Acceptability of a Long-Acting, Multipurpose Vaginal Ring: Findings from a Phase I Trial in the U.S. and Dominican Republic.
J Womens Health (Larchmt)
; 31(9): 1343-1352, 2022 09.
Article
en En
| MEDLINE
| ID: mdl-35363574
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Enfermedades de Transmisión Sexual
/
Infecciones por VIH
/
Dispositivos Anticonceptivos Femeninos
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Qualitative_research
Límite:
Female
/
Humans
País/Región como asunto:
Caribe ingles
/
Dominica
/
Republica dominicana
Idioma:
En
Revista:
J Womens Health (Larchmt)
Asunto de la revista:
GINECOLOGIA
/
SAUDE DA MULHER
Año:
2022
Tipo del documento:
Article
País de afiliación:
Estados Unidos