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

• 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
• Journal Title: JOURNAL OF WOMENS HEALTH
• Volume: Volume 31, Number 9
• Publisher: Mary Ann Liebert | 2022-09-15, Pages 1343-1352
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1089/jwh.2021.0394
• Subjects: Health Sciences, Epidemiology
• Keywords: HIV prevention; contraception; vaginal ring; Multipurpose Prevention Technology; menstrual attitudes

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.