Exploring the Engagement of Racial and Ethnic Minorities in HIV Treatment and Vaccine Clinical Trials: A Scoping Review of Literature and Implications for Future Research

Abstract

HIV disproportionately impacts US racial and ethnic minorities but they participate in treatment and vaccine clinical trials at a lower rate than whites. To summarize barriers and facilitators to this participation we conducted a scoping review of the literature guided by the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines. Studies published from January 2007 and September 2019 were reviewed. Thirty-one articles were identified from an initial pool of 325 records using three coders. All records were then assessed for barriers and facilitators and summarized. Results indicate that while racial and ethnic minority participation in these trials has increased over the past 10 years, rates still do not proportionately reflect their burden of HIV infection. While many of the barriers mirror those found in other disease clinical trials (e.g., cancer), HIV stigma is a unique and important barrier to participating in HIV clinical trials. Recommendations to improve recruitment and retention of racial and ethnic minorities include training health care providers on the importance of recruiting diverse participants, creating interdisciplinary research teams that better represent who is being recruited, and providing culturally competent trial designs. Despite the knowledge of how to better recruit racial and ethnic minorities, few interventions have been documented using these strategies. Based on the findings of this review, we recommend that future clinical trials engage community stakeholders in all stages of the research process through community-based participatory research approaches and promote culturally and linguistically appropriate recruitment and retention strategies for marginalized populations overly impacted by HIV.

Promoting inclusion in clinical trials—a rapid review of the literature and recommendations for action

“…A consistent theme across the literature is that many of the barriers relating to inclusion are the same as those that impact trial design and delivery [ 13 ]. The nuance is around how these barriers present among different, under-served groups, which is often unique to each population’s particular circumstances, background, beliefs, and needs.…”

“…This barrier can present in many different ways and is often context and populationspecific. Examples that arise in the literature include no personal or family history of the condition under study [ 29 ]; stigma surrounding the condition under study [ 13 , 16 , 24 ]; beliefs among older adults that they were too old to participate in trials [ 26 ]; concerns around immigration status for some ethnic minority populations [ 23 ]; concerns about side effects or taking an experimental medicine [ 27 , 35 ]; stress, fatalism, and a conservative attitude to risk-taking among Asian women [ 25 ]; religious beliefs [ 30 ]; “Guinea pig” perceptions [ 36 ]; not feeling comfortable, welcome, or respected [ 36 ]; privacy concerns [ 23 ]; and negative attitudes to clinical trials [ 30 ]. In addition, not only the individual’s own beliefs and attitudes, but also those of their friends and families can prevent under-served groups from taking part in trials, as lack of social approval was found to be an important barrier [ 27 , 28 , 36 , 37 ].…”

“…There was a range of evidence suggesting that inclusion in trials was improved when staff had received specific training on that topic [ 13 , 15 , 19 , 38 – 46 ]. This may include teaching study staff about cultural humility, existing health inequities, and the background and context as to how these have arisen [ 44 ], including previous research abuses (e.g.…”

“…Similarly, in a study conducted with deaf individuals, a variety of contact methods (video call and email) and materials in both sign language video and written English were found to help [ 17 ]. Many studies explicitly aimed to recruit study staff from under-served groups so that research teams are representative of the people being recruited, especially if from the local community [ 13 , 17 , 39 , 47 – 50 , 52 ], and some even matched study team members and participants on ethnicity [ 54 ].…”

Public Knowledge and Attitudes Toward Clinical Trials in the COVID-19 Era

“…In addition, the decision to participate is complex, 6 and racial/ethnic minorities face numerous systemic barriers to clinical trial participation beyond individual-level knowledge and attitudes. 2 , 3 , 7 , 8 …”