Adherence and acceptability in MTN 001: A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women

Academic Article


  • We compared adherence to and acceptability of daily topical and oral formulations of tenofovir (TFV) used as pre-exposure prophylaxis (PrEP) for HIV prevention among women in South Africa, Uganda and the United States. 144 sexually active, HIV-uninfected women participated in a cross-over study of three regimens: oral tablet, vaginal gel, or both. We tested for differences in adherence and evaluated product acceptability. Self-reported adherence for all regimens was high (94 %), but serum TFV concentrations indicated only 64 % of participants used tablets consistently. Most women in the U.S. (72 %) favored tablets over gel; while preferences varied at the African sites (42 % preferred gel and 40 % tablets). Findings indicate a role for oral and vaginal PrEP formulations and highlight the importance of integrating pharmacokinetics-based adherence assessment in future trials. Biomedical HIV prevention interventions should consider geographic and cultural experience with product formulations, partner involvement, and sexual health benefits that ultimately influence use. © 2012 Springer Science+Business Media New York.
  • Authors

    Published In

  • AIDS and Behavior  Journal
  • Digital Object Identifier (doi)

    Author List

  • Minnis AM; Gandham S; Richardson BA; Guddera V; Chen BA; Salata R; Nakabiito C; Hoesley C; Justman J; Soto-Torres L
  • Start Page

  • 737
  • End Page

  • 747
  • Volume

  • 17
  • Issue

  • 2