Original Paper

AIDS and Behavior

, Volume 17, Issue 2, pp 737-747

First online:

Adherence and Acceptability in MTN 001: A Randomized Cross-Over Trial of Daily Oral and Topical Tenofovir for HIV Prevention in Women

  • Alexandra M. MinnisAffiliated withWomen’s Global Health Imperative, RTI InternationalSchool of Public Health, University of California Email author 
  • , Sharavi GandhamAffiliated withSCHARP
  • , Barbra A. RichardsonAffiliated withUniversity of Washington
  • , Vijayanand GudderaAffiliated withSouth African Medical Research Council
  • , Beatrice A. ChenAffiliated withUniversity of Pittsburgh
  • , Robert SalataAffiliated withCase Western Reserve University
  • , Clemensia NakabiitoAffiliated withMU-JHU Research Collaboration
  • , Craig HoesleyAffiliated withUniversity of Alabama at Birmingham
  • , Jessica JustmanAffiliated withMailman School of Public Health, Columbia University
    • , Lydia Soto-TorresAffiliated withDivision of AIDS, National Institute of Allergy and Infectious Diseases, NIH
    • , Karen PattersonAffiliated withUniversity of Washington
    • , Kailazarid GomezAffiliated withFHI360
    • , Craig W. HendrixAffiliated withJohns Hopkins University

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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.


Anti-infective agents HIV Patient compliance Sexual behavior Vaginal creams Foams and jellies Administration Oral PrEP Microbicide