HIV Research in International Settings

1. HIV Research in International Settings Wafaa El-Sadr, MD, MPH Columbia University

2. Overview of Presentation • Status of HIV epidemic • HIV-related research • where done and who is doing it • Priority questions– implementation science • Challenges and solutions • Conclusions

3. Adults and children estimated to be living with HIV  2009 Eastern Europe & Central Asia 1.4 million [1.3 million – 1.6 million] Western & Central Europe 820 000 [720 000 – 910 000] North America 1.5 million [1.2 million – 2.0 million] East Asia 770 000 [560 000 – 1.0 million] Middle East&North Africa 460 000 [400 000 – 530 000] Caribbean 240 000 [220 000 – 270 000] South & South-East Asia 4.1 million [3.7 million – 4.6 million] Sub-Saharan Africa 22.5 million [20.9 million – 24.2 million] Central & South America 1.4 million [1.2 million – 1.6 million] Oceania 57 000 [50 000 – 64 000] Total: 33.3 million[31.4 million – 35.3 million] UNAIDS, 2010

5. Antiretroviral Therapy by Region--2001

7. Number of PLWH receiving ART in low- and middle-income countries, by region, 2002–2009 UNAIDS, 2010

8. Change in HIV Incidence UNAIDS, 2010

9. HIV Treatment Coverage in Low & Middle Income Countries WHO Towards Universal Access 2010

10. Coverage of HIV Prevention–Low Resource Countries, 2004-2009 Estimates of Coverage Unmet HIV Prevention Need HIV testing 61% 5% 20% 39% 70% Condom Use 15% 30% 9% 75% Male Circumcision 10% 25% Antiretroviral Drugs for PMTCT 9% 32% 53% 47% Contraception for PMTCT 72% 20% 14% 28% 0% 40% 60% 80% 100% 20% 2006/7 2004 Unmet HIV Prevention Need 2009 Source: UNAIDS/WHO, 2010 Adapted Ward Cates

12. CROI 2011Oral Abstracts

13. Oral Posters

14. International Scholars

15. Implementation Science The study of methods to improve the uptake, implementation and translation of research findings into routine and common practices with the goal of improving program effectiveness and optimize efficiency Know-Do Evidence to Program Gap

18. Examples of Implementation Science Questions Adapted Padian et al, JAIDS 2011

19. Countries with ICAP-Supported Programs TUNISIA Kazakhstan MOROCCO ALGERIA WESTERN LIBYA EGYPT Uzbekistan SAHARA Turkmenistan Kyrgyzstan MAURITANIA MALI Tajikistan NIGER ERITREA SENEGAL CHAD SUDAN THE DJIBOUTI GAMBIA BURKINA GUINEA GUINEA BISSAU BENIN NIGERIA TOGO ETHIOPIA COTE CENTRAL SIERRA DTVOIRE GHANA AFRICAN LEONE REPUBLIC LIBERIA CAMEROON UGANDA SOMALIA DEMOCRATIC KENYA EQUATORIAL REP. OF REPUBLIC GUINEA THE OF THE CONGO GABON CONGO (ZAIRE) RWANDA BURUNDI TANZANIA ANGOLA MALAWI ANGOLA ZAMBIA MADAGASCAR ZIMBABWE MOZAMBIQUE NAMIBIA BOTSWANA SWAZILAND LESOTHO SOUTH AFRICA

20. ICAP International Research Portfolio • 40 active protocols • 9 countries • 4 studies with a multi-country component

22. A range of methodologies… • Qualitative methods • Key informant interviews • Focus group discussions • Quantitative methods • Group randomized studies • Cohort studies • Cross-sectional surveys • Data collection • Questionnaires/interviews with patients and health workers • Data abstraction from routinely collected data • Site characteristics assessment tools

23. GCP Training • Barriers • Non- Anglophone investigators have difficulty completing GCP training • Module content and examples are US focused and not relevant to international research • Field internet connections hinder completion of web courses • Suggestions • Consider translated modules e.g. French and Portuguese • Design modules with international focus appropriate for international investigators • Adequate local training given at the time of study launch rather than required early in the process

24. The Protocol Approval Process • Multiple levels • Local and international

25. Multiple IRBs Review Processes • Synchronizing reviews,  comments and versions • If submissions are simultaneous, different IRBs will provide feedback at different times • If submissions are done consecutively, the process takes more time • Deciding which IRB to submit to first: • For example, CU IRB usually gives more comments requiring protocol changes yet requires local IRB approval before they provide final approval

26. Field implementation of IRB requirements • Getting timely approvals when there is national/MoH agenda and imperatives • Adhering to required formats e.g. having the international PI name on the consent form, which may conflict with local requirements • Using IRB stamped versions of tools • Running out of these forms

27. Local issues • Local IRBs will usually approve first time protocols within reasonable time but • Renewals/modifications may take longer in some countries • Some countries have several levels of approvals which take more time • Getting certified translators to fulfill IRB requirements can be difficult with some local dialects • Example: Changana and Macua in Mozambique

28. Example: PiCTS study • Multi-country multi-site PHE: Kenya and Tanzania under ICAP, + Namibia • Initial IRB submission done simultaneously in Oct 08 • IRB approval dates: • Kenya local IRB Jan-09 • CDC IRB Feb-09 • CU IRB Feb-09 • Tanzania • Mainland IRB Apr-09 • Zanzibar IRB Jun-09 • Several rounds of revisions

29. Interpretation of IRB Non Human Subject Research (NHSR) determination • Program evaluations can be considered NHSR even if they include interaction with human subjects (with no identifiable information) but • the determination will say ‘no interaction with human subjects’ • Publication of program evaluations may require additional approval but • This is not the case where there is no interaction with human subjects? • How to deal with publications to share local lessons learned?

31. Conclusions • Substantial advances in tackling the HIV epidemic, but many unanswered questions remain • Priority of pragmatic questions—implementation science • Need to respond to the local circumstances and needs • Importance of considering the flow of approvals • Clearer definitions and interpretation of NHSR • Challenge of non-traditional research • Establishing responsive systems for support of international research is a key priority