Engaging Communities of Color in Aging Research

1. Giselle Corbie-Smith, MD University of North Carolina –Chapel Hill Program on Health Disparities Sheps Center for Health Services Research NC Translational and Clinical Science Institute Engaging Communities of Color in Aging Research

2. Overview • How did we get to mandated inclusion? • Are older minorities underrepresented in research? • Influences on participation of older minorities • Role of community engagement

3. How Did We Arrive at Mandated Inclusion? • Public reports of ethical misconduct raised concerns about vulnerability in research • Nuremberg Trials • Willowbrook Study • Jewish Chronic Disease Hospital • US Public Health Study at Tuskegee • Belmont Report reinforced the need to protect groups considered vulnerable by physical, mental or social and economic circumstances

4. How Did We Arrive at Mandated Inclusion? • Little public pressure to enter clinical research due to perception of high risk and low benefit • HIV/AIDS became a pivotal event in research participation • Research seen as offering best and least costly hope to victims • AIDS victims campaigned to gain admission to clinical studies • Shift in clinical research being considered a risky burden to a prized benefit from which no one should excluded

5. Why Worry About Minority Inclusion in Clinical Research • 1993 NIH Revitalization Act • Participation of racial and ethnic minorities in clinical trials is critical for understanding and eliminating racial and ethnic health disparities • to better understand disparities in health • to improve the generalizability of research findings • Clinical research drives advances in medical care • “You gotta be in it to win it”

6. Minority Enrollment for NIH Extramural Phase III Research Protocols(Reported in FY 2003) Percentage # of protocols = 5153 n = 9,378,140 Dept. of Health and Human Services, (2004). Comprehensive Report: Tracking of Human Subjects Research Reported in FY 2002 and FY 2003.

7. Enrollment of nonwhites in heart failure randomized controlled trials Heiat A, Gross CP, Krumholz HM. Arch Intern Med. 2002; 162(15):1684.

9. Barriers to awareness Lack of education about trials Lack of dissemination of study opportunities to patients/providers Lack of knowledge about the origins of cancer Barriers to opportunity Cost Functional status Study’s duration and visit structure Time commitment Lack of or inadequate health insurance Lack of transportation Provider attitudes Barriers to acceptance Perceived harms of clinical trial participation Mistrust of research, researchers, and the medical system Fear Family considerations Barriers to Accrual Ford, Howerton, Bolen, et al. AHRQ Evidence Report. 2005

10. Promoters of accrual • Promoters of awareness • Education programs for community physicians • Adequate knowledge about study • Workshop on trials • Promoters of opportunity • Culturally relevant education about trials • Providing transportation • Promoters of acceptance • Altruism • Perceived benefits of trial participation • Incentives Ford, Howerton, Bolen, et al. AHRQ Evidence Report. 2005

11. Distrust and African Americans • Thought to stem from the history of racial discrimination and exploitation • US Public Health Service Syphilis Study at Tuskegee • Experiences extending back to slavery • Medical and surgical experimentation on slaves • Robbery of Black graves for cadavers in medical education • Current fear of hospitalization

12. African Americans and Distrust • Distrust exists among both Blacks and Whites • African Americans more likely to believe • doctors would ask them to participate in harmful research or expose them to unnecessary risks • doctors would not explain research or would treat them as part of an experiment without their consent • African Americans had 5 times odds of having highest distrust scores • Differences persisted after controlling for markers of socioeconomic status • Still need to explore the contributions of interpersonal and societal trust • Demonstrating our trustworthiness one important step in improving minority participation Corbie-Smith et al, Archives of Internal Medicine, Nov 2002

13. Social and Health Priorities of Older African Americans andLatinos • Focus group with older Latinos and African Americans, and survey of community-based organizations serving older African Americans or Latinos • Affordable housing, enough money to meet their needs, adequate transportation, and safer neighborhoods were urgent priorities for older Latinos and African Americans and superseded their health concerns • Distrust of researchers, lack of information, caregiver obligations, fear of experimentation, and lack of benefits were identified as barriers to research participation • Willing to participate if fully informed, perceive tangible benefits and congruence between the objectives of researchers and participants Nápoles-Springer et al. Research on Aging 2000; 22; 668

14. Consumer Centered Models in Mental Health Research in Older Minorities • Consult with community opinion leaders, gatekeepers, and representative consumers when designing their research • focus groups and advisory boards made up of members from the target community • improves research groups’ ability to understand community-specific recruitment/retention • collaboratively develop methods for overcoming • Include staff members who are ethnically similar to, have experience working with, or are members of the target population • may also be more sensitive to participants’ reactionsand can provide feedback • Method of anticipating respondent burden to minimize attrition • Provide feedback to the target community Arean, The Gerontologist, 2003

15. Success in longitudinal studies of aging • Use of a culturally grounded approach to recruitment and retention • Assign the same interviewers to communicate with and interview study participants for each wave of data collection. • Ensure that all interviewers are knowledgeable of cultural values and norms, possible family dynamics, and social issues within the African American community. • Provide a mechanism by way of the toll-free number for all study participants to contact the project staff at their convenience. • Allow flexibility in scheduling and/or rescheduling interviews at the participant’s convenience. Dilworth-Anderson and Williams, J Aging Health 2004; 16; 137S

16. Surface Structure PSAs on minority radio stations PSAs on television Advertisements in minority newspapers Deep Structure Radio interview with a credible host in the target market, coupled with traditional PSAs Station viewed by the target market, particular hours, and use of cable channels Include a story written about the study and investigators in credible print media, coupled with ads Surface Structure vs. Deep Structure Recruitment Strategies Resnicow et al, Ethn Dis. 1999 Winter;9(1):10-21

17. Suggestions for Effective Recruitment and Retention “Stop by when you don’t want something” Community involvement in research infrastructure Use appropriate channels of communication Demonstrate an appreciation for barriers Offer an incentive that is meaningful to participants Provide feedback and disseminate findings “Ask” people to participate

18. What Happens When You Ask? • Widely claimed that minority groups are less willing than non-Hispanic whites to participate in health research • Examined 20 health research studies • Small differences by race/ethnicity in willingness to participate • non-intervention studies: African Americans had slightly lower consent rates; Clinical and surgical interventions: slightly higher consent rates than non-Hispanic whites Wendler et al. PLoS Med.2006

19. Role of Community Involvement “If you're targeting minority groups, you have a lot of community issues that you've got to work through…buy in from churches, local, opinion leaders… I think you've got a lot more foot work to do and discussions to occur so that the community is fully aware of what the project is about because misperceptions can really destroy a study. Even if the study is done, everything is perfect, the IRB completely agrees and it's been reviewed. The study can be destroyed by misperception.” Investigator, stroke clinical trials in minority communities

20. Why Involve Communities? • Investigators bring technical knowledge about topic and expertise in research methodology • Community members bring in depth knowledge of community concerns, needs, values, and priorities • Providing the framework for study questions, • Identifying ethical concerns about the project, • Suggesting how to modify the study to increase acceptance of the research in the community, • Assuring that data collection instruments are culturally appropriate, • Promoting enrollment and retention in the study. • Input from community members can be important for understanding risks research poses and identifying most acceptable methods of ameliorating them • Enhances ability of community groups to use research results in advocating for social change

21. Examining Ethical Principles • Due to social, historical and economic contexts, ethical principles need to be examined in underserved communities • Respect for persons: Informed consent may need to be examined if participants are vulnerable in many ways and live in communities that lack economic and political power • Beneficence: Participants and community representatives may have a markedly different assessment of benefits and risks of research than researchers or IRBs • Justice: Often focuses on equitable selection of subjects; in communities where there may be multiple vulnerabilities additional issues of power, responsibility, trust, context, and history must be considered

22. Approaches to Community Involvement • Range of involvement from none to passive to active to partner/collaborators • Investigators consult with individuals “at the periphery of community cultural systems” • Investigators consult with influential community members for endorsement and support, but not advice or guidance • Investigators consult with influential community members for support, advice, and guidance, usually through an advisory board • Investigators partner with the community to define problem, identify potential solutions, and conduct research -- community as collaborator -- negotiating goals and conduct of study and analysis and use of findings • Potential for manipulation especially when involvement is limited and decision-making power of community members is absent

23. “If I do all of this and it benefits society… given the way brothers are treated [in this country] how is it going to help me?”

24. Perceptions of Research Participation • Doubt and distrust about research participation • Not sure if research participation will lead to improved health for them or their community • Aware of the disparities in health and access to care • Experiences in clinical care inform their expectation of research participation

25. How Can Investigators Ensure That Participation in Research Translates Into Tangible Benefits for Minority Communities?

26.  Rethinking Benefit • Expected outcome of participation is benefit • Potential direct benefits of receiving a particular intervention in a clinical study • Collateral benefits of study participation such as free medical care • Societal benefits that accrues to others in greater society King NMP. The Journal of Law, Medicine and Ethics 2000

27. “Societal Benefit” and Minority Communities • Disparities in health are in part determined by social and environmental inequities • Consider ways to affect socioeconomic factors • Build capacity among community leaders • Creating opportunities for employment and training • Building and supporting infrastructure • Provide the results of study findings • Take cues from international efforts • HIV/AIDS trials • NBAC guidelines on conducting trials in resource poor countries • Other nations as examples: New Zealand and Maori Corbie-Smith, et al, Archives of Internal Medicine, 2004

28. “Societal Benefit” and Minority Communities • Need a deliberate multidimensional approach • Opportunity to demonstrate our trustworthiness • Close the circle between inclusion of minorities in clinical research and disparate health outcomes • So that research participation is not another example of inequities so evident in this country

29. Types of Engagement • Investigator Initiated Community Based Research • Research Collaborations • One on one • Multiple organizations • Community Advisory Boards • Community Based Participatory Research

30. Why CBPR? • Complex health and social problems ill-suited to “outside expert” research • Increasing community and funder demands for community-driven research • Disappointing results in intervention research • Increasing understanding of importance of local and cultural context • Increasing interest in use of research to improve best practices/best process Source: hsc.unm.edu/som/fcm/cpr/docs/CBPR_Intro.ppt

31. Definition of CBPR “CBPR is a collaborative approach to research that equitably involves all partners in the research process and recognizes the unique strengths that each brings. CBPR begins with a research topic of importance to the community with the aim of combining knowledge and action for social change to improve community health and eliminate health disparities.” W.K. Kellogg Community Scholar’s Program (2001)

32. What is and is not CBPR? • CBPR is an orientation to research • a collaborative approach that changes the role of researcher and researched • CBPR is an applied approach • Goal is to influence change in community health, systems, programs, or policies • CBPR is not a method or set of methods Source: See hsc.unm.edu/som/fcm/cpr/docs/CBPR_Intro.ppt

33. Perspectives on CBPR… extremes of a continuum Community: Research as imposing on or using vs. benefiting or involving the community Academia: Community participation as largely incompatible with rigorous research

34. Community-Based Participatory Research C. helps identify key issues  Incr. motivation to participate C. helps with study design, budget, proposal submission  Incr. acceptability and “buy-in” C. gives guidance re recruitment and retention  Enhanced recruitment and retention C. helps with measures development and testing  Increased reliability and validity C. helps guide intervention development  Greater relevance and likelihood for success C. helps with data interpretation and publications  Enhanced potential for translation and dissemination Data analyzed and interpreted Translation of findings Study Designed and Funding Sought Participants recruited and retention systems implemented Measurement instruments designed and data collected Health Concerns Identified Intervention designed and implemented Intervention designed by researchers based on literature and theory Issues selected from Epid. data Design: science and feasibility Budget: research expenses Recruitment and Retention based on science and “best guesses” Measures adopted or adapted from other studies, psychometric testing Researchers report findings from analysis and publish in peer review journals Traditional Research Approach

35. Principles of CBPR Acknowledges community as a unit of identity Builds on strengths and resources within the community Facilitates a collaborative, equitable partnership in all phases of research, involving an empowering and power-sharing process that attends to social inequalities

36. Principles of CBPR Fosters co-learning and capacity building among all partners Seeks balance between knowledge generation and intervention (research and action) Focuses on the local relevance of public health problems and pays attention to the multiple determinants of health

37. Principles of CBPR • Involves a cyclical and iterative process • Disseminates results to all partners and involves them in the wider dissemination of results • Involves a long-term process, relationship and commitment to sustainability Source: Israel, Eng, Schulz, and Parker 2005

38. CBPR Tools and Approaches • Focus groups • Interviews • Windshield Tours • Community Capacity Inventory • Community Asset Maps • Risk Mapping • Community Dialogues • Photovoice Source: Minkler and Wallerstein, 2008

39. Project GRACE: Building and sustaining effective CBPR partnerships to address HIV disparities Giselle Corbie-Smith, Principal Investigator

40. How Project GRACE Started • NIH Request for Application • National Center for Minority Health and Health Disparities (NCMHD) • Community-Based Participatory Research (CBPR) • Goal to reduce/eliminate health disparities • 3 year needs assessment • Pilot intervention

41. Planned Approach to Partnership Development Stage 1: Initial mobilization Stage 2: Establishment of organizational structure Stage 3: Capacity building for action Stage 4: Planning for action Source: Florin P, Mitchell R, Stevenson J. Identifying training and technical assistance needs in community coalitions: a developmental approach. Health Educ Res 1993;8(3):417-32.

42. Stage 1: Initial Mobilization— Writing the Grant University of North Carolina at Chapel Hill invites the community to the table at the outset Community-based organization (CBO) liaison Assembled a group of CBOs to provide input Components developed by working committees Presentation to the larger community

43. Who is at the Table? • The “Community” • Subcontractors • Agency/CBO Representation • Grassroots Representation • Individual Representation

44. Stage 2: Establish Organizational Structure Research Design Sub-Committee Fiscal/ Budget Sub-Committee Membership & By-Laws Sub-Committee Nominations Sub-Committee Events Planning Sub-Committee Project GRACE Consortium Comprised of **51** organizations and **43** individuals Steering Committee Area L AHEC (Comm Outreach Spec) Nash Co. Health Dept. Better Days Ahead Nash Health Care Systems CEO (Youth LHA Supv)New Sources, Inc. (Parent LHA Supv) Citizens of Edgecombe Co. Project Momentum, Inc. (COC) East Tarboro-Princeville CDC Rocky Mount OIC (Interviewer Supv) Edgecombe Co. Health Dept. Sozo Ministries Freedom Hill Community Health Center Visions, Inc. (Process Consultants) Heritage Hospital Wright Center, Inc. NAACP, Edgecombe County UNC-Chapel Hill (Project Coordinator, PI) Communications & Publications Sub-Committee

45. The Consortium Mission To improve the health of minority and/or high-risk populations by establishing collaborative structures and processes that respond to, empower, and facilitate communities in defining and solving their own problems. Includes volunteers from many fields, including: -HIV/STI prevention and/or care services -Recreation -Edgecombe County and City Government -Private Business -Health Care Services -Mental Health Services & Support -Education & Educational Support for Youth -Character and Life Skills Training -Daycare Services -Employment assistance -Housing Assistance -Religious/Spiritual Support -Legislative Representation -Education & Educational Support for Young Adults and Adults -Local History/Genealogy for African Americans

46. Initial and ongoing multicultural “isms” training Process consultants at each community meeting Annual process evaluation Coalition building sessions Periodic retreats to address concerns, progress and strategic planning Stage 3: Capacity Building for Action

47. Stage 4: Planning for Action Identify community needs and assets to plan intervention 11 focus groups conducted 37 stakeholder interviews Intervention mapping to plan intervention Pre-test curriculum pieces Pilot test intervention

48. Planned approach has resulted in effective engagement of community members Consortium membership increased from 15 to 57 Representation from 51+ community agencies and 43 individuals 82% of steering committee reside or work in the two counties Community members chair 5 of the 6 working committees Over 100 people attended community forums Need for flexibility in by-laws, organizational structure and processes Paying close attention to organizational structure, developing by-laws and focusing on process have been crucial Lessons Learned

49. Summary • Multiple factors influence participation in research • Effective strategies are • Multidimensional • Engage target populations • Address community concerns and expectations

50. NC TraCS and Community Engagement in Translational Research Giselle Corbie-Smith, MD, MSc Deputy Director, NC TraCS Institute Director, Community Engagement Core Director, Program on Health Disparities Sheps Center www.tracs.unc.edu (866) 705-4931