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Diaphragm used with replens gel and risk of bacterial vaginosis: results from a randomized controlled trial
Craig R Cohen1, Su-Chun Cheng, Stephen Shiboski
1Department of Obstetrics, Gynecology and Reproductive Sciences, University of California-San Francisco, 50 Beale Street, San Francisco, CA 94105, USA.
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.
