Strategies to Increase African American Participation Power Point

Strategies to Increase Strategies to Increase African American African American Participation Participation

in Clinical Research in Clinical Research

Mona Newsome Wicks, PhD, RN Mona Newsome Wicks, PhD, RN Professor & Associate Dean for Professor & Associate Dean for

ResearchResearchRobert Wood Johnson Executive Nurse Robert Wood Johnson Executive Nurse

FellowFellowUTHSC College of NursingUTHSC College of Nursing

Presentation ObjectivesPresentation Objectives• Explain the Explain the importanceimportance of African of African American participation in clinical American participation in clinical researchresearch

• Discuss the Discuss the challenges and opportunities challenges and opportunities associated with recruiting African associated with recruiting African American participants in clinical American participants in clinical researchresearch

• Summarize Summarize effective recruitment effective recruitment strategies strategies that work in African American that work in African American communitiescommunities

Definitions Definitions "Black or African American. A person Black or African American. A person havinghaving

origins in any of the Black racial groups origins in any of the Black racial groups of of

Africa.” Africa.” U.S. Census 2000U.S. Census 2000 African-American, African American, Afro-African-American, African American, Afro-American, Black American (an American American, Black American (an American whosewhose

ancestors were born in Africa) ancestors were born in Africa) ]]

http://wordnetweb.princeton.edu/perl/webwn?s=african-americanhttp://wordnetweb.princeton.edu/perl/webwn?s=african-american

http://en.wikipedia.org/wiki/African-American_(U.S._Census)#cite_note-cen-8

Importance of Poor Importance of Poor Minority Participation in Minority Participation in

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

Importance of Poor Importance of Poor Minority Participation in Minority Participation in

Clinical TrialsClinical Trials“……more than a decade following the institution more than a decade following the institution of (the) NIH requirement, enrollment of minority of (the) NIH requirement, enrollment of minority populations into populations into cancercancer trials remains woefully trials remains woefully inadequate.”inadequate.”

Ford et al. (2005). Evid. Rep / Tech Assess., 122: 1-11.Ford et al. (2005). Evid. Rep / Tech Assess., 122: 1-11.

Health DisparitiesHealth Disparities““Eliminating health disparities will require Eliminating health disparities will require

both both individual and societal effortsindividual and societal efforts.”.”

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

Health DisparitiesHealth Disparities““A population is a health disparity population if A population is a health disparity population if there is a significant disparity in the overall rate there is a significant disparity in the overall rate of disease incidence, prevalence, morbidity, of disease incidence, prevalence, morbidity, mortality or survival rates in the population as mortality or survival rates in the population as compared to the health status of the general compared to the health status of the general populationpopulation.”.”

Minority Health and Health Disparities Research and Minority Health and Health Disparities Research and Education Act Education Act United States Public Law 106-525United States Public Law 106-525 (2000), p. 2498 (2000), p. 2498

Health Disparities Health Disparities Experienced by Experienced by

African AmericansAfrican Americans• Account for 13% of the population but Account for 13% of the population but 50% of all new HIV infections50% of all new HIV infections

• Age adjusted rate for all cancers is Age adjusted rate for all cancers is 25.4% higher than for white Americans25.4% higher than for white Americans

• Diabetes age-adjusted death rate more Diabetes age-adjusted death rate more than twice that for white Americans than twice that for white Americans (49.2 vs. 23.0 per 100,000)(49.2 vs. 23.0 per 100,000)

• Age-adjusted death rate of heart Age-adjusted death rate of heart disease 30.1% higher and stroke was disease 30.1% higher and stroke was 41.2% higher than for white Americans41.2% higher than for white Americans

Why is this issue Why is this issue important?important?

Federal MandatesFederal Mandates• NIH Revitalization Amendment 1993 NIH Revitalization Amendment 1993

– Do interventions /therapies studied Do interventions /therapies studied differentially affect women or men differentially affect women or men or members of minority groups?or members of minority groups?

– Annual reporting of gender and Annual reporting of gender and race/ethnicityrace/ethnicity

– Cost is not a legitimate reason for Cost is not a legitimate reason for excluding ethnic minoritiesexcluding ethnic minorities

Challenges: Minority Challenges: Minority Participation in Clinical Participation in Clinical

ResearchResearchInstitutional BarriersInstitutional Barriers

• Provider time Provider time constraintsconstraints

• Competing demandsCompeting demands• Trial locationTrial location

Investigator BarriersInvestigator Barriers• Cultural differencesCultural differences• Lack of knowledgeLack of knowledge• Inadequate pre-Inadequate pre-study preparationstudy preparation

(http://www.cancer.gov/newscenter/benchmarks-vol6-issue4/page1; Uybico, (http://www.cancer.gov/newscenter/benchmarks-vol6-issue4/page1; Uybico, Pavel, Gross, 2007)Pavel, Gross, 2007)

Challenges and Challenges and OpportunitiesOpportunitiesParticipant BarriersParticipant Barriers

• Distrust of Distrust of research research

• Fear of safetyFear of safety• Eligibility Eligibility criteriacriteria

• Schedule Schedule conflictsconflicts

(http://www.cancer.gov/newscenter/benchmarks-vol6-issue4/page1; Uybico, (http://www.cancer.gov/newscenter/benchmarks-vol6-issue4/page1; Uybico, Pavel, Gross, 2007)Pavel, Gross, 2007)

• Confidentiality concernsConfidentiality concerns• Poor access to medical carePoor access to medical care• Lack of knowledge of the Lack of knowledge of the benefits of participationbenefits of participation

Challenges and Challenges and OpportunitiesOpportunities

• Mistrust due to prior unethical Mistrust due to prior unethical practicespractices– A Study of Untreated Syphilis in A Study of Untreated Syphilis in the Negro Malethe Negro Male•400 African American males with 400 African American males with diagnosed syphilis and 200 uninfected diagnosed syphilis and 200 uninfected controlscontrols

•Natural progression of untreated Natural progression of untreated syphilis (1932 – 1972)syphilis (1932 – 1972)

Armstrong et al., 1999. J of Applied SociologyArmstrong et al., 1999. J of Applied Sociology


• Unethical aspects of the Unethical aspects of the Tuskegee studyTuskegee study–Participants uninformed of Participants uninformed of their conditiontheir condition

–Unknowingly transfer from Unknowingly transfer from patient to subjectpatient to subject

–Failure to provide treatmentFailure to provide treatment



• Public knowledge of Public knowledge of scientific misconductscientific misconduct–Fabrication of dataFabrication of data–Selective presentation of dataSelective presentation of data–Inappropriate generalizationInappropriate generalization–Plagiarism Plagiarism



• Unethical treatment of Unethical treatment of vulnerable groupsvulnerable groups–Little documented scientific Little documented scientific misconductmisconduct

–Complex and multi-facetedComplex and multi-faceted• Tuskegee studyTuskegee study• Slavery and segregationSlavery and segregation• Institutional racismInstitutional racism• Class issuesClass issues Armstrong et al., 1999. J of Applied SociologyArmstrong et al., 1999. J of Applied Sociology


• President Clinton’s 1997 President Clinton’s 1997 formal apology for the formal apology for the Syphilis Study at TuskegeeSyphilis Study at Tuskegee–Past injustices acknowledgedPast injustices acknowledged–Opportunity for dialogueOpportunity for dialogue

What do we know about What do we know about African Americans’ African Americans’

attitudes toward research?attitudes toward research?

Armstrong, T. D., Crum, L. D. Rieger, Armstrong, T. D., Crum, L. D. Rieger, R. H., R. H.,

Bennett, T. A., & Edwards, L. J. Bennett, T. A., & Edwards, L. J. (1999). Attitudes (1999). Attitudes

of African Americans toward of African Americans toward participation in participation in

medical research. medical research. Journal of Social Psychology, Journal of Social Psychology, 29(3), 29(3), 552-574. 552-574.

Attitudes of AA Toward Attitudes of AA Toward Participation in Medical Participation in Medical

Research Research • Focus group of all African American or Focus group of all African American or all Caucasian college studentsall Caucasian college students

• Female facilitator of the same Female facilitator of the same ethnicity/raceethnicity/race

• Key themesKey themes– Monetary incentives for time or travel or Monetary incentives for time or travel or paymentpayment

– Primary motivator for somePrimary motivator for some– Exploitation of economically disadvantagedExploitation of economically disadvantaged


Research Research • Key themesKey themes

– Researcher aspirations vs. Researcher aspirations vs. participant well-beingparticipant well-being

– Prestige and financial gain and Prestige and financial gain and lack of willingness to share lack of willingness to share benefits with participantsbenefits with participants

– Career benefits could influence Career benefits could influence interpretation of results and cause interpretation of results and cause harmharm



– Perceived social differences b/w Perceived social differences b/w researchers and participantsresearchers and participants

– Conspiracy theory (AA students)Conspiracy theory (AA students)– Bias toward including Caucasians Bias toward including Caucasians (AA students)(AA students)

– Many Caucasian students unaware of Many Caucasian students unaware of the Tuskegee Syphilis studythe Tuskegee Syphilis study



– Perceived social differences b/w Perceived social differences b/w researchers and participants researchers and participants (Caucasian students)(Caucasian students)

– Not enough attention on Not enough attention on curative/preventive treatments (AA curative/preventive treatments (AA students)students)


Research Research • Questionnaire from focus group Questionnaire from focus group themesthemes– Attitudes toward medical researchAttitudes toward medical research– Perceived risksPerceived risks– Willingness to participateWillingness to participate– Distrust of medical establishmentDistrust of medical establishment


Research Research • Sample CharacteristicsSample Characteristics

– 119 undergraduates119 undergraduates– 41% female and 59% male41% female and 59% male– 51% African American, 49% 51% African American, 49% CaucasianCaucasian

– Parent education 16.9 vs. 16.2 Parent education 16.9 vs. 16.2 yearsyears

– Household income $101K vs. $89KHousehold income $101K vs. $89K


Research Research • Overview of resultsOverview of results

– AA more distrustful of medical establishmentAA more distrustful of medical establishment– Not associated with greater unwillingness to Not associated with greater unwillingness to participateparticipate

• ConclusionsConclusions– StStuudents tend to be less informed about dents tend to be less informed about misconductmisconduct

– Less experienced in research participationLess experienced in research participation– More optimistic about participationMore optimistic about participation– Not having time more of a factor than Not having time more of a factor than incentives (AA students)incentives (AA students)


Research Research • Potential solutionsPotential solutions

– Aware of an attitude of mistrustAware of an attitude of mistrust– How does research benefit AA How does research benefit AA communitiescommunities

– Clearly and accurately report risks as Clearly and accurately report risks as well as the protection against riskswell as the protection against risks

– Meaningful involvement of ethnic Meaningful involvement of ethnic minority researchers and staffminority researchers and staff

– Large incentives may arouse suspicion; Large incentives may arouse suspicion; keep to moderate amountskeep to moderate amounts


Research Research • Potential solutionsPotential solutions

– AA may perceive less time to AA may perceive less time to participate to researchparticipate to research• Flexible scheduling for initial and Flexible scheduling for initial and follow-up contactsfollow-up contacts

• Evenings, weekends, homesEvenings, weekends, homes

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

Reasons Why AA Enroll, Reasons Why AA Enroll, Refuse to Enroll, and Refuse to Enroll, and

Voluntarily Withdraw (N=29)Voluntarily Withdraw (N=29)Sample CharacteristicsSample Characteristics• 3 Groups: 3 Groups: 100% African American100% African American• Age: Age: 63.8 vs. 62.0 vs. 50 years63.8 vs. 62.0 vs. 50 years• Education:Education: 11.9 vs. 9.6 vs. ND 11.9 vs. 9.6 vs. ND yearsyears

• Income >$20K:Income >$20K: 59% vs. 0% vs. ND59% vs. 0% vs. ND• Study info clear:Study info clear: 100% vs. 100% vs. 100% vs. 100% vs. 75%75%

• Respect:Respect: 100% vs. 100% vs. 100%100% vs. 100% vs. 100%ND=no data; those who refused to enroll did not provide these dataND=no data; those who refused to enroll did not provide these data


Voluntarily Withdraw (N=29)Voluntarily Withdraw (N=29)GroupGroup ReasonReason n(%)n(%)

Participated (n=19)

Personal Rationale for ParticipatingReduce personal risk for strokeFind a cure or help othersInfluenced By OthersEncouragement from personal MDEncouragement from family/friends

16(84)6(32)

6(32)9(47)

Withdrew (n=4) Personal Rationale for WithdrawalGuinea pig/experimentation Influenced of OthersFamily/Friends supported withdrawal and concerns about government research

4(100)

2(100)


Voluntarily Withdraw (N=29)Voluntarily Withdraw (N=29)GroupGroup ReasonReason n(%)n(%)

Refused to Participate (n=6)

Personal Rationale for ParticipatingGuinea pig/experimentationOther reasons (meds, too busy, move)Influenced By OthersGuinea pig/experimentation

2(33)3(50)

5(83)

Recruitment TriangleRecruitment Triangle

Key Family

Key Family

Members/Friends

Members/Friends

PCP/Other Healthcare

PCP/Other Healthcare

Providers

Providers

Study Study ParticipantParticipant

Successful Successful Recruitment and Recruitment and Retention in Retention in

Clinical ResearchClinical Research

Glue: trust, education, and social support

What recruitment What recruitment strategies work?strategies work?

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

Most Commonly Reported Most Commonly Reported SolutionsSolutions

• Social marketing (82%)*Social marketing (82%)*• Community outreach (80%)Community outreach (80%)• Health system recruitment (52%)*Health system recruitment (52%)*• Referrals (28%)*Referrals (28%)*

*Indicates the most successful strategies*Indicates the most successful strategies


• Social marketing (82%)*Social marketing (82%)*– Mass mailingMass mailing– Mass telephone callsMass telephone calls– Media Media

• Newspaper/magazines, Flyers, Radio, Newspaper/magazines, Flyers, Radio, TV, Newsletters, Brochures, PSA, TV, Newsletters, Brochures, PSA, Specialty Publications, OtherSpecialty Publications, Other


• Health system recruitment Health system recruitment (52%)*(52%)*– HCP asked to referHCP asked to refer– Staff recruiting in clinicStaff recruiting in clinic– Registry/patient chart reviewRegistry/patient chart review

(UyBico, Pavel, & Gross, 2007)(UyBico, Pavel, & Gross, 2007)


• Community outreach (80%)Community outreach (80%)– ChurchChurch– Community leaders or organizationsCommunity leaders or organizations– Community presentations or Community presentations or meetingsmeetings

– Health screeningsHealth screenings– Door to door canvassing Door to door canvassing – OtherOther


• Referrals (28%)*Referrals (28%)*– Referred by friends/familyReferred by friends/family– Referred by other study Referred by other study participantsparticipants

– Referred by another studyReferred by another study– Staff, employers, coworkersStaff, employers, coworkers

Gillis, et al., (2001). Gillis, et al., (2001). Recruitment and retention of Recruitment and retention of healthy minority women into healthy minority women into community-based longitudinal community-based longitudinal research. research. Journal of Women’s Health & Journal of Women’s Health & Gender-based Medicine, 10(10), Gender-based Medicine, 10(10), 77-85.77-85.

What Worked Generally?What Worked Generally?• Broadcast media = more potential Broadcast media = more potential subjects but high ineligibilitysubjects but high ineligibility

• Printed material = 2Printed material = 2ndnd largest group largest group but high ineligibilitybut high ineligibility

• Face-to-face = more European American Face-to-face = more European American women but women but high eligibilityhigh eligibility

• Direct referrals = small numbers Direct referrals = small numbers across all groupsacross all groups

• Internet = low potential subjects and Internet = low potential subjects and enrollmentenrollment

What worked for African What worked for African Americans?Americans?

• Face-to-face (72%), Face-to-face (72%), ineligibility (21%)ineligibility (21%)

• Direct referral (59%)Direct referral (59%)• Printed material and broadcast Printed material and broadcast media least effectivemedia least effective

• Low African American attrition Low African American attrition (8%)(8%)

What drew women to the What drew women to the study?study?

• Endorsement by their church, their Endorsement by their church, their child’s school, or other trusted child’s school, or other trusted agencyagency

• Ability to ask initial questions Ability to ask initial questions of data collectors and recruitersof data collectors and recruiters

• Something they did for themselvesSomething they did for themselves• I wanted to do this for my peopleI wanted to do this for my people

Why did they stay?Why did they stay?• Relationships developed with Relationships developed with data collectorsdata collectors

• Flexibility of the staffFlexibility of the staff• Felt understood and respectedFelt understood and respected

Strategic Plan on Reducing Strategic Plan on Reducing Health Disparities Health Disparities

NIH Clinical Center NIH Clinical Center • Infrastructure and outreach Infrastructure and outreach activitiesactivities– Establish active public Establish active public information/outreachinformation/outreach• Increase public awareness of research Increase public awareness of research • Eliminate misinformationEliminate misinformation• Foster positive public perceptionsFoster positive public perceptions• Present video on minority patient Present video on minority patient recruitment to community organizationsrecruitment to community organizations

• Target minority media, newspaper, Target minority media, newspaper, magazinesmagazines


NIH Clinical Center NIH Clinical Center • Infrastructure and outreach Infrastructure and outreach activitiesactivities– Tailor recruitment and referral Tailor recruitment and referral process to facilitate minority process to facilitate minority participation in clinical trialsparticipation in clinical trials• Translation services for ESL participantsTranslation services for ESL participants• Maintain an ethnically diverse staffMaintain an ethnically diverse staff• Track minority accrual and referral ratesTrack minority accrual and referral rates• Evaluate effectiveness of minority Evaluate effectiveness of minority recruitment strategiesrecruitment strategies


NIH Clinical Center NIH Clinical Center • Infrastructure and outreach Infrastructure and outreach activitiesactivities– Raise awareness among minority Raise awareness among minority patients and physicianspatients and physicians• Periodic mailings to minority physiciansPeriodic mailings to minority physicians• Present a video on minority patient Present a video on minority patient recruitment to increase understanding recruitment to increase understanding of the clinical research processof the clinical research process

• Target minority media, newspaper, Target minority media, newspaper, magazinesmagazines

Issues to ConsiderIssues to Consider• Who is your target population?Who is your target population?

– Will child care or elder care be an Will child care or elder care be an issue?issue?

– Can you collect data in the community?Can you collect data in the community?– Will transportation be an issue?Will transportation be an issue?– Can people who work shifts participate?Can people who work shifts participate?– Where does your population spend time?Where does your population spend time?

• What are the benefits and risk of What are the benefits and risk of the project for the community?the project for the community?

Issues to ConsiderIssues to Consider• What relationships do you have in What relationships do you have in the community that can facilitate the community that can facilitate recruitment?recruitment?

• Can you contribute something to the Can you contribute something to the community?community?

• How can you better prepare yourself How can you better prepare yourself or your staff to be comfortable or your staff to be comfortable interacting with diverse groups?interacting with diverse groups?

Final ThoughtsFinal Thoughts• More preparation before we design a More preparation before we design a studystudy

• Research in the African American Research in the African American community facilitated by community facilitated by communication, trust, and communication, trust, and relationship buildingrelationship building

• Importance of cultural competenceImportance of cultural competencehttp://www.hrsa.gov/culturalcompetence/http://www.hrsa.gov/culturalcompetence/

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