Feasibility and Acceptability of the Novel Tu'Washindi Intervention to Increase PrEP Use among Adolescent Girls and Young Women in Siaya County, Kenya.

The Tu'Washindi intervention addressed intimate partner violence (IPV) and relationship dynamics to increase PrEP use among adolescent girls and young women (AGYW) in Siaya County, Kenya. We evaluated feasibility and acceptability in a cluster-randomized trial in six DREAMS Safe Spaces. The multilevel intervention, delivered over 6 months, included three components delivered by DREAMS staff with support from the study team: an 8-session structured support club; community sensitization of male partners; and a couples PrEP education and health fair ("Buddy Day"). Feasibility and acceptability assessments included implementation process measures, questionnaires, and focus group discussions with AGYWs and post-intervention questionnaires with intervention providers. The study included 103 AGYWs aged 17 to 24 (N = 49 intervention), with 97% retention. Median age was 22, 54% were married, and 84% were mothers. At enrollment, 45% used PrEP and 61% reported lifetime IPV. All intervention participants attended at least one support club session (mean = 5.2 of 8) and 90% attended Buddy Day. At 6 months, most participants perceived Tu'Washindi to be effective: all agreed (with 54% reporting "strongly agree") that the intervention improved partner communication and 60% agreed they were better able to gain partner support for their PrEP use. Providers believed the intervention resonated with community values. Tu'Washindi was highly acceptable and feasible and it was perceived by AGYW participants and providers as being effective in improving partner relationships and supporting PrEP use.

Jitegemee (rely on yourself): a multi-phase process of co-creating a personal savings intervention with female sex workers in western Kenya to reduce their HIV risk.

BACKGROUND: HIV prevalence among female sex workers (FSW) is significantly higher than among women in the general population. Studies have shown that FSW engage in unprotected sex which provides higher compensation when they face emergency situations. We co-created a savings intervention - Jitegemee (rely on yourself) - with FSW to encourage them to save part of their earnings to withdraw in emergency situations in order to reduce risk. METHODS: We undertook a five-phase intervention development process between February 2021 and July 2023: 1) qualitative interviews with FSW to identify essential intervention features; 2) pilot trial to assess intervention feasibility; 3) literature review of studies on economic empowerment of FSW; 4) scoring of key components of Phases 1-3 on a scale of 1-5 (1 = definitely exclude, 5 = definitely include), for inclusion in the intervention package; 5) workshops with FSW and other key stakeholders to co-design the intervention. RESULTS: In phase 1, nearly all participants (99%) found the intervention acceptable to them and 95% believed it would be acceptable to other FSW. Participants suggested inclusion of financial literacy (75%), savings groups (38%) and goal-setting (24%). In the feasibility assessment, 41% saved, of whom 46% withdrew some savings. Condom use was higher among FSW who withdrew their savings compared to those who did not (χ2 7.52; p = 0.006). In Phase 3, we identified 14 intervention components. In phase 4, all suggested intervention components scored 4.5 on average. In phase 5, we held 3 workshops with FSW to co-design the intervention, which included instructions for how to save and make withdrawals, financial literacy training, and formation of savings groups. CONCLUSIONS: A savings intervention for and by FSW was highly acceptable and feasible. Involving end-users in the design process is likely to result in greater economic security among FSW and lower engagement in higher risk transactional sex.

"I didn't support PrEP because I didn't know what it was": Inadequate information undermines male partner support for young women's pre-exposure prophylaxis use in western Kenya.

The HIV infection rate is higher among adolescent girls and young women (AGYW) in Africa than men in the same age range. Pre-exposure prophylaxis (PrEP) can be used by women discreetly; however, for most AGYW, male partner approval is desired. We explored PrEP use in the context of relationship violence and power dynamics through focus group discussions and support club sessions with AGYW, in-depth interviews and male sensitisation sessions with male partners of AGYW, and joint sessions with AGYW and their male partners. Many male partners reported hesitancy in supporting partner's PrEP use without sufficient information; most of these became supportive following their engagement in study activities; and most preferred participation in decisions around PrEP use. For AGYW, male involvement minimised partner violence around their PrEP use. The findings support the need for correct PrEP information to be provided to male partners of AGYW and to involve them early on, in decision-making about PrEP use. This is likely to improve uptake of and adherence to PrEP.

The development of a conceptual framework on PrEP stigma among adolescent girls and young women in sub-Saharan Africa.

INTRODUCTION: Stigma is a well-known barrier to HIV testing and treatment and is an emerging barrier to pre-exposure prophylaxis (PrEP) use. To guide future research, measurement and interventions, we developed a conceptual framework for PrEP stigma among adolescent girls and young women (AGYW) in sub-Saharan Africa, a priority population for PrEP. METHODS: A literature review, expert consultations and focus group discussions (FGDs) were conducted to adapt the Health Stigma and Discrimination Framework, describing the stigmatization process nested within the socio-ecological framework. We reviewed all articles on PrEP stigma and on HIV, contraceptive or sexuality stigma among AGYW from 2009 to 2019. Expert consultations were conducted with 10 stigma or PrEP researchers and two Kenyan youth advisory boards to revise the framework. Finally, FGDs were conducted with AGYW PrEP users (4 FGDs; n = 20) and key influencers (14 FGDs; n = 72) in Kenya with the help of a Youth Research Team who aided in FGD conduct and results interpretation. Results from each phase were reviewed and the framework was updated to incorporate new and divergent findings. This was validated against an updated literature search from 2020 to 2023. RESULTS: The conceptual framework identifies potential drivers, facilitators and manifestations of PrEP stigma, its outcomes and health impacts, and relevant intersecting stigmas. The main findings include: (1) PrEP stigma is driven by HIV, gender and sexuality stigmas, and low PrEP community awareness. (2) Stigma is facilitated by factors at multiple levels: policy (e.g. targeting of PrEP to high-risk populations), health systems (e.g. youth-friendly service availability), community (e.g. social capital) and individual (e.g. empowerment). (3) Similar to other stigmas, manifestations include labelling, violence and shame. (4) PrEP stigma results in decreased access to and acceptability of PrEP, limited social support and community resistance, which can impact mental health and decrease PrEP uptake and adherence. (5) Stigma may engender resilience by motivating AGYW to think of PrEP as an exercise in personal agency. CONCLUSIONS: Our PrEP stigma conceptual framework highlights potential intervention targets at multiple levels in the stigmatization process. Its adoption would enable researchers to develop standardized measures and compare stigma across timepoints and populations as well as design and evaluate interventions.

Breaking down relationship barriers to increase PrEP uptake and adherence among adolescent girls and young women in Kenya: safety and preliminary effectiveness results from a pilot cluster-randomized trial.

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.

Tu'Washindi na PrEP: Working With Young Women and Service Providers to Design an Intervention for PrEP Uptake and Adherence in the Context of Gender-Based Violence.

HIV pre-exposure prophylaxis (PrEP) reduces HIV acquisition among adolescent girls and young women (AGYW). Existing evidence suggests that uptake and adherence are low among AGYW and that relationship factors such as gender-based violence (GBV) are important barriers. Through a community-based participatory research (CBPR) process, a youth advisory board (YAB), service providers (SP), and a study team developed the Tu'Washindi na PrEP intervention to support AGYW PrEP use in the context of GBV. The YAB also guided the formative research and interpretation of results. The authors pretested the intervention with SP, AGYW and their partners, and community change agents, and then developed guides for AGYW support clubs, community-based male sensitization sessions, and couples-based events that included formulation of story lines for dramatized PrEP negotiation and information dissemination skills. Stakeholder engagement led to an intervention responsive to AGYW's needs for PrEP support in the context of their relationships, which was evaluated through a 6-month pilot community randomized controlled trial.

PrEP and the syndemic of substance use, violence, and HIV among female and male sex workers: a qualitative study in Kisumu, Kenya.

INTRODUCTION: Female and male sex workers experience heightened vulnerability to HIV and other health harms that are compounded by substance use, physical and sexual violence, and limited access to health services. In Kisumu, Kenya, where sex work is widespread and substance use is a growing public health concern, offering pre-exposure prophylaxis (PrEP) for HIV prevention could help curtail the HIV epidemic. Our study examines "syndemics," or mutually reinforcing epidemics of substance use, violence and HIV, in relation to PrEP acceptability and feasibility among female and male sex workers in Kenya, one of the first African countries to approve PrEP for HIV prevention. METHODS: From 2016 to 2017, sex workers in Kisumu reporting recent alcohol or drug use and experiences of violence participated in qualitative interviews on HIV risk and perspectives on health service needs, including PrEP programming. Content analysis identified themes relating to PrEP knowledge, acceptability, access challenges and delivery preferences. RESULTS: Among 45 female and 28 male sex workers, median age was 28 and 25 respectively. All participants reported past-month alcohol use and 91% of women and 82% of men reported past-month drug use. Violence was pervasive, with most women and men reporting past-year physical (96% women, 86% men) and sexual (93% women, 79% men) violence. Concerning PrEP, interviews revealed: (1) low PrEP knowledge, especially among women; (2) high PrEP acceptability and perceived need, particularly within syndemic contexts of substance use and violence; and (3) preferences for accessible, non-stigmatizing PrEP delivery initiatives designed with input from sex workers. CONCLUSIONS: Through a syndemic lens, substance use and violence interact to increase HIV vulnerability and perceived need for PrEP among female and male sex workers in Kisumu. Although interest in PrEP was high, most sex workers in our sample, particularly women, were not benefiting from it. Syndemic substance use and violence experienced by sex workers posed important barriers to PrEP access for sex workers. Increasing PrEP access for sex workers will require addressing substance use and violence through integrated programming.