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

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Abstract

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.

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Acknowledgments

MTN-001 was sponsored by the US National Institutes of Health (NIH); and co-sponsored by CONRAD and Gilead Sciences, Inc. CONRAD supplied the tenofovir gel product and Gilead Sciences provided the tenofovir disoproxil fumarate (Viread) tablets. The study was designed and implemented by the Microbicide Trials Network (MTN), based at Magee-Womens Research Institute and the University of Pittsburgh. MTN principal investigator is Sharon Hillier, Ph.D., and co-principal investigator is Ian McGowan, M.D., Ph.D. The MTN (U01AI068633) has been funded by NIAID, NICHD, and NIMH. The trial is registered with clinicalttrials.gov (NCT00592124). The principal contributions of each author are as follows: AM Minnis (design of behavioral aims and measures; led manuscript development); S Gandham (statistical analysis); BA Richardson (study design development and lead statistician); V Guddera, B Chen, R Salata, C Nakabiito, C Hoesley, and J Justman (site investigators); K Patterson (data management oversight); K Gomez (study operations lead manager); L Soto-Torres (Division of AIDS medical officer); C Hendrix (protocol chair). All authors reviewed the manuscript. The authors are grateful to all site staff for rigorous implementation of the study as well as to the MTN core in Pittsburgh for leadership in numerous areas of protocol development and implementation. We would like to thank Ms. Arendevi Pather, site leader at Botha’s Hill, South Africa and Sherri Johnson at FHI360 for substantial contributions to study implementation.

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Authors and Affiliations

  1. Women’s Global Health Imperative, RTI International, 114 Sansome Street Suite 500, San Francisco, CA, 94104, USA

    Alexandra M. Minnis

  2. School of Public Health, University of California, Berkeley, CA, USA

    Alexandra M. Minnis

  3. SCHARP, Seattle, WA, USA

    Sharavi Gandham

  4. University of Washington, Seattle, WA, USA

    Barbra A. Richardson & Karen Patterson

  5. South African Medical Research Council, Durban, South Africa

    Vijayanand Guddera

  6. University of Pittsburgh, Pittsburgh, PA, USA

    Beatrice A. Chen

  7. Case Western Reserve University, Cleveland, OH, USA

    Robert Salata

  8. MU-JHU Research Collaboration, Kampala, Uganda

    Clemensia Nakabiito

  9. University of Alabama at Birmingham, Birmingham, AL, USA

    Craig Hoesley

  10. Mailman School of Public Health, Columbia University, New York, NY, USA

    Jessica Justman

  11. Division of AIDS, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, USA

    Lydia Soto-Torres

  12. FHI360, Durham, NC, USA

    Kailazarid Gomez

  13. Johns Hopkins University, Baltimore, MD, USA

    Craig W. Hendrix

Authors
  1. Alexandra M. Minnis
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  2. Sharavi Gandham
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  3. Barbra A. Richardson
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  4. Vijayanand Guddera
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  5. Beatrice A. Chen
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  6. Robert Salata
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  7. Clemensia Nakabiito
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  8. Craig Hoesley
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  9. Jessica Justman
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  10. Lydia Soto-Torres
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  11. Karen Patterson
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  12. Kailazarid Gomez
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  13. Craig W. Hendrix
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Corresponding author

Correspondence to Alexandra M. Minnis.

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This study is conducted for the MTN-001 Protocol Team.

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Minnis, A.M., Gandham, S., Richardson, B.A. et al. Adherence and Acceptability in MTN 001: A Randomized Cross-Over Trial of Daily Oral and Topical Tenofovir for HIV Prevention in Women. AIDS Behav 17, 737–747 (2013). https://doi.org/10.1007/s10461-012-0333-8

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  • DOI: https://doi.org/10.1007/s10461-012-0333-8

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