Transcript Strategies to Increase African American Participation in Clinical Research Mona Newsome Wicks, PhD, RN Professor & Associate Dean for Research Robert Wood Johnson Executive Nurse.

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
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
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, AfroAmerican, Black American (an American whose
ancestors were born in Africa) ]
http://wordnetweb.princeton.edu/perl/webwn?s=african-american
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
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.
Health Disparities
“Eliminating health disparities will require both
individual and societal efforts.”
http://www.healthycarolinians.org/2010objs/elimdispar.htm
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
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
Why is this issue important?
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
Challenges: Minority Participation in
Clinical Research
Institutional Barriers
• Provider time constraints
• Competing demands
• Trial location
Investigator Barriers
• Cultural differences
• Lack of knowledge
• Inadequate pre-study
preparation
(http://www.cancer.gov/newscenter/benchmarks-vol6-issue4/page1; Uybico, Pavel, Gross, 2007)
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)
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
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
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
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
Challenges and Opportunities
• President Clinton’s 1997 formal apology
for the Syphilis Study at Tuskegee
– Past injustices acknowledged
– Opportunity for dialogue
What do we know about African
Americans’ attitudes toward research?
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.
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
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
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
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)
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
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
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)
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
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
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.
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
Reasons Why AA Enroll, Refuse to
Enroll, and Voluntarily Withdraw (N=29)
Group
Participated (n=19)
Withdrew (n=4)
Reason
n(%)
Personal Rationale for Participating
Reduce personal risk for stroke
Find a cure or help others
16(84)
6(32)
Influenced By Others
Encouragement from personal MD
Encouragement from family/friends
6(32)
9(47)
Personal Rationale for Withdrawal
Guinea pig/experimentation
4(100)
Influenced of Others
Family/Friends supported withdrawal
and concerns about government
research
2(100)
Reasons Why AA Enroll, Refuse to
Enroll, and Voluntarily Withdraw (N=29)
Group
Refused to Participate
(n=6)
Reason
n(%)
Personal Rationale for Participating
Guinea pig/experimentation
Other reasons (meds, too busy, move)
2(33)
3(50)
Influenced By Others
Guinea pig/experimentation
5(83)
Recruitment Triangle
Successful Recruitment
and Retention in Clinical
Research
Study Participant
Glue: trust, education, and social support
What recruitment strategies work?
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.
Most Commonly Reported Solutions
•
•
•
•
Social marketing (82%)*
Community outreach (80%)
Health system recruitment (52%)*
Referrals (28%)*
*Indicates the most successful strategies
Most Commonly Reported Solutions
• Social marketing (82%)*
– Mass mailing
– Mass telephone calls
– Media
• Newspaper/magazines, Flyers, Radio, TV, Newsletters,
Brochures, PSA, Specialty Publications, Other
Most Commonly Reported Solutions
• Health system recruitment (52%)*
– HCP asked to refer
– Staff recruiting in clinic
– Registry/patient chart review
(UyBico, Pavel, & Gross, 2007)
Most Commonly Reported Solutions
• Community outreach (80%)
– Church
– Community leaders or organizations
– Community presentations or meetings
– Health screenings
– Door to door canvassing
– Other
Most Commonly Reported Solutions
• Referrals (28%)*
– Referred by friends/family
– Referred by other study participants
– Referred by another study
– Staff, employers, coworkers
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.
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
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%)
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
Why did they stay?
• Relationships developed with data collectors
• Flexibility of the staff
• Felt understood and respected
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
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
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
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?
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?
Final Thoughts
• More preparation before we design a study
• Research in the African American community
facilitated by communication, trust, and
relationship building
• Importance of cultural competence
http://www.hrsa.gov/culturalcompetence/