title: 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.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, University of California-San Francisco, 50 Beale Street, San Francisco, CA 94105, USA.
authors.forename: Craig R
authors.initials: CR
authors.lastname: Cohen
authors.forename: Su-Chun
authors.initials: SC
authors.lastname: Cheng
authors.forename: Stephen
authors.initials: S
authors.lastname: Shiboski
authors.forename: Tsungai
authors.initials: T
authors.lastname: Chipato
authors.forename: Martin
authors.initials: M
authors.lastname: Matu
authors.forename: James
authors.initials: J
authors.lastname: Mwangi
authors.forename: Monalisa E S
authors.initials: ME
authors.lastname: Mutimutema
authors.forename: Jennifer
authors.initials: J
authors.lastname: Tuveson
authors.forename: Mavis
authors.initials: M
authors.lastname: Kamba
authors.forename: Nancy
authors.initials: N
authors.lastname: Padian
authors.forename: Ariane
authors.initials: A
authors.lastname: van der Straten
mesh_terms: D000293:Adolescent; D000328:Adult; D015331:Cohort Studies; D003274:Contraceptive Devices, Female / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008055:Lipids / Q000008:administration & dosage; D008875:Middle Aged; D016017:Odds Ratio; D016032:Randomized Controlled Trials as Topic; D012306:Risk; D013019:South Africa / Q000453:epidemiology; D014621:Vagina / Q000382:microbiology; D016585:Vaginosis, Bacterial / Q000453:epidemiology* / Q000517:prevention & control; D015030:Zimbabwe / Q000453:epidemiology
chemical_list: D008055:Lipids; C085472:Replens