Acceptability of a bioadhesive nonoxynol-9 gel delivered by an applicator as a rectal microbicide

Sex Transm Dis. 1999 Nov;26(10):572-8. doi: 10.1097/00007435-199911000-00006.

Abstract

Background and objectives: Potential rectal microbicides, as an adjunct to condoms for HIV/STD prevention, have not been studied previously.

Goal of this study: Advantage 24 (1.5 ml of a bioadhesive gel containing 52.5 mg nonoxynol-9 administered by single-use applicator)-under investigation as a vaginal microbicide-was evaluated for acceptability among male couples.

Study design: Twenty-five HIV-negative and 10 HIV-positive male couples participated in a frequency use escalation trial. Diaries and self-administered questionnaires assessed product use, acceptability, sexual behavior, and gastrointestinal and urologic side effects.

Results: Excluding participants who felt no need for an HIV prevention method, 58% said they would use Advantage 24 if approved for rectal use; 69% of receptive users reported rectal fullness and related side effects after insertion of the gel, and 68% reported applicator-related discomfort; 59% of insertive participants found the gel too sticky.

Conclusions: Acceptability remains inconclusive and warrants further study of redesigned applicators and ways to minimize rectal side effects.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Anti-Infective Agents / administration & dosage*
  • Anti-Infective Agents / adverse effects
  • Anti-Infective Agents / therapeutic use
  • HIV Infections / prevention & control*
  • Homosexuality, Male
  • Humans
  • Male
  • Middle Aged
  • Nonoxynol / administration & dosage*
  • Nonoxynol / adverse effects
  • Nonoxynol / therapeutic use
  • Patient Compliance
  • Rectum*
  • Sexual Behavior
  • Surveys and Questionnaires

Substances

  • Anti-Infective Agents
  • Nonoxynol