Models for Community Input

1. Models for Community Input Rona Siskind Division of AIDS National Institute of Allergy and Infectious Diseases September 14, 2004

3. Division of AIDS • Established 1986 • Increase basic knowledge of the pathogenesis and transmission of the HIV • Support the development of therapies for HIV infection and its complications and co-infections • Support the development of vaccines and other prevention strategies, including topical microbicides • AIDS Clinical Trials Group (ACTG) • Established 1987 • First national multi-center research network devoted to development and evaluation of HIV/AIDS treatments

6. Chronology • Formation of AIDS Clinical Trials Group (ACTG) in 1987 • Act-Up/NY attended 7th ACTG meeting – uninvited! • Community representatives invited to the 8th ACTG meeting in 1990 • The ACTG Community Constituency Group (CCG) was formed with 22 national representatives • In 1991 CCG members were participating on protocol teams and scientific committees • By 1996 local Community Advisory Boards (CABs) were required at each ACTG site • National and local CABs required of all future networks

7. Key Lesson Learned • You can either include the community and hear from them directly, or • Exclude them from the process and hear from them indirectly!

8. Definition of Community • Investigator/scientific community • Industry • Affected community • HIV-infected and at-risk populations • Advocates • Current and former trial participants • Children/youth, pregnant women, older adults, injection drug users, transgender, etc. • Racial/ethnic minority communities • Domestic and International communities

9. Overall Goals • Build trust/acceptance of research • Information exchange – between DAIDS, researchers and community • Voice for study participants and community • Share research results with community • Allow for community role in development of research agenda and specific studies • Encourage trial participation

10. Opportunities for Community Involvement • Advisory Committees • Scientific • Outreach/education • Consultations/Websites • Subject Specific • Community Advisory Boards • National/network level • Local/site level

11. Advisory Role • Community input and guidance in all aspects of our clinical research effort • No formal or legal authority to require changes to a program or trial

12. Opportunities for Community Involvement • Advisory Committees • Scientific • Outreach/education • Consultations/Websites • Subject Specific • Community Advisory Boards • National/network level • Local/site level

13. Advisory Committee Participation • National Advisory Allergy and Infectious Diseases Council • AIDS Research Advisory Committee (ARAC) • Established by law in 1988 • Reviews progress & productivity of ongoing efforts • Identifies critical gaps in research portfolio & obstacles to progress • Approves new programs and funding levels • Of 13 members, 2 public representatives

14. Advisory Committee Participation • HIV Vaccine Communications Steering Group • Guidance on communications to educate public about HIV vaccine research, esp. racial/ethnic minority communities • Create a supportive environment for future vaccine studies • Membership: vaccine advocates, community based organizations, industry, government, communications specialists • Successes: • Identified knowledge and attitudes about HIV vaccines research • Broaden public outreach through HIV Vaccine Awareness Day • Outreach/funding to community based organizations

15. Advisory Committees: Lessons Learned • Clearly defined purpose and role • Meaningful engagement • Timely information exchange • Limited ability to represent all sectors of the community and all aspects of HIV/AIDS research • Inclusion of target communities

16. Opportunities for Community Involvement • Advisory Committees • Scientific • Outreach/education • Consultations/Websites • Subject Specific • Community Advisory Boards • National/network level • Local/site level

17. Consulations/Website Example: Reorganization of Clinical Trials Networks • Over 30 community consultations • Broadly publicized website with link for online comments • Successfully solicited broad input • Lessons learned • Engage community early on in process • Provide regular feedback • Community is larger than we think

18. Opportunities for Community Involvement • Advisory Committees • Scientific • Outreach/education • Consultations/Websites • Subject Specific • Community Advisory Boards • National/network level • Local/site level

19. What is a Community Advisory Board (CAB)? • A group of volunteers from the general public and from the diverse communities affected by AIDS • Organized to assist and advise the Division of AIDS and researchers within a given network or site

20. CAB Mission • CABs exist to ensure that the needs of the community are considered in all matters regarding the provision of research related care, program management, and the establishment of the scientific agenda …” CAB Handbook

21. Community Advisory Boards • National/Network Level • Community Constituency Groups (CCG) • National and Global Community Advisory Boards (NCAB or GCAB) • Local/Site Level • Community Advisory Boards (CAB)

22. Prototype Network Structure Executive Committee Operations Scientific Committee Scientific Committee Scientific Committee Community Advisory Board Biostatistics Domestic Sites Data Management International Sites Specialized Labs

23. What is the Value of a CAB? • DAIDS: • Trust and acceptance of research • Information exchange • Researchers: • Build trust • Recruit and retain diverse population • Facilitate acceptance/increase awareness of study • Community: • Involvement in science that effects clinical practice • Address ethical issues • Ensure appropriate/culturally sensitive information

24. Who Comprises the CAB? • Representatives from the area in which the research is being conducted • Representatives of the population involved in the research

25. CAB Membership and Structure • Each national CAB has its own bylaws • 1-2 representatives from each site within the network • Chair/co-chair and a committee structure to address specific issues • Monthly conference calls, annual retreats, national meetings • Varying degree of support through operations office – administrative, outreach, community education/training • Site CABs – monthly or bi-monthly gatherings, informal & formal meetings, lunch or dinner receptions

26. What Do/Can CABS Do? • Serve as eyes and ears of the community as it relates to conducting research • Serve as the main link between the researchers and the community

27. What Do/Can National CABS Do? • Input into the scientific agenda • Identifying research priorities • Participate in study development, e.g. informed consent, ethical issues • Develop and review educational materials • Community outreach/serve as spokespeople

28. Examples of CAB Influence • “Input tends to simplify clinic visits and reduce blood draws” • Change in eligibility criteria to allow participation of people with diabetes • Change in questionnaire to include a behavior of injection drug users that researchers were unaware of, e.g. renting needles vs. sharing them • Reduction of amount of human growth hormone given to participants to help increase compliance and reduce having participants sell it off to others, which was common at the time • Clarification in the protocol to clarify which study medications to take at one time

29. What Do/Can Local CABS Do? • Provide advice on issues affecting the conducting a clinical trial – community interest, materials, operational issues • Foster supportive environment for trial participation • Provide legitimacy to the research site • Liaison between staff and volunteers • Conflict resolution (staff/volunteer interaction) • Mentoring new CAB members

30. Components of a Successful CAB • Diverse/representative membership • Education - commitment to learn about research process & science and stay current • Ongoing and sufficient support • Clear mechanisms for information exchange • Meeting accessibility, e.g. transportation, child care • Appreciation of volunteer efforts

31. Challenges • Different knowledge-base/experience/expertise within broader community • Inclusion of “hard to reach populations,” e.g., injection drug users, racial/ethnic minorities, men who have sex with men • Global research efforts • Effective international CAB participation • Logistics, language barriers, cultural differences • Definition of community • Maintaining CAB involvement & commitment

32. Lessons Learned • Commitment of DAIDS and researchers • Clear channels of communication between DAIDS, researchers and CABs • Ongoing support and training • Administrative – conference calls, meeting summaries • Scientific training/education • Other training – developing a mission, orienting new volunteers, working with site investigators and staff

33. Lessons Learned • All network and site CABs share common concerns and goals • Value in exchange of ideas and pooled resources • Role of non-network affiliated community representatives

34. Cross-CAB Activities & Training • Information exchange across CABs • Convene cross-CAB representatives • Initiated cross-CAB calls – now self-sustained group with identifiable goals • Training • National Community Training – 1997 • Model Regional Training Program – Chicago 1998 • Community Training on Ethics in Clinical Research – 2001 • Education/Outreach • US Conference on AIDS • “Models of Community Participation” – 2002 • “What Does it Mean” – 2003” • “What’s in it for Me?” – 2004

35. New Directions • Reorganization of all DAIDS funded clinical research networks • Community involvement will remain a critical component • Additional structure being created for overarching activities • Extensive efforts to solicit community input

36. Key Lesson Learned • You can either include the community and hear from them directly, or • Exclude them from the process and hear from them indirectly!

37. Community Involvement: From Past to Present