Abstract
Given future potential use of vaginal rings to prevent HIV infection, we examined the association of contraceptive vaginal ring (CVR) non-adherence with user dissatisfaction, tolerability, demographic, and behavioral factors. In an open-label single-group study, sexually active women aged 18-34 years using oral or injectable hormonal contraception, conveniently sampled from general population, were assigned to 6-month use of a commercial CVR currently not licensed for use in Kenya. Non-adherence in any CVR cycle completed was assessed from: (1) self-report (not used for at least 1 day), and (2) pharmacy record (failure to timely receive a new CVR or return a used one). Additionally, non-adherence was assessed in a subset of participants by residual progestin and estrogen levels measured in returned CVRs. Of 202 participants who underwent CVR insertion by a study clinician, 142 completed all 6 visits, 172 responded to questions about ring use, and 43 provided used CVRs from months 1, 3, and 6 for residual hormone analysis. Non-adherence was 14.0% (24/172) by self-report and 54.5% (110/202) by pharmacy record. Non-adherence by pharmacy record was significantly reduced among women with a salary-based income (prevalence ratio (PR) 0.71, 95% confidence interval (CI) (0.55-0.91)] compared to women with income not salary-based or no income. Participants dissatisfied with CVR on ≥4 aspects (ambiguity of instructions, inconvenience of use, sensation, sexual discomfort, etc.) were more likely to report non-adherence (PR 2.69, 95% CI=(1.31-5.52)] compared to those dissatisfied with ≤3 aspects. Non-adherence by residual hormone levels was identified in 46.5% (20/43) participants. Over time, this subset of participants showed increasing non-adherence (P=0.004). We found lack of agreement among the various measures of non-adherence. Economic empowerment interventions, especially those emphasizing partner-independent income options, and expanded education on CVR features may alleviate non-adherence. Addressing CVR dissatisfaction preemptively may also help mitigate non-adherence.
Highlights
Given future potential use of vaginal rings to prevent HIV infection, we examined the association of contraceptive vaginal ring (CVR) non-adherence with user dissatisfaction, tolerability, demographic, and behavioral factors
HIV prevention researchers anticipate that vaginal delivery of ARV drugs by long-acting (i.e., >28-day) methods will help avoid various adherence issues observed for some women with oral daily 3 or peri-coitally dosed pre-exposure prophylaxis (PrEP). 4 Contraceptive vaginal rings (CVRs) may offer valuable insights on users’ experiences, including potential adherence challenges associated with use of this technology, in particular among first-time users
9 While high satisfaction, tolerability, favorable bleeding control, and adherence have been reported by women initiating CVR use 2, a continuation rate of 26% after 6 months by new CVR users has been observed, which is even lower than the 29% reported for combined oral contraceptives. 10
Summary
In an open-label single-group study, sexually active women aged [18-34] years using oral or injectable hormonal contraception, conveniently sampled from general population, were assigned to 6-month use of a commercial CVR currently not licensed for use in Kenya. Non-adherence was assessed in a subset of participants by residual progestin and estrogen levels measured in returned CVRs. Between April 2014 and August 2015, an open-label singlegroup study of NuvaRing® (Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA) use was conducted in Kisumu, Kenya. As a part of the study clinic’s standard services, women received feminine sanitary pads, condoms, and hormonal contraceptives (at study exit or CVR discontinuation). Participants and their children were eligible to present to the study clinic at any time for diagnosis of common ailments and, if appropriate, referral for treatment.
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