1. Enhancing Community Participation in HIV Prevention Research Steve Morin, Ph.D. AIDS Policy Research Center AIDS Research Institute University of California, San Francisco

2. UCSF Research Team Stephen F. Morin T. Anne Richards Andre Maiorana Marisa McLaughlin Nicolas Sheon Kimberly Koester Karen Vernon Sheri Storey Andrew Herring

3. Acknowledgements Community Working Group Co-Chairs Janet Frohlich Mike Shriver Family Health International Stella Kirkendale Wayne Wilson

4. Specific Aims F F To assess the views of CAB and research team members regarding community consultation in HIV research F F To assess motivation and barriers to participation in prevention trials

5. Background F Community Advisory Boards (CABs) in AIDS research have their roots in AIDS activism F AZT trial in 1987 pointed to need for partnership with community F Educated and desperate people with HIV organize to demand a seat at the table

6. NIH History of CABs F Community Constituency Group formed F NIH guidance to AIDS clinical trials units to establish local CABs F Role -- to provide advice and communicate community preferences F With HIVNET, CABs go international F HPTN continues emphasis on community participation

7. Questions Do CABs work…. In the absence of organized activists? In prevention trials v. treatment trials?

8. Rapid Assessment F Goal is a preliminary, qualitative understanding F Field teams visit for five days to get picture at one point in time F Triangulation of data sources vsecondary reports vethnographic observations vsemi-structured interviews

9. Site Interviews

10. Sites Rapid Assessment - 6 month snapshot

11. Data Analysis F Interviews transcribed F Data entered into Ethnograph F Reviewed for broad themes and subthemes F Codes assigned and verified F Summaries and cross-site analysis

12. Conflicting World Views Researchers F Scientific questions F Randomized trials F Recruitment/retention F Community Participants F Basic life needs F Medical care F HIV & STD screening F Research

13. World View

14. What is the role of the CAB?

15. CAB As Bridge

16. CAB Members View of Role F Bridge, link, go-between, liaison F Provide advice on protocols F Identify potential research ideas F Clearinghouse for ethical issues F Legitimize research in communities v respond to misinformation v provide access v social marketing/public relations

17. Conflict in Role “To whom is the CAB accountable? Is it to the community? Is it to the local municipal authorities? Or, is it to the research programs? That is a gray area. That is an area we are struggling with.” -- CAB Member

18. Representation: How do you put a CAB together?

19. Broad Community Model F Cross-section of larger community (Zimbabwe & Thailand) v government officials v educators v religious leaders v NGO representatives v people living with HIV F Long term view of mission F Want sustainability

20. Population Specific Model F Needs of a specific group vAfrican Americans vWomen vIDUs vMSM F Protocol driven (Philadelphia, Birmingham) F Preparedness driven (LA, Peru)

21. Recruitment & Retention: Why do people serve on CABs?

22. CAB Motivation F Concern about impact of HIV on their community or population F Personal experience. e.g., HIV-infected F Opportunity to learn about other agencies, research, influence policy F Reimbursement -- lunch, tokens, travel and stipends F Prestige -- self worth; having something to contribute

23. Self Worth & Meaning “Just being part of something that means something. Sometimes when you are a drug user or ex-drug user. You know, being a part of something good and right means something.” -- CAB Member

24. CAB Barriers -- Recruitment F Site needs to decide on a model F Need to recruit accordingly vFind community leaders with time to commit to the project vIdentify and retain members from marginalized populations

25. CAB Barriers -- Retention F Disparities in knowledge F Practical concerns -- e.g. time, transportation, child care F Illness -- people living with HIV F Setting reasonable expectations

26. Disparities in Knowledge “It’s frustrating when you got to keep interrupting to tell them could you explain that? Or, could you talk in layman’s terms? They make you feel stupid.” -- CAB Member

27. What do CAB and research team members want from each other?

28. Research Team Wants F Feedback -- constructive criticism to help improve protocols F Limits -- help in clarifying to participants what will not be provided F Understanding -- why people do or do not participate in protocol F Access -- ability to move research into new areas -- access to communities, populations

29. CAB Wants F Validation - respect for their expertise and recommendations F Standing -- to be seen as resource for information in community F Training -- HIV, research details, translating scientific language F Feedback -- research findings to community F Action -- impatient to act now

30. Why do people participate in prevention trials?

31. Motivations F Altruism - desire to help community F Reimbursements -- need money F Access to HIV & STD testing F Access to quality medical care F Support networks F Gain knowledge about HIV

32. Barriers F Lack of knowledge about research F Distrust of medical establishment F Distrust of researchers F Fear of HIV testing F Fear of needles F HIV-related stigma F Fear of being identified with a stigmatized group

33. What is the role of the CAB in identifying and resolving ethical issues?

34. Identifying Ethical Issues F Ethical issues permeated interviews with both CAB members and research team members F CABs view themselves as protecting vulnerable people F Participants and CAB members often from poor or stigmatized groups

35. Respect for Persons -- Informed Consent CABs worked to assure that participants had adequate information about procedures and risks “People must know what are the consequences and advantages are before going into the study”

36. Problems with Informed Consent F Emphasis on forms rather than process F Individual autonomy may be a culturally bound concept F CABs see their role as protecting vulnerable people, rather than individuals protecting themselves F Little discussion of extent to which participation is voluntary; often viewed no real alternatives

37. Beneficence --Risk/Benefits F Established CABs have been involved in debate about risks and benefits of participation studies F But emerging CABs have not

38. HPTN Problem CABs identified problem of lack of treatment or social support for people who are diagnosed with HIV and not eligible for trial -- “We open that Pandora’s Box and that person is positive. What then?” -- CAB Member

39. Distributive Justice “Guinea pig” term was used by participants or CAB members at 4 sites --- “Why is a vaccine study being conducted in Peru since they might not see benefit from it.” --- “Are we being sacrificed in order to develop a better product?”

40. International Sites Research must be practical for host country -- need to leave something behind -- “Historically researchers came in, drew blood and left to write their papers.”

41. An Example F Important debatable question brought to CAB -- Should participants be give the results of CCR-5 testing? F Briefing provided by research team member in lay language with Q & A F CAB debates and outlines many reasons not to give feedback F “In the end, the CAB said you’ve got to tell people.”

42. Right to Know “...the issue wasn’t about can we predict how people are gonna react, but do people have a right to know....if you’re testing something from their bodies … these are not just people who are here for you to draw specimens from.”

43. Recommendations F Develop strategies to make CAB meetings more productive vBring debatable issues to the table vBring participants into meetings F Continuous formal and informal training to respond to disparities in knowledge vcross site networking for CAB members vTrain researchers in talking to community

44. Recommendations F Work with CABs to develop alternative methods of genuine informed consent vGreater emphasis on process vIncrease attention on voluntary participation F Community building and leadership training as part of CAB development vBefore organizing a meeting, may need to organize a community

45. Recommendations F Stipends to support CAB service vNeed to remove disincentives F Develop plans for timely feedback of research findings to communities F Develop plans for sustainability