1. Putting Policy to Practice Patrick Ndase, MD, MPH MTN Regional Physician Palomar Hotel, Washington DC June 19- 20, 2008

2. Goal: Access to care & treatment Sponsors, Researchers, Activists, & Trial participants agree that ensuring long-term access to HIV treatment and care for trial participants is an indispensable component of HIV prevention research efforts

3. Policy regarding care Must be operational Must be operational  Requires understanding of potential challenges to chosen policy challenges to chosen policy  Clearly defined pathways for ensuring access Sustainable & equitable Sustainable & equitable

4. Two main policy positions Develop effective linkages with existing ART care facilities to which participants can be referred Develop effective linkages with existing ART care facilities to which participants can be referred Creation of a separate fund by sponsors to ensure ART access when eventually needed Creation of a separate fund by sponsors to ensure ART access when eventually needed  Run vertically  Run through as an Insurance scheme  Incorporate Fund into public ART sector

5. Assessment/ Evaluation Pros If well executed, would ensure participants get timely care If well executed, would ensure participants get timely care Saves participants from overburdened public ART sector Saves participants from overburdened public ART sector Ensures ppts get based standard care available internationally Ensures ppts get based standard care available internationally A Special Fund: Cons  Fund abuse  From infection to ART, variable variable  ART for life, sustainability  Equity in considering screen-outs screen-outs  Potential attraction for “street smart” participants “street smart” participants  Stigma for trial positives

6. Fund incorporation into public sector ART program Fund a small drop into the ocean Fund a small drop into the ocean Gov’t institutions may have little regard for agreements Gov’t institutions may have little regard for agreements Staff retention in gov’t institutions Staff retention in gov’t institutions No real obligations on service providers (esp after 5-10 yrs) No real obligations on service providers (esp after 5-10 yrs)

7. Use of Local ART Referral Linkages Pros More sustainable approach More sustainable approach More in agreement with notion of voluntarism More in agreement with notion of voluntarism Equitable to all who make an effort to join study Equitable to all who make an effort to join study Not prone to abuse Not prone to abuse Cons  Overburdened ART systems systems  Local National ART standards may be short standards may be short of international ones of international ones  Local ART sites patient load increases load increases

8. MTN’s approach o Establish functional referral linkages for care o Institute good follow up mechanisms for referred o MoU with referral sites o Enhance follow up of sero-converters post- specific trials (MTN 015)

9. MTN’s approach: Referral Linkages MTN is a relatively new Network MTN is a relatively new Network  Became operational when ART landscape in developing world had changed

10. Develop specific strategies to address “cons” of chosen approach? Overburdened public ART facilities: Overburdened public ART facilities:  Develop MoU’s alongside good rapport  Sites with multiple studies (ACTG) What if local standard of care is below international standards: What if local standard of care is below international standards:  MTN 015 Sero-converter protocol (VL, CD4 & Resistance testing) Referral sites’ concern over increased patient load: Referral sites’ concern over increased patient load:  Lilongwe Physicians rotate in ART clinic

11. Approach is 100% perfect Sponsors (NIH) Sponsors (NIH) Investigators Investigators Participants Participants ? Activists ? Activists Everybody happily co-existing