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: Introduction: Oral pre‐exposure prophylaxis (PrEP) has the potential to reduce HIV acquisition among adolescent girls and young women (AGYW) in sub‐Saharan Africa, a priority population for epidemic control. However, intimate partner violence (IPV) and low relationship power can create significant challenges to PrEP use. The Tu'Washindi intervention aimed to increase PrEP use by addressing relationship‐ and violence‐related barriers among AGYW enrolled in the DREAMS Initiative in Siaya County, Kenya. Methods: Our multi‐level, community‐based intervention was piloted in a cluster‐randomized controlled trial conducted at six DREAMS sites from April to December 2019 (NCT03938818). Three intervention components were delivered over 6 months: an eight‐session empowerment‐based support club, community sensitization targeted towards male partners and a couples’ PrEP education event. Participants were ages 17–24, HIV negative and either eligible for, or already taking, PrEP. Over 6 months of follow‐up, we assessed IPV (months 3 and 6) and PrEP uptake and continuation (month 6) through interviewer‐administered questionnaires; PrEP adherence was assessed with Wisepill electronic monitoring devices. These outcomes were compared using adjusted Poisson and negative binomial regression models. Results: We enrolled 103 AGYW with median age of 22 years (IQR 20–23); one‐third were currently taking PrEP and 45% reported IPV in the past 3 months. Retention was 97% at month 6. Compared to the control arm, intervention arm participants were more likely to initiate PrEP, if not already using it at enrolment (52% vs. 24%, aRR 2.28, 95% CI 1.19–4.38, p = 0.01), and those taking PrEP had more days with device openings (25% of days vs. 13%, aRR 1.94, 95% CI 1.16–3.25, p = 0.01). Twenty percent of participants reported IPV during follow‐up. There were trends towards fewer IPV events (aIRR 0.66, 95% CI 0.27–1.62, p = 0.37) and fewer events resulting in injury (aIRR 0.21, 95% CI 0.04–1.02, p = 0.05) in the intervention versus control arm. Conclusions: Tu'Washindi shows promise in promoting PrEP uptake and adherence among AGYW without concomitant increases in IPV; however, adherence was still suboptimal. Further research is needed to determine whether these gains translate to increases in the proportion of AGYW with protective levels of PrEP adherence and to evaluate the potential for the intervention to reduce IPV risk., INTRODUCTION Adolescent girls and young women (AGYW; ages 15–24) in sub‐Saharan Africa are disproportionately affected by HIV. More than one in four new HIV acquisitions in this region are among [...]

IntroductionAdherence to HIV prevention methods is a challenge, particularly for young women in Sub-Saharan Africa. End-user research during product development can inform modifiable factors to increase future uptake and adherence.MethodsPreferences for four vaginally inserted placebo HIV prevention methods were assessed among Zimbabwean and South African young women using a crossover clinical design. For each of months 1 to 4, participants were asked to use a pre-coitally inserted film, insert (vaginal tablet) and gel once/week for a month, and a monthly ring in a randomly assigned sequence. Participants subsequently chose one preferred product to use as directed for the final study month. Women ranked the four products from most preferred to least preferred at enrolment and after trying all products.ResultsA total of 200 women aged 18 to 30 (mean 23) were enrolled; 178 (89%) completed follow-up. At baseline, 41% of participants selected the gel as their most preferred product and 61% selected the ring as least preferred. During the crossover period, most (82% to 85%) self-reported using each product at least once a week, although only half the time with sex. Objective biomarker data confirmed adequate use of all products. After trying each product, rankings changed with the film, ring, insert and gel being selected by 29%, 28%, 26% and 16% respectively. Choice varied significantly by country (p

Introduction: Existing biomedical HIV prevention options, though highly effective, present substantial adherence challenges. End-user input on early-stage design of new HIV prevention approaches is critical to yielding products that achieve high uptake and adherence. The iPrevent Study examined youths' preferences for key attributes of long-acting Pre-Exposure Prophylaxis (PrEP), with a focus on characteristics pertinent to product delivery alongside key modifiable product attributes. Methods: A discrete choice experiment was conducted with female and male youth aged 18 to 24 in two high-density communities in Cape Town, South Africa during the period July 2017 to January 2019. Sexually active, PrEP-naive youth were recruited using population-based sampling; targeted sampling was used to enrol men who have sex with men (MSM). In a series of nine questions, participants were asked to choose between two hypothetical products composed of five attributes (form, dosing frequency, access, pain, insertion site). We used a random-parameters logit model to estimate preference weights and trade-offs among product alternatives. We examined differences across three subgroups: females, men who have sex with only women (MSW) and MSM. Results: A total of 807 participants (401 female) were enrolled with a median age of 21 years. Males included 190 MSM. Most youth had tested for HIV (95%) and reported being HIV-negative (91%). Across all groups, duration of effectiveness was the most important attribute, with strong preference for less frequent dosing. Injections were favoured over implants, though these preferences were strongest for females and MSM. Females preferred a product offered at a health clinic and disliked pharmacy access; all groups preferred the arm as the insertion site. Youth were willing to trade their preferred product form for longer duration. Conclusions: Youth indicated strong preferences for longer duration products. Each attribute nonetheless influenced preferences, offering insight into trade-offs that inform long-acting PrEP development. Keywords: HIV prevention; long-acting pre-exposure prophylaxis; discrete choice experiment; acceptability; adolescent girls and young women; men who have sex with men, 1 | INTRODUCTION End-user input on early stage design of new HIV prevention approaches is critical to yielding products that achieve high uptake and adherence. As evidenced by multiple clinical [...]

Introduction: Preventing 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 l).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. Results: 277 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 HlV-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 (Cl) 58%, 70%; p < 0.001), and by more South Africans than Kenyans (odds ratio (OR) 2.01, 95% Cl: 1.17, 3.43; p = 0.01). There was no significant difference in choosing tablets versus ring (21%, 95% Cl: 16%, 26% vs. 15%, 95% Cl: 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. Conclusion: In 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. Keywords: multipurpose prevention technologies; end-user research; HIV prevention; product preference; contraception; Africa, 1 | INTRODUCTION Sexually active women at risk for HIV also need to prevent unintended pregnancies. In sub-Saharan Africa, 40% to 60% of pregnancies remain unintended [1,2]; likewise, young women [...]

: Introduction: Adherence to HIV prevention methods is a challenge, particularly for young women in Sub?Saharan Africa. End?user research during product development can inform modifiable factors to increase future uptake and adherence. Methods: Preferences for four vaginally inserted placebo HIV prevention methods were assessed among Zimbabwean and South African young women using a crossover clinical design. For each of months 1 to 4, participants were asked to use a pre?coitally inserted film, insert (vaginal tablet) and gel once/week for a month, and a monthly ring in a randomly assigned sequence. Participants subsequently chose one preferred product to use as directed for the final study month. Women ranked the four products from most preferred to least preferred at enrolment and after trying all products. Results: A total of 200 women aged 18 to 30 (mean 23) were enrolled; 178 (89%) completed follow?up. At baseline, 41% of participants selected the gel as their most preferred product and 61% selected the ring as least preferred. During the crossover period, most (82% to 85%) self?reported using each product at least once a week, although only half the time with sex. Objective biomarker data confirmed adequate use of all products. After trying each product, rankings changed with the film, ring, insert and gel being selected by 29%, 28%, 26% and 16% respectively. Choice varied significantly by country (p < 0.001): More Zimbabweans chose the film (45%), and more South Africans chose the insert (34%). Among women choosing the ring, 88% reported using it every time with sex. By contrast, self?reported adherence was lower for ?on?demand? (coitally associated) products, with 40% to 55% using them every time during sex (p < 0.001). Conclusions: Preferences for these four dosage forms varied before and after use, and both within and across countries ? there was no clear favourite ? indicating the need for a range of options for end?users. The ring's popularity increased the most with use, was the second most preferred delivery system, and per self?report, provided more coverage during sex. These end?user perspectives provide important information to product developers and funding agencies., Introduction Adolescents and young women in Africa are at disproportionately high risk for HIV acquisition and the identification and delivery of safe, effective female?initiated prevention interventions is a public health [...]