title: Passing 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.
abstract: 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.
authors.affiliation: Oregon State University, College of Public Health and Human Sciences, 118C Milam Hall, Corvallis, OR 97331, USA. Electronic address: jonathan.garcia@oregonstate.edu.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Garcia
authors.affiliation: Columbia University, Mailman School of Public Health, 722W. 168 Street, New York, NY 10032, USA; Columbia University, ICAP, 215 W. 125th St., 1st fl, Ste. B, New York, NY 10027, USA.
authors.forename: Paul W
authors.initials: PW
authors.lastname: Colson
authors.affiliation: Columbia University, Mailman School of Public Health, 722W. 168 Street, New York, NY 10032, USA.
authors.forename: Caroline
authors.initials: C
authors.lastname: Parker
authors.affiliation: Columbia University, Mailman School of Public Health, 722W. 168 Street, New York, NY 10032, USA.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Hirsch
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000517:prevention & control; D001741:Black or African American; D000884:Anthropology, Cultural; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D015658:HIV Infections / Q000517:prevention & control*; D007722:Health Knowledge, Attitudes, Practice; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D055118:Medication Adherence / Q000523:psychology*; D010342:Patient Acceptance of Health Care; D065129:Pre-Exposure Prophylaxis / Q000379:methods*; D017010:Reminder Systems; D012107:Research Design; D012657:Self-Help Groups; D060756:Social Networking
chemical_list: D019380:Anti-HIV Agents
keywords: Adherence trial; African American; Ethnography; HIV; Men who have sex with men; pre-exposure prophylaxis