Vaginal Microbicide and Diaphragm Use for Sexually Transmitted Infection Prevention: A Randomized Acceptability and Feasibility Study Among High-Risk Women in Madagascar

Sex Transm Dis. 2008 Sep;35(9):818-26. doi: 10.1097/OLQ.0b013e318175d8ab.

Abstract

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Anti-Infective Agents, Local / administration & dosage*
  • Anti-Infective Agents, Local / adverse effects
  • Condoms
  • Contraceptive Devices, Female / adverse effects
  • Contraceptive Devices, Female / statistics & numerical data*
  • Feasibility Studies
  • Female
  • Humans
  • Middle Aged
  • Patient Acceptance of Health Care*
  • Patient Compliance
  • Pilot Projects
  • Regression Analysis
  • Safe Sex
  • Sexually Transmitted Diseases / prevention & control*
  • Women's Health

Substances

  • Anti-Infective Agents, Local