Using FRAME to characterize provider-identified adaptations to a stepped care intervention for adolescents and youth living with HIV in Kenya: a mixed methods approach.

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 (ß = 0.011, 95% CI: 0.002, 0.020, p = 0.016), appropriateness (ß = 0.012, 95% CI: 0.007, 0.027, p<0.001) and feasibility (ß = 0.013, 95% CI: 0.004, 0.022, p = 0.005). CONCLUSIONS: Provider-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.

Facility characteristics preferred by older men seeking medical male circumcision services in Kenya: qualitative findings from the 'Tasco' study (May 2014-June 2016).

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.

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

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

Shifting reasons for older men remaining uncircumcised: Findings from a pre- and post-demand creation intervention among men aged 25-39 years in western Kenya.

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.

How men influence young women taking PrEP: perspectives from young women, male partners, and male peers in Siaya county, Western Kenya.

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.

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

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

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

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

'I feel that I should decide on my own .': who should be involved in the decision-making process for adolescent involvement in HIV research?

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.

Understanding sexual behaviors of youth from the lens of caregivers, teachers, local leaders and youth in Homabay County, Kenya.

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).

Navigating antiretroviral adherence in boarding secondary schools in Nairobi, Kenya: A qualitative study of adolescents living with HIV, their caregivers and school nurses.

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.

Early infant male circumcision: Potential for changing adverse gender norms associated with traditional male circumcision among circumcising communities in Kenya.

Introduction: Traditional male circumcision (TMC) inculcates masculine-dominance norms in young men. Early infant male circumcision (EIMC) and medical male circumcision (MMC) can potentially minimise these adverse gender norms. We explored the perceptions about EIMC and MMC among communities practising TMC in Kenya.Method: We conducted focus group discussions with men and women and councils of elders, and key informant interviews with traditional circumcisers. Data were analysed using NVivo 10.Results: Most participants described MC as a rite of passage into adulthood, with the preferred age for MC to occur at 10 to 15 years old. Interestingly, awareness of the advantages of EIMC, especially among younger men and women, was high. Participants acknowledged that TMC reinforces hegemonic masculinity that undermines gender equality. Except among traditional circumcisers and some members of councils of elders, MMC and female providers were largely deemed acceptable.Conclusion: EIMC and MMC are slowly gaining acceptance, providing important tools to challenge adverse gender norms associated with TMC.

Development and validation of a prediction tool to support engagement in HIV care among young people ages 10-24 years in Kenya.

INTRODUCTION: Loss 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. METHODS: We 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. RESULTS: Data 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). CONCLUSIONS: Clinical 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.

Multilevel Factors Influencing Interruptions in PrEP Use Among Young Women in Siaya County, Kenya.

Young women in sub-Saharan Africa continue to be disproportionately at risk for HIV. Oral pre-exposure prophylaxis (PrEP) can reduce women's HIV risk when taken daily throughout their "seasons of risk". We used photovoice to describe community views on factors influencing interruptions in PrEP use among young cisgender women in Siaya County, Kenya. Through group discussions, young women taking PrEP and their social network members (female peers, male peers/partners, family, and community members) shared photographs and identified broad social-ecological causes of PrEP interruptions, including: (1) widespread misinformation about PrEP, (2) social pressures from religious communities, (3) health care staff recommendations to interrupt PrEP use, (4) partner rejection of PrEP, (5) changes in women's risk awareness, and (6) a personal desire to occasionally pause daily use. Collectively, participants identified strategies to address these challenges. These findings can inform future programs targeting the broader social-ecological influences on young women's persistent use of PrEP.

Access to Oral Fluid-Based Human Immunodeficiency Virus Self-Tests Increases Testing Among Male Partners of Adolescent Girls in Kenya: A Randomized Controlled Trial.

PURPOSE: The risk of human immunodeficiency virus (HIV) among adolescent girls (AGs) may be reduced if they know the HIV status of their male partners. We assessed the ability of AGs in Siaya County, Kenya, to offer HIV self-tests to their partners to promote partner and couples testing. METHODS: Eligible AGs were 15-19 years old, self-tested HIV-negative, and had a male partner not tested in the past 6 months. Participants were randomly assigned to receive two oral fluid-based self-tests (intervention arm) or a referral coupon for facility-based testing (comparison arm). The intervention included counseling on ways to safely introduce self-tests to partners. Follow-up surveys were conducted within 3 months. RESULTS: Among 349 AGs enrolled, median age was 17 years (interquartile range 16-18), 88.3% of primary partners were noncohabiting boyfriends, and 37.5% were unaware if their partner had ever tested. At 3 months, 93.9% of the intervention arm and 73.9% of the comparison arm reported that partner testing occurred. Compared to the comparison arm, partner testing was more likely in the intervention arm (risk ratio = 1.27; 95% confidence interval 1.15-1.40; p < .001). Among participants whose partners got tested, 94.1% and 81.5% in the intervention and comparison arms, respectively, reported that couples testing occurred; couples testing was more likely in the intervention than comparison arm (risk ratio = 1.15; 95% confidence interval 1.15-1.27; p = .003). Five participants reported partner violence, one study-related. DISCUSSION: Provision of multiple self-tests to AGs for the purpose of promoting partner and couples testing should be considered in Kenya and other settings where AGs face a high risk of HIV acquisition.

Strategies to increase uptake of voluntary medical male circumcision among men aged 25-39 years in Nyanza Region, Kenya: Results from a cluster randomized controlled trial (the TASCO study).

INTRODUCTION: Voluntary 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 METHODS: We 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. RESULTS: At 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. DISCUSSION: Using 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 REGISTRATION: clinicaltrials.gov identifier: NCT02497989.

Effect of HIV stigma on depressive symptoms, treatment adherence, and viral suppression among youth with HIV.

OBJECTIVE: We estimated the effects of HIV stigma on mental health and treatment outcomes for youth with HIV (YWH). DESIGN: Secondary analysis of data for YWH ages 15-24 years in Western Kenya. METHODS: Participants completed a longitudinal survey (baseline, months 6 and 12) assessing socio-demographics, antiretroviral therapy (ART) adherence, depressive symptoms (PHQ-9), and HIV stigma (10-item Wright scale). First viral load (VL) after enrollment was abstracted from records. We estimated risk of depressive symptoms (score > 4), nonadherence (missing ≥2 days of ART in a month), and detectable VL (≥50 copies/ml) for each standard deviation (SD) increase in HIV stigma score, adjusted for age and sex (and regimen in VL model). The generalizing estimating equation models included measures for the three visits. RESULTS: Median age for the 1011 YWH was 18 years. At baseline, frequency of nonadherence, depressive symptoms and detectable VL was 21%, 21%, and 46%, respectively. Mean stigma score was 25 (SD = 7.0). Each SD stigma score increment was associated with higher risk of depressive symptoms {adjusted relative risk [aRR] 1.31 [95% confidence interval (CI): 1.20-1.44]}, nonadherence [aRR 1.16 (CI: 1.05-1.27)] and detectable VL [aRR 1.20 (CI: 1.08-1.32)]. Experienced and anticipated stigma were associated with detectable VL [aRR 1.16 (CI: 1.10-1.22) and aRR 1.23 (CI: 1.12-1.35), respectively]. Internalized and perceived community stigma were associated with depressive symptoms [aRR 1.31 (CI: 1.21-1.40) and aRR 1.24 (CI: 1.13-1.36), respectively]. CONCLUSIONS: Stigma was associated with depressive symptoms, nonadherence and detectable VL. Interventions to decrease stigma may improve virologic and mental health outcomes in YWH.

"[T]he laws need to change to reflect current society": Insights from stakeholders involved in development, review or implementation of policies about adolescent consent for HIV testing, care and research in Kenya.

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.

Individual-, Interpersonal- and Institutional-Level Factors Associated with HIV Stigma Among Youth in Kenya.

HIV stigma remains a barrier in achieving optimal HIV treatment. We studied the prevalence and predictors of HIV stigma among adolescents and youth with HIV (AYWHIV) ages 15-24 years in Western Kenya. Of 1011 AYWHIV, 69% were female with a median age of 18 years. Most (59%) attended adolescent clinic days, and 40% attended support groups. One-quarter (27%) had experienced physical, 18% emotional, and 7% sexual violence. The majority of AYWHIV (88%) reported disclosure concerns, 48% reported perceived community stigma, 36% experienced, and 24% internalized stigma. Compared to AYWHIV attending adolescent clinics, those in general/adult clinics had higher internalized stigma. Similarly, having dropped out of school was associated with higher internalized stigma. AYWHIV in sexual relationships had higher experienced stigma and disclosure concerns. Lastly, exposure to violence was associated with higher experienced, internalized, perceived community stigma and disclosure concerns. These risk factors can be targeted when developing stigma-prevention interventions.

Integrated Health Care Delivery for Adolescents Living with and at Risk of HIV Infection: A Review of Models and Actions for Implementation.

Integrated service delivery, providing coordinated services in a convenient manner, is important in HIV prevention and treatment for adolescents as they have interconnected health care needs related to HIV care, sexual and reproductive health and disease prevention. This review aimed to (1) identify key components of adolescent-responsive integrated service delivery in low and middle-income countries, (2) describe projects that have implemented integrated models of HIV care for adolescents, and (3) develop action steps to support the implementation of sustainable integrated models. We developed an implementation science-informed conceptual framework for integrated delivery of HIV care to adolescents and applied the framework to summarize key data elements in ten studies or programs across seven countries. Key pillars of the framework included (1) the socioecological perspective, (2) community and health care system linkages, and (3) components of adolescent-focused care. The conceptual framework and action steps outlined can catalyze design, implementation, and optimization of HIV care for adolescents.

A savings intervention to reduce men's engagement in HIV risk behaviors: study protocol for a randomized controlled trial.

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.