TB/HIV Research
Approaches and Challenges
Naomi Bock, MD
Global AIDS Program
Centers for Disease Control and Prevention
February 14, 2005
There is a clear complimentarity and interrelationship between monitoring and evaluation
(M&E), some specific surveillance activities and
operational research. All derive “strategic
information”, new knowledge and data that will
make up the evidence base on ART delivery in
resource-limited settings.
Approaches (1)
D.C.
State of Georgia, USA
Information
as
Intervention
Dini et al, J Pub Health Manage Prac, 1996
•
•
•
•
Assessment
Feedback
Incentive
eXchange
Dini et al, J Pub Health Manage Prac, 1996
Vaccination Series Completion Rates
Georgia Compared with U.S.
LeBaron et al,
JAMA, 1997
Approaches (2)
Western Europe
Eastern Europe
& Central Asia
520 000 – 680 1.2 – 1.8
790 000 – 1.2
million East Asia & Pacific
000
700 000 – 1.3
million
North Africa & Middle
Caribbean
South
million
350 000 – 590 000 470 000East
&
South-East
Asia
– 730 000
4.6 – 8.2
Sub-Saharan Africa
million
Latin America
25.0 – 28.2
Australia
1.3 – 1.9 million
& New Zealand
million
12 000 – 18 000
North America
NNRTI Response Study
Observational Study of
Treatment Effectiveness and Resistance Patterns among
Women Initiating Treatment with Non-nucleoside Reversetranscriptase Inhibitor-based HAART after Previous Single
Dose Nevirapine (SD NVP) in Pregnancy
HOME
CALENDAR
CONTACT US
PROTOCOL
PROJECT
MANUAL
FORMS
CODE BOOKS
PROGRESS
REPORTS
Welcome to the NNRTI Response Study Website.
The Epidemiology Branch of the Division of HIV/AIDS Prevention and the
Care and Treatment Branch of the Global AIDS Program (GAP), U.S.
Centers for Disease Control and Prevention in Atlanta are jointly
coordinating this study to examine the response to highly active
antiretroviral therapy (HAART) that includes nevirapine (NVP) among
women who have been exposed to prior single-dose (SD) NVP as
compared to those who have not. This is a prospective observational
study consistent with the goal to conduct clinically applicable
operational research that is expected to directly inform program
implementation.
This study will be conducted in at least 2 sites, including Zambia and in
Thailand, under the direction of the Principal Investigators listed. The
sites where the study will be conducted are providing non-nucleoside
reverse transcriptase inhibitors (NNRTI)-based HAART to persons
attending their clinics. Some of the women attending these clinics have
received SD-NVP for PMTCT in the past and others have not. This study
intends to use the opportunity that has been presented at the early stage
of a period of rapid expansion of antiretroviral therapy in resourceconstrained settings to generate data to address the important question of
response to NNRTI-based HAART therapy among women who have
received SD-NVP for PMTCT as compared to women who have not.
†
International Union Against Tuberculosis
and Lung Disease
Study A
Report of a Controlled Clinical Trial of
Two Durations of Chemotherapy for
the Treatment of Tuberculosis
Amina Jindani, Andrew Nunn, Donald Enarson
For the Clinical Trials Programme Investigators
The TB Trials Consortium (TBTC)
• Funded since 1998 by the Division of TB
Elimination, CDC
• 28 clinical sites worldwide
• Links to local TB control programs
• TBTC Mission: “… to conduct programmatically
relevant clinical, laboratory, and epidemiologic
research concerning the diagnosis, clinical
management, and prevention of tuberculosis
infection and disease.”
Barcelona
Kampala
28 clinical sites
worldwide
CDC Administrative,
Statistical, and Data
Management Center
Rio de Janeiro
Durban
World Health Organization
WHO> WHO sites
Home
About WHO
Database on global MDR-TB research activities
Countries
Background
Health Topics
Publications
Research tools
WHO sites
Currently, there is a lack of evidence available to develop policy
recommendations for the management of multidrug-resistant tuberculosis
(MDR-TB) in low- and middle-income settings. As a result, WHO and
partners developed the DOTS-Plus strategy which is currently being tested
through pilot projects and operational research activities. In order to
stimulate global MDR-TB research activities the Stop TB Working Group on
DOTS-Plus for MDR-TB has developed a prioritised research agenda for DOTSPlus.
-A prioritised research agenda for DOTS-Plus for multidrug-resistant
-tuberculosis (MDR-TB) [pdf 51kb]
The Stop TB Working Group on DOTS-Plus for MDR-TB. International
-Journal of Tuberculosis and Lung Disease 2003, 7(5): 410-414.
In addition, a database on global MDR-TB research activities has been created
with the following purpose:
http://www.who.int/tb_search/
World Health Organization
WHO> WHO sites
Home
About WHO
DOTS Plus and the Green Light Committee
Countries
WHAT IS DOTS-PLUS?
Health Topics
Based upon DOTS, DOTS-Plus is a comprehensive management
strategy under development and testing that includes the five
tenets of the DOTS strategy. DOTS-Plus takes into account
specific issues (such as the use of second-line anti-TB drugs)
that need to be addressed in areas where there is high
prevalence of MDR-TB. Thus, DOTS-Plus works as a supplement
to the standard DOTS strategy. By definition, it is impossible to
conduct DOTS-Plus in an area without having an effective
DOTS-based TB control programme in place.. ..
Publications
Research tools
WHO sites
WHAT IS THE GREEN LIGHT COMMITTEE?
http://www.who.int/tb/dots/dotsplus/management/en/
Feedback loop
Policy definition/revision
Evaluation and
operations
research
Program
implementation
Challenges
• Local involvement
• Protection of human subjects
Local Involvement
• National / District / Local programs
involved in planning as well as
implementation
• Strengthen TB programs
• Avoid redirecting scarce resources
• Include the community of people with TB
and HIV
Local Involvement
• National / District / Local programs
involved in planning as well as
implementation
• Strengthen TB programs
• Avoid redirecting scarce resources
• Include the community of people with TB
and HIV
• HIV programs involved in planning,
implementation, evaluation, policy
Feedback loop
Policy definition/revision
Evaluation and
operations
research
Program
implementation
Feedback loop
Policy definition/revision
Evaluation and
operations
research
Program
implementation
Challenges
• Local Involvement
• Protection of human subjects
Declaration of Helsinki
“Concern for the
interests of the subject
must always prevail
over the interests of
science and society.”
1975
revision
Tuskegee Study of
Untreated Syphilis
• Conducted
– To study the natural history of untreated
latent syphilis
– By US Public Health Service, with
support from the Milbank Memorial
Fund
– Beginning in 1932
Non-therapeutic lumbar puncture
Tuskegee Syphilis Ad Hoc Panel, 1973
•
•
•
•
No informed consent
Vulnerable population
Undue inducements - burial costs
Participants not informed when
penicillin therapy became
available in the 1950s
• Participants systematically
blocked from receiving treatment
In 1997, surviving participants
of the Tuskegee Syphilis
Study and their families
gathered at the White House
to witness the President's
apology on behalf of the
United States government
Proposed Roles of WHO
• Database of research studies
• GLC approach to those programs
interested in participating in research
– Program strengthening with partners
– DTBE/CDC and Union operational research
courses
Proposed Roles of WHO (2)
• Facilitating human resource expansion
– Identifying training grants which fund masters
or doctoral students for in-country research
– Stimulating donors to create more such
programs
• “Club” of National/District/local programs
participating in research at program level,
including multi-centre research