Acceptability of potential rectal microbicide delivery systems for HIV prevention: a randomized crossover trial

AIDS Behav. 2013 Mar;17(3):1002-15. doi: 10.1007/s10461-012-0358-z.

Abstract

We assessed the acceptability of three of over-the-counter products representative of potential rectal microbicide (RM) delivery systems. From 2009 to 2010, 117 HIV-uninfected males (79 %) and females (21 %) who engage in receptive anal intercourse participated in a 6-week randomized crossover acceptability trial. Participants received each of three products (enema, lubricant-filled applicator, suppository) every 2 weeks in a randomized sequence. CASI and T-ACASI scales assessed product acceptability via Likert responses. Factor analysis was used to identify underlying factors measured by each scale. Random effects models were fit to examine age and gender effects on product acceptability. Three underlying factors were identified: Satisfaction with Product Use, Sexual Pleasure, and Ease of Product Use. For acceptability, the applicator ranked highest; however, differences between product acceptability scores were greatest among females and younger participants. These findings indicate that RM delivery systems impact their acceptability and should be considered early in RM development to enhance potential use.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Administration, Rectal
  • Adult
  • Anti-Infective Agents, Local / administration & dosage*
  • Anti-Infective Agents, Local / adverse effects*
  • Cross-Over Studies
  • Drug Delivery Systems / instrumentation
  • Drug Delivery Systems / methods*
  • Enema / statistics & numerical data
  • Female
  • HIV Infections / prevention & control*
  • Humans
  • Lubricants / administration & dosage
  • Lubricants / adverse effects
  • Male
  • Middle Aged
  • Patient Acceptance of Health Care / psychology*
  • Rectum / chemistry
  • Rectum / drug effects*
  • Sexual Behavior
  • Suppositories / administration & dosage
  • Suppositories / adverse effects
  • Treatment Outcome

Substances

  • Anti-Infective Agents, Local
  • Lubricants
  • Suppositories