Unit 4:
Specimen and Data Collection
#3-4-1
Warm Up Questions: Instructions

Take five minutes now to try the Unit 4 warm
up questions in your manual.

Please do not compare answers with other
participants.

Your answers will not be collected or graded.

We will review your answers at the end of the
unit.
#3-4-2
What You Will Learn

By the end of this unit you should be able to:

understand the rationale for conducting
unlinked anonymous testing for HIV
sentinel surveillance

explain methods for keeping samples
anonymous and unlinked
#3-4-3
What You Will Learn, Cont.

By the end of this unit you should be able to:

explain the importance of standardised
forms for data collection

describe the protocols for data collection

identify the necessary demographic
information to be collected for analysis
#3-4-4
Objectives of HIV Testing

counselling persons on their infection

referring them to care

reducing the risk of transmitting or acquiring HIV

ensuring the safety of the blood supply

scientific research

determining eligibility for certain types of employment
or health insurance
#3-4-5
Participation Bias in HIV Testing

To use HIV testing data for surveillance, you
must ensure that your data represent the
whole target population.

Persons offered testing may have reasons to
accept or decline the test.

The HIV testing approach you choose will
affect participation bias
#3-4-6
Considerations in Selecting a
Testing Approach

There are 5 considerations that should guide
the selection of a testing approach:
Participation bias
 Informed consent
 Confidentiality
 Linking
 Result disclosure

#3-4-7
Approaches to HIV Testing

There are 6 main approaches for HIV testing for
surveillance purposes:






Unlinked anonymous testing without informed consent
Unlinked anonymous testing with informed consent
Linked confidential testing with informed consent
Linked anonymous testing with informed consent
Mandatory testing
Compulsory testing
#3-4-8
Recommended Approach for
Sentinel Surveillance

Unlinked anonymous testing (UAT) without
informed consent is the recommended testing
approach for sentinel surveillance.

UAT is done only in clinic settings where
blood is collected regularly for other
purposes.

The major disadvantage of UAT is that
persons do not get their test results.
#3-4-9
Recommended Approach for
Sentinel Surveillance, Cont.

Linked testing (confidential or anonymous)
with informed consent is the preferred
approach when the specimens are collected
explicitly for the purpose of HIV testing.

An example of when this would happen is HIV
surveillance through community-based serosurveys.
#3-4-10
Unlinked Anonymous Testing
Without Informed Consent

HIV testing is done on specimens of blood
collected for other purposes

Individuals do not need to give consent to
have HIV testing performed on their blood.

Personal identifying information is
permanently stripped from specimen tubes
prior to testing for HIV.
#3-4-11
Unlinked Anonymous Testing
Without Informed Consent, Cont.

Data are recorded using codes that do not
identify individuals.

Persons do not choose to participate or not
participate.

Persons do not get their HIV test results.
#3-4-12
Determining Eligibility – UAT

The first step in UAT is to identify persons
who are eligible for the sample.

This is preferably done at the time of the visit
by clinic personnel

Another less desirable way to decide is to
review information from the clinic records
after the visit.
#3-4-13
Obtaining Information – UAT

Types of information to be collected include:

basic demographic information
• age
• sex
• geographic area of residence

additional helpful information that can confirm
eligibility, such as:
• date of visit
• reasons for the current visit
• date of last visit (if available) in order to verify eligibility
#3-4-14
Obtaining Information – UAT, Cont.

Other possible data to be collected include:



Additional demographic data
• socio-economic or educational level
• occupation
• marital status
Additional behavioural data
• number of sexual partners
• condom use
Additional clinical data
• signs and symptoms of HIV
• signs and symptoms of other STIs
#3-4-15
Step-By-Step Procedure for UAT
1. Clinic staff member #1 collects specimen
from patient, and labels it with a code.
2. Clinic staff member #1 labels a clinic form
with the same code, and collects
demographic and routine clinical information
from patient.
#3-4-16
Step-By-Step Procedure
for UAT, Cont.
3. Clinic staff member #1 removes an aliquot of
blood sample and places it in a second tube.
4. The second tube with the aliquot of blood is
labelled with a new code not linked to
personally identifying information.
#3-4-17
Step-By-Step Procedure
for UAT, Cont.
5. The first tube is sent for routine clinical
testing (for example: anaemia, syphilis).
6. Staff member #1 records new code on a
surveillance form and transfers demographic
information (not linked to personal identifying
information) from the clinic form to the
surveillance form.
#3-4-18
Step-By-Step Procedure
for UAT, Cont.
7. Clinic staff member #2 performs HIV test on
blood sample labelled with new code.
8. HIV test results are recorded in a laboratory
log-book with the new code and the HIV test
result.
9. Demographic information from surveillance
forms is matched with HIV test results using
the new codes, and then analysed.
#3-4-19
Labeling Specimens and Logging
Test Results

Clear, consistent, and durable labeling of
specimens is very important in UAT

Test results should be logged in a book with
only the specimen code and the HIV test
result

In labeling specimens and logging results,
great care must be taken to protect
confidentiality
#3-4-20
#3-5-46
Flow of Data Collection Forms
#3-4-21
Warm Up Review

Take a few minutes now to look back at your
answers to the warm up questions at the
beginning of the unit.

Make any changes you want to.

We will discuss the questions and answers in
a few minutes.
#3-4-22
Answers to Warm Up Questions
1. True or false? In unlinked anonymous
testing, it is okay to maintain information
about the identity of the patient, in order to
inform them about their treatment options if
they test positive. False
#3-4-23
Answers to Warm Up Questions,
Cont.
2. Place the following events in the correct
order, corresponding to the proper
procedure for unlinked anonymous testing.
a. blood is collected and labelled with a code
b. specimen is tested for HIV
c. personal identifying information is removed from
specimen
d. aliquot is removed into new tube for HIV testing
a, d, c, b
#3-4-24
Answers to Warm Up Questions,
Cont.
3. True or false? Unlinked anonymous testing
without informed consent can sharply
reduce participation bias. True
#3-4-25
Answers to Warm Up Questions,
Cont.
4. Place the following events in the correct
order, corresponding to the preferred data
collection method for unlinked anonymous
testing:
a. send form to laboratory
b. add HIV test result to form
c. add demographic data to form
d. remove demographic section of form and
send to data manager
c, d, a, b
#3-4-26
Answers to Warm Up Questions,
Cont.
5. Which of the following is not a reason for the use of
standardised data collection forms?
a. to ensure that the necessary information is obtained
b. to ensure that data from different sites can be easily
compared
c. to ensure that a patient’s personal information can be
matched with their test result
d. none of the above
Standardised data collection forms allow for
greater ease in data collection. Matching a
patient’s information to their test result is
irrelevant, and sometimes is even undesired.
#3-4-27
Answers to Warm Up Questions,
Cont.
6. True or false? For linked confidential
surveys, a separate laboratory form for
serologic results should be used so that
laboratory personnel do not have access to
the patient’s personal identifying information.
True. Since testing is confidential,
laboratory personnel should not be able
to identify the patient with his or her test
result.
#3-4-28
Answers to Warm Up Questions,
Cont.
7. For unlinked anonymous testing, as it is used in
sentinel surveillance, which of the following
variables would be inappropriate to collect:
a. patients age
b. patients marital status
c. Patients number of children
d. None of the above
Knowing the patient’s number of children is
not necessary.
#3-4-29
Small Group Discussion:
Instructions

Get into small groups to discuss these
questions.

Choose a speaker for your group who will
report back to the class.

Take 15 minutes for this exercise.
#3-4-30
Small Group Reports

Select one member from your group to
present your answers.

Discuss with the rest of the class.
#3-4-31
Case Study: Instructions

Try this case study individually.

We’ll discuss the answers in class.
#3-4-32
Case Study Review

Follow along as we go over the case study in
class.

Discuss your answers with the rest of the
class.
#3-4-33
Questions, Process Check

Do you have any questions on the information
we just covered?

Are you happy with how we worked on Unit 4?

Do you want to try something different that will
help the group?
#3-4-34
CDC Global AIDS Program
Annex 4.2: Unlinked Anonymous
Testing (UAT) for HIV Sentinel
Surveillance
#3-4-35
Purpose of Unlinked Anonymous
HIV Testing (UAT)




To monitor trends
To develop estimates and projections
To assist with program planning
To target interventions more accurately
#3-4-36
UAT without Informed Consent



1. UAT without informed consent must only use
left-over blood/fluids from routinely-collected
specimens.
2. Data resulting from surveillance using UAT
methods must be irreversibly unlinked and
rendered anonymous prior to HIV testing.
3. Rapid HIV testing for UAT surveillance should
not be conducted at the point and time of service
provision.
#3-4-37
UAT without Informed Consent,
Cont.



4. Data collection for UAT surveillance should be
limited to that which is routinely collected as part
of clinical services.
5. Voluntary counseling and testing (VCT) should
be available and accessible to patients from sites
where UAT surveillance is being conducted.
6. Data generated through UAT-based HIV
sentinel surveillance should be used for program
planning and evaluation, and for advocacy
purposes.
#3-4-38
UAT with Informed Consent

The procedures for conducting UAT with
informed consent are the same as those for
UAT without informed consent, except:


Blood/fluids collected for non-routine purposes
may be used
Data collected do not need to be limited to that
which is routinely collected as part of clinical
services
#3-4-39
UAT with Informed Consent, Cont.


The consent must explain the purpose of the
survey and that HIV test results will not be
returned.
The anonymising procedure methods must
be irreversibly unlinked and rendered
anonymous prior to HIV testing, with
additional provisions to assure anonymity,
despite face-to-face contact between the
client and the surveillance staff.
#3-4-40
Recommendations

The CDC Global AIDS Program encourages
all countries and programs that are
supporting UAT surveillance in antenatal
clinics to do the following:


Collect information on the availability and uptake
of PMTCT services that are located in UAT ANC
sites
Examine the possibility of using PMTCT data for
surveillance
#3-4-41