title: Consistent use of a combination product versus a single product in a safety trial of the diaphragm and microbicide in Harare, Zimbabwe.
abstract: BACKGROUND
  We examined the use and acceptability of a combination product (diaphragm and gel) compared to a single product (gel) during a 6-month safety trial in Zimbabwe.
  
  
  METHODS
  Women were randomized to the use of a diaphragm with gel or the use of gel alone, in addition to male condoms. Ever use and use of study product on the last act of sexual intercourse were assessed monthly by Audio Computer-Assisted Self-Interviewing. Acceptability, correct use and consistent use (use at every sexual act during the previous 3 months) were measured on the last visit by face-to-face interview. Predictors of consistent use were examined using multivariate logistic regression analyses.
  
  
  RESULTS
  In this sample of 117 sexually active, monogamous, contracepting women, rates of consistent use were similar in both groups (59.7% for combination method vs. 56.4% for gel alone). Product acceptability was high, but was not independently associated with consistent use. Independent predictors of consistent use included age [adjusted odds ratio (AOR)=1.08; 95% confidence interval (95% CI)=1.01-1.16], consistent condom use (AOR=3.85; 95% CI=1.54-9.63) and having a partner who approves of product use (AOR=2.66; 95% CI=1.10-6.39).
  
  
  CONCLUSIONS
  Despite high reported acceptability and few problems with the products, the participants reported only moderate product adherence levels. Consistent use of condoms and consistent use of products were strongly associated. If observed in other studies, this may bias the estimation of product effectiveness in future trials of female-controlled methods.
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, Women's Global Health Imperative, University of California San Francisco, San Francisco, CA 94105, USA. ariane@rti.org
authors.forename: Ariane
authors.initials: A
authors.lastname: van der Straten
authors.forename: Jie
authors.initials: J
authors.lastname: Moore
authors.forename: Sue
authors.initials: S
authors.lastname: Napierala
authors.forename: Kate
authors.initials: K
authors.lastname: Clouse
authors.forename: Christine
authors.initials: C
authors.lastname: Mauck
authors.forename: Nii
authors.initials: N
authors.lastname: Hammond
authors.forename: Nancy
authors.initials: N
authors.lastname: Padian
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage; D017280:Condoms / Q000706:statistics & numerical data; D003267:Contraception / Q000379:methods* / Q000706:statistics & numerical data*; D042121:Contraception, Barrier / Q000706:statistics & numerical data; D003274:Contraceptive Devices, Female / Q000706:statistics & numerical data*; D004338:Drug Combinations; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D013089:Spermatocidal Agents / Q000008:administration & dosage; D015030:Zimbabwe
chemical_list: D000890:Anti-Infective Agents; D004338:Drug Combinations; D013089:Spermatocidal Agents