Diaphragm Used with Replens Gel and Risk of Bacterial Vaginosis: Results from a Randomized Controlled Trial. (24th October 2012)

• Record Type: Journal Article
• Authors: Cohen, Craig R.; Cheng, Su-Chun; Shiboski, Stephen; Chipato, Tsungai; Matu, Martin; Mwangi, James; Mutimutema, Monalisa E. S.; Tuveson, Jennifer; Kamba, Mavis; Padian, Nancy; van der Straten, Ariane
• Other Names: Nelson Deborah B. Academic Editor.
• Is Part Of: Infectious diseases in obstetrics and gynecology. Volume 2012(2012)
• Publication Date: 2012-10-24
• Subjects: Generative organs, Female -- Infections -- Periodicals; Communicable diseases in pregnancy -- Periodicals; 618.142005
• DOI: 10.1155/2012/921519
• Languages: English
• ISSNs: 1064-7449

Abstract

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.