Introduction Innovative approaches for delivery of hormonal contraception and antiretrovirals are urgently needed. Intravaginal vaginal rings are a promising strategy since they obviate the need for daily dosing, a challenge in some HIV prevention studies in sub-Saharan Africa (SSA). Changes in the vaginal microbiome associated with increased risk of bacterial vaginosis (BV) are a risk for HIV acquisition and transmission, as is pregnancy. Therefore, hormonal interventions that prevent unintended pregnancies (UIP) and promote vaginal health could reduce this risk. However, there is little data on acceptability of intravaginal rings in SSA countries. We assessed uptake and acceptability of a contraceptive vaginal ring (CVR) among women with BV.
Methods We conducted a prospective study among women aged 18–40 years in Thika, Kenya. Participants were recruited from community venues and public health facilities. If interested and eligible, they were randomised to cyclical or continuous use of the CVR at month 1 visit and were followed up monthly for 7 months. At follow-up visits behavioural data was obtained and pregnancy testing performed. We used univariate methods to determine CVR uptake and survival methods to determine time to incident pregnancy.
Results Between April to December 2016, 363 women screened, 101 enrolled and 79 (78.2%) initiated CVR at randomization visit, 12 (11.9%) did not return for randomization and were considered lost to follow-up, 7 (6.9%) expressly refused to use CVR, and 3 (3.0%) terminated due to investigator’s decision or other reasons. Reasons for refusal included lack of a stable partner, need to consult partners, and preference for other contraceptive methods. We observed 4 incident pregnancies, at an incidence of 18.7 per 100 person-years (95% CI 5.1–48.0).
Conclusions Contraceptive vaginal ring was highly acceptable among women with BV with few incident pregnancies, suggesting that combination prevention with antiretrovirals using this delivery system should be feasible for this population.
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