Journal article
Vaginal microbicide and diaphragm use for sexually transmitted infection prevention: A randomized acceptability and feasibility study among high-risk women in Madagascar
Sexually transmitted diseases, Vol.35(9), pp.818-826
09/01/2008
DOI: 10.1097/OLQ.0b013e318175d8ab
PMCID: PMC5826650
PMID: 18562985
Abstract
Background: In preparation for a randomized controlled trial (RCT), we conducted a pilot RCT of the acceptability and feasibility of diaphragm.,; and candidate vaginal microbicide for sexually transmitted infection prevention among high-risk women in Madagascar.
Methods: Participants were randomized to four arms: (1) diaphragm (worn continuously) with Acidform (TM) applied in the dome; (2) diaphragm (worn continuously) with placebo gel hydroxyethylcellulose (HEC) in the dome; (3) HEC applied intravaginally before sex; (4) Acidform applied intravaginally before sex. All women were given condoms. Participants were followed weekly for 4 weeks. We fit unadjusted negative binomial regression models with robust variance estimators to generate the proportion of sex acts with casual partners where condoms and experimental study products were used.
Results: Retention was 98% among 192 participants. Experimental product use with casual partners was high, reported in 85%, 91%. 74%, and 81% of sex acts for women in the Acidform-diaphragm, HEC-diaphragm, HEC-alone, and Acidform-alone arms, respectively. However, the proportion reporting product use during 100% of acts with casual partners over the full follow-up period was much lower: 28% to 29% in the gel-diaphragm arms and 6% to 10% in gel-alone arms. Women used condoms in 62% to 67% of sex acts with casual partners, depending on the randomization arm. Participants found diaphragms easy to insert (97%) and remove (96%). Acidform users (with or without the diaphragm) reported more genitourinary symptoms than HEC users (14% vs. 5% of visits).
Conclusions: A sexually transmitted infection prevention RCT of candidate microbicide with and without the diaphragm appears acceptable and feasible in this population.
Details
- Title: Subtitle
- Vaginal microbicide and diaphragm use for sexually transmitted infection prevention: A randomized acceptability and feasibility study among high-risk women in Madagascar
- Creators
- Frieda M. Behets - Univ N Carolina, Sch Publ Hlth, Dept Epidemiol, Chapel Hill, NC 27599 USAAbigail Norris Turner - Univ N Carolina, Sch Publ Hlth, Dept Epidemiol, Chapel Hill, NC 27599 USAKathleen Van Damme - Univ N Carolina, Sch Publ Hlth, Dept Epidemiol, Chapel Hill, NC 27599 USANy Lovaniaina Rabenja - UNC, MAD, Antananarivo, MadagascarNoro Ravelomanana - UNC, MAD, Antananarivo, MadagascarTeresa A. Swezey - Univ N Carolina, Sch Publ Hlth, Dept Epidemiol, Chapel Hill, NC 27599 USAApril J. Bell - United States Ctr Dis Control & Prevent, Div Reprod Hlth, Womens Hlth & Fertil Branch, CDC, Atlanta, GA USADaniel R. Newman - United States Ctr Dis Control & Prevent, Div Reprod Hlth, Womens Hlth & Fertil Branch, CDC, Atlanta, GA USAD'Nyce L. Williams - CONRAD, Arlington, VA USADenise J. Jamieson - United States Ctr Dis Control & Prevent, Div Reprod Hlth, Womens Hlth & Fertil Branch, CDC, Atlanta, GA USAMad STI Prevention Group
- Resource Type
- Journal article
- Publication Details
- Sexually transmitted diseases, Vol.35(9), pp.818-826
- Publisher
- Lippincott Williams & Wilkins
- DOI
- 10.1097/OLQ.0b013e318175d8ab
- PMID
- 18562985
- PMCID
- PMC5826650
- ISSN
- 0148-5717
- eISSN
- 1537-4521
- Number of pages
- 9
- Grant note
- T32DA007233 / NATIONAL INSTITUTE ON DRUG ABUSE; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute on Drug Abuse (NIDA); European Commission T32 DA007233 / NIDA NIH HHS; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute on Drug Abuse (NIDA)
- Language
- English
- Date published
- 09/01/2008
- Academic Unit
- Obstetrics and Gynecology; VPMA - Administration
- Record Identifier
- 9984446280502771
Metrics
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