title: Adherence and Acceptability of a Multidrug Vaginal Ring for HIV Prevention in a Phase I Study in the United States.
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.
authors.affiliation: Women's Global Health Imperative (WGHI), RTI International, 351 California St., Suite, 500, San Francisco, CA, 94104, USA. ariane@rti.org.|Department of Medicine, Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA. ariane@rti.org.
authors.forename: Ariane
authors.initials: A
authors.lastname: van der Straten
authors.affiliation: The Fenway Institute, Boston, MA, USA.
authors.forename: Lori
authors.initials: L
authors.lastname: Panther
authors.affiliation: Women's Global Health Imperative (WGHI), RTI International, 351 California St., Suite, 500, San Francisco, CA, 94104, USA.
authors.forename: Nicole
authors.initials: N
authors.lastname: Laborde
authors.affiliation: University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Craig J
authors.initials: CJ
authors.lastname: Hoesley
authors.affiliation: Women's Global Health Imperative (WGHI), RTI International, 351 California St., Suite, 500, San Francisco, CA, 94104, USA.
authors.forename: Helen
authors.initials: H
authors.lastname: Cheng
authors.affiliation: Statistical Center for HIV/AIDS Research & Prevention/Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Marla J
authors.initials: MJ
authors.lastname: Husnik
authors.affiliation: FHI 360, Durham, NC, USA.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Horn
authors.affiliation: International Partnership for Microbicides (IPM), Silver Spring, MD, USA.
authors.forename: Annalene
authors.initials: A
authors.lastname: Nel
authors.affiliation: NIAID/DAIDS, Bethesda, MD, USA.
authors.forename: Lydia
authors.initials: L
authors.lastname: Soto-Torres
authors.affiliation: Magee-Womens Research Institute and University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Beatrice A
authors.initials: BA
authors.lastname: Chen
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D003274:Contraceptive Devices, Female; D003510:Cyclohexanes / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005240:Feasibility Studies; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007406:Interview, Psychological; D000077592:Maraviroc; D055118:Medication Adherence; D010342:Patient Acceptance of Health Care; D065129:Pre-Exposure Prophylaxis; D015397:Program Evaluation; D011743:Pyrimidines / Q000008:administration & dosage*; D013019:South Africa; D060145:Text Messaging; D014230:Triazoles / Q000008:administration & dosage*
chemical_list: D019380:Anti-HIV Agents; D003510:Cyclohexanes; D011743:Pyrimidines; D014230:Triazoles; D000077592:Maraviroc; C481671:Dapivirine
keywords: Acceptability; Adherence; HIV prevention; Microbicides; Pre-exposure prophylaxis; Vaginal ring
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