BACKGROUND: Preventing HIV and unintended pregnancies are key health priorities in young women. To understand attributes of future Multipurpose Prevention Technologies associated with adherence, we evaluated three placebo delivery forms in a cohort of Kenyan and South African women.
METHODS: HIV-negative, sexually active, non-pregnant women aged 18-30 were enrolled and randomized to use each placebo product (daily oral tablets, monthly injections and monthly vaginal rings) for one month (N=277). At their Month-3 visit (M3), participants chose one product to use for two additional months. We assessed the following components of adherence during the usage period: Initiation/compliance with two injections of 1ml saline in the gluteus. For tablets/rings we assessed regimen initiation and completion (last dose/ring in situ at return visit) by direct observation at the clinic, and execution (correct use) by questionnaire. Non-persistence was measured by the proportion of women who switched product at their Month-4 visit (M4). We examined demographic and behavioral correlates of non-persistence by multivariable logistic regression.
RESULTS: Ninety percent (N=249) reached M3, and 89% (N=247) completed the study (M5). Mean age was 23.2 years, 49% were Kenyan and 51% South African. At M3 all chose a product (64% injections, 21% tablets, 15% ring) and >99% initiated use. At M4, >80% completed their tablet/ring regimen. For each product, initiation, execution and completion levels were similar at M4 and M5. Fifty women (20%) were non-persistent. The top reasons for switching were: wanting to gain experience with another product, preference for another mode of administration, and perceived side effects. Only one mild ring-related adverse event (vaginal pruritis) was documented during the usage period. Choosing injections at M3 (versus ring) was associated with a substantial reduction in the odds of non-persistence in South Africa only (AOR=0.2, p=0.012).
CONCLUSIONS: All participants agreed to choose and use a placebo product, a majority appeared adherent and all products were safe. Injections were chosen most often, used with perfect compliance, and in South Africa, were associated with higher persistence. Larger multisite studies with active products are needed to further inform the tolerability of and persistence with these delivery forms across settings.
