African-American and Hispanic perceptions of HIV vaccine clinical research: a qualitative study.

For individual use only. Duplication or distribution prohibited by law.

HIV Vaccine Clinical Research; African and Hispanic Americans

African-American and Hispanic Perceptions of HIV Vaccine Clinical Research: A Qualitative Study Lauren Toledo, MPH; Eleanor McLellan-Lemal, MA; Sonya Arreola, PhD, MPH; Chadwick Campbell, MPH; Madeline Sutton, MD, MPH Abstract Purpose. To examine perceptions of phase-I human immunodeficiency virus (HIV) vaccine trial participation among African-Americans and Hispanics in San Francisco, California. Design. Qualitative, semistructured interviews. Setting. San Francisco Department of Health. Participants. Thirty-six African-American and Hispanic men and women, 18 to 50 years of age, residing in the San Francisco Bay Area. Method. Purposive sampling using advertisements, community-based organization rosters, and snowball referrals. Thematic analysis of transcripts identified salient themes and patterns. Results. Participants viewed participation in HIV research as important; however, they held that HIV was not a health priority given limited awareness about HIV research or beliefs that only infected or high-risk persons were eligible for participation. Altruism and personal gain, trustworthy trial staff, convenient schedules and facilities, and involvement of trusted community groups in recruitment were perceived to motivate participants. Concerns about the social consequences of participating in HIV research and product-related side effects were seen as discouraging participation. Limitations include the possibility that participants in interview research have more favorable views of biomedical research than those who refuse to participate. Conclusion. Historically, African-Americans and Hispanics in the United States have had limited participation in HIV trials. Understanding their perceptions of HIV biomedical research, identifying facilitators and barriers to participation, addressing misinformation about HIV, distorted risk perceptions, HIV stigma, and providing accessible opportunities to participate are imperative to ensure health equity and generalizability of findings. (Am J Health Promot 2014;29[2]:e82–e90.) Key Words: AIDS Vaccine, Biomedical Research, Clinical Trials, AfricanAmericans, Hispanic Americans, Prevention Research. Manuscript format: research; Research purpose: descriptive; Study design: qualitative; Outcome measure: behavioral; Setting: clinical/health care; Health focus: medical self-care; Strategy: behavior change; Target population age: adults; Target population circumstances: geographic location, race/ethnicity

PURPOSE Clinical trial research adds to the body of medical knowledge by examining new ways to treat, prevent, and diagnose diseases or conditions.1 This research is conducted in a series of phases that aim to test the safety and/ or effectiveness of a drug or treatment and require increasing numbers of human volunteers (Table 1).2–4 Recruitment of adequate numbers of volunteers is essential for the success of clinical trial research.5 In the United States, African-Americans and Hispanics have historically been underrepresented among participants in biomedical clinical trials despite experiencing a disproportionate disease burden for certain diseases such as the human immunodeficiency virus (HIV).5,6 Ensuring that representative numbers of African-Americans and Hispanics are enrolled in clinical trials allows researchers to evaluate disease treatments and prevention in subsegments of the population, provides information regarding the generalizability of outcomes and appropriately targeted therapeutic responses, and

Lauren Toledo, MPH, is with ICF International, Atlanta, Georgia. Lauren Toledo, MPH; Eleanor McLellan-Lemal, MA; and Madeline Sutton, MD, MPH, are with the Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia. Sonya Arreola, PhD, MPH, is with the Urban Health Program, Research Triangle Institute, San Francisco, California. Chadwick Campbell, MPH, is with the Center for Research and Education on Gender and Sexuality, San Francisco State University, San Francisco, California. Send reprint requests to Lauren Toledo, MPH, ICF International, Centers for Disease Control and Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Division of HIV/AIDS Prevention, Epidemiology Branch, 1600 Clifton Rd, MS E-45, Atlanta, GA 30333; [email protected]. This manuscript was submitted January 25, 2013; revisions were requested April 8 and July 24, 2013; the manuscript was accepted for publication August 1, 2013. Copyright Ó 2014 by American Journal of Health Promotion, Inc. 0890-1171/14/$5.00 þ 0 DOI: 10.4278/ajhp.130125-QUAL-48

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American Journal of Health Promotion

November/December 2014, Vol. 29, No. 2


Table 1 Phases of Clinical Trials Involving Human Subjects* Phase I No. of volunteers Volunteer type General HIV vaccine trials Purpose General

HIV vaccine trials (compare HIV vaccine to control or placebo)

Duration General HIV vaccine trials

Phase II

Phase III

20–80

Few dozen to 300

Healthy Healthy, uninfected, low HIV risk

Have a certain disease or condition Have a certain disease or condition Healthy, uninfected, varying degrees of Healthy, uninfected, high HIV risk HIV risk

Evaluate safety, determine a safe dosage range, and identify side effects

Evaluate effectiveness and further evaluate safety

Provide information about vaccine safety and initial data on the dose and administration schedule

Characterize vaccine safety and immune response caused by the vaccine Examine further questions about dosage range and scheduling of injections

1 mo 12–18 mo

Several months 2þ y

.300

Confirm effectiveness, monitor side effects, compare test treatment/drug to commonly used treatments/drugs, and collect information to allow the drug or treatment to be used safely Further assess vaccine effectiveness in preventing HIV infection

Several years 3–5 y

* Table adapted from Clinical Trial Phases (http://www.nlm.nih.gov/services/ctphases.html), The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective (http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm), and Phases of Testing and Clinical Trials (http://www.hvtn.org/ science/phases.html). HIV indicates human immunodeficiency virus.

addresses health equity by increasing these groups’ access to information and potential innovations in prevention and treatment.7–9 Guidelines published by the National Institutes of Health in 1994 mandated the inclusion of minority participants in clinical research,10 prompting many researchers to identify barriers to enrollment for these populations and to develop strategies to engage minorities in research. These studies identified barriers such as mistrust, lack of information about clinical trials and HIV disease origin, and concerns about the trial intervention (e.g., perceived harms associated with trial participation), experimentation, side effects, confidentiality, travel distances to clinics, loss of time or income, and the negative social consequences of participation such as discrimination or social disapproval from peers.5,8,11–14 Although barriers to participation have been identified, recent publications regarding clinical trial enrollment have shown mixed results regarding inclusion of African-American and Hispanic participants.9,15,16 An examination of demographic data provided by two of the largest phase-I


clinical trial facilities in the United States found that African-American and Hispanic participation was greater than that of whites (63.9% vs. 36.1%).9 A review of phase-III trials funded by the National Institute of Neurological Disorders and Stroke revealed that while the fraction of African-Americans participating in these studies had increased since 1995 and exceeded their proportional representation in the general population, Hispanics were underrepresented and enrollment had decreased.15 A review of phase-I and phase-II HIV trials conducted between 1988 and 2002 with healthy, low-risk adults showed that minorities (including African-Americans, Hispanics, Asians, Pacific Islanders, Native Americans) accounted for only 17% of total enrollment.16 Although the U.S. Department of Health and Human Services collects information about clinical trials with human subjects,17,18 no centralized database with detailed information about clinical trial volunteer demographics exists to monitor trends in participation over time. African-Americans and Hispanics account for 12.6% and 16.3% of the U.S. population, respectively,19 yet in

2009, 44% of new HIV infections were among African-Americans and 20% were among Hispanics.20 This disproportionate representation highlights the vital need to engage AfricanAmericans and Hispanics in HIV clinical trial research if we hope to better understand and curb the epidemic. More than 60% of incident HIV infections in African-American and Hispanic communities are attributed to male-to-male sexual contact.21 Enrollment of healthy African-American and Hispanic volunteers in HIV clinical trials may remain limited owing to the stigma carried by HIV and homosexuality in these communities.22–24 In addition, as demonstrated in an analysis of HIV Vaccine Trial Network screening data, African-Americans and Hispanics who met medical criteria for enrollment were more likely than whites to discontinue or be found ineligible by study staff during screening.25 As efforts to identify effective biomedical solutions to the HIV epidemic intensify, more clinical trials will require the participation of representative numbers of African-Americans and Hispanics in the United States. Learn-


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Table 2 Interview Guide Questions, Project Embrace/Brazos Abiertos Study, 2005–2006* Self-identification Please tell me how you would describe yourself. How do you see yourself within the communities with which you feel most connected? Vaccine and HIV-AIDS knowledge I would like to get a general idea of your understanding of vaccines and HIV. Please tell me what you know about vaccines in general. Please tell me what you know about HIV/AIDS. What do you know about HIV vaccines? Perceptions of HIV and HIV clinical trials Please describe how you see HIV in relation to other health concerns in your life. What do you know about HIV vaccine research studies in San Francisco? Whom do you believe is likely to take part in these studies? What are your thoughts on HIV vaccine research studies being conducted with AfricanAmericans/Hispanics? Motivators and barriers to participation in HIV clinical trials Describe how you think your family and friends would react if they found out you were thinking of participating in an HIV vaccine research study. What are barriers to taking part in HIV vaccine research studies? What are the biggest concerns you would have in taking part in an HIV vaccine research studies? What are reasons for taking part in HIV vaccine research studies? What do you believe would encourage (African-Americans/Hispanics) to take part in research studies? Recommended recruitment strategies for African-American and Hispanic clinical trial participants What qualities would you consider important for vaccine research staff recruiting (AfricanAmericans/Hispanics) for HIV vaccine studies? What strategies would you recommend for recruiting (African-Americans/Hispanics) for HIV vaccine research studies? What would be the best way to increase participation of (African-Americans/Hispanics) in HIV vaccine research studies? * HIV indicates human immunodeficiency virus; and AIDS, acquired immune deficiency syndrome.

ing how African-Americans and Hispanics perceive participation in phase-I clinical trials is an important step towards addressing concerns of potential participants, identifying inclusionary recruitment tactics, and limiting loss to follow-up. Recognizing and addressing barriers to enrollment of low-risk participants in phase-I trials may also help inform recruitment strategies for phase-II and phase-III trials that face the additional challenge of enrolling participants with higher risk for HIV infection.26 To identify preferred methods of recruitment for future clinical trials, this qualitative study explored how African-Americans and Hispanics living in the San Francisco Bay area perceived HIV disease and phase-I HIV vaccine clinical trials and solicited information on motivators and barriers to participation.

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DESIGN AND SETTING This study used a cross-sectional qualitative design. Staff from the San Francisco Department of Public Health (SFDPH) and two of the study authors (S.A., C.C.) along with a small staff of outreach workers, community educators, and data collectors, conducted face-to-face, semistructured interviews in the SFDPH offices from November 2005 to March 2006 (see Table 2 for interview guide). All study-related staff had extensive training and experience with in-depth interviewing techniques and clinical trial recruitment in the San Francisco Bay Area. During the period in which the study was conducted, six phase-I HIV vaccine trials were actively recruiting and enrolling volunteers in the San Francisco Bay area and four were in the planning stages.

Participants To be eligible to take part in the study, persons had to be between 18 and 50 years of age, self-identify as African-American and/or Hispanic, and reside within the San Francisco Bay area. Participants were recruited by using the standard outreach and advertising approaches used by the HIV Research Section of the SFDPH for clinical trial recruitment, including advertisements in national and local publications, on kiosks, bus shelters, billboards, and postcards; street-based outreach; snowball referrals from participants; and networking with advocacy groups and community organizations that provided direct services to African-American and Hispanic men and women. All participants contacted by study staff agreed to participate. A theoretical sampling approach was used to determine the point at which no new information or themes were emerging from the interviews and interviewing could be discontinued. Theoretical sampling focuses on uncovering a full range of knowledge, experiences, and attitudes theorized to be relevant to the research question. It emphasizes the importance of selecting a sampling element, such as a person or a social setting, on the basis of its likely contribution of theory to the research.27 We reached theoretical saturation for all interview questions after conducting 36 interviews. Method Data Collection. The ethical review boards of the University of California, San Francisco and the Centers for Disease Control and Prevention reviewed and approved the research protocol and survey instruments. Interviewers obtained verbal informed consent to participate in a recorded interview from all participants and offered to interview and consent in either English or Spanish for Hispanic participants. When possible, the interviewers were matched to participants by race/ethnicity and sex. Interviews lasted 60 to 120 minutes; participants were provided an incentive of $50 for taking part in the study. Data Analysis. A transcription service transcribed audio recordings of all interviews verbatim and a study team


For individual use only. Duplication or distribution prohibited by law. vides additional demographic information.

Table 3

Demographic Characteristics of Participants, Project Embrace/Brazos Abiertos*

Sex Male Female Age categories, y 18–24 25–34 34–44 45–50 Not reported Sexuality MSM/WSW MSW/WSM Not reported HIV status HIV uninfected HIV infected Not reported

African-American (n ¼ 18, 50%)

Hispanic (n ¼ 18, 50%)

Total (N ¼ 36, 100%)

9 (25%) 9 (25%)

11 (31%) 7 (19%)

20 (56%) 16 (44%)

4 5 6 3 0

(11%) (14%) (17%) (8%) (0%)

1 9 3 0 5

(3%) (25%) (8%) (0%) (14%)

5 14 9 3 5

(14%) (39%) (25%) (8%) (14%)

9 (25%) 9 (25%) 0 (0%)

8 (22%) 8 (22%) 2 (6%)

17 (47%) 17 (47%) 2 (6%)

1 (3%) 4 (11%) 13 (36%)

0 0 18 (50%)

1 (3%) 4 (11%) 31 (86%)

* MSM/WSW indicates men who have sex with men/women who have sex with women; MSW/ WSM, men who have sex with women/women who have sex with men; and HIV, human immunodeficiency virus.

member reviewed the transcriptions for accuracy. Two authors (L.T., E.ML.) experienced in qualitative coding and data analysis analyzed transcripts by using AnSWR: Analysis Software for Word-Based Records (Centers for Disease Control and Prevention, Atlanta, Georgia).28 The first author applied structural codes to the data to identify each interview question and the participant’s response.29 The first four authors thoroughly reviewed the transcripts and provided insight into the creation of an emergent, data-driven coding lexicon. The first author then applied the codes in AnSWR. While no intercoder agreement assessments were carried out, the first author used an iterative coding process whereby code definitions were reviewed, confirmed, and revised as necessary with each pass of the data to ensure that all relevant data had been coded and that the codes were applied consistently and correctly throughout the analysis and aligned with the final codebook. The analysis and interpretation process focused on identifying salient and cooccurring concepts, which the first two authors then categorized into broader, more abstract thematic categories. Although the interview guide also asked


about participants’ self-identity and HIV and vaccine knowledge, our thematic analysis focused on three domains of inquiry: (1) perceptions of HIV and HIV clinical trials, (2) motivators and barriers to participation in HIV clinical trials, and (3) recommended recruitment strategies for African-American and Hispanic clinical trial participants.

RESULTS Participant Characteristics We interviewed 36 persons (18 African-Americans, 18 Hispanics). The age ranges for participants were as follows: 14% (n ¼ 5) were aged 18 to 24 years, 39% (n ¼ 14) were aged 25 to 34 years, 25% (n ¼ 9) were aged 35 to 44 years, 8% (n ¼ 3) were aged 45 to 50 years, and 14% (n ¼ 5) did not report an age group. Fifty-six percent (n ¼ 20) of participants were male, 47% identified as men who have sex with men (MSM) or women who have sex with women (WSW), and 47% as men who have sex with women (MSW) or women who have sex with men (WSM). Eleven percent of participants reported they were HIV seropositive and 86% had an undisclosed HIV status. Table 3 pro-

Thematic Analysis Perceptions of HIV and HIV Clinical Trials. Our thematic analysis identified four dominant perceptions of HIV and HIV clinical trials: (1) HIV infection is not a health priority; (2) people have limited information or uncertainties about HIV clinical trials, in particular how an HIV vaccine works; (3) HIV research is for infected persons and non-Hispanic white MSM; and (4) African-American and Hispanic participation in HIV vaccine research is important and valuable both to ensure that these groups receive trial benefits and to guarantee scientific rigor. HIV Is Not a Health Priority. Many participants expressed that they did not consider HIV infection a health priority, especially when comparing it with other health issues that they perceived to be of more importance to their everyday lives, such as hypertension or cancer. These participants perceived their risk for HIV infection to be low and thought that they did not frequently encounter or associate with persons living with HIV infection (PLWHIV). One African-American WSM noted, ‘‘I know a lot of people who have had cancer or who have family members who have died from cancer or [are] going through remission—that’s probably a bigger concern, generally.’’ Participants indicated that HIV was rarely discussed in their communities. They thought this reluctance to talk about HIV was fueled by the stigma surrounding an HIV diagnosis and its connection to homosexuality, intravenous drug use, and risky sexual behaviors. Having Limited Information or Uncertainties About Research. Participants reported being uninformed about HIV vaccine research occurring in the San Francisco Bay area and knew few details about the HIV vaccine research process. Some guessed that researchers enrolled subjects to ‘‘try a vaccine to see if it works’’ or that researchers would enroll ‘‘a bunch of people and run tests on them.’’ Their thoughts varied on whether vaccine trial participants were HIV uninfected, HIV infected, or both. One Hispanic MSM stated, ‘‘As far as how this vaccine


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For individual use only. Duplication or distribution prohibited by law. works, I don’t know. I don’t know if it’s for people that don’t have HIV and it stops [them] from getting it. . .or if [the studies are] with people that already have HIV and. . .the vaccine is going to kill the virus.’’ HIV Research Is for Infected Persons and Non-Hispanic White MSM. Participants said that persons who believed that they were at risk for HIV or could personally benefit from HIV treatment would be more likely to participate in HIV research. Many participants, such as an African-American WSM, thought non-racial/ethnic minorities best fit into this category, ‘‘White gay men. . .– they are the group that is more common with HIV and AIDS and they’re more educated about HIV and AIDS in a lot of ways. . ..They feel like they could definitely benefit from the study.’’ Some participants viewed PLWHIV as more likely to be interested in taking part in a trial either because they believed that the vaccine was meant to treat (‘‘How could I participate if I am not infected?’’ – Hispanic WSM) or did not have to worry about getting HIV from the vaccine (‘‘As a positive person, I’m already exposed. I have less to risk than if I came in negative.’’ – African-American MSM). Importance and Value of Including Minorities in Research. A commonly held belief was that African-Americans and Hispanics had previously not enjoyed the benefits of clinical research because they had been excluded from participating. Participants stressed the value of the participation of minority groups in HIV vaccine research, including the advantage of having access to and knowledge of, new, effective interventions as well as the importance of having racially and ethnically diverse study samples in order to achieve more accurate study results. As one Hispanic WSW noted, ‘‘If people really want to participate. . .they absolutely should. I think it’s good that people of color have access again if they want it. . .That way, if and when they do find the right vaccine, one that works, then we’ll get it too. . .If it was just white people being part of this research. . .then, it will be. . .their little secret, they will have access first. . ..If you’re on the inside, if you are part of the research, then you will know everything. You’ll be in the

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know. . .People of color might have different habits, and I know AfricanAmericans specifically will get sickle cell anemia, and Hispanics and blacks have a higher tendency to get diabetes. . .Not that you would necessarily need a vaccine for white people and one for people of color. . .but it’s really important that. . .everybody, children, every walk of life, be a part of the research for the vaccine because you need to know how it works in different people, different races.’’ Participants emphasized that research focused exclusively on minorities was not desirable, as illustrated by this African-American WSW’s comment, ‘‘Just as long as it’s not done exclusively in [the] African-American or Hispanic community, I’m okay with that. I guess I would feel like it would be more of like a black sheep type of thing if it was done only for [those groups]. I mean everybody should have that knowledge.’’ Motivators and Barriers to Participation in HIV Trials. We found that motivators and barriers to trial participation were aligned with five themes: (1) fear of association and potential social consequences, (2) altruism and personal gains, (3) rapport with and trust in trial staff to provide accurate information about the study, (4) side-effect concerns, and (5) convenient visit schedules and facility access. Fear of Association and Social Consequences. Participants expressed concern about how participation in an HIV study would affect their reputations among peers, who may assume they were HIV positive or engaging in highrisk behaviors, such as homosexual sex or intravenous drug use (‘‘There’s a fear of association’’ – Hispanic MSM). Some participants noted that persons who did not feel at risk for HIV would especially have no desire to subject themselves to such negative interpersonal and social consequences. A Hispanic MSM explained, ‘‘[HIV is] the big taboo in the Latino community. ‘HIV is only for gays. I’m not that way, so, in the first place I’m never going to get HIV because it doesn’t run in the group that I hang out with. I only hang out with straight people so therefore there’s no way I can get HIV’. . .There’s no way for them to get HIV so

therefore it stops them from getting tested or participating in these kind of trials, because if they do then everybody will find out, ‘Oh! You slept with a man.’’’ Despite having concerns about the social repercussions of HIV research participation, most participants indicated that once they had reached a decision to take part in a vaccine study, the opinions of their friends and family would no longer matter. However, Hispanic participants were more likely to say that their families could cause them to reconsider enrollment to avoid upsetting family members or creating familial conflict. Altruism and Personal Gain. Most participants perceived that participation in HIV vaccine research was motivated by altruism, or a desire to have a role in contributing toward the ‘‘greater good,’’ or personal gain, including receiving a monetary incentive and protection against HIV infection. An African-American WSW explained that her motivation to participate was ‘‘Because it’s going to just help people at large. . .That’s why I would be interested in doing it. Because I know that, the little needle stick may hurt like a little bit but I may be helping them. Because of my blood type or because of a combination of things that’s going to help them make a better drug to help people to maybe keep more people around [and] I mean, money, let’s face it everybody would like money. . .I mean I think it would be unrealistic to expect a large number of people and pay them no money.’’ An African-American MSM noted, ‘‘[People] want to participate because of the big picture. . .in the long run it would help our community. So they want to help our community. Um, again, incentives. [The] hope that. . .that [participants] will learn and that they’ll be, you know, vaccinated against. . .contracting HIV. And I think the hope of one day, being able to have sex with someone without the fear of HIV, of death.’’ Rapport With and Trust in Study Staff to Provide Information. The most commonly cited participation barrier was a lack of understanding about what occurs during a vaccine study. Participants, such as this Hispanic MSM, stated that they wanted to fully under-


For individual use only. Duplication or distribution prohibited by law. stand the research process before committing to participation, ‘‘Make sure they explain what are they doing [sic], explain the risks, talk about myths. . .not being well informed, I think that will prevent anyone from not being a part of it.’’ Participants noted that the promise of positive interactions with research staff that were open and upfront about potential risks could influence participation interest. When asked what would encourage Hispanics to participate in HIV clinical trials, a Hispanic WSW explained, ‘‘[Latinos should participate] for a cure. But [the research team] should also tell the person who is going to participate about all of the risks that they run by getting the vaccine, if they could get sick or if there aren’t any risks. The researchers need to be completely frank with the person who is going to participate in the study.’’ The ability to relate to or identify with study recruiters was also an important motivator for participants, such as having shared race/ethnicity and clothing styles, as well as using recruiters from the community. Hispanic participants also mentioned the importance of having Spanish-speaking or bilingual recruiters. Ideal recruiters were described as ‘‘people persons’’ and good listeners who could convey information about a study in a conversational tone without lecturing or preaching. Participants also noted the importance of recruiters who genuinely believed in the research they were promoting. A Hispanic MSW man explained that ‘‘[a good recruiter would be] someone with a lot of energy, somebody that can know how to talk. . .he likes what he does. . .Somebody that can give you a message, not making you listen. . .but [who can] have a conversation. . .interactive kind of people.’’ Hispanic participants were more likely to stress a preference for recruiters who were nonjudgmental of their lifestyles and personal situations. This Hispanic MSM noted, ‘‘[Recruiters should be] just really sensitive. . .not just culturally, but sensitive, humanly. There’s just no judging. . .We’re not here judging anyone. . .That you care, that you’re not judging.’’


Participants indicated that building rapport and trusting relationships with study staff might mitigate the negative impact of historical research injustices on willingness to participate. Cited injustices included the Tuskegee trial, forced sterilization, discrimination, and singling out by the medical community. This African-American MSW explains, ‘‘I was just thinking the other day about the dreaded Tuskegee experiment, years ago. . ..[Scientists] still do weird stuff like that. It’s just, you know, we don’t know about it. So I don’t doubt for a moment there’s some type of Tuskegee experiment going on right now somewhere in the world. . .I just have to be convinced in some kind of way, supernaturally convinced that they know what they’re doing and this is safe, it’s for a good purpose.’’ Side Effect Concerns. Possible vaccineinduced side effects concerned many participants (‘‘You can have twenty side effects. . .You can get a rash, you can get sleepless[ness], can lose your appetite, fatigue, all kinds of things.’’ – African-American MSM). There was also the perception among participants that volunteers would be exposed to HIV, either through the vaccine itself or other research procedures, as opposed to personal risk-taking behaviors. One Hispanic WSM commented, ‘‘If I had to actually be exposed, which I would imagine I would be exposed to HIV, the potential to be sick, that would be the greatest deterrent for me. I wouldn’t do it. And again, I guess it’s because I don’t feel particularly affected by [HIV] and I feel that I’d rather put my energy and attention to other things without risking damaging my health.’’ Convenience. African-American participants were more likely than Hispanics to mention the importance of a convenient enrollment and attendance schedule (‘‘anything that can make it less of a hassle, convenient, smooth is always a wonderful incentive’’ – African-American WSM). These participants noted that people have various obligations and priorities that could hinder their ability to participate, such as this Hispanic woman who shared, ‘‘I’m with my boyfriend, he has a daughter, I helped raise her. My mother has mental problems some-

times and so I help with her too, I financially help her, I emotionally help her. I have two little sisters and they count on me. I feel like I have a lot of personal responsibilities.’’ Having the research office in the community, flexible office visit schedules, compensation for travel to the study office, and being mindful of a participant’s time were all perceived to positively impact one’s decision to participate. This African-American MSM who was involved in HIV outreach emphasized, ‘‘I think if we went to [the participants it would make it easier for them to take part]. . .But a lot of times that’s not our number one priority, it’s asking a lot on the [participant] to come in. . .Sometimes we need to go to them and have those conversations. Inconvenience ourselves more than they would be inconvenienced.’’ Recommended Recruitment Strategies. Recommendations for improving recruitment strategies to increase African-American and Hispanic clinical trial participation included the provision of HIV educational information as well as details about the research study. Participants suggested that recruitment messages should emphasize an individual’s risk for HIV (‘‘Get more [in] their heads that it’s a reality, HIV can attack anybody’’ – Hispanic MSM) and provide transparent information about participation (‘‘all the details and specifics about what exactly it takes, what’s going on, risks and everything’’ – Hispanic male). Hispanic participants expressed preference for messages provided in Spanish. In addition, it was perceived that involving community groups and organizations in recruitment efforts would reach greater numbers of AfricanAmericans and Hispanics and increase feelings of trust towards the researchers.

CONCLUSION In the United States, while growing numbers of minorities may be participating in some clinical trials, achieving optimal participation for trials of biomedical interventions to prevent HIV infection (e.g., vaccines, microbicides) may still pose a challenge that requires attention. Even though minorities may


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For individual use only. Duplication or distribution prohibited by law. view the inclusion of diverse racial and ethnic groups in research as valuable, other factors such as misinformation, low perceived risk for HIV, HIV stigma, researchers’ lack of cultural competence, and inconvenient study locations or hours may continue to present barriers to participation. As Newman, et al.30 suggest, researchers must first understand the public discourse surrounding HIV vaccine trials by consulting with the community to develop successful knowledge translation and continued community engagement in the HIV vaccine research process. Similar to other qualitative studies examining barriers and motivations to research participation among AfricanAmerican and Hispanic adults,13,31 our findings suggest that although some African-Americans and Hispanics have concerns about past research injustices, they view the inclusion of minorities in HIV clinical trials as important. Participants in the present study who were wary of research targeting minorities noted the importance of not singling out particular racial ethnic and racial groups. This finding suggests that researchers may be able to address mistrust and lack of information or misinformation to develop comprehensive and comprehensible explanations regarding the who, what, when, why, and how details about a trial to reduce participation barriers. In addition, particular attention should be given to forming culturally and racially diverse research teams and relying on trusted community organizations in the recruitment process. Other studies have demonstrated that minorities are less aware of clinical trials than whites and they tend to lack information about clinical trials when awareness is present.32,33 Not only were participants in this study unaware of research taking place, they were also unclear about eligibility requirements of participants in an HIV vaccine trial and how HIV vaccines provide protection against disease. This lack of information may be influential in heightening concerns about vaccineinduced exposure and seropositivity or infection as a result of study procedures. Participants shared that HIV is perceived to be a disease primarily of gay men and drug users. They indicated

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that this belief enables potential participants to disassociate themselves from risk, to not prioritize HIV as a personal health issue, and thus lessens willingness to participate in HIV vaccine trials. The stigma surrounding HIV and homosexuality was identified as a notable barrier to participation. Participants feared that association with an HIV study equaled an admission of high-risk behavior or a positive HIV status and were concerned that it could have potential negative effects on interpersonal relationships. Implementation of strategies to increase community-level awareness may help mitigate perceptions toward and experiences of social burdens due to study participation. Such tailored strategies would necessitate a multilevel approach, such as one described by Corbie-Smith et al.,34 that includes initiating early communication about upcoming trials, detailed descriptions of the research process, and trialspecific requirements for participation. Collaboration between researchers and trusted local organizations could facilitate this process. Additionally, targeted recruitment campaigns should feature multicultural images, emphasize altruistic motivations, and employ culturally competent and diverse staff that can relate to potential participants. Participants shared that although they may be interested in participating in an HIV vaccine trial, they had many obligations, such as caring for family members or demanding jobs that would prevent them from participating. The literature review by Wendler et al.35 on willingness to participate in clinical intervention trials found that racial and ethnic minorities in the United States are as willing as whites to participate in health research, suggesting that the underrepresentation of minority groups in health research is likely the result of other factors, such as study location or inviting an insufficient number of individuals from marginalized groups to participate. Researchers should strive to improve access to trials through measures such as targeted recruiting efforts, providing child care during appointments, offering flexible study hours in convenient locations, and providing transportation for participants.

There were several limitations to this study. First, we used a purposive sample. Although we had similar findings to other studies examining AfricanAmerican and Hispanic perceptions of biomedical research, Hispanics and African-Americans in other areas of the United States may have different attitudes. Second, our data were collected 7 years ago; perceptions and concerns regarding HIV and HIV vaccine trials may have changed in the time since the conclusion of this study. However, recent studies examining barriers and willingness to participate in HIV clinical trials had similar findings regarding perceptions of HIV, HIV risk, and knowledge of HIV trials.13,36 Third, no one who was approached refused participation in this study; therefore, there is a possibility that participants were predisposed to completing an interview or were motivated by the incentive. Persons willing to participate in interview research may have more favorable views of biomedical research than those who refuse to participate. Also, interview participants were not required to take part in the screening process for a phase-I trial. This study examined some of the individual and interpersonal level factors that contribute to African-Americans’ and Hispanics’ attitudes towards participation in HIV vaccine clinical trials; however, other factors may influence willingness and ability of African-Americans and Hispanics to participate, such as eligibility requirements, recruiter bias, and economic conditions. Although this study focused on phase-I HIV vaccine trials, many themes expressed by our sample may also be relevant for research regarding other HIV biomedical interventions such as preexposure prophylaxis or microbicidal gels. Historically, African-Americans and Hispanics in the United States have had limited participation in biomedical research, particularly in prevention trials. Minorities bear an unequal burden of HIV disease and are at greater risk of HIV infection. HIV prevention researchers seeking biomedical solutions to the HIV epidemic need to increase minority participation in clinical trials to ensure health equity and the generalizability of findings. Understanding how African-Americans


For individual use only. Duplication or distribution prohibited by law. and Hispanics perceive HIV vaccines and biomedical research, identifying both individual and structural motivators and barriers to participation, and addressing known issues such as misinformation about HIV and vaccines, distorted risk perceptions, HIV stigma, and mistrust of research, as well as providing convenient and accessible opportunities to participate, will facilitate their successful recruitment and retention in HIV vaccine research.

SO WHAT? Implications for Health Promotion Practitioners and Researchers What is already known on this topic? Attempts to include African-Americans and Hispanics in biomedical research in the United States have shown mixed results. What does this article add? Findings suggest that while African-Americans and Hispanics may value the inclusion of diverse racial and ethnic groups in research, other factors such as misinformation, risk perception, HIV stigma, lack of researchers’ cultural competence, and inconvenience present barriers to participation. What are the implications for health promotion practice or research? Providing information about HIV vaccine trials may not be sufficient. Researchers must establish and maintain dialogue with the community and emphasize the communitylevel benefits of trial participation without discounting the individuallevel benefits. Using diverse research teams and trusted community organizations in the recruitment process is recommended. Targeted recruiting and increasing the convenience of participation could also improve access to research trials.

Acknowledgments Funding for this research was provided by U.S. Centers for Disease Control and Prevention under Grant No. U65 CCU923369. The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the U.S. Centers for Disease Control and Prevention. All authors declare that they have no conflicts with this research study or the content of this article. The authors thank the Project Embrace/Brazos Abiertos Study participants, Project Embrace/Brazos Abiertos Study Team, and San Francisco Department of Public Health without whom this study could not have been done. A special thanks to the CDC Minority HIV/AIDS Research Initiative for funding and mentorship support for this research study.


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