion, the project will be working closely alongside organizations working with key populations.
This ongoing consultation will serve not only to improve study outcomes but also build capacity in
certain technical areas.
8 TIMELINE
The study will start simultaneously in both survey groups. For both groups, behavioral and biological
surveys will be conducted for the period of three months (see Table 15). Based on the results of the
formative assessment among PWID and MSM, and in consultation with local stakeholders shortly
before the survey launch, we will decide the study (interview and testing) sites operational days and
hours. Participation in the survey for one survey group is not an exclusion criterion for participation
in the survey among another survey group, if one belongs to both survey groups and received
recruitment coupons from both PWID and MSM peers. For instance, if MSM injecting drugs
received recruitment coupons from both PWID and MSM peers, and he already took a part in the
survey for MSM, he still can take part in the survey for PWID if she meets the eligibility criteria.
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
Table 15: Timeline for study implementation
#
Study activity
Quarter / Month
FY 2020
FY 2021
Q4
Jul
1
Working on the protocol and required forms
2
Discussion of the draft protocols and required
forms with the stakeholders
3
Revision of the draft protocols and required
forms based on the comments received from
stakeholders
4
First draft of protocol and required forms ready
to be submitted to CDC ADS and to be
translated into Russian
5
Translate protocol and tools to Russian and
Kyrgyz
6
Visit NGOs working with PWID and MSM, AIDS
centers, and MAT clinics in the survey sites to
discuss accommodation of the study sites
7
Comments received from CDC ADS
8
Working on clarifications (CDC, ICAP, RAC,
local IRB and other stakeholders) for the
comments made by CDC ADS
9
Workshop to discuss clarifications prepared for
the comments made by CDC ADS for protocol
and required forms
10
Incorporate comments from workshop
11
Submit revised protocol and required forms for
approval to CDC ADS, ICAP IRB, Bioethics
Committee of the Scientific Productive Center
“Preventive Medicine” under the MOH of the
Kyrgyz Republic
12
Pre-test tools and make changes based on the
pre-test findings
13
Meet with NGOs working with PWID and MSM
n the survey sites to discuss recruitment of
participants
14
Obtain final CDC ADS, ICAP IRB, and Bioethics
Committee of the Ethical Committee under the
Scientific-Productive Center “Preventive
Medicine” under the MOH of KR
15
Recruit study team, including site mangers,
interviewers, screeners, lab technician
16
Procurement of the items required for BBS
implementation (tests kits, laboratory
expandable materials, etc.)
17
Train study team members, including site
mangers, interviewers, screeners, lab
technician on data collection, performing the
required tests and data entry
18
Conduct field stage of the BBS (data collection,
testing and collection of DBS)
19
Train data analysts on data analysis
71
Q1
Aug
Sep
Oct
Nov
Q2
Dec
Jan
Q3
Feb
Mar
Apr
Q4
May
Jun
Jul
Aug
Sep
BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
20
Draft preliminary report
21
Present preliminary findings to stakeholders
22
Finalize report
23
Dissemination meeting
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BBS MSM AND PWID IN KG | v 3.1 March 17, 2021
9 REFERENCES
1. Statistical report of the Republican AIDS center, January 2019, Kyrgyzstan.
2. Key Population size estimation report, Republican AIDS center, 2013, Kyrgyzstan.
3. Republican AIDS Center, BBS among PWID, 2016, Kyrgyzstan.
4. Republican AIDS Center, BBS among MSM, 2016 Kyrgyzstan.
5. Baral SD, Poteat T, Stromdahl S, Wirtz AL, Guadamuz TE, Beyrer C. Worldwide
burden of
HIV in transgender women: a systematic review and meta-analysis. The Lancet Infectious
Disease. 13(3): 214–222 March 2013.
6. Biobehavioral Survey Guidelines For Populations At Risk For HIV. Global HIV Strategic
Information Working Group, 2017 (accessed 27 Jan 2021)
7. Salganik MJ. Variance Estimation, Design Effects, and Sample Size Calculations for
Respondent-Driven Sampling. J Urban Health. 2006 Nov; 83(Suppl 1): 98–112. DOI:
10.1007/s11524-006-9106-x (accessed 23 Nov 2020)
8. Botheju, W. S., Zghyer, F., Mahmud, S., Terlikbayeva, A., El-Bassel, N., & Abu-Raddad, L.
J. (2019). The epidemiology of hepatitis C virus in Central Asia: Systematic review, metaanalyses, and meta-regression analyses. Scientific reports, 9(1), 1-15.
9. STI Action Kit. How to Provide STI Test Results. Johns Hopkins University. Baltimore, MD,
2020. https://jhcchr.org/sti-action-kit/ (accessed 28 Jan 2021)
10. Centers for Disease Control and Prevention. Implementing HIV Testing in Nonclinical
Settings. A Guide for HIV Testing Providers. 2016.
https://www.cdc.gov/hiv/pdf/testing/cdc_hiv_implementing_hiv_testing_in_nonclinical_setting
s.pdf (accessed 28 Jan 2021)
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10 APPENDICES
Appendix A: BBS participation checklist: Kyrgyzstan Behavioral Health Survey (PWID)
Appendix B: BBS Participation checklist: Kyrgyzstan Behavioral Health Survey (MSM)
Appendix C: PWID Questionnaire
Appendix D: MSM Questionnaire
Appendix E: MSM Informed Consent Form
Appendix F: PWID Informed Consent Form
Appendix G: BBS Participation Registration Logbook
Appendix H: Recruitment Coupon for Primary Respondents (Seeds)
Appendix I: Recruitment and Compensation Coupon for RDS
Appendix J: Survey Participant Registration Card
Appendix K: Previous registration as HIV+ in EHCMS or confirmatory test results
Appendix L: BBS Participation Rejection and Criteria Ineligibility Logbook
Appendix M: Referral form for MSM, who are less than 18 years old
Appendix M1: Referral form for PWID, who are less than 18 years old
Appendix N: Guidance for Provision Pre- and Post-test Counseling
Appendix O: Referral Coupon for HCV Treatment
Appendix P: Referral Coupon for Syphilis Treatmnent
Appendix Q: HIV, HCV, Recency and Syphilis Rapid Testing Log
Appendix R: Referral Coupon to Local AIDS Center
Appendix S: Agreement on Confidentiality and Security of BBS participants information
Appendix T: National HIV diagnostic algorithm
Appendix U: PWID Questionnaire for second visit
Appendix V: MSM Questionnaire for second visit
Appendix W: Formative Assessment among PWID--Brief Report
Appendix X: Formative Assessment among MSM—Brief Report
Appendix Y: Sampling based on VLS Among MSM and PWID (Excel file)
Appendix Z: BBS Biomarker Testing Algorithm
Appendix AA: Consent for Piloting Questionnaire MSM
Appendix BB: Consent for Piloting Questionnaire PWID
Appendix CC: Compensation Log for MSM Questionnaire Piloting
Appendix DD: Compensation Log for PWID Questionnaire Piloting
Appendix EE: Script for Returning HIV Results
Appendix FF: Script for Returning HCV Results
Appendix GG: Script for Returning Syphilis Results
Appendix HH: Approved Formative Assessment protocol
Appendix II: CDC/CGH/ADS Approval of Formative Assessment
Appendix JJ: Local ADS Approval of Formative Assessment
Appendix KK: SOP – UO Distribution MSM
Appendix LL: SOP – UO Distribution PWID
Appendix MM: BBS – SOP – SARS-cOv-2 Universal Precautions.
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