Document Detail


Adherence and acceptability in MTN 001: a randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women.
MedLine Citation:
PMID:  23065145     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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
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Publication Detail:
Type:  Clinical Trial, Phase II; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  AIDS and behavior     Volume:  17     ISSN:  1573-3254     ISO Abbreviation:  AIDS Behav     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-02-01     Completed Date:  2013-08-06     Revised Date:  2014-10-02    
Medline Journal Info:
Nlm Unique ID:  9712133     Medline TA:  AIDS Behav     Country:  United States    
Other Details:
Languages:  eng     Pagination:  737-47     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00592124
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MeSH Terms
Descriptor/Qualifier:
Adenine / administration & dosage,  analogs & derivatives*
Administration, Oral
Administration, Topical
Adolescent
Adult
Anti-HIV Agents / administration & dosage*
Cross-Over Studies
Female
HIV Infections / epidemiology,  prevention & control*,  psychology
Humans
Medication Adherence / psychology,  statistics & numerical data*
Middle Aged
Organophosphonates / administration & dosage*
Patient Acceptance of Health Care / psychology,  statistics & numerical data*
Patient Preference / psychology,  statistics & numerical data*
Sexual Partners / psychology
South Africa / epidemiology
Uganda / epidemiology
United States / epidemiology
Vaginal Creams, Foams, and Jellies
Grant Support
ID/Acronym/Agency:
U01 AI068633/AI/NIAID NIH HHS; U01AI068633/AI/NIAID NIH HHS; UL1 RR024153/RR/NCRR NIH HHS; UL1 TR000005/TR/NCATS NIH HHS; UM1 AI068615/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/Organophosphonates; 0/Vaginal Creams, Foams, and Jellies; 107021-12-5/tenofovir; JAC85A2161/Adenine
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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