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AIDS Behav. 2016 Nov;20(11):2644-2653.

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

Author information

1
Women's Global Health Imperative (WGHI), RTI International, 351 California St., Suite, 500, San Francisco, CA, 94104, USA. ariane@rti.org.
2
Department of Medicine, Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA. ariane@rti.org.
3
The Fenway Institute, Boston, MA, USA.
4
Women's Global Health Imperative (WGHI), RTI International, 351 California St., Suite, 500, San Francisco, CA, 94104, USA.
5
University of Alabama at Birmingham, Birmingham, AL, USA.
6
Statistical Center for HIV/AIDS Research & Prevention/Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
7
FHI 360, Durham, NC, USA.
8
International Partnership for Microbicides (IPM), Silver Spring, MD, USA.
9
NIAID/DAIDS, Bethesda, MD, USA.
10
Magee-Womens Research Institute and University of Pittsburgh, Pittsburgh, PA, USA.

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

PMID:
26837628
PMCID:
PMC4970965
DOI:
10.1007/s10461-016-1299-8
[Indexed for MEDLINE]
Free PMC Article

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