1. Your Tax Dollars at Work: Community Participation in DAIDS Funded HIV Clinical Trials Claire Rappoport, Dwight Peavy, Hamilton Richardson and Rona Siskind HIV Research Catalyst Forum Conference Baltimore, MD April 21, 2010

2. Outline of Workshop General overview of clinical research Role of AIDS activism in the formation of community advisory boards (CABs) Engaging Community Personal perspectives on participating Discussion Role of community in the NIAID-DAIDS funded AIDS research networks and Community Partners Discussion

3. Clinical Research and the role AIDS activism had in the formation of Community Advisory Boards (CABs) Claire Rappoport HIV Research Catalyst Forum Conference Baltimore, MD April 21, 2010

4. Why is Worldwide HIV Research Important? HIV is a worldwide crisis. Research questions relevant to the person with HIV disease anywhere might be able to be answered elsewhere in the world. No single entity, group or organization has the resources to complete needed HIV/AIDS research. Different populations may need different strategies to answer the same research question (due to cultural or logistical factors.) Research vs. Treatment Research is a systematic investigation to establish fact. Treatment is the care provided to improve a clinical situation.

5. Clinical research means that it is done in people and correlates with illness and symptoms that people develop while in the trial Clinical research includes: Medical and behavioral research (involving volunteer participants) Investigations that are carefully developed and conducted with clinical outcomes recorded (ie, what happens medically to the participant) Trials that test new treatments, clinical management and outcomes, and long–term studies Strict scientific guidelines Ethical principles to protect participants What Is Clinical Research?

6. How did community get to the research table? People with HIV fought to be at the research table– why? Because it was their lives on the line! In the 1980s, AIDS activists in the U.S. and Europe demanded that researchers and regulatory authorities move more quickly to find medications to fight HIV. 1987 NIAID established its first clinical trials networkthe AIDS Clinical Trials Group but no community input was included. 1988 Meetings were convened (by Jack Killen, then Deputy Director of AIDS within NIAID) with community representatives, advocacy groups, people with HIV/AIDS, health care providers to discuss what the government should do and what types of research programs were needed (8 meetings in cities around the country; 1200-1500 people attended.) 1988 First Community Advisory Board (CAB) was established in San Francisco for the Community Consortium, a network of physicians and people with AIDS conducting community based research in clinicians offices. 1989 NIAID launched pilot project called Community Programs for Clinical Research on AIDS (CPCRA) focusing on community based/clinician led research in primary care settings. The CPCRA established the Community Constituency Group (CCG) comprised of local representatives from each of their research sites CABs. 1989 ACT-UP attended an ACTG meeting (uninvited) to voice community concerns about the research process. 1990 Community representatives were invited to an ACTG meeting and formed the Community Constituency Group (CCG), the ACTG network CAB.

7. How has AIDS Community Activism Influenced Clinical Research? Community activism in AIDS disease has changed the way that all medical research is conducted Changed the way that medical providers interact with their patients/study participants Influenced people with other diseases to fight for their rights and treatments (now it is common place) Forced the FDA to streamline their medication approval process Forced the FDA to offer expanded access to those who would not qualify for treatment otherwise AIDS activists have and continue to bring the price of HIV treatment down AIDS activists have created strategies for both bringing attention to specific diseases and creating change, by demanding the inclusion of people with the diagnosis (and/or their loved ones) in the participation in the disease research planning and resource allocation processes The list goes on…

8. Chronology of Community Involvement in NIAID-funded HIV/AIDS Research 1994 DAIDS brought together the leadership of the CCG and other network CABs that were subsequently established, to exchange ideas and concerns 1996 DAIDS convened an external panel to review network CABs NIAID required CABs at each research site affiliated with a clinical trials network 1997 First cross-network CAB training on clinical trials research 1998 Model regional training for researchers and community held in Chicago on how to establish a CAB 2001 Second cross-network CAB training on ethics in clinical research 2003 First Cross-CAB Working Group conference call Cross-CAB Working Group established 2007 Establishment of Community Partners

9. Development of a Partnership between Researchers and CABs Early on, AIDS Activists and researchers had an antagonistic relationship with activists challenging the researchers for inclusion and to be heard. As CABs developed they were comprised of individuals representing various parts of the community, such as religious groups, schools or universities, media and non- government organizations (NGOs)/community-based organizations (CBOs) and most importantly – people living with HIV and trial participants from researchers practices. Researchers and CAB members form a partnership with the establishment of a CAB with CAB members recognized for their unique expertise. These non-scientist/CAB members review protocols, watch how trials are proceeding, and help educate and inform the rest of the community. Researchers know it is important to have general support from the communities that will be involved in the research for a trial to be successful. Partnership has become the new model.

10. The National Institutes of Health (NIH) is part of the U.S. Department of Health and Human Services (DHHS). The DHHS is the primary Federal agency for conducting and supporting medical research. Composed of 27 Institutes and Centers, the NIH provides leadership and financial support to researchers in every state and throughout the world.

11. Web site: http://www.nih.govhttp://www.nih.gov

12. ACTG – AIDS Clinical Trial Network Conducts translational and therapeutic research (http://www.aactg.org) HPTN – HIV Prevention Treatment Network Develops and tests the safety and efficacy of primarily non-vaccine interventions designed to prevent the transmission of HIV (http://www.hptn.org) HVTN --HIV Vaccines Trials Network To facilitate the process of testing preventive vaccines against HIV/AIDS, conducting all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy (http://hvtn.org) IMPAACT –International Maternal Pediatric Adolescent AIDS Clinical Trials Group Develop and evaluate safe and cost effective approaches for the interruption of mother-to-infant transmission; evaluating treatments for HIV- infected children, adolescents, and pregnant women; and evaluating vaccines for the prevention of HIV sexual transmission among adolescents. (http://www.impaactgroup.org) INSIGHT- International Network for Strategic Initiatives in Global HIV Trials Defines optimal strategies for the management of HIV and other infectious diseases through a global clinical research (http://www.insight-trials.org)www.insight-trials.org MTN – Microbicides Trials Network Reduce the sexual transmission of HIV through the development and evaluation of microbicide products (http://www.mtnstopshiv.org) There are 6 HIV clinical research networks funded, in part, by DAIDS.