title: Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men.
abstract: The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while others perceived approval as irrelevant or less significant than other sources of information. Our results suggest that FDA approval sends a signal that directly shapes PrEP acceptability among some MSM, while indirect influences of approval may affect uptake by others. Efforts to educate MSM about PrEP can increase acceptability by incorporating information about FDA approval, and outreach strategies should consider how this information may factor into personal decisions about PrEP use.
authors.affiliation: Yale Law School/Yale Center for Interdisciplinary Research on AIDS, Yale University, PO Box 208215, New Haven, CT, 06520, USA, kristen.underhill@yale.edu.
authors.forename: Kristen
authors.initials: K
authors.lastname: Underhill
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Morrow
authors.forename: Don
authors.initials: D
authors.lastname: Operario
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D018890:Chemoprevention / Q000706:statistics & numerical data*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000068679:Emtricitabine; D017144:Focus Groups; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control*; D007722:Health Knowledge, Attitudes, Practice; D018451:Homosexuality, Male; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D063065:Organophosphonates / Q000008:administration & dosage; D010342:Patient Acceptance of Health Care; D010465:Perception; D036301:Qualitative Research; D012237:Rhode Island; D060386:Sex Workers; D000068698:Tenofovir; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D044966:Anti-Retroviral Agents; D063065:Organophosphonates; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine