title: Predictors of adherent use of diaphragms and microbicide gel in a four-arm, randomized pilot study among female sex workers in Madagascar.
abstract: BACKGROUND
  Participants' protocol adherence may influence assessments of the effectiveness of new female-controlled methods for sexually transmitted infection prevention.
  
  
  METHODS
  In 2005 we conducted a randomized pilot study among female sex workers (FSWs) in Madagascar in preparation for sexually transmitted infection prevention trial of diaphragms and a vaginal microbicide. Participants (n = 192) were randomized into 4 arms: diaphragm plus microbicide (Acidform), diaphragm plus placebo gel hydroxyethyl cellulose (HEC), Acidform alone, or HEC alone. FSWs were seen weekly for 4 weeks. Using multivariable regression with generalized estimating equations, we assessed predictors of adherent product use during all sex acts in the last week. We collapsed the gel-diaphragm arms together and the gel-only arms together for this analysis.
  
  
  RESULTS
  Between 43% and 67% of gel-diaphragm users (varying by visit) reported using study products during all sex acts in the last week, compared with 20% to 45% of gel-only users. Adherence increased with follow-up [visit 4 vs. visit 1 risk ratio (RR) for gel-diaphragm users: 1.55, P <0.01; for gel-only users, RR: 1.58, P = 0.01]. Gel-diaphragm users whose casual partners were never aware of products (RR: 2.02, P = 0.03) and who had experienced partner violence after requesting condom use (RR: 1.45, P <0.01) were more adherent. Gel-only users reporting lower sexual frequency (1-9 weekly acts vs. >or=19 acts, RR: 1.98, P <0.01) and no sex with primary partners in the past week (RR: 1.54, P = 0.02) were more adherent.
  
  
  CONCLUSIONS
  Gel-diaphragm users had better adherence than gel-only users, and predictors of adherence differed between groups. Addressing modifiable factors during counseling sessions may improve adherence.
authors.affiliation: Department of Epidemiology, School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7435, USA. ant@unc.edu
authors.forename: Abigail Norris
authors.initials: AN
authors.lastname: Turner
authors.forename: Kathleen
authors.initials: K
authors.lastname: Van Damme
authors.forename: Denise J
authors.initials: DJ
authors.lastname: Jamieson
authors.forename: Maria R
authors.initials: MR
authors.lastname: Khan
authors.forename: Audrey E
authors.initials: AE
authors.lastname: Pettifor
authors.forename: Theresa A
authors.initials: TA
authors.lastname: Swezey
authors.forename: April J
authors.initials: AJ
authors.lastname: Bell
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Newman
authors.forename: Ana
authors.initials: A
authors.lastname: Penman-Aguilar
authors.forename: Mbolatiana S M
authors.initials: MS
authors.lastname: Raharinivo
authors.forename: Bodo
authors.initials: B
authors.lastname: Randrianasolo
authors.forename: Felasoa Noroseheno
authors.initials: FN
authors.lastname: Ramiandrisoa
authors.forename: Frieda M
authors.initials: FM
authors.lastname: Behets
mesh_terms: D000293:Adolescent; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D017280:Condoms / Q000706:statistics & numerical data; D003274:Contraceptive Devices, Female / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008270:Madagascar; D008875:Middle Aged; D010349:Patient Compliance; D010865:Pilot Projects; D011237:Predictive Value of Tests; D011477:Sex Work; D012749:Sexually Transmitted Diseases / Q000517:prevention & control; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D000891:Anti-Infective Agents, Local; D014622:Vaginal Creams, Foams, and Jellies