strategies to increase african american participation in clinical research mona newsome wicks, phd,...

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

in Clinical Research in Clinical Research

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

Robert Wood Johnson Executive Nurse FellowRobert Wood Johnson Executive Nurse FellowUTHSC College of NursingUTHSC College of Nursing

Presentation ObjectivesPresentation Objectives

• Explain the Explain the importanceimportance of African American of African American participation in clinical researchparticipation in clinical research

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

• Summarize Summarize effective recruitment strategies effective recruitment strategies that work in African American communitiesthat work in African American communities

Definitions Definitions

"Black or African American. A person havingBlack or African American. A person havingorigins in any of the Black racial groups of origins in any of the Black racial groups 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 whoseAmerican, Black American (an American whoseancestors 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 Minority Importance of Poor Minority Participation in Clinical TrialsParticipation in Clinical 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 Minority Importance of Poor Minority Participation in Clinical TrialsParticipation in Clinical 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 both Eliminating health disparities will require both individual and societal effortsindividual and societal efforts.”.”

http://www.healthycarolinians.org/2010objs/elimdispar.htmhttp://www.healthycarolinians.org/2010objs/elimdispar.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 Education Act Minority Health and Health Disparities Research and Education Act United United States Public Law 106-525States Public Law 106-525 (2000), p. 2498 (2000), p. 2498

Health Disparities Experienced by Health Disparities Experienced by African AmericansAfrican Americans

• Account for 13% of the population but 50% of all Account for 13% of the population but 50% of all new HIV infectionsnew HIV infections

• Age adjusted rate for all cancers is 25.4% higher Age adjusted rate for all cancers is 25.4% higher than for white Americansthan for white Americans

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

• Age-adjusted death rate of heart disease 30.1% Age-adjusted death rate of heart disease 30.1% higher and stroke was 41.2% higher than for white higher and stroke was 41.2% higher than for white AmericansAmericans

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

Federal MandatesFederal Mandates

• NIH Revitalization Amendment 1993 NIH Revitalization Amendment 1993 – Do interventions /therapies studied differentially Do interventions /therapies studied differentially

affect women or men or members of minority affect women or men or members of minority groups?groups?

– Annual reporting of gender and race/ethnicityAnnual reporting of gender and race/ethnicity– Cost is not a legitimate reason for excluding ethnic Cost is not a legitimate reason for excluding ethnic

minoritiesminorities

Challenges: Minority Participation in Challenges: Minority Participation in Clinical ResearchClinical Research

Institutional BarriersInstitutional Barriers• Provider time constraintsProvider time constraints• Competing demandsCompeting demands• Trial locationTrial location

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

preparationpreparation

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

Challenges and OpportunitiesChallenges and Opportunities

Participant BarriersParticipant Barriers• Distrust of research Distrust of research

• Fear of safetyFear of safety• Eligibility criteriaEligibility criteria• Schedule conflictsSchedule conflicts

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


• Mistrust due to prior unethical practicesMistrust due to prior unethical practices– A Study of Untreated Syphilis in the Negro MaleA Study of Untreated Syphilis in the Negro Male• 400 African American males with diagnosed syphilis 400 African American males with diagnosed syphilis

and 200 uninfected controlsand 200 uninfected controls• Natural progression of untreated syphilis (1932 – 1972)Natural progression of untreated syphilis (1932 – 1972)

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


• Unethical aspects of the Tuskegee studyUnethical aspects of the Tuskegee study– Participants uninformed of their conditionParticipants uninformed of their condition–Unknowingly transfer from patient to subjectUnknowingly transfer from patient to subject– Failure to provide treatmentFailure to provide treatment



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



• Unethical treatment of vulnerable Unethical treatment of vulnerable groupsgroups– Little documented scientific misconductLittle documented scientific misconduct– Complex and multi-facetedComplex and multi-faceted• Tuskegee studyTuskegee study• Slavery and segregationSlavery and segregation• Institutional racismInstitutional racism• Class issuesClass issues



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

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

Armstrong, T. D., Crum, L. D. Rieger, R. H., Armstrong, T. D., Crum, L. D. Rieger, R. H., Bennett, T. A., & Edwards, L. J. (1999). Attitudes Bennett, T. A., & Edwards, L. J. (1999). Attitudes of African Americans toward participation in of African Americans toward 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 Participation Attitudes of AA Toward Participation in Medical Research in Medical Research

• Focus group of all African American or all Focus group of all African American or all Caucasian college studentsCaucasian college students

• Female facilitator of the same ethnicity/raceFemale facilitator of the same ethnicity/race• Key themesKey themes– Monetary incentives for time or travel or paymentMonetary incentives for time or travel or payment– Primary motivator for somePrimary motivator for some– Exploitation of economically disadvantagedExploitation of economically disadvantaged


• Key themesKey themes– Researcher aspirations vs. participant well-beingResearcher aspirations vs. participant well-being– Prestige and financial gain and lack of willingness to Prestige and financial gain and lack of willingness to

share benefits with participantsshare benefits with participants– Career benefits could influence interpretation of Career benefits could influence interpretation of

results and cause harmresults and cause harm


• Key themesKey themes– Perceived social differences b/w researchers and Perceived social differences b/w researchers and

participantsparticipants– Conspiracy theory (AA students)Conspiracy theory (AA students)– Bias toward including Caucasians (AA students)Bias toward including Caucasians (AA students)– Many Caucasian students unaware of the Tuskegee Many Caucasian students unaware of the Tuskegee

Syphilis studySyphilis study


• Key themesKey themes– Perceived social differences b/w researchers and Perceived social differences b/w researchers and

participants (Caucasian students)participants (Caucasian students)– Not enough attention on curative/preventive Not enough attention on curative/preventive

treatments (AA students)treatments (AA students)


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


• Sample CharacteristicsSample Characteristics– 119 undergraduates119 undergraduates– 41% female and 59% male41% female and 59% male– 51% African American, 49% Caucasian51% African American, 49% Caucasian– Parent education 16.9 vs. 16.2 yearsParent education 16.9 vs. 16.2 years– Household income $101K vs. $89KHousehold income $101K vs. $89K


• Overview of resultsOverview of results– AA more distrustful of medical establishmentAA more distrustful of medical establishment– Not associated with greater unwillingness to participateNot associated with greater unwillingness to participate

• ConclusionsConclusions– StStuudents tend to be less informed about misconductdents tend to be less informed about misconduct– Less experienced in research participationLess experienced in research participation– More optimistic about participationMore optimistic about participation– Not having time more of a factor than incentives (AA Not having time more of a factor than incentives (AA

students)students)


• Potential solutionsPotential solutions– Aware of an attitude of mistrustAware of an attitude of mistrust– How does research benefit AA communitiesHow does research benefit AA communities– Clearly and accurately report risks as well as the Clearly and accurately report risks as well as the

protection against risksprotection against risks– Meaningful involvement of ethnic minority Meaningful involvement of ethnic minority

researchers and staffresearchers and staff– Large incentives may arouse suspicion; keep to Large incentives may arouse suspicion; keep to

moderate amountsmoderate amounts


• Potential solutionsPotential solutions– AA may perceive less time to participate to researchAA may perceive less time to participate to research• Flexible scheduling for initial and follow-up contactsFlexible scheduling for initial and follow-up contacts• Evenings, weekends, homesEvenings, weekends, homes

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

Reasons Why AA Enroll, Refuse to Reasons Why AA Enroll, Refuse to Enroll, and Voluntarily Withdraw (N=29)Enroll, and 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 years11.9 vs. 9.6 vs. ND years• Income >$20K:Income >$20K: 59% vs. 0% vs. ND59% vs. 0% vs. ND• Study info clear:Study info clear: 100% vs. 100% vs. 75%100% vs. 100% vs. 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


GroupGroup ReasonReason n(%)n(%)Participated (n=19) Personal Rationale for Participating

Reduce personal risk for strokeFind a cure or help others

Influenced 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)


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

Members/

Friends

Key Family

Members/

Friends PCP/Other Healthcare Providers

PCP/Other Healthcare Providers

Study ParticipantStudy Participant

Successful Recruitment Successful Recruitment and Retention in Clinical and Retention in Clinical

ResearchResearch

Glue: trust, education, and social support

What recruitment strategies work?What recruitment strategies work?

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

Most Commonly Reported SolutionsMost Commonly Reported Solutions

• 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, TV, Newsletters, Newspaper/magazines, Flyers, Radio, TV, Newsletters,

Brochures, PSA, Specialty Publications, OtherBrochures, PSA, Specialty Publications, Other


• Health system recruitment (52%)*Health system recruitment (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 meetingsCommunity presentations or meetings– 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 participantsReferred by other study participants– Referred by another studyReferred by another study– Staff, employers, coworkersStaff, employers, coworkers

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

What Worked Generally?What Worked Generally?

• Broadcast media = more potential subjects but Broadcast media = more potential subjects but high ineligibilityhigh ineligibility

• Printed material = 2Printed material = 2ndnd largest group but high largest group but high ineligibilityineligibility

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

• Direct referrals = small numbers across all groupsDirect referrals = small numbers across all groups• Internet = low potential subjects and enrollmentInternet = low potential subjects and enrollment

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

• Face-to-face (72%), ineligibility (21%)Face-to-face (72%), ineligibility (21%)• Direct referral (59%)Direct referral (59%)• Printed material and broadcast media least Printed material and broadcast media least

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

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

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

• Ability to ask initial questions of data Ability to ask initial questions of data collectors and recruiterscollectors 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 data collectorsRelationships developed with data collectors• Flexibility of the staffFlexibility of the staff• Felt understood and respectedFelt understood and respected

Strategic Plan on Reducing Health Strategic Plan on Reducing Health Disparities NIH Clinical Center Disparities NIH Clinical Center

• Infrastructure and outreach activitiesInfrastructure and outreach activities– Establish active public information/outreachEstablish active public information/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 recruitment to Present video on minority patient recruitment to

community organizationscommunity organizations• Target minority media, newspaper, magazinesTarget minority media, newspaper, magazines


• Infrastructure and outreach activitiesInfrastructure and outreach activities– Tailor recruitment and referral process to facilitate Tailor recruitment and referral process to facilitate

minority participation in clinical trialsminority participation 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 recruitment strategiesEvaluate effectiveness of minority recruitment strategies


• Infrastructure and outreach activitiesInfrastructure and outreach activities– Raise awareness among minority patients and Raise awareness among minority patients and

physiciansphysicians• Periodic mailings to minority physiciansPeriodic mailings to minority physicians• Present a video on minority patient recruitment to Present a video on minority patient recruitment to

increase understanding of the clinical research processincrease understanding of the clinical research process• Target minority media, newspaper, magazinesTarget minority media, newspaper, magazines

Issues to ConsiderIssues to Consider

• Who is your target population?Who is your target population?– Will child care or elder care be an issue?Will child care or elder care be an 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 the project What are the benefits and risk of the project for the community?for the community?

Issues to ConsiderIssues to Consider

• What relationships do you have in the What relationships do you have in the community that can facilitate recruitment?community that can facilitate recruitment?

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

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

Final ThoughtsFinal Thoughts

• More preparation before we design a studyMore preparation before we design a study

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

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

strategies to increase african american participation in clinical research mona newsome wicks, phd,...

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