Diaphragm used with replens gel and risk of bacterial vaginosis: results from a randomized controlled trial.

Abstract

BACKGROUND:

Bacterial vaginosis (BV) has been linked to female HIV acquisition and transmission. We investigated the effect of providing a latex diaphragm with Replens and condoms compared to condom only on BV prevalence among participants enrolled in an HIV prevention trial.

METHODS:

We enrolled HIV-seronegative women and obtained a vaginal swab for diagnosis of BV using Nugent's criteria; women with BV (score 7-10) were compared to those with intermediate (score 4-6) and normal flora (score 0-3). During quarterly follow-up visits over 12-24 months a vaginal Gram stain was obtained. The primary outcome was serial point prevalence of BV during followup.

RESULTS:

528 participants were enrolled; 213 (40%) had BV at enrollment. Overall, BV prevalence declined after enrollment in women with BV at baseline (OR = 0.4, 95% CI 0.29-.56) but did not differ by intervention group. In the intention-to-treat analysis BV prevalence did not differ between the intervention and control groups for women who had BV (OR = 1.01, 95% CI 0.52-1.94) or for those who did not have BV (OR = 1.21, 95% CI 0.65-2.27) at enrollment. Only 2.1% of participants were treated for symptomatic BV and few women (5-16%) were reported using anything else but water to cleanse the vagina over the course of the trial.

CONCLUSIONS:

Provision of the diaphragm, Replens, and condoms did not change the risk of BV in comparison to the provision of condoms alone.

• Authors: Craig R Cohen, Su-Chun Cheng, Stephen Shiboski, Tsungai Chipato, Martin Matu, James Mwangi, Monalisa E S Mutimutema, Jennifer Tuveson, Mavis Kamba, Nancy Padian, Ariane van der Straten
• Journal: Infectious diseases in obstetrics and gynecology (Infect Dis Obstet Gynecol) Vol. 2012 Pg. 921519 ( 2012) ISSN: 1098-0997 [Electronic] Egypt
• PMID: 23133307 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Lipids
• Replens

Topics

• Adolescent
• Adult
• Cohort Studies
• Contraceptive Devices, Female (statistics & numerical data)
• Female
• Humans
• Lipids (administration & dosage)
• Middle Aged
• Odds Ratio
• Randomized Controlled Trials as Topic
• Risk
• South Africa (epidemiology)
• Vagina (microbiology)
• Vaginosis, Bacterial (epidemiology, prevention & control)
• Zimbabwe (epidemiology)