Strategies to increase african american participation in clinical research
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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.

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Strategies to increase african american participation in clinical research

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

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

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


Importance of poor minority participation in clinical trials

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 trials1

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

Health Disparities

“Eliminating health disparities will require both

individual and societal efforts.”

http://www.healthycarolinians.org/2010objs/elimdispar.htm


Health disparities1

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

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

Why is this issue important?


Federal mandates

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

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)


Challenges and opportunities

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 opportunities1

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 opportunities2

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 opportunities3

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 opportunities4

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 opportunities5

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

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


Strategies to increase african american participation in clinical 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

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 research1

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 research2

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 research3

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 research4

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 research5

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 research6

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 research7

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 research8

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


Strategies to increase african american participation in clinical research

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

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 291

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


Reasons why aa enroll refuse to enroll and voluntarily withdraw n 292

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


Recruitment triangle

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


What recruitment strategies work

What recruitment strategies work?


Strategies to increase african american participation in clinical research

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

Most Commonly Reported Solutions

  • Social marketing (82%)*

  • Community outreach (80%)

  • Health system recruitment (52%)*

  • Referrals (28%)*

    *Indicates the most successful strategies


Most commonly reported solutions1

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 solutions2

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 solutions3

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 solutions4

Most Commonly Reported Solutions

  • Referrals (28%)*

    • Referred by friends/family

    • Referred by other study participants

    • Referred by another study

    • Staff, employers, coworkers


Strategies to increase african american participation in clinical research

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

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

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

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

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

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 center1

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 center2

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

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 consider1

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

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/


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