Acceptability of a Long-Acting, Multipurpose Vaginal Ring: Findings from a Phase I Trial in the U.S. and Dominican Republic

• Type of Material: Article
• Authors: Elizabeth E Tolley, FHI 360, Durham; Seth Zissette, Emory University; Jamilah Taylor, Duke University; Homaira Hanif, Eastern Virginia Medical School; Susan Ju, Eastern Virginia Medical School; Jill Schwarz, Eastern Virginia Medical School, Norfolk; Andrea Thurman, Eastern Virginia Medical School; Danielle Tyner, Profamilia, Santo Domingo; Vivian Brache, Profamilia, Santo Domingo; Gustavo F Doncel, Eastern Virginia Medical School, Norfolk
• Language: English
• Date: 2022-09-15
• Publisher: Mary Ann Liebert
• Publication Version: Final Published Version
• Copyright Statement: © Elizabeth E. Tolley et al. 2022; Published by Mary Ann Liebert, Inc.
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1089/jwh.2021.0394
• Title of Journal or Parent Work: JOURNAL OF WOMENS HEALTH
• Volume: 31
• Issue: 9
• Start Page: 1343
• End Page: 1352
• Grant/Funding Information: This study and the clinical development of the TFV/LNG ring were supported by the United States Agency for International Development (USAID) with funds from The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) under Cooperative Agreements (AID-OAA-A-10-00068, AID-OAA-A-14-00010, and AID-OAA-A-14-00011). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the article.
• Keywords: HIV prevention; contraception; vaginal ring; Multipurpose Prevention Technology; menstrual attitudes
• Research Categories: Health Sciences, Epidemiology

Abstract

Background: Women worldwide face risks from pregnancy, HIV, and other sexually transmitted infections (STIs). To date, highly effective contraceptive methods provide no HIV/STI protection, and HIV prevention products, excluding condoms, provide no pregnancy protection. Intravaginal rings (IVRs) delivering antiretrovirals and contraceptives are a promising multipurpose prevention technology (MPT). Methods: Embedded within a Phase I randomized, placebo-controlled trial, we examined acceptability of continuous versus interrupted use of a 90-day MPT IVR among 47 low-risk women in Norfolk, Virginia and the Dominican Republic. A baseline survey assessed menstruation attitudes, risk perceptions and trial-related motivations. Follow-up surveys (M1/M3) examined user experiences with and preferences for IVR attributes; 18 women also participated in two in-depth interviews. Results: Most women rated the IVR's flexibility and smoothness (86%) and ease of insertion/removal (76%) as very acceptable. Fewer women similarly rated the IVR size (57%) and changes in color from menstruation (52%). Most participants experienced no changes or less bleeding. Those reporting more/heavier bleeding (20% M1, 15% M3) disliked the change. Overall, women preferred a 3-month (75%) to a 1-month IVR (7.5%) or a bimonthly injectable (10%). In qualitative interviews, women were willing to continuously use an IVR for 6–12 months, providing it did not “degrade” inside the body. Reasons for trial participation and prevention preferences, menstrual attitudes, and perceived IVR benefits and doubts varied by site. Conclusions: Findings provide strong evidence of demand for an MPT IVR that protects from pregnancy and HIV/STIs, lasts longer than 1 month, minimally disrupts menstrual bleeding, and is in women's control. numberClinicalTrials.gov: #NCT03279120.