title: Effect of treatment assignment on intravaginal cleansing in a randomized study of the diaphragm with candidate microbicide.
abstract: BACKGROUND
  Intravaginal cleansing may predispose women to adverse health outcomes and may interfere with the effectiveness and safety of female-initiated methods for preventing sexually transmitted infections (STIs). In a 4-week randomized study of 192 Malagasy sex workers, we evaluated associations between self-reported intravaginal cleansing and randomization assignment: diaphragm with viscous candidate microbicide gel (Acidform™, TOPCAD, Chicago, IL, licensed to Instead, Coppell, TX), diaphragm with placebo hydroxyethylcellulose gel (HEC, ReProtect LLC, Baltimore, MD), Acidform alone, or HEC alone.
  
  
  METHODS
  Women were counseled to avoid intravaginal cleansing and were blinded to gel assignment. We evaluated changes in self-reported intravaginal cleansing across the study and assessed the effects of treatment assignment and covariates on frequent (more than once daily) intravaginal cleansing. Significant predictors in domain-specific models were evaluated in an all-domain multiple regression model.
  
  
  RESULTS
  The proportion of women reporting intravaginal cleansing decreased from baseline (97%) to week 1 (82%) (p < 0.001). Self-reported frequent intravaginal cleansing decreased from baseline (87% to 56%) during the same time period (p < 0.001). In adjusted analyses, the Acidform-diaphragm group had 60% lower odds of frequent intravaginal cleansing during the study (odds ratio [OR] 0.4, 95% confidence interval [CI] 0.2-0.8) compared to the control group (HEC only). HEC-diaphragm and Acidform only users did not differ from controls. Living on the coast of Madagascar, not cohabiting, frequent intravaginal cleansing at enrollment, and high coital frequency predicted frequent intravaginal cleansing during follow-up.
  
  
  CONCLUSIONS
  Gel characteristics and the diaphragm's presence likely influenced women's cleansing. Viscous gel delivered by a cervical barrier (such as a diaphragm) may minimize the likelihood of frequent intravaginal cleansing.
authors.affiliation: Women's Health and Fertility Branch, Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, Georgia 30341, USA. bpv4@cdc.gov
authors.forename: Ana
authors.initials: A
authors.lastname: Penman-Aguilar
authors.forename: Jennifer
authors.initials: J
authors.lastname: Legardy-Williams
authors.forename: Abigail Norris
authors.initials: AN
authors.lastname: Turner
authors.forename: Tiana O O
authors.initials: TO
authors.lastname: Rabozakandriana
authors.forename: D'Nyce
authors.initials: D
authors.lastname: Williams
authors.forename: Sandra
authors.initials: S
authors.lastname: Razafindravoavy
authors.forename: Frieda
authors.initials: F
authors.lastname: Behets
authors.forename: Kathleen
authors.initials: K
authors.lastname: Van Damme
authors.forename: Denise J
authors.initials: DJ
authors.lastname: Jamieson
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D003274:Contraceptive Devices, Female / Q000706:statistics & numerical data*; D003964:Diaphragm; D005260:Female; D006801:Humans; D008270:Madagascar; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D010349:Patient Compliance / Q000706:statistics & numerical data*; D011477:Sex Work / Q000706:statistics & numerical data*; D007507:Therapeutic Irrigation / Q000009:adverse effects; D016896:Treatment Outcome; D014621:Vagina / Q000187:drug effects; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage*; D016585:Vaginosis, Bacterial / Q000517:prevention & control; D055815:Young Adult
chemical_list: D000891:Anti-Infective Agents, Local; D014622:Vaginal Creams, Foams, and Jellies