Transcript TE/OR Subcommittee

TE/OR Subcommittee
Presented to the
Emergency Plan for AIDS Relief Scientific
Steering Committee
October 19, 2004
Members of the TE/OR Subcommittee
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Sandra Lehrman, MD (Co-chair) - NIH Director, Therapeutics Research Program,
DAIDS/NIAID
Caroline Ryan, MD, MPH (Co-Chair) - CDC/HHS Chief, HIV Prevention Branch, Global
AIDS Program (GAP)
R. Cameron Wolf, Ph.D., M.Sc.(Co-Chair) - USAID Senior Technical Advisor, Office of
HIV/AIDS
Jose Sanchez, MD, MPH - DOD Chief, Department of Epidemiology & Threat Assessment,
Walter Reed
Tim Fowler, MA, BA - U.S. Census Bureau Chief, Health Studies Branch International
Programs
Kathleen Handley, Ph.D - Health Resources Services Administration
Jonathan Mermin, MD, MPH - CDC/HHS Director, CDC-Uganda
Stefan Wiktor, MD, MPH - CDC/HHS Chief, Surveillance and Infrastructure Development
Branch, GAP
Tom Kenyon, MD, MPH - CDC/HHS Director, CDC- Namibia
Thomas C. Quinn, MD, M.Sc.- NIAID Senior Investigator, International HIV and STD Section
Chuck Oster, MD – NIAID Senior Medical Officer
Samuel Adeniyi-Jones, MD, Ph.D. - -NIAID Medical Officer Vaccine and Prevention
Research
Agency for Healthcare Research and Quality (AHRQ) – TBd
Michael A. Strong, Ph.D. – USAID Senior Health Program Manager Office of Population
and Health/ USAID Kenya
Michael Cassell, Ph.D., MEM, MA - USAID Primary Prevention Advisor
Glenn Post, MD, MPH - USAID Senior Medical Advisor Global Health
Nadine Rogers, Ph.D., M.S - Office of the U.S. Global AIDS Coordinator Strategic
Information Officer
Accomplished and Planned Activities to
Date
Accomplished
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Three subcommittee conference calls
Announcement in “Notes to the Field”
Planned
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Systematic review of all USG funded TE/OR activities
Country level funded mechanism for TE/OR activities
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Subcommittee review and catalogue of TE/OR activities in FY 05
COPS
Centrally funded mechanism for TE/OR activities
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Purpose:
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fill in the gaps,
quick hit to get an answer for mid-term adjustment
Tailor approaches appropriate to individual focus countries
Coordinate efforts for TA and training for TE/OR capacity building
Different models possible
SPNS Evaluation Center Model
Supports development and evaluation of innovative models of HIV care, typically
funding 5-10 demonstration sites and an Evaluation and Support Center which
provides leadership in design and evaluation of interventions including:
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Lead and facilitate the demonstration sites in refining interventions and local
evaluation
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Provide TA to the demonstration sites and responsible for developing centralized
training, communication and dissemination activities
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Conduct needs assessment of site capacity to perform intervention and participate in
cross-site evaluation activities (e.g. data collection and transfer)
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Design and conduct cross-site evaluation including development of standardized core
data elements (biologic, clinical and psychosocial outcomes)
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Develop common evaluation and research protocols
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Design and oversee initiative website, plans meetings, site visits
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Some challenges - working with existing sites that have:
diverse interventions in various stages of development
different resource needs and capacity/willingness to do evaluation
Timing of Funding
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Evaluation Center is funded prior to the demonstration sites
Example: Prevention with Positives Initiative – UCSF, Steve Morin, PI
Advantages:
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A head start on planning cross-site evaluation, communication, website and
other responsibilities
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Develop RFA for demonstration sites
Disadvantages:
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Takes longer to get interventions up and running
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Cross-site is less collaborative
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Evaluation Center is funded at the same time as the demonstration sites
Example: Caribbean Peer Support Initiative – AED, Elvis Fraser, PI
Advantages:
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Sites work with Center on development of cross site evaluation
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Interventions can start sooner
Disadvantages:
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Decision making less centralized (messy)
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Demonstration site RFA is less focused, prescriptive
NIH Pilot Projects
Concept Title
PEPFAR Program
Country
Targeted Evaluation of Antiretroviral Therapy Outcome and Acute Infection:
Building Capacity for HIV-1 Drug Resistance Surveillance in Haiti
Track 1.5
Haiti
The Effect of Baseline Polymorphisms on Development of Resistance Mutations in
Subtype G and CRF02 (A/G) in Nigerian Patients Treated with Antiretroviral Therapy
Harvard SPH
Nigeria
A Pilot Study of HIV-HBV Coinfection in PEPFAR in Nigeria: Prevalence,
Hepatotoxicity and Effects on Antiretroviral Efficacy
Harvard SPH
Nigeria
Pilot Study on Effect of Antiretroviral Therapy (ART) on Hepatitis B Viral Infection
Harvard SPH
South Africa
Economic Welfare and Quality of Life in Patients on Antiretroviral Therapy:
Implications for patient Adherence, Treatment Cost, and Sustainability of
Interventions as Evaluated in Right To Care a PEPFAR Funded Program In South
Africa
Right to Care
South Africa
Evolution and Predictors of HIV Resistance Among Persons Initiating Antiretroviral
Therapy in PEPFAR Sponsored Treatment Programs in Africa
Project Heart (Glaser)
Rwanda
Prevalence of Antiretroviral Drug Resistance in Patients Monitored by Virus Load
Versus CD4 Count: Comparative Outcome of the Harvard School of Public Health
PEPFAR Programs in Botswana and Tanzania
Harvard SPH
Botswana
Tanzania
Evaluation of the Right To Care PEPFAR Funded Treatment Programme in Gauteng
and Mpumalanga Provinces of South Africa
Right to Care
South Africa
What is the Durability of the Current WHO Recommended Second Line Regimen to
Induce Sustained Viral Suppression (24 Months or More) When Initiated After
Evidence of Treatment Failure when Defined by Virologic Failure, by Immunological
Failure or by Clinical Failure Following a Primary Thymidine Analog, Cytosine Analog
and NNRTI Regimen Treatment Regimen
AIDS Relief Consortium
Nigeria/Uganda
Investigation of the Role of Chronic Hepatitis C Virus Infection in Persons Co
infected with HIV in Nigeria
Harvard SPH
Nigeria
What is the impact of ARV care delivery systems used during the initiation of ARV
therapy on treatment durability?
AIDS Relief Consortium
Nigeria/Uganda
Focus of Emphasis
Priority 1: Clinical implications of ARV treatment scale-up
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What are optimal approaches for ensuring drug adherence and minimizing
disinhibition in Emergency Plan focus countries?
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What are the characteristics and causes of viral resistance to ARV treatment in
Emergency Plan focus countries?
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What is the differential effect on patient outcomes for ARV treatment provided by
physician versus non-physician providers?
Priority 2: Behavior change
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What is the effect of the ABC approach to prevention on HIV risk behavior in
Emergency Plan focus countries?
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What is the effect of widely available care and Tx on approaches to HIV prevention?
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What is the effect of PMTCT/PMTCT+ on HIV risk behaviors of participating mothers?
Priority 3: Care and support
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What are the components of successful care models for OVC?
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What are the components of successful palliative care models?
Other studies:
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Other studies may be conducted based on SI requirements or other needs
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Does the administration of single-dose nevirapine reduce mother-to-child
transmission in Emergency Plan focus countries?
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What are the components of a successful networked health care system?
CAVEAT: Need to listen to what the countries define as their TE/OR needs
Challenges/Considerations/Opportunities
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Time
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Gaps
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RFAs, standardized outcome measures, results
Expect new issues to be identified after FY05 COP
review and development of compendium of TE/OR
Diversity of group
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HQ + Field staff
Differing perspectives of TE/OR mission
 Program evaluation
Public health impact
 Clinical outcomes/biologic markers
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