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Abstract Primary healthcare facilities are central to the implementation of voluntary medical male circumcision (VMMC) as points of access to integrated health services in line with the Kenya AIDS Strategic Framework II (2020/21-2024/25). Knowledge of factors that explain men’s uptake of VMMC and sexual health services at these facilities and preferences of where to get the services remain poorly understood. Using qualitative methodologies, we examined factors that determined facility choice for VMMC services and reasons for preferring the facility among men aged 25–39 years who previously underwent VMMC. The current study draws from focus group discussion interviews with circumcised men and their partners conducted as part of a randomized controlled trial to assess impact of two demand creation interventions in western Kenya. This involved 12 focus group discussions (FGD) with 6–10 participants each. Six FGDs were conducted with circumcised men, and 6 with their sex partners. Thematic issues relevant to a predetermined framework were identified. The themes were organized as follows: service availability, accessibility, affordability, appropriateness and, acceptability. Facility location, physical layout, organization of patient flow, infrastructure, and service provider skills were the outstanding factors affecting the choice of VMMC service outlets by men aged 25–39 years. Additionally, preferences were influenced by individual’s disposition, attitudes, knowledge of VMMC services and tacit balance between their own recognized health needs versus desire to conform to social-cultural norms. Facility choice and individual preference are intricate issues, simultaneously involving multiple but largely intra-personal and facility-level factors. The intrapersonal dimensions elicited may also reflect differential responses to strategic communications and demand creation messages with promotion and prevention frames.

Abstract Background Daily oral pre-exposure prophylaxis (PrEP) is an effective HIV prevention option for those who are most vulnerable to HIV infection, especially young women (YW). Objection by or lack of support from male sexual partners has been shown to impact YW’s ability to take PrEP consistently. We explored the views of YW, and male partners and male peers of YW in Siaya County, Western Kenya, to illustrate how men influence, and can support, YW in using PrEP. Methods We used Photovoice to capture the views of YW ages 18–24 who were currently or previously enrolled in the DREAMS program and with current or previous experience taking PrEP. We also captured the views of YW’s sexual partners and male peers. The YW completed eight photo assignments that focused on identifying factors influencing their PrEP use, and male participants completed four photo assignments focused on identifying ways men support or hinder YW’s PrEP use. Photographs were presented and discussed in same- and mixed-gender groups using the SHOWeD method. YW also participated in in-depth interviews. The analysis focused on identifying themes that described men’s influence on YW’s PrEP adherence and persistence. Results Among YW, a restricting male influence on PrEP use emerged in the majority of photo assignments such that YW’s photographs and discussions revealed that men were more often viewed as barriers than supporters. YW perceived that they had little autonomy over their sexual lives and choice to use PrEP. YW’s PrEP use was perceived to be hindered by stigmatizing community narratives that influenced men’s support of PrEP use among women. Male participants suggested that men would support YW’s PrEP use if PrEP was better promoted in the community and if men were more knowledgeable about its benefits. Conclusions A lack of support from male partners and peers and stigmatizing community narratives influence YW’s PrEP use. Community-based programs should include education about PrEP specifically for male partners and peers of YW to positively influence PrEP use among YW.

Abstract Introduction The 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. Methods Between 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. Results Providers 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

Abstract 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.

Abstract In Kenya similar to other countries in Eastern and Southern Africa There is a disproportionately high burden of the global HIV incidence among youth ages 15–24 years, and where adolescent girls and young women account for up to a third of all incident HIV infections and more than double the burden of HIV compared to their male peers. Previous work has shown early sexual debut as entry point into risks to sexual and reproductive health among young people including STI/HIV acquisition. This was a formative assessment of the local context of three sexual risk behaviors among youth ages of 15–24 years: early sexual debut, multiple sexual partnerships, and age-mixing /intergenerational sex for purposes of informing comprehensive combination HIV intervention program design. We conducted a cross-sectional formative qualitative study in four sub-counties within Homabay county a high HIV prevalence region of Kenya. Participants were recruited through youth groups, schools, government offices and, community gatekeepers using approved fliers, referred to a designated venue for focus group discussion (FGD). After oral informed consent, twelve FGDs of 8–10 participants were carried out. Transcripts and field notes were uploaded to Atlas.ti qualitative data analysis and research software (version 8.0, 2017, ATLAS.ti GmbH). Open coding followed by grouping, categorization of code groups, and thematic abstraction was used to draw meaning for the data. A total of 111 youth participated in the FGD, 65 males and 46 females. The main findings were that youth engaged in early sex for fear of being labeled ‘odd’ by their peers, belief (among both male and female) that ‘practice makes perfect’, curiosity about sex, media influence, need to prove if one can father a child (among male), the notion that sex equals love with some of the youth using this excuse to coerce their partners into premature sex, and the belief that sex is a human right and parents/guardians should not intervene. Male youth experienced more peer-pressure to have sex earlier. Female youths cited many reasons to delay coitarche that included fear of pregnancy, burden of taking care of a baby, and religious doctrines. Having multiple sexual partners and intergenerational sexual relationships were common among the youth driven by perceived financial gain and increased sexual prowess. HIV prevention strategies need to address gender vulnerabilities, as well as promoting a protective environment, hence application of combination prevention methods is a viable solution to the HIV pandemic. Trial registration number: The study was approved by the KNH/UoN Ethics review committee (KNH/UoN ERC-P73/03/2011) and New York University (NYU Reg no.–00000310).

Voluntary medical male circumcision (VMMC) reduces men's risk of acquiring Human immunodeficiency virus (HIV) through vaginal sex. However, VMMC uptake remains lowest among Kenyan men ages 25-39 years among whom the impact on reducing population-level HIV incidence was estimated to be greatest at the start of the study in 2014. We conducted a pre- and post-intervention survey as part of a cluster randomized controlled trial to determine the effect of two interventions (interpersonal communication (IPC) and dedicated service outlets (DSO), delivered individually or together) on improving VMMC uptake among men ages 25-39 years in western Kenya between 2014 and 2016. The study had three intervention arms and a control arm. In arm one, an IPC toolkit was used to address barriers to VMMC. In arm two, men were referred to DSO that were modified to address their preferences. Arm three combined the IPC and DSO. The control arm had standard of care. At baseline, uncircumcised men ranked the top three reasons for remaining uncircumcised. An IPC demand creation toolkit was used to address the identified barriers and men were referred for VMMC at study-designated facilities. At follow-up, those who remained uncircumcised were again asked to rank the top three reasons for not getting circumcised. There was inconsistency in ranking of reported barriers at pre- and post- intervention: 'time/venue not convenient' was ranked third at baseline and seventh at follow-up; 'too busy to go for circumcision' was tenth at baseline but second at follow-up, and concern about 'what I/family will eat' was ranked first at both baseline and follow-up, but the proportion reduced from 62% to 28%. Men ages 25-39 years cited a variety of logistical and psychosocial barriers to receiving VMMC. After exposure to IPC, most of these barriers shifted while some remained the same. Additional innovative interventions to address on-going and shifting barriers may help improve VMMC uptake among older men.

Abstract 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 Efforts to improve health outcomes among adolescents and young adults living with HIV (ALHs) are hampered by limited adolescent engagement in HIV-related research. We sought to understand the views of adolescents, caregivers and healthcare workers (HCWs) about who should make decisions regarding ALHs’ research participation.Methods We conducted focus group discussions (FGDs) and in-depth interviews (IDIs) with ALHs (aged 14–24 years), caregivers of ALHs and HCWs from six HIV care clinics in Western Kenya. We used semi-structured guides to explore ALHs’ involvement in research decisions. Transcripts were analysed using thematic analysis; perspectives were triangulated between groups.Results We conducted 24 FGDs and 44 IDIs: 12 FGDs with ALHs, 12 with caregivers, and 44 IDIs with HCWs, involving 216 participants. HCWs often suggested that HIV research decision-making should involve caregivers and ALHs deciding together. In contrast, ALHs and parents generally thought decisions should be made individually, whether by HCWs/research teams (although this is likely ethically problematic), adolescents or caregivers. Caregiver and ALH preferences depended on ALHs’ age, with younger ALHs requiring more support. A few caregivers felt that ALHs should consult with the research team/HCWs due to their greater knowledge of clinical care. ALHs emphasised that they should independently decide because they thought they had the right to do so and the capacity to consent. Poor communication and parental non-disclosure of HIV status influenced ALHs’ views to exclude caregivers from decision-making. Regarding influences on research decision-making, ALHs were more willing to participate based on perceived contribution to science and less interested in participating in studies with potential risks, including loss of confidentiality.Discussion While research teams and HCWs felt that adolescents and caregivers should jointly make research decisions, ALHs and caregivers generally felt individuals should make decisions. As ALHs sometimes find caregiver support lacking, improving family dynamics might enhance research engagement.

Abstract Background In much of eastern and southern Africa, the incidence of HIV and other sexually transmitted infections (STIs) remains high despite the scale-up of promising biomedical and behavioral interventions. Studies have documented the crucial role of transactional sex—the exchange of money, material support, or goods, in sexual relationships—and heavy alcohol use in contributing to men’s and women’s health outcomes. Existing policy responses to this challenge have largely focused on women, through the provision of pre-exposure prophylaxis (PrEP) or structural interventions such as education subsidies and cash transfers. However, the effectiveness of these interventions has been hindered by the relative lack of interventions and programs targeting men’s behavior. We describe the protocol for a study that will test an economic intervention designed to reduce men’s engagement in HIV/STI-related risk behaviors in Kenya. Methods We will conduct a randomized controlled trial among income-earning men in Kenya who are aged 18–39 years and self-report alcohol use and engagement in transactional sex. The study will enroll 1500 participants and randomize them to a control group or savings group. The savings group will receive access to a savings account that includes lottery-based incentives to save money regularly, opportunities to develop savings goals/strategies, and text message reminders about their savings goals. The control group will receive basic health education. Over a period of 24 months, we will collect qualitative and quantitative data from participants and a subset of their female partners. Participants will also be tested for HIV and other STIs at baseline, 12, and 24 months. Discussion The findings from this study have the potential to address a missing element of HIV/STI prevention efforts in sub-Saharan Africa by promoting upstream and forward-looking behavior and reducing the risk of acquiring HIV/STIs in a high HIV/STI burden setting. If this study is effective, it is an innovative approach that could be scaled up and could have great potential for scientific and public health impact in Kenya. Trial registration ClinicalTrials.gov NCT05385484 . Registered on May 23, 2022

Abstract Background Nearly 50% of men living with HIV in many countries are unaware of their HIV status; men also have lower uptake of HIV treatment and pre-exposure prophylaxis (PrEP). In SSA, highly mobile men such as those working in fishing communities alongside Lake Victoria have low uptake of HIV testing and low rates of linkage to HIV treatment and PrEP, despite increasing availability of these services. HIV self-testing (HIVST) kits hold promise for overcoming barriers to HIV testing and linkage to services for HIV-positive and HIV-negative men. We describe here a protocol for an HIV status-neutral, social network-based approach to promote HIV testing, linkage to care and prevention, and better health outcomes, including adherence, in fishermen around Lake Victoria. Methods Utilizing beach management unit (BMU) registries of fishermen operating in three Lake Victoria fishing communities in Siaya County, Kenya, we completed a census and social network mapping to identify close social networks of men. Network clusters identified by a socially-central lead (“promotor”) and selected to ensure maximal separation between treatment and control will be randomized. Promotors in both arms will receive basic HIV training; intervention promotors are further trained in HIVST to distribute kits to their cluster, while control promotors will distribute to their cluster vouchers for free HIVST at nearby clinics. We will test whether these promoters can enhance linkage to ART and PrEP after self-testing, thereby addressing a key limitation of HIVST. We will also measure 6- and 12-month viral load in those living with HIV and PrEP adherence among those without HIV via urine tenofovir levels as objective markers of adherence. Discussion This study has the potential to improve HIV health and promote HIV prevention among a hard to reach, at-risk, and highly mobile population of men in Western Kenya—a critical population in Kenya’s HIV prevention and treatment program. Further, if successful, this innovative social networks-based model could be scaled at the regional level to address HIV prevention and care among similarly at-risk populations of men in eastern Africa and inland fisheries settings across the continent. Trial registration Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men, registered on February 26, 2021, registration # NCT04772469 .

In Kenya, adolescents spend much of their formative years in boarding secondary schools, which presents a challenging environment for antiretroviral (ART) adherence support among adolescents living with HIV (ALHIV). We examined the experiences of ALHIV, caregivers of adolescents, and school nurses regarding navigating ART adherence in boarding secondary schools. Between July and November 2022, we conducted focus group discussions (FGDs) among ALHIV attending boarding schools in Nairobi, Kenya, and caregivers of ALHIV, and in-depth interviews (IDIs) with school nurses. Clinic records were used to identify ALHIV and caregivers, who were invited to participate based on their availability. We categorized boarding schools into national, county, and sub-county levels and selected two schools from each category. We obtained permission from head teachers and invited school nurses to take part in virtual IDIs. The interviews were audio-recorded, transcribed verbatim, and analyzed thematically. We conducted two FGDs with 11 caregivers, two FGDs with 18 adolescents, and 7 IDIs with school nurses. Most of the ALHIV reported having disclosed their HIV status to a school nurse or teacher during admission. School nurse friendliness, being understanding, fair, and confidential were qualities associated with ALHIV willingness to confide in them. Strategies ALHIV used to adhere to medication included: waiting until students were engaged in other activities, waking up early, stepping away from others, and stating their drugs were for different ailments. Caregivers were nervous about school-based adherence counseling, fearing it could lead to inadvertent disclosure of adolescents' HIV status and stigmatization by fellow students. All school nurses reported lacking appropriate training in HIV adherence counseling for adolescents. ALHIV have devised innovative strategies to navigate pill-taking and enlist quiet support while operating in stigmatized school environments. Establishment of a strong school nurse-adolescent rapport and building nurses' skills are key to improving school-based support for ALHIV.

IntroductionLoss to follow-up (LTFU) among adolescents and young adults living with HIV (AYALWH) is a barrier to optimal health and HIV services. We developed and validated a clinical prediction tool to identify AYALWH at risk of LTFU.MethodsWe used electronic medical records (EMR) of AYALWH ages 10 to 24 in HIV care at 6 facilities in Kenya and surveys from a subset of participants. Early LTFU was defined as >30 days late for a scheduled visit in the last 6 months, which accounts for clients with multi-month refills. We developed a tool combining surveys with EMR ('survey-plus-EMR tool'), and an 'EMR-alone' tool to predict high, medium, and low risk of LTFU. The survey-plus-EMR tool included candidate sociodemographics, partnership status, mental health, peer support, any unmet clinic needs, WHO stage, and time in care variables for tool development, while the EMR-alone included clinical and time in care variables only. Tools were developed in a 50% random sample of the data and internally validated using 10-fold cross-validation of the full sample. Tool performance was evaluated using Hazard Ratios (HR), 95% Confidence Intervals (CI), and area under the curve (AUC) ≥ 0.7 for good performance and ≥0.60 for modest performance.ResultsData from 865 AYALWH were included in the survey-plus-EMR tool and early LTFU was (19.2%, 166/865). The survey-plus-EMR tool ranged from 0 to 4, including PHQ-9 ≥5, lack of peer support group attendance, and any unmet clinical need. High (3 or 4) and medium (2) prediction scores were associated with greater risk of LTFU (high, 29.0%, HR 2.16, 95%CI: 1.25-3.73; medium, 21.4%, HR 1.52, 95%CI: 0.93-2.49, global p-value = 0.02) in the validation dataset. The 10-fold cross validation AUC was 0.66 (95%CI: 0.63-0.72). Data from 2,696 AYALWH were included in the EMR-alone tool and early LTFU was 28.6% (770/2,696). In the validation dataset, high (score = 2, LTFU = 38.5%, HR 2.40, 95%CI: 1.17-4.96) and medium scores (1, 29.6%, HR 1.65, 95%CI: 1.00-2.72) predicted significantly higher LTFU than low-risk scores (0, 22.0%, global p-value = 0.03). Ten-fold cross-validation AUC was 0.61 (95%CI: 0.59-0.64).ConclusionsClinical prediction of LTFU was modest using the surveys-plus-EMR tool and the EMR-alone tool, suggesting limited use in routine care. However, findings may inform future prediction tools and intervention targets to reduce LTFU among AYALWH.

IntroductionVoluntary medical male circumcision (VMMC) for HIV prevention began in Nyanza Region, Kenya in 2008. By 2014, approximately 800,000 VMMCs had been conducted, and 84.9% were among males aged 15-24 years. We evaluated the impact of interpersonal communication (IPC) and dedicated service outlets (DSO) on VMMC uptake among men aged 25-39 years in Nyanza Region.Materials and methodsWe conducted a cluster randomized controlled trial in 45 administrative Locations (clusters) in Nyanza Region between May 2014 and June 2016 among uncircumcised men aged 25-34 years. In arm one, an IPC toolkit was used to address barriers to VMMC. In the second arm, men were referred to DSO that were modified to address their preferences. Arm three combined the IPC and DSO arms, and arm four was standard of care (SOC). Randomization was done at Location level (11-12 per arm). The primary outcome was the proportion of enrolled men who received VMMC within three months. Generalized estimating equations were used to evaluate the effect of interventions on the outcome.ResultsAt baseline, 9,238 households with men aged 25-39 years were enumerated, 9,679 men were assessed, and 2,792 (28.8%) were eligible. For enrollment, 577 enrolled in the IPC arm, 825 in DSO, 723 in combined IPC + DSO, and 667 in SOC. VMMC uptake among men in the SOC arm was 3.2%. In IPC, DSO, and combined IPC + DSO arms, uptake was 3.3%, 4.5%, and 4.4%, respectively. The adjusted odds ratio (aOR) of VMMC uptake in the study arms compared to SOC were IPC aOR = 1.03; 95% CI: 0.50-2.13, DSO aOR = 1.31; 95% CI: 0.67-2.57, and IPC + DSO combined aOR = 1.31, 95% CI: 0.65-2.67.DiscussionUsing these interventions among men aged 25-39 years did not significantly impact VMMC uptake. These findings suggest that alternative demand creation strategies for VMMC services are needed to reach men aged 25-39 years.Trial registrationclinicaltrials.gov identifier: NCT02497989.

Abstract Introduction Engaging 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. Methods Semi‐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. Results Our 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. Conclusions Revising 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.

Introduction Male clients (MCs) are integral to sex work-driven HIV transmission dynamics as sexual partners of female sex worker (FSW). MCs contribute disproportionately to incident HIV globally and in sub-Saharan Africa, with 27% of new infections attributed to MCs of FSW and other partners of key populations. Gaps in coverage of HIV testing and prevention services for men, including MCs, are well-documented, yet research and innovative interventions to improve MC uptake of effective prevention services, including pre-exposure prophylaxis (PrEP), are scarce.Methods and analysis MPrEP+ is a cohort study designed to assess the feasibility and acceptability of a PrEP-focused HIV prevention strategy providing daily oral tenofovir/emtricitabine (TDF/FTC) in combination with three adherence self-management interventions: (1) use of a validated point-of-care urine drug-level assay with real-time feedback and tailored self-management counselling; (2) frequent HIV self-testing; and (3) weekly one-way text messaging. This package of interventions is being delivered to 120 MCs enrolled in the study in Kisumu, Kenya over a 6-month period. The primary outcome is PrEP adherence at 6 months as measured by PrEP drug levels. Bivariate and multivariable regression models will be used to identify predictors of PrEP adherence. We will also explore associations of sociodemographic characteristics and PrEP beliefs with PrEP adherence.Ethics and dissemination The study was approved by the Columbia University Irving Medical Center Institutional Review Board and the Maseno University Ethical Review Committee. Study enrolment was initiated in November 2021 with participant follow-up planned through August 2022. Study results will be submitted for publication in peer-reviewed journals. Summaries and infographics of study findings will be developed and distributed to MC, FSW and stakeholders working in HIV prevention and support for people who sell and buy sex, including Kenya’s Ministry of Health.Trial registration number NCT04898699; Registered on 24 May 2021.

Abstract Background As countries make progress towards HIV epidemic control, there is increasing need to identify finer geographic areas to target HIV interventions. We mapped geographic clusters of new HIV diagnoses, and described factors associated with HIV-positive diagnosis, in order to inform targeting of HIV interventions to finer geographic areas and sub-populations. Methods We analyzed data for clients aged > 15 years who received home-based HIV testing as part of a routine public health program between May 2016 and July 2017 in Siaya County, western Kenya. Geospatial analysis using Kulldorff’s spatial scan statistic was used to detect geographic clusters (radius 35 years (aRR 2.44, 95% CI 1.99–3.00); those in polygamous marriage (aRR 1.84, 95% CI 1.55–2.16), or separated/divorced (aRR 3.36, 95% CI 2.72–4.08); and clients who reported having never been tested for HIV (aRR 2.35, 95% CI 2.02–2.72), or having been tested > 12 months ago (aRR 1.53, 95% CI 1.41–1.66). Conclusion Our study used routine public health program data to identify granular geographic clusters of higher new HIV diagnoses, and sub-populations with higher HIV-positive yield in the setting of a generalized HIV epidemic. In order to target HIV testing and prevention interventions to finer granular geographic areas for maximal epidemiologic impact, integrating geospatial analysis into routine public health programs can be useful.

Introduction Adolescents and youth living with HIV (AYLHIV) have lower retention in care, adherence to treatment, and viral suppression compared with adults. Stepped care is a process by which clients are assigned to increasingly intensive services or ‘steps’ according to level of need. Differentiated care, in which stable clients access less frequent services, can be combined with stepped care to align needs and preferences of youth to promote optimal engagement in care.Methods and analysis This hybrid type I effectiveness implementation cluster randomised trial aims to evaluate a data-informed stepped care (DiSC) intervention for AYLHIV. AYLHIV ages 10–24 receiving care at 24 HIV treatment facilities in Kisumu, Homabay and Migori counties in Kenya will be enrolled. Twelve facilities will be randomised to the DiSC intervention, and 12 will provide standard care. A clinical assignment tool developed by the study team will be used at intervention sites to assign AYLHIV to one of four steps based on risk for loss to follow-up: differentiated care, standard care, counselling services or intensive support services. The primary clinical outcome is retention in care, specifically missed visits (failure to return within 30 days for any visit) and 12-month loss to follow-up. Implementation outcomes are based on the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Proportions of missed visits will be compared using mixed effect models clustered by facility and participant.Ethics and dissemination This study has been approved by the University of Washington Institutional Review Board (STUDY00011096), Maseno University Ethical Review Committee (MUERC/00917/20) and the Kenya National Commission for Science, Technology and Innovation (444824). AYLHIV provide written informed consent when legally permitted, or assent with caregiver permission for minors. Study staff will work with a Community Advisory Board, including youth members, to disseminate results via discussions, presentations, journal publications and local or international conferences.Trial registration number NCT05007717.

Abstract Background HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant women. In the Jamii Bora (“Better Family” in Swahili) Study, we seek to test the efficacy of an interdependence theory-based couple intervention. The intervention reaches pregnant women and male partners through home visits by male-female pairs of lay health workers. The aim is to increase access to home-based couples’ HIV testing and counseling services to improve family health. Methods This is a three-arm randomized control trial among 1080 pregnant women 15 years of age or older, living with their male partners, and who have not undergone couples’ HIV testing and counseling in Kisumu and Migori Counties in Kenya. Couples will be randomized into three groups: home-based couple visits, HIV self-testing kits for couple use, or standard care (male partner clinic invitation letters). Participants will be followed up to 18 months postpartum. The study has three aims: in aim 1, we will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIV self-testing kits and standard care; in aim 2, we will examine the intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization, as well as secondary health outcomes of maternal viral suppression and HIV-free child survival up to 18 months for couples living with HIV; and in aim 3, we will compare the cost-effectiveness of the home-based couple intervention to the less resource-intensive strategies used in the other two study arms. Assessments with couples are conducted at baseline, late pregnancy, and at months 3, 6, 12, and 18 after birth. Discussion The results from this study will inform decision-makers about the cost-effective strategies to engage pregnant couples in the prevention of mother-to-child transmission and family health, with important downstream benefits for maternal, paternal, and infant health. Trial registration ClinicalTrials.gov NCT03547739 . Registered on May 9, 2018

Unintended pregnancy and unmet need for modern contraception contribute substantially to reproductive health disparities globally. In sub-Saharan Africa they occur in contexts of disproportionately high rates of HIV infection. Multipurpose prevention technologies (MPTs) can address HIV and pregnancy prevention needs in a single “2-in-1” product; however, few studies have solicited end-user views to inform design of new MPTs. We conducted the Tablets, Ring, Injections as Options (TRIO) study with young women aged 18−30 in Kenya and South Africa (N = 277) to examine preferences and acceptability of future MPTs. In a randomised clinical cross-over study in which women used three placebo delivery forms, we complemented quantitative acceptability assessments with in-depth interviews and focus group discussions (N = 88 participants). We examined anticipated enablers and barriers to adoption and use of future MPTs and synthesised novel product design recommendations. Participants expressed high interest in MPTs. Anticipated side effects constituted a primary concern; however, many expected barriers were not dosage form-specific, but addressed contextual factors instead, such as fears regarding use of new biomedical technologies, misunderstandings and stigma regarding use, and navigating partner disclosure and engagement. Women preferred MPTs that offered discreetness and long-duration protection to minimise user-burden, did not interfere with their relationships, and conferred protection for unanticipated situations. End-user research to identify and pre-emptively address potential barriers while underscoring benefits to a new MPT product is vital. Attention to cultural contexts in implementation of new MPTs is important to communicating perceived benefits, achieving acceptability and maximising public health benefits.

In 2017, Kenya became one of the first African countries to provide pre-exposure prophylaxis (PrEP) in its national HIV prevention plan. We sought to characterize factors associated with PrEP uptake and persistence among a cohort of women at risk of HIV infection during the early stages of PrEP scale-up in Kenya. HIV-negative women ≥18 years with ≥2 sexual partners in the past 4 weeks were recruited as part of an ongoing cluster randomized trial of an HIV self-testing intervention. PrEP use was assessed at baseline and at 6- and 12-month follow-up visits. Between June 2017 and August 2018, 2,086 were enrolled and had complete baseline data. 138 (6.6%) reported PrEP use during the first year of the study. Although PrEP use increased, persistence on PrEP was low, and less than half of individuals reported continuing PrEP at follow-up visits. In multivariate analyses, PrEP use was associated with recent STIs, having an HIV-positive primary partner, having regular transactional sex in the past 12 months, and being a female sex worker. In the early stages of PrEP scale-up in Kenya, uptake increased modestly among women with risk factors for HIV infection, but overall uptake and persistence was low.

Background Male partner awareness and acceptance of microbicide and family planning product use has been shown to increase women’s own acceptance and adherence of a product. However, little is known about preferences regarding potential Multipurpose Prevention Technology (MPT) product delivery forms. As part of the TRIO study, men’s reactions to their female partner’s TRIO product use and comparisons of men’s and women’s views of TRIO product attributes and use acceptability were explored to better understand product preferences. Methods Women in TRIO used three placebo products that represented potential MPTs: daily oral tablets, monthly vaginal rings, and monthly dual injections. Male partners (N = 39) and women (N = 88) completed in-depth interviews on their own and their partner’s experiences with these products. Qualitative coding and analyses followed a conceptual model of HIV prevention product acceptability, and here, we explored themes of disclosure, trust and infidelity as they informed barriers and facilitators to product use. Results Men expressed a desire to know of their partner’s product use decisions and be informed and educated on the products to better support their partners, in some cases, expressing a high level of concern regarding maximizing the ease of product adherence for their partner. They also wanted to understand the effects of products on sexual encounters with their partner, but in some cases, wanted more knowledge in order to control their partner’s product use decisions. Similarly to women, men found long-acting, discreet products that have little to no effect on sexual encounters or libido the most acceptable for their female partners’ use. Product use was most acceptable to men if they were informed of use without inadvertent discovery. Conclusions Men’s product attribute preferences often aligned with women’s opinions of the same products. To support women’s correct use of MPTs, further research is needed to determine the best strategy for achieving male partner acceptance and support of product use, particularly for less familiar delivery forms, such as the vaginal ring.

IntroductionKenya started implementing voluntary medical male circumcision (VMMC) for HIV prevention in 2008 and adopted the use of decision makers program planning tool version 2 (DMPPT2) in 2016, to model the impact of circumcisions performed annually on the population prevalence of male circumcision (MC) in the subsequent years. Results of initial DMPPT2 modeling included implausible MC prevalence estimates, of up to 100%, for age bands whose sustained high uptake of VMMC pointed to unmet needs. Therefore, we conducted a cross-sectional survey among adolescents and men aged 10-29 years to determine the population level MC prevalence, guide target setting for achieving the goal of 80% MC prevalence and for validating DMPPT2 modelled estimates.MethodsBeginning July to September 2019, a total of 3,569 adolescents and men aged 10-29 years from households in Siaya, Kisumu, Homa Bay and Migori Counties were interviewed and examined to establish the proportion already circumcised medically or non-medically. We measured agreement between self-reported and physically verified circumcision status and computed circumcision prevalence by age band and County. All statistical were test done at 5% level of significance.ResultsThe observed MC prevalence for 15-29-year-old men was above 75% in all four counties; Homa Bay 75.6% (95% CI [69.0-81.2]), Kisumu 77.9% (95% CI [73.1-82.1]), Siaya 80.3% (95% CI [73.7-85.5]), and Migori 85.3% (95% CI [75.3-91.7]) but were 0.9-12.4% lower than DMPPT2-modelled estimates. For young adolescents 10-14 years, the observed prevalence ranged from 55.3% (95% CI [40.2-69.5]) in Migori to 74.9% (95% CI [68.8-80.2]) in Siaya and were 25.1-32.9% lower than DMMPT 2 estimates. Nearly all respondents (95.5%) consented to physical verification of their circumcision status with an agreement rate of 99.2% between self-reported and physically verified MC status (kappa agreement p-valueConclusionThis survey revealed overestimation of MC prevalence from DMPPT2-model compared to the observed population MC prevalence and provided new reference data for setting realistic program targets and re-calibrating inputs into DMPPT2. Periodic population-based MC prevalence surveys, especially for established programs, can help reconcile inconsistencies between VMMC program uptake data and modeled MC prevalence estimates which are based on the number of procedures reported in the program annually.

Background: The likelihood that research will be relevant to and accepted by end-users and their communities is enhanced when the perspectives of both the “researchers” and the “researched” are considered. The Tablets, Ring, Injections as Options (TRIO) Study, conducted with young women in Kenya and South Africa, assessed the acceptability and preferences of three placebo-only multi-purpose technology (MPT) forms for prevention of HIV and unintended pregnancy. The objective of this analysis was to assess whether, and if so how, the women participating in the TRIO Study perceived themselves as co-designers of the three MPT products. Methods: We conducted 55 in-depth interviews, 6 focus group discussions, and 5 dissemination workshops with TRIO Study participants. Woven throughout these activities were questions and opportunities for participants to reflect on their role in the study, and to what extent they identified with their role as a co-designer. Qualitative data from these activities were analyzed thematically. Results: The analysis revealed four key themes about what resulted in the women’s views as co-designers: altruism, respectful treatment, agency, and reciprocity. The women were aware of their role in determining what end-users would and would not prefer and were motivated by a desire to help themselves and others. They recognized their role as co-designers and cited being treated well by study staff, being given a chance to make choices during the study period, and being recognized as equal partners of the researchers as the main reasons. Conclusions: If prevention products are going to be successfully developed, end-users and researchers must work hand in hand. Engaging participants meaningfully as co-designers in product development research can be a powerful tool in the effort to ensure new prevention products brought to market are acceptable to the population of interest.

Background: Nearly half of Kenyan men with HIV-positive partners do not know their partner’s status. We carried out a qualitative substudy to explore the experiences of a sample of HIV-positive women when distributing HIV self-tests (HIVST) to their sexual partners. Methods: HIV-positive women were invited for in-depth interviews to share their experiences in offering HIVST to their partners and how self-testing impacted their relationships. Results: Two hundred ninety-seven women were randomized to HIVST, 12 of whom self-reported being HIV positive and 11 participated in the interview. Self-testing procedures and interpretation of results were well understood. Participants were strategic in approaching their partners, thus avoided partner violence. Couple testing was high, which strengthened relationships, improved condom use, and empowered women to make joint decisions concerning their health. Conclusions: Giving HIV-positive women HIVST kits to distribute to their male partners is feasible and safe. Providers who have challenges reaching male partners with testing should consider HIVST.

To meet the reproductive health needs of women, especially those in sub-Saharan Africa, multipurpose prevention technologies (MPTs) that combine pregnancy and HIV prevention into a single product could be highly beneficial. This qualitative study with health care providers in Kenya and South Africa examined health system factors that may facilitate or inhibit the delivery of these MPTs. Twelve qualitative interviews were conducted with health care providers at each site (24 interviews total). Providers were presented with pictures and actual placebo prototypes of 4 MPTs: a vaginal ring, an oral pill, an injectable, and an implant. Four themes emerged related to health care providers’ reported interest in offering the proposed MPTs: (1) perceptions of young women’s interest in the MPTs, (2) considerations about product administration, (3) feedback about product attributes, and (4) providers’ training needs. Overwhelmingly, health care providers are eager to offer a product that prevents both HIV and unintended pregnancy in young women.

INTRODUCTION:Since 2011, Kenya has been evaluating ShangRing device for use in its voluntary medical male circumcision (VMMC) program according to World Health Organization (WHO) guidelines. Compared to conventional surgical circumcision, the ShangRing procedure is shorter, does not require suturing and gives better cosmetic outcomes. After a pilot evaluation of ShangRing in 2011, Kenya conducted an active surveillance for adverse events associated with its use from 2016-2018 to further assess its safety, uptake and to identify any operational bottlenecks to its widespread use based on data from a larger pool of procedures in routine health care settings. METHODS:From December 2017 to August 2018, HIV-negative VMMC clients aged 13 years or older seeking VMMC at six sites across five counties in Kenya were offered ShangRing under injectable local anesthetic as an alternative to conventional surgical circumcision. Providers described both procedures to clients before letting them make a choice. Outcome measures recorded for clients who chose ShangRing included the proportions who were clinically eligible, had successful device placement, experienced adverse events (AEs), or failed to return for device removal. Clients failing to return for follow up were sought through phone calls, text messages or home visits to ensure removal and complete information on adverse events. RESULTS:Out of 3,692 eligible clients 1,079 (29.2%) chose ShangRing; of these, 11 (1.0%) were excluded due to ongoing clinical conditions, 17 (1.6%) underwent conventional surgery due to lack of appropriate device size at the time of the procedure, 97.3% (1051/1079) had ShangRing placement. Uptake of ShangRing varied from 11% to 97% across different sites. There was one severe AE, a failed ShangRing placement (0.1%) managed by conventional wound suturing, plus two moderate AEs (0.2%), post removal wound dehiscence and bleeding, that resolved without sequelae. The overall AE rate was 0.3%. All clients returned for device removal from fifth to eleventh day after placement. CONCLUSION:ShangRing circumcision is effective and safe in the Kenyan context but its uptake varies widely in different settings. It should be rolled out under programmatic implementation for eligible males to take advantage of its unique benefits and the freedom of choice beyond conventional surgical MMC. Public education on its availability and unique advantages is necessary to optimize its uptake and to actualize the benefit of its inclusion in VMMC programs.

Self-reported male circumcision (MC) status is widely used to estimate community prevalence of circumcision, although its accuracy varies in different settings depending on the extent of misreporting. Despite this challenge, self-reported MC status remains essential because it is the most feasible method of collecting MC status data in community surveys. Therefore, its accuracy is an important determinant of the reliability of MC prevalence estimates based on such surveys. We measured the concurrence between self-reported and physically verified MC status among men aged 25-39 years during a baseline household survey for a study to test strategies for enhancing MC uptake by older men in Nyanza region of Kenya. The objective was to determine the accuracy of self-reported MC status in communities where MC for HIV prevention is being rolled out.Agreement between self-reported and physically verified MC status was measured among 4,232 men. A structured questionnaire was used to collect data on MC status followed by physical examination to verify the actual MC status whose outcome was recorded as fully circumcised (no foreskin), partially circumcised (foreskin is past corona sulcus but covers less than half of the glans) or uncircumcised (foreskin covers half or more of the glans). The sensitivity and specificity of self-reported MC status were calculated using physically verified MC status as the gold standard.Out of 4,232 men, 2,197 (51.9%) reported being circumcised, of whom 99.0% were confirmed to be fully circumcised on physical examination. Among 2,035 men who reported being uncircumcised, 93.7% (1,907/2,035) were confirmed uncircumcised on physical examination. Agreement between self-reported and physically verified MC status was almost perfect, kappa (k) = 98.6% (95% CI, 98.1%-99.1%. The sensitivity of self-reporting being circumcised was 99.6% (95% CI, 99.2-99.8) while specificity of self-reporting uncircumcised was 99.0% (95% CI, 98.4-99.4) and did not differ significantly by age group based on chi-square test. Rate of consenting to physical verification of MC status differed by client characteristics; unemployed men were more likely to consent to physical verification (odds ratio [OR] = 1.48, (95% CI, 1.30-1.69) compared to employed men and those with post-secondary education were less likely to consent to physical verification than those with primary education or less (odds ratio [OR] = 0.61, (95% CI, 0.51-0.74).In this Kenyan context, both sensitivity and specificity of self-reported MC status was high; therefore, MC prevalence estimates based on self-reported MC status should be deemed accurate and applicable for planning. However MC programs should assess accuracy of self-reported MC status periodically for any secular changes that may undermine its usefulness for estimating community MC prevalence in their unique settings.

Promoting awareness of serostatus and frequent HIV testing is especially important among high risk populations such as female sex workers (FSW) and their sexual partners. HIV self-testing is an approach that is gaining ground in sub-Saharan Africa as a strategy to increase knowledge of HIV status and promote safer sexual decisions. However, little is known about self-test distribution strategies that are optimal for increasing testing access among hard-to-reach and high risk individuals. We conducted a qualitative study with 18 FSW who participated in a larger study that provided them with five oral fluid-based self-tests, training on how to use the tests, and encouragement to offer the self-tests to their sexual partners using their discretion. Women demonstrated agency in the strategies they used to introduce self-tests to their partners and to avoid conflict with partners. They carefully considered with whom to share self-tests, often assessing the possibility for negative reactions from partners as part of their decision making process. When women faced negative reactions from partners, they drew on strategies they had used before to avoid conflict and physical harm from partners, such as not responding to angry partners and forgoing payment to leave angry partners quickly. Some women also used self-tests to make more informed sexual decisions with their partners.

Uptake of voluntary medical male circumcision (VMMC) as an intervention for prevention of HIV acquisition has been low among men aged ≥25 years in Nyanza region, western Kenya. We conducted a baseline survey of the prevalence and predictors of VMMC among men ages 25-39 years as part of the preparations for a cluster randomized controlled trial (cRCT) called the Target, Speed and Coverage (TASCO) Study. The TASCO Study aimed to assess the impact of two demand creation interventions-interpersonal communication (IPC) and dedicated service outlets (DSO), delivered separately and together (IPC + DSO)-on VMMC uptake.As part of the preparatory work for implementation of the cRCT to evaluate tailored interventions to improve uptake of VMMC, we conducted a survey of men aged 25-39 years from a traditionally non-circumcising Kenyan ethnic community within non-contiguous locations selected as study sites. We determined their circumcision status, estimated the baseline circumcision prevalence and assessed predictors of being circumcised using univariate and multivariate logistic regression.A total of 5,639 men were enrolled of which 2,851 (50.6%) reported being circumcised. The odds of being circumcised were greater for men with secondary education (adjusted Odds Ratio (aOR) = 1.65; 95% CI: 1.45-1.86, p

Achieving higher rates of partner HIV testing and couples testing among pregnant and postpartum women in sub-Saharan Africa is essential for the success of combination HIV prevention, including the prevention of mother-to-child transmission. We aimed to determine whether providing multiple HIV self-tests to pregnant and postpartum women for secondary distribution is more effective at promoting partner testing and couples testing than conventional strategies based on invitations to clinic-based testing.We conducted a randomized trial in Kisumu, Kenya, between June 11, 2015, and January 15, 2016. Six hundred antenatal and postpartum women aged 18-39 y were randomized to an HIV self-testing (HIVST) group or a comparison group. Participants in the HIVST group were given two oral-fluid-based HIV test kits, instructed on how to use them, and encouraged to distribute a test kit to their male partner or use both kits for testing as a couple. Participants in the comparison group were given an invitation card for clinic-based HIV testing and encouraged to distribute the card to their male partner, a routine practice in many health clinics. The primary outcome was partner testing within 3 mo of enrollment. Among 570 participants analyzed, partner HIV testing was more likely in the HIVST group (90.8%, 258/284) than the comparison group (51.7%, 148/286; difference = 39.1%, 95% CI 32.4% to 45.8%, p < 0.001). Couples testing was also more likely in the HIVST group than the comparison group (75.4% versus 33.2%, difference = 42.1%, 95% CI 34.7% to 49.6%, p < 0.001). No participants reported intimate partner violence due to HIV testing. This study was limited by self-reported outcomes, a common limitation in many studies involving HIVST due to the private manner in which self-tests are meant to be used.Provision of multiple HIV self-tests to women seeking antenatal and postpartum care was successful in promoting partner testing and couples testing. This approach warrants further consideration as countries develop HIVST policies and seek new ways to increase awareness of HIV status among men and promote couples testing.ClinicalTrials.gov NCT02386215.

Despite their perceived vulnerability to HIV, East African street youth have been neglected in HIV prevention research. We examined HIV seroprevalence and correlates of HIV infection in a sample of male street youth in Kisumu, Kenya.We enrolled a street-recruited sample of 13-21 year old street youth. Participants completed a survey followed by voluntary HIV counseling and testing. Survey items included demographics, homelessness history, survival activities, sexual behavior and substance use. We examined the relationship between predictor variables, markers of coercion and marginalization and HIV.The sample included 296 males. Survival activities included garbage picking (55%), helping market vendors (55%), begging (17%), and working as porters (46%) or domestic workers (4%). Forty-nine percent of participants reported at least weekly use of alcohol and 32% marijuana. Forty-six percent of participants reported lifetime inhalation of glue and 8% fuel. Seventy-nine percent of participants reported lifetime vaginal sex, 6% reported lifetime insertive anal sex and 8% reported lifetime receptive anal sex. Twelve (4.1%; 95% CI: 2.3-7.0) participants tested positive for HIV. Of those, all had been on the street for at least one year and all had engaged in vaginal sex. Occupations placing youth at particular risk of coercion by adults, including helping market vendors (prevalence ratio (PR) = 8.8; 95% CI: 1.2-67.5) and working as domestic workers (PR = 4.6; 95% CI: 1.1-19.0), were associated with HIV infection. Both insertive anal sex (PR = 10.2; 95% CI: 3.6-29.4) and receptive anal sex (PR = 3.9; 95% CI: 1.1-13.4) were associated with HIV infection. Drug use, begging, and garbage picking were not associated with HIV infection.Although HIV prevalence in our sample of street youth is comparable to that of similarly-aged male youth in Nyanza Province, our findings highlight behavioral factors associated with HIV infection that offer opportunities for targeted prevention among street youth in East Africa.

INTRODUCTION:Several clinical trials have demonstrated the efficacy of pre-exposure prophylaxis (PrEP) in reducing HIV risk. One concern with introducing PrEP is whether users will engage in riskier sexual behaviors. METHODS:We assessed the effect that PrEP may have on sexual risk behaviors by administering a survey to 799 women in Bondo, Kenya, and Pretoria, South Africa. Participants were asked about their sexual behavior intentions twice--once as if they were taking PrEP and once as if they were not taking PrEP--within four risk situations (vignettes). They responded using a 5-point ordinal scale. We used a series of linear mixed effects models with an unstructured residual covariance matrix to estimate the between- and within-subject differences in the mean likelihood of engaging in risky sexual behavior across the PrEP and non-PrEP contexts. We also calculated the total percentage of participants who reported a greater likelihood of engaging in risky sexual behavior if taking PrEP than if not taking PrEP, by vignette. RESULTS:We found statistically significant differences in the mean likelihood of engaging in risky sexual behavior with the between-subject comparison (-0.17, p < 0.01) and with the within-subject comparison (-0.31, p < 0.001). Depending on the vignette, 27% to 40% of participants reported a greater likelihood of engaging in risky sexual behavior if taking PrEP than if not taking PrEP. CONCLUSIONS:Our findings indicate that modest increases in risky sexual behavior could occur with PrEP. Although responses from the majority of participants suggest they would not be more likely to engage in risky sexual behavior if they took PrEP, a substantial proportion might. Programs rolling out PrEP should be prepared to assist similar women in making informed choices about reducing their risk of HIV and about their sexual health beyond HIV prevention.

INTRODUCTION:FEM-PrEP did not demonstrate a reduction in HIV acquisition because of low study pill adherence. Yet, plasma and intracellular drug concentrations indicated that some participants had evidence of recent pill use. We conducted a follow-up study to identify, among other topics, participants' reasons for taking the study pill. METHODS:Qualitative, semi-structured interviews (SSIs) were conducted with 88 FEM-PrEP participants. Participants were purposefully selected based on their adherence drug concentrations collected during FEM-PrEP and placed into three adherence interview groups: "high," "moderate," and "none/scarce." Participants in the high and moderate groups described reasons why they adhered most or some of the time, including factors that facilitated their adherence. Participants in all groups described what they believed made it possible for other FEM-PrEP participants to adhere. In addition, 224 FEM-PrEP participants reported on their reasons for taking the study pills through a quantitative, audio computer-assisted self-interview (ACASI). Thematic analysis and descriptive statistics were used to analyze the qualitative and quantitative data, respectively. RESULTS:Five themes were identified from the SSIs as facilitating factors of adherence: 1) participants' support for the research, 2) HIV risk reduction, 3) routine formation and use of tools, 4) adherence counseling, and 5) partner awareness and support. Participants described similar facilitators when they spoke about other participants' adherence. Among the 172 participants who reported in ACASI that they had taken a study pill, wanting to help answer the research question was the most frequently stated reason for taking the pills (94%, n = 161). We also found evidence of preventive misconception. CONCLUSIONS:Adherence was facilitated by personal motivations, such as risk reduction and interest in the research outcome, and by adherence strategies consisting of external cues, reminders, and support. These findings can inform future HIV prevention clinical trials and the rollout of effective antiretroviral-based HIV prevention technologies for women.

This analysis explores the association between elements of surgical efficiency in voluntary medical male circumcision (VMMC), quality of surgical technique, and the amount of time required to conduct VMMC procedures in actual field settings. Efficiency outcomes are defined in terms of the primary provider's time with the client (PPTC) and total elapsed operating time (TEOT).Two serial cross-sectional surveys of VMMC sites were conducted in Kenya, Republic of South Africa, Tanzania and Zimbabwe in 2011 and 2012. Trained clinicians observed quality of surgical technique and timed 9 steps in the VMMC procedure. Four elements of efficiency (task-shifting, task-sharing [of suturing], rotation among multiple surgical beds, and use of electrocautery) and quality of surgical technique were assessed as explanatory variables. Mann Whitney and Kruskal Wallis tests were used in the bivariate analysis and linear regression models for the multivariate analyses to test the relationship between these five explanatory variables and two outcomes: PPTC and TEOT. The VMMC procedure TEOT and PPTC averaged 23-25 minutes and 6-15 minutes, respectively, across the four countries and two years. The data showed time savings from task-sharing in suturing and use of electrocautery in South Africa and Zimbabwe (where task-shifting is not authorized). After adjusting for confounders, results demonstrated that having a secondary provider complete suturing and use of electrocautery reduced PPTC. Factors related to TEOT varied by country and year, but task-sharing of suturing and/or electrocautery were significant in two countries. Quality of surgical technique was not significantly related to PPTC or TEOT, except for South Africa in 2012 where higher quality was associated with lower TEOT.SYMMACS data confirm the efficiency benefits of task-sharing of suturing and use of electrocautery for decreasing TEOT. Reduced TEOT and PPTC in high volume setting did not result in decreased quality of surgical care.

Incidence rates in the FEM-PrEP and VOICE trials demonstrate that women from diverse sub-Saharan African communities continue to be at substantial HIV risk.To describe and compare the sexual risk context of the study population from two FEM-PrEP trial sites-Bondo, Kenya, and Pretoria, South Africa.At baseline we collected information about demographics, sexual behaviors, and partnership beliefs through quantitative questionnaires with all participants (Bondo, n = 720; Pretoria, n = 750). To explore the sexual risk context, we also conducted qualitative, semi-structured interviews with HIV-negative participants randomly selected at several time points (Bondo, n = 111; Pretoria, n = 69).Demographics, sexual behavior, and partnership beliefs varied significantly between the sites. Bondo participants were generally older, had fewer years of schooling, and were more likely to be employed and married compared to Pretoria participants. Bondo participants were more likely to report multiple partners and not knowing whether their partner had HIV than Pretoria participants. A significantly higher percentage of Bondo participants reported engaging in sex without a condom with their primary and other partners compared to Pretoria participants. We found a borderline association between participants who reported not using condoms in the 4 weeks prior to baseline and lower risk of HIV infection, and no association between having more than one sexual partner at baseline and HIV infection.Despite significantly different demographics, sexual behaviors, and partnership beliefs, many women in the FEM-PrEP trial were at risk of acquiring HIV as demonstrated by the sites' high HIV incidence. Though gender dynamics differed between the populations, they appear to play a critical role in women's sexual practices. The findings highlight different ways women from diverse contexts may be at-risk for HIV and the importance of providing HIV prevention options that are both effective and feasible given personal and social circumstances.

BACKGROUND: Several sub-Saharan African countries plan to scale-up infant male circumcision (IMC) for cost-efficient HIV prevention. Little data exist about the safety of IMC in East and southern Africa. We calculated adverse event (AE) rate and risks for AEs associated with introduction of IMC services at five government health facilities in western Kenya. METHODS: AE data were analyzed for IMC procedures performed between September, 2009 and November, 2011. Healthy infants aged ≤ 2 months and weighing ≥ 2.5 kg were eligible for IMC. Following parental consent, trained clinicians provided IMC services free of charge under local anesthesia using the Mogen clamp. Odds ratios and 95% confidence intervals were used to explore AE risk factors. FINDINGS: A total of 1,239 IMC procedures were performed. Median age of infants was 4 days (IQR=1, 16). The overall AE rate among infants reviewed post-operatively was 2.7% (18/678; 95%CI: 1.4, 3.9). There was one severe AE involving excision of a small piece of the lateral aspect of the glans penis. Other AEs were mild or moderate and were treated conservatively. Babies one month of age or older were more likely to have an AE (OR 3.20; 95%CI: 1.23, 8.36). AE rate did not differ by nurse versus clinical officer or number of previous procedures performed. CONCLUSION: IMC services provided in Kenyan Government hospitals in the context of routine IMC programming have AE rates comparable to those in developed countries. The optimal time for IMC is within the first month of life.

Since the World Health Organization and the Joint United Nations Programme on HIV/AIDS recommended implementation of medical male circumcision (MC) as part of HIV prevention in areas with low MC and high HIV prevalence rates in 2007, the government of Kenya has developed a strategy to circumcise 80% of uncircumcised men within five years. To facilitate the quick translation of research to practice, a national MC task force was formed in 2007, a medical MC policy was implemented in early 2008, and Nyanza Province, the region with the highest HIV burden and low rates of circumcision, was prioritized for services under the direction of a provincial voluntary medical male circumcision (VMMC) task force. The government's early and continuous engagement with community leaders/elders, politicians, youth, and women's groups has led to the rapid endorsement and acceptance of VMMC. In addition, several innovative approaches have helped to optimize VMMC scale-up. Since October 2008, the Kenyan VMMC program has circumcised approximately 290,000 men, mainly in Nyanza Province, an accomplishment made possible through a combination of governmental leadership, a documented implementation strategy, and the adoption of appropriate and innovative approaches. Kenya's success provides a model for others planning VMMC scale-up programs.

In 2007, the World Health Organization endorsed male circumcision as an effective HIV prevention strategy. In 2008, the Government of Kenya (GoK) launched the national voluntary medical male circumcision (VMMC) program in Nyanza Province, the geographic home to the Luo, the largest non-circumcising ethnic group in Kenya. Currently, several other African countries are in the early stages of implementing this intervention.This paper uses data from a health facility needs assessment (n = 81 facilities) and a study to evaluate the implementation of VMMC services in 16 GoK facilities (n = 2,675 VMMC clients) to describe Kenya's experience in implementing the national program. The needs assessment revealed that no health facility was prepared to offer the minimum package of services as outlined by the national guidelines, and partner organizations were called upon to fill this gap. The findings concerning human resource shortages facilitated the GoK's decision to endorse trained nurses to provide VMMCs, enabling more facilities to offer the service. Findings from the evaluation study resulted in replacing voluntary counseling and testing (VCT) with provider-initiated testing and counseling (PITC) and subsequently doubling the proportion of VMMC clients tested for HIV.This paper outlines how certain challenges, like human resource shortages and low HIV test rates, were addressed through national policy changes, while other challenges, like large fluctuations in demand, were addressed locally. Currently, the program requires significant support from partner organizations, but a strategic plan is under development to continue to build capacity in GoK staff and facilities. Coordination between all parties was essential and was facilitated through the formation of national, provincial, and district VMMC task forces. The lessons learned from Kenya's VMMC implementation experience are likely generalizable to other African countries.

BACKGROUND: Numerous studies have demonstrated that male circumcision (MC) reduces the incidence of the Type-1 human immunodeficiency virus (HIV) among heterosexual men by at least half. METHODS: One year after the launch of a national Voluntary Medical Male Circumcision program in Kenya, this study conducted 12 focus group discussions among uncircumcised men in Nyanza Province to assess the revealed, non-hypothetical, facilitators and barriers to the uptake of MC. RESULTS: The primary barriers to MC uptake included time away from work; culture and religion; possible adverse events; and the post-surgical abstinence period. The primary facilitators of MC uptake included hygiene; social pressure; protection against HIV and other sexually transmitted infections; and improved sexual performance and satisfaction. CONCLUSIONS: Some activities which might increase MC uptake include dispelling MC misconceptions; increasing involvement of religious leaders, women's groups, and peer mobilizers for MC promotion; and increasing the relevance of MC among men who are already practicing an HIV prevention method.

Three randomized controlled trials (RCTs) have confirmed that male circumcision (MC) significantly reduces acquisition of HIV-1 infection among men. The objective of this study was to perform a comprehensive, prospective evaluation of risk compensation, comparing circumcised versus uncircumcised controls in a sample of RCT participants.Between March 2004 and September 2005, we systematically recruited men enrolled in a RCT of MC in Kenya. Detailed sexual histories were taken using a modified Timeline Followback approach at baseline, 6, and 12 months. Participants provided permission to obtain circumcision status and laboratory results from the RCT. We evaluated circumcised and uncircumcised men's sexual behavior using an 18-item risk propensity score and acquisition of incident infections of gonorrhea, chlamydia, and trichomoniasis. Of 1780 eligible RCT participants, 1319 enrolled (response rate = 74%). At the baseline RCT visit, men who enrolled in the sub-study reported the same sexual behaviors as men who did not. We found a significant reduction in sexual risk behavior among both circumcised and uncircumcised men from baseline to 6 (p

OBJECTIVE: To determine factors associated with the incidence of adverse events associated with voluntary medical male circumcision (VMMC) for the prevention of HIV infection in Nyanza province, Kenya. METHODS: Males aged 12 years or older who underwent VMMC between November 2008 and March 2010 in 16 clinics in three districts were followed through passive surveillance to monitor the incidence of adverse events during and after surgery. A subset of clinic participants was randomly selected for active surveillance post-operatively and was monitored for adverse events through a home-based, in-depth interview and a genital exam 28 to 45 days after surgery. Performance indicators were assessed for 167 VMMC providers. FINDINGS: The adverse event rate was 0.1% intra-operatively and 2.1% post-operatively among clinic system participants (n = 3705), and 7.5% post-operatively among participants under active surveillance (n = 1449). Agreement between systems was moderate (κ: 0.20; 95% confidence interval, CI: 0.09-0.32). Providers who performed more than 100 procedures achieved an adverse event rate of 0.7% and 4.3% in the clinic and active surveillance systems, respectively, and had decreased odds of performing a procedure resulting in an adverse event. With provider experience, the mean duration of the procedure also dropped from 24.0 to 15.5 minutes. Among providers who had performed at least 100 procedures, nurses and clinicians provided equivalent services. CONCLUSION: To reduce the adverse event rate, one must ensure that providers achieve a desired level of experience before they perform unsupervised procedures. Adverse events observed by the provider as well as those perceived by the client should both be monitored.