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Infectious Diseases in Obstetrics and Gynecology
Volume 2012, Article ID 921519, 8 pages
Clinical Study

Diaphragm Used with Replens Gel and Risk of Bacterial Vaginosis: Results from a Randomized Controlled Trial

1Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, 50 Beale Street, Suite 1200, San francisco, CA 94105, USA
2Department of Biostatistics, University of California, San Francisco, 50 Beale Street, Suite 1200, San Francisco, CA 94105, USA
3University of Zimbabwe-UCSF Collaborative Research Programme, 15 Phillips Ave, Belgravia, Harare, Zimbabwe
4Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 54840-00200, Nairobi, Kenya
5African Medical and Research Foundation, Clinical and Diagnostics Programme, P.O. Box 27691-00506, Nairobi, Kenya
6School of Public Health, University of California at Berkeley, 50 University Hall, MC 7360, Berkeley, CA 94720-7360, USA
7Women’s Global Health Imperative, RTI International, 114 Sansome Street, San Francisco, CA 94104, USA

Received 2 July 2012; Accepted 26 September 2012

Academic Editor: Deborah B. Nelson

Copyright © 2012 Craig R. Cohen et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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 ( , 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 ( , 95% CI 0.52–1.94) or for those who did not have BV ( , 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.