Strategies to Increase African American Participation in Clinical Research

1. Strategies to Increase African American Participation in Clinical Research Mona Newsome Wicks, PhD, RN Professor & Associate Dean for Research Robert Wood Johnson Executive Nurse Fellow UTHSC College of Nursing

2. Presentation Objectives • Explain the importance of African American participation in clinical research • Discuss the challenges and opportunities associated with recruiting African American participants in clinical research • Summarize effective recruitment strategies that work in African American communities

3. Definitions "Black or African American. A person having origins in any of the Black racial groups of Africa.” U.S. Census 2000 African-American, African American, Afro- American, Black American (an American whose ancestors were born in Africa) ] http://wordnetweb.princeton.edu/perl/webwn?s=african-american

4. Importance of Poor Minority Participation in Clinical Trials “Clinical research is a critical resource for the development of new prevention, diagnosis, and treatment techniques for a number of diseases….The ability to trust and apply the results of a clinical trial, as well as transfer them into clinical practice, is related to the type and number of patients enrolled in that trial. If trials do not include minorities, then there is a question of whether or not the results of the studies are relevant to everyone across the board.” http://www.cancer.gov/newscenter/benchmarks-vol6-issue4/page1

5. Importance of Poor Minority Participation in Clinical Trials “…more than a decade following the institution of (the) NIH requirement, enrollment of minority populations into cancer trials remains woefully inadequate.” Ford et al. (2005). Evid. Rep / Tech Assess., 122: 1-11.

6. Health Disparities “Eliminating health disparities will require both individual and societal efforts.” http://www.healthycarolinians.org/2010objs/elimdispar.htm

7. Health Disparities “A population is a health disparity population if there is a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality or survival rates in the population as compared to the health status of the general population.” Minority Health and Health Disparities Research and Education Act United States Public Law 106-525 (2000), p. 2498

8. Health Disparities Experienced by African Americans • Account for 13% of the population but 50% of all new HIV infections • Age adjusted rate for all cancers is 25.4% higher than for white Americans • Diabetes age-adjusted death rate more than twice that for white Americans (49.2 vs. 23.0 per 100,000) • Age-adjusted death rate of heart disease 30.1% higher and stroke was 41.2% higher than for white Americans

9. Why is this issue important?

10. Federal Mandates • NIH Revitalization Amendment 1993 • Do interventions /therapies studied differentially affect women or men or members of minority groups? • Annual reporting of gender and race/ethnicity • Cost is not a legitimate reason for excluding ethnic minorities

11. Challenges: Minority Participation in Clinical Research Institutional Barriers Investigator Barriers Cultural differences Lack of knowledge Inadequate pre-study preparation • Provider time constraints • Competing demands • Trial location (http://www.cancer.gov/newscenter/benchmarks-vol6-issue4/page1; Uybico, Pavel, Gross, 2007)

12. Challenges and Opportunities Participant Barriers • Distrust of research • Fear of safety • Eligibility criteria • Schedule conflicts • Confidentiality concerns • Poor access to medical care • Lack of knowledge of the • benefits of participation (http://www.cancer.gov/newscenter/benchmarks-vol6-issue4/page1; Uybico, Pavel, Gross, 2007)

13. Challenges and Opportunities • Mistrust due to prior unethical practices • A Study of Untreated Syphilis in the Negro Male • 400 African American males with diagnosed syphilis and 200 uninfected controls • Natural progression of untreated syphilis (1932 – 1972) Armstrong et al., 1999. J of Applied Sociology

14. Challenges and Opportunities • Unethical aspects of the Tuskegee study • Participants uninformed of their condition • Unknowingly transfer from patient to subject • Failure to provide treatment Armstrong et al., 1999. J of Applied Sociology

15. Challenges and Opportunities • Public knowledge of scientific misconduct • Fabrication of data • Selective presentation of data • Inappropriate generalization • Plagiarism Armstrong et al., 1999. J of Applied Sociology

16. Challenges and Opportunities • Unethical treatment of vulnerable groups • Little documented scientific misconduct • Complex and multi-faceted • Tuskegee study • Slavery and segregation • Institutional racism • Class issues Armstrong et al., 1999. J of Applied Sociology

17. Challenges and Opportunities • President Clinton’s 1997 formal apology for the Syphilis Study at Tuskegee • Past injustices acknowledged • Opportunity for dialogue

18. What do we know about African Americans’ attitudes toward research?

19. Armstrong, T. D., Crum, L. D. Rieger, R. H., Bennett, T. A., & Edwards, L. J. (1999). Attitudes of African Americans toward participation in medical research. Journal of Social Psychology, 29(3), 552-574.

20. Attitudes of AA Toward Participation in Medical Research • Focus group of all African American or all Caucasian college students • Female facilitator of the same ethnicity/race • Key themes • Monetary incentives for time or travel or payment • Primary motivator for some • Exploitation of economically disadvantaged

21. Attitudes of AA Toward Participation in Medical Research • Key themes • Researcher aspirations vs. participant well-being • Prestige and financial gain and lack of willingness to share benefits with participants • Career benefits could influence interpretation of results and cause harm

22. Attitudes of AA Toward Participation in Medical Research • Key themes • Perceived social differences b/w researchers and participants • Conspiracy theory (AA students) • Bias toward including Caucasians (AA students) • Many Caucasian students unaware of the Tuskegee Syphilis study

23. Attitudes of AA Toward Participation in Medical Research • Key themes • Perceived social differences b/w researchers and participants (Caucasian students) • Not enough attention on curative/preventive treatments (AA students)

24. Attitudes of AA Toward Participation in Medical Research • Questionnaire from focus group themes • Attitudes toward medical research • Perceived risks • Willingness to participate • Distrust of medical establishment

25. Attitudes of AA Toward Participation in Medical Research • Sample Characteristics • 119 undergraduates • 41% female and 59% male • 51% African American, 49% Caucasian • Parent education 16.9 vs. 16.2 years • Household income $101K vs. $89K

26. Attitudes of AA Toward Participation in Medical Research • Overview of results • AA more distrustful of medical establishment • Not associated with greater unwillingness to participate • Conclusions • Students tend to be less informed about misconduct • Less experienced in research participation • More optimistic about participation • Not having time more of a factor than incentives (AA students)

27. Attitudes of AA Toward Participation in Medical Research • Potential solutions • Aware of an attitude of mistrust • How does research benefit AA communities • Clearly and accurately report risks as well as the protection against risks • Meaningful involvement of ethnic minority researchers and staff • Large incentives may arouse suspicion; keep to moderate amounts

28. Attitudes of AA Toward Participation in Medical Research • Potential solutions • AA may perceive less time to participate to research • Flexible scheduling for initial and follow-up contacts • Evenings, weekends, homes

29. Gorelick, P. B., Harris, Y., Burnett, B., & Bonecutter, F. J. (1998). The recruitment triangle: Reasons why African Americans enroll, refuse to enroll, or voluntarily withdraw from a clinical trial. Journal of the National Medical Association, 90(3), 141-145.

30. Reasons Why AA Enroll, Refuse to Enroll, and Voluntarily Withdraw (N=29) Sample Characteristics • 3 Groups: 100% African American • Age: 63.8 vs. 62.0 vs. 50 years • Education: 11.9 vs. 9.6 vs. ND years • Income >$20K: 59% vs. 0% vs. ND • Study info clear: 100% vs. 100% vs. 75% • Respect: 100% vs. 100% vs. 100% ND=no data; those who refused to enroll did not provide these data

31. Reasons Why AA Enroll, Refuse to Enroll, and Voluntarily Withdraw (N=29)

32. Reasons Why AA Enroll, Refuse to Enroll, and Voluntarily Withdraw (N=29)

33. Recruitment Triangle Successful Recruitment and Retention in Clinical Research Key Family Members/Friends PCP/Other Healthcare Providers Study Participant Glue: trust, education, and social support

34. What recruitment strategies work?

35. Uybico, S. J., Pavel, S., & Gross, C. P. (2007). Recruiting vulnerable population into research: A systematic review of recruitment interventions. Journal of General Internal Medicine, 22, 852-863.

36. Most Commonly Reported Solutions • Social marketing (82%)* • Community outreach (80%) • Health system recruitment (52%)* • Referrals (28%)* *Indicates the most successful strategies

37. Most Commonly Reported Solutions • Social marketing (82%)* • Mass mailing • Mass telephone calls • Media • Newspaper/magazines, Flyers, Radio, TV, Newsletters, Brochures, PSA, Specialty Publications, Other

38. Most Commonly Reported Solutions • Health system recruitment (52%)* • HCP asked to refer • Staff recruiting in clinic • Registry/patient chart review (UyBico, Pavel, & Gross, 2007)

39. Most Commonly Reported Solutions • Community outreach (80%) • Church • Community leaders or organizations • Community presentations or meetings • Health screenings • Door to door canvassing • Other

40. Most Commonly Reported Solutions • Referrals (28%)* • Referred by friends/family • Referred by other study participants • Referred by another study • Staff, employers, coworkers

41. Gillis, et al., (2001). Recruitment and retention of healthy minority women into community-based longitudinal research. Journal of Women’s Health & Gender-based Medicine, 10(10), 77-85.

42. What Worked Generally? • Broadcast media = more potential subjects but high ineligibility • Printed material = 2nd largest group but high ineligibility • Face-to-face = more European American women but high eligibility • Direct referrals = small numbers across all groups • Internet = low potential subjects and enrollment

43. What worked for African Americans? • Face-to-face (72%), ineligibility (21%) • Direct referral (59%) • Printed material and broadcast media least effective • Low African American attrition (8%)

44. What drew women to the study? • Endorsement by their church, their child’s school, or other trusted agency • Ability to ask initial questions of data collectors and recruiters • Something they did for themselves • I wanted to do this for my people

45. Why did they stay? • Relationships developed with data collectors • Flexibility of the staff • Felt understood and respected

46. Strategic Plan on Reducing Health Disparities NIH Clinical Center • Infrastructure and outreach activities • Establish active public information/outreach • Increase public awareness of research • Eliminate misinformation • Foster positive public perceptions • Present video on minority patient recruitment to community organizations • Target minority media, newspaper, magazines

47. Strategic Plan on Reducing Health Disparities NIH Clinical Center • Infrastructure and outreach activities • Tailor recruitment and referral process to facilitate minority participation in clinical trials • Translation services for ESL participants • Maintain an ethnically diverse staff • Track minority accrual and referral rates • Evaluate effectiveness of minority recruitment strategies

48. Strategic Plan on Reducing Health Disparities NIH Clinical Center • Infrastructure and outreach activities • Raise awareness among minority patients and physicians • Periodic mailings to minority physicians • Present a video on minority patient recruitment to increase understanding of the clinical research process • Target minority media, newspaper, magazines

49. Issues to Consider • Who is your target population? • Will child care or elder care be an issue? • Can you collect data in the community? • Will transportation be an issue? • Can people who work shifts participate? • Where does your population spend time? • What are the benefits and risk of the project for the community?

50. Issues to Consider • What relationships do you have in the community that can facilitate recruitment? • Can you contribute something to the community? • How can you better prepare yourself or your staff to be comfortable interacting with diverse groups?