TitlePassing the baton: Community-based ethnography to design a randomized clinical trial on the effectiveness of oral pre-exposure prophylaxis for HIV prevention among Black men who have sex with men.
Publication TypeJournal Article
Year of Publication2015
AuthorsGarcia, J, Colson, PW, Parker, C, Hirsch, JS
JournalContemp Clin Trials
IssuePt B
Date Published11/2015
KeywordsAcquired Immunodeficiency Syndrome, African Americans, Anthropology, Cultural, Anti-HIV Agents, Health Knowledge, Attitudes, Practice, HIV Infections, Homosexuality, Male, Humans, Male, Medication Adherence, Patient Acceptance of Health Care, Pre-Exposure Prophylaxis, Reminder Systems, Research Design, Self-Help Groups, Social Networking

Although HIV interventions and clinical trials increasingly report the use of mixed methods, studies have not reported on the process through which ethnographic or qualitative findings are incorporated into RCT designs. We conducted a community-based ethnography on social and structural factors that may affect the acceptance of and adherence to oral pre-exposure prophylaxis (PrEP) among Black men who have sex with men (BMSM). We then devised the treatment arm of an adherence clinical trial drawing on findings from the community-based ethnography. This article describes how ethnographic findings informed the RCT and identifies distilled themes and findings that could be included as part of an RCT. The enhanced intervention includes in-person support groups, online support groups, peer navigation, and text message reminders. By describing key process-related facilitators and barriers to conducting meaningful mixed methods research, we provide important insights for the practice of designing clinical trials for 'real-world' community settings.

Alternate JournalContemp Clin Trials
PubMed ID26476286
PubMed Central IDPMC4674295
Grant ListP30 MH043520 / MH / NIMH NIH HHS / United States
R01 MH098723 / MH / NIMH NIH HHS / United States