Adherence and Acceptability of a Multidrug Vaginal Ring for HIV Prevention in a Phase I Study in the United States

AIDS Behav. 2016 Nov;20(11):2644-2653. doi: 10.1007/s10461-016-1299-8.

Abstract

We evaluated the adherence and acceptability of a vaginal ring containing dapivirine, maraviroc, or both drugs for 28 days during a Phase I placebo-controlled trial in 48 HIV-negative sexually abstinent U.S. women aged 18-40. Adherence was assessed weekly by clinical interview and computer-assisted self-interviewing; acceptability assessment occurred at the last product-use visit. Study retention was 98 % (47/48); 94 % (45/48) reported being fully adherent with ring use during the 28-day period. Two participants experienced the ring partially coming out. Analysis was blinded and behavioral data were combined across study groups. Most women reported being very comfortable having the ring in their vagina; 44 % preferred continuous use, whereas 51 % had no preference compared to episodic use. Although a range of minor ring concerns were expressed, few were actually experienced. High adherence to and acceptability of this vaginal ring in this Phase I trial contributes to its promise as a sustained mechanism for multidrug vaginal microbicide delivery.

Keywords: Acceptability; Adherence; HIV prevention; Microbicides; Pre-exposure prophylaxis; Vaginal ring.

Publication types

  • Clinical Trial, Phase I
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Anti-HIV Agents / administration & dosage*
  • Contraceptive Devices, Female*
  • Cyclohexanes / administration & dosage*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Feasibility Studies
  • Female
  • HIV Infections / prevention & control*
  • Humans
  • Interview, Psychological
  • Maraviroc
  • Medication Adherence*
  • Patient Acceptance of Health Care*
  • Pre-Exposure Prophylaxis*
  • Program Evaluation
  • Pyrimidines / administration & dosage*
  • Südafrika
  • Text Messaging*
  • Triazoles / administration & dosage*

Substances

  • Anti-HIV Agents
  • Cyclohexanes
  • Pyrimidines
  • Triazoles
  • Maraviroc
  • Dapivirine