title: Diaphragm and lubricant gel acceptance, skills and patterns of use among women in an effectiveness trial in Southern Africa.
abstract: OBJECTIVE
  We examined diaphragm and gel-related skills, patterns of use, and problems, among women who participated in the MIRA study, a multisite phase III diaphragm trial in Zimbabwe and South Africa.
  
  
  METHODS
  We evaluated whether baseline characteristics were associated with the ability to correctly insert/remove the diaphragm prior to randomisation by means of multivariate logistic regression modeling. Employing face-to-face interviews with intervention arm participants, patterns of use and comfort using the products were measured at Month 3 and Exit, and reported problems with the products were assessed quarterly.
  
  
  RESULTS
  At baseline, 72.5% of women correctly inserted/removed the diaphragm within one attempt, and this skill was most strongly associated with the Johannesburg study site. At exit, over 90% of intervention women were very comfortable inserting, wearing, cleaning and removing the diaphragm; however, 31.8% reported usual removal of the diaphragm before the prescribed six hours after sex. During the 12-24 month follow-up period there were only 133 (<1%) reported problems with the diaphragm and gel over 14,544 follow-up visits.
  
  
  CONCLUSIONS
  Diaphragm skills were easily acquired and few problems were reported during the course of the trial. Reviving the diaphragm as a contraceptive option or as a reusable microbicide delivery mechanism seems feasible in these settings.
authors.affiliation: Women's Global Health Imperative, RTI International, San Francisco Project Office, San Francisco, CA 94104, USA. emontgomery@rti.org
authors.forename: Elizabeth T
authors.initials: ET
authors.lastname: Montgomery
authors.forename: Kelly
authors.initials: K
authors.lastname: Blanchard
authors.forename: Helen
authors.initials: H
authors.lastname: Cheng
authors.forename: Tsungai
authors.initials: T
authors.lastname: Chipato
authors.forename: Guy
authors.initials: G
authors.lastname: de Bruyn
authors.forename: Gita
authors.initials: G
authors.lastname: Ramjee
authors.forename: Nancy
authors.initials: N
authors.lastname: Padian
authors.forename: Ariane
authors.initials: A
authors.lastname: van der Straten
mesh_terms: D000328:Adult; D003268:Contraception Behavior / Q000523:psychology / Q000706:statistics & numerical data*; D003274:Contraceptive Devices, Female / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000517:prevention & control; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D015999:Multivariate Analysis; D010342:Patient Acceptance of Health Care / Q000523:psychology / Q000706:statistics & numerical data*; D010349:Patient Compliance / Q000706:statistics & numerical data*; D021841:Safe Sex / Q000706:statistics & numerical data; D012749:Sexually Transmitted Diseases / Q000517:prevention & control; D013019:South Africa; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D014622:Vaginal Creams, Foams, and Jellies