Community-Based HIV Clinical Trials: An Integrated Approach in Underserved, Rural, Minority Communities

Abstract

Background Although racial and ethnic minorities have disproportionately high rates of HIV infection, these groups are underrepresented in HIV-related clinical trials. This illustrates the need for more innovation in attempts to engage underrepresented populations in calls for interdisciplinary and translational research. Objectives Eleven focus groups and 35 interviews were conducted with people living with HIV/AIDS (PLWHA) to explore the perspectives of rural community leaders, service providers, and PLWHA about bringing HIV-related research, including clinical trials, into rural communities. Methods Over a period of 3 months in spring 2007, we collected qualitative data from three sources: Community leaders, service providers, and PLWHA. Text data were analyzed using the constant comparative method and content analysis techniques of theme identification. Results Respondents want an integrated approach to HIV research that builds trust, meets community needs, and respects their values. They conceptualize HIV research as part of a broader spectrum of HIV testing, prevention, and care, and suggest integrating HIV trials with existing community services, organizations, and structures, engaging various segments of the community, and conducting research using a personal approach. Conclusions These findings support calls for more relevant, translational, and engaged research. An integrated approach may be an important innovation to transform the research enterprise to meet these goals and more directly improve the health of individuals.

Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence

“…Of the 108 studies, 48 studies (44.4%) conducted stakeholder engagement in high‐income countries 5, 23, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70. In contrast, fewer studies conducted stakeholder engagement in middle‐ (30 studies; 27.8%) 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93,...…”

“…All five of these studies were published from the year 2005 onward, suggesting more recent diversification of stakeholder engagement methods. Additionally, many studies used a combination of both individual and group methods for stakeholder engagement; for example, 19 studies (17.6%) paired focus group discussions with stakeholder interviews 5, 16, 27, 32, 33, 79, 82, 89, 90, 96, 98, 100, 101, 106, 108, 109, 116, 125, 128.…”

“…Some examples of stakeholders include trial participants, members of local communities in which a trial is conducted, governmental organizations and funders who shape the research process. Strong stakeholder engagement can potentially result in trials that more effectively address stakeholders’ needs and perspectives 4, as well as improve health equity, access and participant welfare 5. Stakeholder engagement is particularly important in HIV clinical trials, which require careful consideration of the unique physical, psychological and social vulnerabilities associated with HIV infection 6 and subsequent ethical obligations towards trial participants 7.…”

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

“…Of these, nine were cross-sectional surveys 36,[44][45][46][47][48][49][50][51] and seven were qualitative assessments. [52][53][54][55][56][57][58] Another eight studies addressed factors to participating specifically in a vaccine trial (four cross-sectional, [59][60][61][62] four qualitative [63][64][65][66] ). The remaining studies reported on small pilot or full randomized behavioral interventions aimed at increasing intention to or actual participation in a clinical trial.…”

“…occur. 44,46,48,52 Corbie-Smith et al 52 found that if research is conducted with a personal approach and integrated in existing trusted community agencies, racial and ethnic minorities would be more inclined to participate. Other studies have indicated that participation is more likely if it is convenient for them and if there are incentives, including money, the provision of health care, and access to new or better medications.…”