TE/OR Subcommittee

Presented to theEmergency Plan for AIDS Relief Scientific Steering CommitteeOctober 19, 2004

Members of the TE/OR Subcommittee 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 DateAccomplished Three subcommittee conference calls Announcement in “Notes to the Field”

Planned Systematic review of all USG funded TE/OR activities Country level funded mechanism for TE/OR activities

Subcommittee review and catalogue of TE/OR activities in FY 05 COPS

Centrally funded mechanism for TE/OR activities Purpose:

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:

Lead and facilitate the demonstration sites in refining interventions and local evaluation

Provide TA to the demonstration sites and responsible for developing centralized training, communication and dissemination activities

Conduct needs assessment of site capacity to perform intervention and participate in cross-site evaluation activities (e.g. data collection and transfer)

Design and conduct cross-site evaluation including development of standardized core data elements (biologic, clinical and psychosocial outcomes)

Develop common evaluation and research protocols Design and oversee initiative website, plans meetings, site visits

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 Funding1. Evaluation Center is funded prior to the demonstration sites

Example: Prevention with Positives Initiative – UCSF, Steve Morin, PI

Advantages: A head start on planning cross-site evaluation, communication, website and

other responsibilities Develop RFA for demonstration sites

Disadvantages: Takes longer to get interventions up and running Cross-site is less collaborative

2. Evaluation Center is funded at the same time as the demonstration sites

Example: Caribbean Peer Support Initiative – AED, Elvis Fraser, PI

Advantages: Sites work with Center on development of cross site evaluation Interventions can start sooner

Disadvantages: Decision making less centralized (messy) Demonstration site RFA is less focused, prescriptive

NIH Pilot ProjectsConcept 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

BotswanaTanzania

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 EmphasisPriority 1: Clinical implications of ARV treatment scale-up What are optimal approaches for ensuring drug adherence and minimizing disinhibition in

Emergency Plan focus countries? What are the characteristics and causes of viral resistance to ARV treatment in Emergency

Plan focus countries? What is the differential effect on patient outcomes for ARV treatment provided by physician

versus non-physician providers?

Priority 2: Behavior change     What is the effect of the ABC approach to prevention on HIV risk behavior in Emergency

Plan focus countries? What is the effect of widely available care and Tx on approaches to HIV prevention? What is the effect of PMTCT/PMTCT+ on HIV risk behaviors of participating mothers?

Priority 3: Care and support What are the components of successful care models for OVC? What are the components of successful palliative care models?

Other studies: Other studies may be conducted based on SI requirements or other needs Does the administration of single-dose nevirapine reduce mother-to-child transmission in

Emergency Plan focus countries? 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

Time RFAs, standardized outcome measures, results

Gaps Expect new issues to be identified after FY05 COP

review and development of compendium of TE/OR Diversity of group

HQ + Field staff Differing perspectives of TE/OR mission

Program evaluation Public health impact Clinical outcomes/biologic markers