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 Hendrix

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)737-747
Number of pages11
JournalAIDS and Behavior
Volume17
Issue number2
DOIs
StatePublished - Feb 2013

Fingerprint

Tenofovir
Cross-Over Studies
Tablets
HIV
Gels
Foams and Jellies Vaginal Creams
Uganda
Reproductive Health
Insurance Benefits
South Africa
Pharmacokinetics
Serum

Keywords

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

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Infectious Diseases
  • Social Psychology

Cite this

Adherence and acceptability in MTN 001 : A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women. / Minnis, Alexandra M.; Gandham, Sharavi; Richardson, Barbra A.; Guddera, Vijayanand; Chen, Beatrice A.; Salata, Robert; Nakabiito, Clemensia; Hoesley, Craig; Justman, Jessica; Soto-Torres, Lydia; Patterson, Karen; Gomez, Kailazarid; Hendrix, Craig.

In: AIDS and Behavior, Vol. 17, No. 2, 02.2013, p. 737-747.

Research output: Contribution to journalArticle

Minnis, AM, Gandham, S, Richardson, BA, Guddera, V, Chen, BA, Salata, R, Nakabiito, C, Hoesley, C, Justman, J, Soto-Torres, L, Patterson, K, Gomez, K & Hendrix, C 2013, 'Adherence and acceptability in MTN 001: A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women', AIDS and Behavior, vol. 17, no. 2, pp. 737-747. https://doi.org/10.1007/s10461-012-0333-8
Minnis, Alexandra M. ; Gandham, Sharavi ; Richardson, Barbra A. ; Guddera, Vijayanand ; Chen, Beatrice A. ; Salata, Robert ; Nakabiito, Clemensia ; Hoesley, Craig ; Justman, Jessica ; Soto-Torres, Lydia ; Patterson, Karen ; Gomez, Kailazarid ; Hendrix, Craig. / Adherence and acceptability in MTN 001 : A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women. In: AIDS and Behavior. 2013 ; Vol. 17, No. 2. pp. 737-747.
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