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AbstractIntroductionStigma 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.MethodsA 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.ResultsThe 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.ConclusionsOur 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.

AbstractIntroductionWithout significant increases in uptake of HIV testing among men, it will be difficult to reduce HIV incidence to disease elimination levels. Secondary distribution of HIV self‐tests by women to their male partners is a promising approach for increasing male testing that is being implemented in several countries. Here, we examine male partner and couples testing outcomes and sexual decision making associated with this approach in a cluster randomized trial.MethodsWe examined data from women at higher risk of HIV participating in the intervention arm of an ongoing pair‐matched cluster randomized trial in Kenya. HIV‐negative women ≥18 years who self‐reported ≥2 partners in the past month were eligible. Participants received self‐tests at enrolment and three‐monthly intervals. They were encouraged to offer tests to sexual partners with whom they anticipated condomless sex. At six months, we collected data on self‐test distribution, male partner and couples testing, and testing and sexual behaviour in the three most recent transactional sex encounters. We used descriptive analyses and generalized estimating equation models to understand how sexual behaviour was influenced by self‐test distribution.ResultsFrom January 2018 to April 2019, 921/1057 (87%) participants completed six‐month follow‐up. Average age was 28 years, 65% were married, and 72% reported income through sex work. Participants received 7283 self‐tests over six months, a median of eight per participant. Participants offered a median three self‐tests to sexual partners. Of participants with a primary partner, 94% offered them a self‐test. Of these, 97% accepted the test. When accepted, couples testing was reported among 91% of participants. Among 1954 transactional sex encounters, 64% included an offer to self‐test. When offered self‐tests were accepted by 93% of partners, and 84% who accepted conducted couples testing. Compared to partners with an HIV‐negative result, condom use was higher when men had a reactive result (56.3% vs. 89.7%, p < 0.01), were not offered a self‐test (56.3% vs. 62.0%, p = 0.02), or refused to self‐test (56.3% vs. 78.3, p < 0.01).ConclusionsProviding women with multiple self‐tests facilitated male partner and couples testing, and led to safer sexual behaviour. These findings suggest secondary distribution is a promising approach for reaching men and has HIV prevention potential.Clinical Trial Number: NCT03135067.

AbstractIntroductionFemale 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.MethodsFrom 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.ResultsAmong 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.ConclusionsThrough 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.

BACKGROUND: Illegal drug markets are shaped by multiple forces, including local actors and broader economic, political, social, and criminal justice systems that intertwine to impact health and social wellbeing. Ethnographic analyses that interrogate multiple dimensions of drug markets may offer both applied and theoretical insights into drug use, particularly in developing nations where new markets and local patterns of use traditionally have not been well understood. This paper explores the emergent drug market in Kisumu, western Kenya, where our research team recently documented evidence of injection drug use. METHODS: Our exploratory study of injection drug use was conducted in Kisumu from 2013 to 2014. We draw on 151 surveys, 29 in-depth interviews, and 8 months of ethnographic fieldwork to describe the drug market from the perspective of injectors, focusing on their perceptions of the market and reports of drug use therein. RESULTS: Injectors described a dynamic market in which the availability of drugs and proliferation of injection drug use have taken on growing importance in Kisumu. In addition to reports of white and brown forms of heroin and concerns about drug adulteration in the market, we unexpectedly documented widespread perceptions of cocaine availability and injection in Kisumu. Examining price data and socio-pharmacological experiences of cocaine injection left us with unconfirmed evidence of its existence, but opened further possibilities about how the chaos of new drug markets and diffusion of injection-related beliefs and practices may lend insight into the sociopolitical context of western Kenya. CONCLUSIONS: We suggest a need for expanded drug surveillance, education and programming responsive to local conditions, and further ethnographic inquiry into the social meanings of emergent drug markets in Kenya and across sub-Saharan Africa.

IntroductionThe customs of widow cleansing and widow inheritance are practiced in several communities throughout sub‐Saharan Africa. In the Nyanza Province of Kenya, according to tradition, Luo widows are expected to engage in sexual intercourse with a "cleanser," without the use of a condom, in order to remove the impurity ascribed to her after her husband's death. Luo couples, including widows, are also expected to engage in sex preceding specific agricultural activities, building homes, funerals, weddings, and other significant cultural and social events. Widows who are inherited for the purpose of fulfilling cultural obligation have a higher prevalence of HIV than those who remain un‐inherited or are inherited for the purpose of companionship.MethodsAs part of a larger descriptive qualitative study to inform study procedures for FEM‐PrEP, an HIV prevention pre‐exposure prophylaxis clinical trial, we conducted 15 semi‐structured interviews (SSIs) with widows, 15 SSIs with inheritors, and four focus group discussions with widows in the Bondo and Rarieda districts in Nyanza Province to explore the HIV risk context within widow cleansing and inheritance practices. Thematic qualitative analysis was used to analyze the data.ResultsThe majority of widows reported in the demographic questionnaire being inherited, and most widows in the SSIs described participating in the cleansing ritual. We identified two main themes related to HIV prevention within the context of widow cleansing and inheritance: 1) widows must balance limiting their risk for HIV infection with meeting cultural expectations and ensuring that their livelihood needs are met, and 2) sexual abstinence undermines cultural expectations in widowhood while the use of condoms is deemed inappropriate in fulfilling culturally prescribed sexual rituals, and is often beyond the widow's ability to negotiate.ConclusionsWomen‐controlled HIV prevention methods such as antiretroviral‐based oral pre‐exposure prophylaxis, vaginal gels, and vaginal rings are needed for HIV‐negative widows who engage in sexual rituals related to widowhood.

AbstractIntroductionOral 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.MethodsOur 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.ResultsWe 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.ConclusionsTu'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.

IntroductionRisk perception is a core construct in many behaviour change theories in public health. Individuals who believe they are at risk of acquiring an illness may be more likely to engage in behaviours to reduce that risk; those who do not feel at risk may be unlikely to engage in risk reduction behaviours. Among participants who seroconverted in two FEM‐PrEP sites – Bondo, Kenya, and Pretoria, South Africa – we explored perceived HIV risk and worry about acquiring HIV prior to HIV infection.MethodsFEM‐PrEP was a phase III clinical trial of once‐daily, oral emtricitabine and tenofovir disoproxil fumarate for HIV prevention among women in sub‐Saharan Africa. We asked all participants about their perceived HIV risk in the next four weeks, prior to HIV testing, during a quantitative face‐to‐face interview at enrolment and at quarterly follow‐up visits. Among participants who seroconverted, we calculated the frequencies of their responses from the visit conducted closest to, but before, HIV acquisition. Also among women who seroconverted, we conducted qualitative, semi‐structured interviews (SSIs) at weeks 1, 4 and 8 after participants' HIV diagnosis visit to retrospectively explore feelings of HIV worry. Applied thematic analysis was used to analyse the SSI data.ResultsAmong participants who seroconverted in Bondo and Pretoria, 52% reported in the quantitative interview that they had no chance of acquiring HIV in the next four weeks. We identified four processes of risk rationalization from the SSI narratives. In "protective behaviour," participants described at least one risk reduction behaviour they used to reduce their HIV risk; these actions made them feel not vulnerable to HIV, and therefore they did not worry about acquiring the virus. In "protective reasoning," participants considered their HIV risk but rationalized, based on certain events or beliefs, that they were not vulnerable and therefore did not worry about getting HIV. In "recognition of vulnerability," participants described reasons for being worried about getting HIV but said no or limited action was taken to reduce their perceived vulnerability. Participants with "no rationalization or action" did not describe any HIV worry or did not engage in HIV risk reduction behaviours.ConclusionsWomen who are at substantial risk of acquiring HIV may underestimate their actual risk. Yet, others who accurately understand their HIV risk may be unable to act on their concerns. Perceived HIV risk and risk rationalization are important concepts to explore in risk reduction counselling to increase the use of HIV prevention strategies among women at risk of HIV.

AbstractIntroductionPreventing 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.MethodsHIV‐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.

AbstractIntroductionThe Data‐informed Stepped Care (DiSC) study is a cluster‐randomized trial implemented in 24 HIV care clinics in Kenya, aimed at improving retention in care for adolescents and youth living with HIV (AYLHIV). DiSC is a multi‐component intervention that assigns AYLHIV to different intensity (steps) of services according to risk. We used the Framework for Reporting Adaptations and Modifications‐Expanded (FRAME) to characterize provider‐identified adaptations to the implementation of DiSC to optimize uptake and delivery, and determine the influence on implementation outcomes.MethodsBetween May and December 2022, we conducted continuous quality improvement (CQI) meetings with providers to optimize DiSC implementation at 12 intervention sites. The meetings were guided by plan‐do‐study‐act processes to identify challenges during early phase implementation and propose targeted adaptations. Meetings were audio‐recorded and analysed using FRAME to categorize the level, context and content of planned adaptations and determine if adaptations were fidelity consistent. Providers completed surveys to quantify perceptions of DiSC acceptability, appropriateness and feasibility. Mixed effects linear regression models were used to evaluate these implementation outcomes over time.ResultsProviders participated in eight CQI meetings per facility over a 6‐month period. A total of 65 adaptations were included in the analysis. The majority focused on optimizing the integration of DiSC within the clinic (83%, n = 54), and consisted of improving documentation, addressing scheduling challenges and improving clinic workflow. Primary reasons for adaptation were to align delivery with AYLHIV needs and preferences and to increase reach among AYLHIV: with reminder calls to AYLHIV, collaborating with schools to ensure AYLHIV attended clinic appointments and addressing transportation challenges. All adaptations to optimize DiSC implementation were fidelity‐consistent. Provider perceptions of implementation were consistently high throughout the process, and on average, slightly improved each month for intervention acceptability (β = 0.011, 95% CI: 0.002, 0.020, p = 0.016), appropriateness (β = 0.012, 95% CI: 0.007, 0.027, p<0.001) and feasibility (β = 0.013, 95% CI: 0.004, 0.022, p = 0.005).ConclusionsProvider‐identified adaptations targeted improved integration into routine clinic practices and aimed to reduce barriers to service access unique to AYLHIV. Characterizing types of adaptations and adaptation rationale may enrich our understanding of the implementation context and improve abilities to tailor implementation strategies when scaling to new settings.

AbstractIntroductionEngaging adolescents in HIV care and research promotes the development of interventions tailored to their unique needs. Guidelines generally require parental permission for adolescents to receive HIV care/testing or participate in research, with exceptions. Nevertheless, parental permission requirements can restrict adolescent involvement in care and research. To better appreciate prospects for policy reform, we sought to understand the perspectives of stakeholders involved in the development, review and implementation of policies related to adolescents living with HIV.MethodsSemi‐structured individual interviews (IDIs) were conducted from October 2019 to March 2020 with 18 stakeholders with expertise in the (1) development of policy through membership in the Law Society of Kenya or work as a health policy official; (2) review of policy through ethics review committee service; or (3) implementation of policy through involvement in adolescent education. IDIs were conducted in English by Kenyan social scientists, audio‐recorded and transcribed verbatim. We used thematic analysis to identify themes around how policies can be reformed to improve adolescent engagement in HIV care and research.ResultsOur analysis identified three major themes. First, policies should be flexible rather than setting an age of consent. Stakeholders noted that adolescents' capacity for engagement in HIV care and research depended on context, perceived risks and benefits, and "maturity"—and that age was a poor proxy for the ability to understand. Second, policies should evolve with changing societal views about adolescent autonomy. Participants recognized a generational shift in how adolescents learn and mature, suggesting the need for a more frequent review of HIV care and research guidelines. Third, adults should empower adolescent decision‐making. Stakeholders felt that caregivers can gradually involve adolescents in decision‐making to equip them to gain ownership over their health and lives, improving their confidence and capacity.ConclusionsRevising relevant laws to consider context, alternative measures of maturity, and evolving societal views about adolescence, along with supporting caregivers to assist in developing adolescent autonomy may promote more equitable and representative participation of adolescents in HIV care and research. Additional research should explore how to support caregivers and other adults to empower adolescents and improve stakeholder engagement in a more routine process of policy reform.

Zebedee Mwandi and colleagues discuss Kenya's scale-up of voluntary medical male circumcision services, highlighting government leadership, a clear implementation strategy, and program flexibility and innovation as keys to Kenya's success.