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

Elizabeth E Tolley, Seth Zissette, Jamilah Taylor, Homaira Hanif, Susan Ju, Jill Schwarz, Andrea Thurman, Danielle Tyner, Vivian Brache, Gustavo F Doncel, Elizabeth E Tolley, Seth Zissette, Jamilah Taylor, Homaira Hanif, Susan Ju, Jill Schwarz, Andrea Thurman, Danielle Tyner, Vivian Brache, Gustavo F Doncel

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.

Keywords: HIV prevention; Multipurpose Prevention Technology; contraception; menstrual attitudes; vaginal ring.

Conflict of interest statement

No competing financial interests exist.

Figures

FIG. 1.
FIG. 1.
(a). Acceptability of product attributes, DR Site. (b). Acceptability of product attributes, U.S. Site. DR, Dominican Republic.

References

    1. Barot S. Sexual and reproductive health and rights are key to global development: The case for ramping up investment. Guttmacher Policy Review 2015;18:1–7.
    1. Karim SA, Baxter C, Frohlich J, Karim QA. The need for multipurpose prevention technologies in sub-Saharan Africa. BJOG 2014;121 Suppl 5:27–34.
    1. Singh S, Sedgh G, Hussain R. Unintended pregnancy: Worldwide levels, trends, and outcomes. Stud Fam Plann 2010;41:241–250.
    1. UN Women. New York, NY: Facts and figures: HIV and AIDS, 2018.
    1. Ross J, Hardee K. Access to contraceptive methods and prevalence of use. J Biosoc Sci 2013;45:761–778.
    1. Tsui AO, Brown W, Li Q. Contraceptive practice in sub-Saharan Africa. Popul Dev Rev 2017;43(Suppl Suppl 1):166–191.
    1. Sonfield A. Why family planning policy and practice must guarantee a true choice of contraceptive methods. Guttmacher Policy Rev 2017;20:103–107.
    1. Blackstone SR, Nwaozuru U, Iwelunmor J. Factors influencing contraceptive use in sub-Saharan Africa: A systematic review. Int Q Community Health Educ 2017;37:79–91.
    1. Minnis AM, Montgomery ET, Napierala S, Browne EN, van der Straten A. Insights for implementation science from 2 multiphased studies with end-users of potential multipurpose prevention technology and HIV prevention products. J Acquir Immune Defic Syndr 2019;82 Suppl 3:S222–S229.
    1. Quaife M, Eakle R, Cabrera Escobar MA, et al. . Divergent preferences for HIV prevention: A discrete choice experiment for multipurpose HIV prevention products in South Africa. Med Decis Making 2018;38:120–133.
    1. Vickerman P, Quaife M, Kilbourne-Brook M, Mvundura M, Eakle R, Terris-Prestholt F. HIV prevention is not all about HIV—Using a discrete choice experiment among women to model how the uptake and effectiveness of HIV prevention products may also rely on pregnancy and STI protection. BMC Infect Dis 2020;20:704.
    1. Brache V, Payan LJ, Faundes A. Current status of contraceptive vaginal rings. Contraception 2013;87:264–272.
    1. Kiser PF, Johnson TJ, Clark JT. State of the art in intravaginal ring technology for topical prophylaxis of HIV infection. AIDS Rev 2012;14:62–77.
    1. Knopf AS, Gilbert AL, Zimet GD, et al. . Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents. AJOB Empir Bioeth 2017;8:145–152.
    1. Friend DR, Kiser PF. Assessment of topical microbicides to prevent HIV-1 transmission: Concepts, testing, lessons learned. Antiviral Res 2013;99:391–400.
    1. Thurman AR, Clark MR, Hurlburt JA, Doncel GF. Intravaginal rings as delivery systems for microbicides and multipurpose prevention technologies. Int J Womens Health 2013;5:695–708.
    1. Vargas SE, Midoun MM, Guillen M, et al. . A qualitative systematic review of women's experiences using contraceptive vaginal rings: Implications for new technologies. Perspect Sex Reprod Health 2019;51:71–80.
    1. Shapley-Quinn MK, Manenzhe KN, Agot K, Minnis AM, van der Straten A. “We are not the same”: African women's view of multipurpose prevention products in the TRIO clinical study. Int J Womens Health 2019;11:97–107.
    1. Brooks-Gunn J, Ruble DN. The menstrual attitude questionnaire. Psychosom Med 1980;42:503–512.
    1. Tolley EE, Guthrie KM, Zissette S, et al. . Optimizing adherence in HIV prevention product trials: Development and psychometric evaluation of simple tools for screening and adherence counseling. PLoS One 2018;13:e0195499.
    1. Montgomery ET, Beksinska M, Mgodi N, et al. . End-user preference for and choice of four vaginally delivered HIV prevention methods among young women in South Africa and Zimbabwe: The Quatro Clinical Crossover Study. J Int AIDS Soc 2019;22:e25283.
    1. Van der Straten A, Agot K, Ahmen K, et al. . The Tablets, Ring, Injections as Options (TRIO) study: What young African women chose and used for future HIV and pregnancy prevention. J Int AIDS Soc 2018;21(epub25094):1–9.
    1. Baeten J, Palanee-Phillips T, Mgodi N, et al. . High adherence and sustained impact on HIV-1 incidence: Final results of an open-label extension trial of the dapivirine vaginal ring. 10th IAS Conference on HIV Science; Mexico City, Mexico: International AIDS Society, 2019.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever