AIDS and Behavior

, Volume 17, Issue 2, pp 737–747 | Cite as

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

  • Alexandra M. Minnis
  • Sharavi Gandham
  • Barbra A. Richardson
  • Vijayanand Guddera
  • Beatrice A. Chen
  • Robert Salata
  • Clemensia Nakabiito
  • Craig Hoesley
  • Jessica Justman
  • Lydia Soto-Torres
  • Karen Patterson
  • Kailazarid Gomez
  • Craig W. Hendrix
Original Paper

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.

Keywords

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

Notes

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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Copyright information

© Springer Science+Business Media New York 2012

Authors and Affiliations

  • Alexandra M. Minnis
    • 1
    • 2
  • Sharavi Gandham
    • 3
  • Barbra A. Richardson
    • 4
  • Vijayanand Guddera
    • 5
  • Beatrice A. Chen
    • 6
  • Robert Salata
    • 7
  • Clemensia Nakabiito
    • 8
  • Craig Hoesley
    • 9
  • Jessica Justman
    • 10
  • Lydia Soto-Torres
    • 11
  • Karen Patterson
    • 4
  • Kailazarid Gomez
    • 12
  • Craig W. Hendrix
    • 13
  1. 1.Women’s Global Health Imperative, RTI InternationalSan FranciscoUSA
  2. 2.School of Public HealthUniversity of CaliforniaBerkeleyUSA
  3. 3.SCHARPSeattleUSA
  4. 4.University of WashingtonSeattleUSA
  5. 5.South African Medical Research CouncilDurbanSouth Africa
  6. 6.University of PittsburghPittsburghUSA
  7. 7.Case Western Reserve UniversityClevelandUSA
  8. 8.MU-JHU Research CollaborationKampalaUganda
  9. 9.University of Alabama at BirminghamBirminghamUSA
  10. 10.Mailman School of Public Health, Columbia UniversityNew YorkUSA
  11. 11.Division of AIDSNational Institute of Allergy and Infectious Diseases, NIHBethesdaUSA
  12. 12.FHI360DurhamUSA
  13. 13.Johns Hopkins UniversityBaltimoreUSA

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