Journal article
Effect of Treatment Assignment on Intravaginal Cleansing in a Randomized Study of the Diaphragm with Candidate Microbicide
Journal of women's health (Larchmont, N.Y. 2002), Vol.20(2), pp.187-195
02/01/2011
DOI: 10.1089/jwh.2010.2143
PMCID: PMC3391708
PMID: 21314445
Abstract
Background: Intravaginal cleansing may predispose women to adverse health outcomes and may interfere with the effectiveness and safety of female-initiated methods for preventing sexually transmitted infections (STIs). In a 4-week randomized study of 192 Malagasy sex workers, we evaluated associations between self-reported intravaginal cleansing and randomization assignment: diaphragm with viscous candidate microbicide gel (Acidform (TM), TOPCAD, Chicago, IL, licensed to Instead, Coppell, TX), diaphragm with placebo hydroxyethylcellulose gel (HEC, ReProtect LLC, Baltimore, MD), Acidform alone, or HEC alone.
Methods: Women were counseled to avoid intravaginal cleansing and were blinded to gel assignment. We evaluated changes in self-reported intravaginal cleansing across the study and assessed the effects of treatment assignment and covariates on frequent (more than once daily) intravaginal cleansing. Significant predictors in domain-specific models were evaluated in an all-domain multiple regression model.
Results: The proportion of women reporting intravaginal cleansing decreased from baseline (97%) to week 1 (82%) (p < 0.001). Self-reported frequent intravaginal cleansing decreased from baseline (87% to 56%) during the same time period (p< 0.001). In adjusted analyses, the Acidform-diaphragm group had 60% lower odds of frequent intravaginal cleansing during the study (odds ratio [OR] 0.4, 95% confidence interval [CI] 0.2-0.8) compared to the control group (HEC only). HEC-diaphragm and Acidform only users did not differ from controls. Living on the coast of Madagascar, not cohabiting, frequent intravaginal cleansing at enrollment, and high coital frequency predicted frequent intravaginal cleansing during follow-up.
Conclusions: Gel characteristics and the diaphragm's presence likely influenced women's cleansing. Viscous gel delivered by a cervical barrier (such as a diaphragm) may minimize the likelihood of frequent intravaginal cleansing.
Details
- Title: Subtitle
- Effect of Treatment Assignment on Intravaginal Cleansing in a Randomized Study of the Diaphragm with Candidate Microbicide
- Creators
- Ana Penman-Aguilar - Centers for Disease Control and PreventionJennifer Legardy-Williams - Centers for Disease Control and PreventionAbigail Norris Turner - The Ohio State UniversityTiana O. O. Rabozakandriana - UNC Madagascar, Antananarivo, MadagascarD'Nyce Williams - Morehouse School of MedicineSandra Razafindravoavy - UNC Madagascar, Antananarivo, MadagascarFrieda Behets - University of North Carolina at Chapel HillKathleen Van Damme - UNC Madagascar, Antananarivo, MadagascarDenise J. Jamieson - Centers for Disease Control and Prevention
- Resource Type
- Journal article
- Publication Details
- Journal of women's health (Larchmont, N.Y. 2002), Vol.20(2), pp.187-195
- Publisher
- Mary Ann Liebert, Inc
- DOI
- 10.1089/jwh.2010.2143
- PMID
- 21314445
- PMCID
- PMC3391708
- ISSN
- 1540-9996
- eISSN
- 1931-843X
- Number of pages
- 9
- Grant note
- U.S. Centers for Disease Control and Prevention through U.S. Agency for International Development; United States Agency for International Development (USAID) UL1RR025755 / NATIONAL CENTER FOR RESEARCH RESOURCES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Research Resources (NCRR)
- Language
- English
- Date published
- 02/01/2011
- Academic Unit
- Obstetrics and Gynecology; VPMA - Administration
- Record Identifier
- 9984446534302771
Metrics
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