Predictors of adherent use of diaphragms and microbicide gel in a four-arm, randomized pilot study among female sex workers in Madagascar.
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.
Turner
Abigail Norris
AN
Department of Epidemiology, School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7435, USA. ant@unc.edu
Van Damme
Kathleen
K
Jamieson
Denise J
DJ
Khan
Maria R
MR
Pettifor
Audrey E
AE
Swezey
Theresa A
TA
Bell
April J
AJ
Newman
Daniel R
DR
Penman-Aguilar
Ana
A
Raharinivo
Mbolatiana S M
MS
Randrianasolo
Bodo
B
Ramiandrisoa
Felasoa Noroseheno
FN
Behets
Frieda M
FM
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
D000891:Anti-Infective Agents, Local; D014622:Vaginal Creams, Foams, and Jellies