TE/OR Subcommittee

1. TE/OR Subcommittee Presented to the Emergency Plan for AIDS Relief Scientific Steering Committee October 19, 2004

2. 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

3. Accomplished and Planned Activities to Date Accomplished • 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

4. 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

5. Timing of Funding • 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 • 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

6. NIH Pilot Projects

7. Focus of Emphasis Priority 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

8. 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