The Tablets, Ring, Injections as Options (TRIO) study: what young African women chose and used for future HIV and pregnancy prevention

Abstract

IntroductionPreventing HIV and unintended pregnancies are key global health priorities. To inform product rollout and to understand attributes of future multipurpose prevention technologies (MPT) associated with preference and use, we evaluated three placebo delivery forms: daily oral tablets, a monthly vaginal ring, and two monthly intramuscular injections in TRIO, a five‐month study among young Kenyan and South African women.Methods HIV‐negative, sexually active, non‐pregnant women aged 18 to 30 were enrolled and randomized to use each placebo delivery form for one month (stage 1). Then, participants chose one product to use for two additional months (stage 2). We assessed safety, product ranking, choice, and use. We examined demographic and behavioural correlates of choice and, reciprocally, unwillingness to use in the future with logistic regression models.Results277 women enrolled, 249 completed stage 1 and 246 completed stage 2. Median age was 23 years, 49% were Kenyan and 51% were South African. Three participants became pregnant during the study and one participant HIV‐seroconverted. There were 18 product‐related adverse events, six tablets‐related, 11 ring‐related, and one injection‐related. After trying each product, 85% preferred a TRIO product over condoms. Injections were chosen most (64%, 95% confidence interval (CI) 58%, 70%; p < 0.001), and by more South Africans than Kenyans (odds ratio (OR) 2.01, 95% CI: 1.17, 3.43; p = 0.01). There was no significant difference in choosing tablets versus ring (21%, 95% CI: 16%, 26% vs. 15%, 95% CI: 11%, 20%; p = 0.11). Tablet and ring adherence, based on direct observations and self‐reports, improved over time. However, participants’ self‐reported use of tablets did not match objective data from the electronic dose monitoring device. Participants were fully compliant with injections.ConclusionIn this population at risk for HIV and pregnancy, all participants agreed to choose and use a placebo MPT delivery form. A majority of participants preferred TRIO products to male condoms, an existing MPT. Injections were most liked and best used, however, they are years away from reaching the clinics. In the meantime, expanding the availability of tablets and giving access to rings can begin to fulfill the promise of choice for HIV prevention technologies and inform the development of suitable delivery forms as MPT.

Perceptions of HIV transmission and pre-exposure prophylaxis among health care workers and community members in Rwanda

“…Similarly, in a study where HIV negative, sexually active, non-pregnant women in Kenya and South Africa were randomized to receive either tablets, a monthly vaginal ring or intramuscular injection placebo delivery systems for multipurpose prevention of pregnancy and HIV, and subsequently given the choice of any delivery method, the participants expressed a preference for injectables above the other options. [ 22 ] The preference of oral pills observed in our study compared to other formulations of PrEP could be explained by lack of sufficient information with regards to the pros and cons of oral pills compared to parenteral formulations, and association of efficacy with HIV treatment formulations that are predominantly oral-based therapies. Also, the preference of oral pills observed in this study was different from that seen in the Voice-D (MTN-003D) study, with parenteral formulations being the most preferred among participants.…”

Acceptability of a long‐acting injectable HIV prevention product among US and African women: findings from a phase 2 clinical Trial (HPTN 076)

“…Several studies in African settings that assessed preferences among hypothetical or placebo PrEP products suggested that women’s acceptability of injectable products would be high, but that product choice and use patterns would also be shaped by individual and social context and geographies . Although a decision was made not to further evaluate TMC 278 LA as a prevention agent, in part due to requirements for cold‐chain storage, this study provides one of the first opportunities to examine acceptability of an injectable PrEP product among a geographically diverse group of women using an active product.…”

Perspectives from Young South African and Zimbabwean Women on Attributes of Four (Placebo) Vaginal Microbicide Delivery Forms

“…When longer durations of use (1 year) were proposed for the ring, the proportion stating the duration would be acceptable decreased. While there is some evidence that longeracting HIV prevention products, such as injections, are more favored by end-users [28][29][30][31][32], longer may not translate into better for the ring, as women may not want to leave the ring inserted beyond 1 month due to hygiene or comfort concerns. This nuance warrants closer examination in future research to determine the optimal duration for different products, as well as counseling around hygiene, acceptable intermittent removals for menses and other concerns, given that longer-acting products are currently in development [33].…”