Vaginal microbicide and diaphragm use for sexually transmitted infection prevention: a randomized acceptability and feasibility study among high-risk women in Madagascar.
BACKGROUND
In preparation for a randomized controlled trial (RCT), we conducted a pilot RCT of the acceptability and feasibility of diaphragms and candidate vaginal microbicide for sexually transmitted infection prevention among high-risk women in Madagascar.


METHODS
Participants were randomized to four arms: (1) diaphragm (worn continuously) with Acidform applied in the dome; (2) diaphragm (worn continuously) with placebo gel hydroxyethylcellulose (HEC) in the dome; (3) HEC applied intravaginally before sex; (4) Acidform applied intravaginally before sex. All women were given condoms. Participants were followed weekly for 4 weeks. We fit unadjusted negative binomial regression models with robust variance estimators to generate the proportion of sex acts with casual partners where condoms and experimental study products were used.


RESULTS
Retention was 98% among 192 participants. Experimental product use with casual partners was high, reported in 85%, 91%, 74%, and 81% of sex acts for women in the Acidform-diaphragm, HEC-diaphragm, HEC-alone, and Acidform-alone arms, respectively. However, the proportion reporting product use during 100% of acts with casual partners over the full follow-up period was much lower: 28% to 29% in the gel-diaphragm arms and 6% to 10% in gel-alone arms. Women used condoms in 62% to 67% of sex acts with casual partners, depending on the randomization arm. Participants found diaphragms easy to insert (97%) and remove (96%). Acidform users (with or without the diaphragm) reported more genitourinary symptoms than HEC users (14% vs. 5% of visits).


CONCLUSIONS
A sexually transmitted infection prevention RCT of candidate microbicide with and without the diaphragm appears acceptable and feasible in this population.
Department of Epidemiology, School of Public Health, University of North Carolina, Chapel Hill, North Carolina 27599-7435, USA. frieda_behets@unc.edu
Frieda M
FM
Behets
Abigail Norris
AN
Turner
Kathleen
K
Van Damme
Ny Lovaniaina
NL
Rabenja
Noro
N
Ravelomanana
Teresa A
TA
Swezey
April J
AJ
Bell
Daniel R
DR
Newman
D'Nyce L
DL
Williams
Denise J
DJ
Jamieson
D000293:Adolescent; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage* / Q000009:adverse effects; D017280:Condoms; D003274:Contraceptive Devices, Female / Q000009:adverse effects / Q000706:statistics & numerical data*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010349:Patient Compliance; D010865:Pilot Projects; D012044:Regression Analysis; D021841:Safe Sex; D012749:Sexually Transmitted Diseases / Q000517:prevention & control*; D016387:Women's Health
D000891:Anti-Infective Agents, Local