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We examined the association between serum aflatoxin B1‐lysine adduct (AFB1‐lys) levels in pregnant women and adverse pregnancy outcomes (low birthweight, miscarriage and stillbirth) through a nested matched case–control study of pregnant women enroled at ≤28 weeks' gestation in Mombasa, Kenya, from 2017 to 2019. Cases comprised women with an adverse birth outcome, defined as either delivery of a singleton infant weighing <2500 g, or a miscarriage, or a stillbirth, while controls were women who delivered a singleton live infant with a birthweight of ≥2500 g. Cases were matched to controls at a ratio of 1:2 based on maternal age at enrolment, gestational age at enrolment and study site. The primary exposure was serum AFB1‐lys. The study included 125 cases and 250 controls. The median gestation age when serum samples were collected was 23.0 weeks (interquartile range [IQR]: 18.1–26.0) and 23.5 (IQR: 18.1–26.5) among cases and controls, respectively. Of the 375 tested sera, 145 (38.7%) had detectable serum AFB1‐lys: 36.0% in cases and 40.0% in controls. AFB1‐lys adduct levels were not associated with adverse birth outcomes on multivariable analysis. Mid‐upper arm circumference was associated with a 6% lower odds of adverse birth outcome for every unit increase (p = 0.023). Two‐fifths of pregnant women had detectable levels of aflatoxin midway through pregnancy. However, we did not detect an association with adverse pregnancy outcomes, likely because of low serum AFB1‐lys levels and low power, restricting meaningful comparison. More research is needed to understand the public health risk of aflatoxin in pregnant women to unborn children. Key messages: Aflatoxin B1 (AFB1), a commonly ingested toxin, can cross the placental barrier and cause adverse pregnancy outcomes.Two‐fifths of participants had detectable serum AFB1‐lys levels, a marker of aflatoxin exposure, but the low levels recorded were not associated with adverse pregnancy outcomes.Every unit increase in mid‐upper arm circumference (MUAC) during pregnancy was associated with a 6% reduced likelihood of adverse pregnancy outcomes, highlighting the potential protective role of adequate maternal nutrition.There is need for additional studies in different settings on the determinants and mechanisms of the relationship between aflatoxin exposure and adverse pregnancy outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Adverse birth outcomes particularly preterm births and congenital anomalies, are the leading causes of infant mortality globally, and the burden is highest in developing countries. We set out to determine the frequency of adverse birth outcomes and the risk factors associated with such outcomes in a cohort of pregnant women in Kenya. Methods: From October 2017 to July 2019, pregnant women < 28 weeks gestation were enrolled and followed up until delivery in three hospitals in coastal Kenya. Newborns were examined at delivery. Among women with birth outcome data, we assessed the frequency of congenital anomalies defined as gastroschisis, umbilical hernia, limb abnormalities and Trisomy 21, and adverse birth outcomes, defined as either stillbirth, miscarriage, preterm birth, small for gestational age, or microcephaly. We used log-binomial regression to identify maternal characteristics associated with the presence of at least one adverse outcome. Results: Among the 2312 women enrolled, 1916 (82.9%) had birth outcome data. Overall, 402/1916 (20.9%; 95% confidence interval (CI): 19.1–22.8) pregnancies had adverse birth outcomes. Specifically, 66/1916 (3.4%; 95% CI: 2.7–4.4) were stillbirths, 34/1916 (1.8%; 95% CI: 1.2–2.4) were miscarriages and 23/1816 (1.2%; 95% CI: 0.8–1.9) had congenital anomalies. Among the participants with anthropometric measurements data, 142/1200 (11.8%; 95% CI: 10.1 − 13.8) were small for gestational age and among the participants with ultrasound records, 143/1711 (8.4%; 95% CI: 7.1–9.8) were preterm. Febrile illnesses in current pregnancy (adjusted risk ratio (aRR): 1.7; 95% CI: 1.1–2.8), a history of poor birth outcomes in prior pregnancy (aRR: 1.8; 95% CI: 1.3–2.4) and high blood pressure in pregnancy (aRR: 3.9, 95% CI: (1.7–9.2) were independently associated with adverse birth outcomes in a model that included age, education, human immunodeficiency virus status and high blood pressure at enrolment. Conclusion: We found similar rates of overall adverse birth outcomes, congenital anomalies, and small for gestational age but higher rates of stillbirths and lower rates of prematurity compared to the rates that have been reported in the sub-Saharan Africa region. However, the rates of adverse birth outcomes in this study were comparable to other studies conducted in Kenya. Febrile illnesses during the current pregnancy, previous history of poor birth outcomes and high blood pressure in pregnancy are predictive of an increased risk of adverse birth outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Adolescents with HIV in sub-Saharan Africa face challenges transitioning to adult HIV care, which can affect long-term HIV care adherence and retention. An adolescent transition package (ATP) focused on transition tools can improve post-transition clinical outcomes, but its implementation costs are unknown. Methods: We estimated the average cost per patient of an HIV care visit and ATP provision to adolescents. Data was collected from 13 HIV clinics involved in a randomized clinical trial evaluating ATP in western Kenya. We conducted a micro-costing and activity-driven time estimation to assess costs from the provider perspective. We developed a flow-map, conducted staff interviews, and completed time and motion observation. ATP costs were estimated as the difference in average cost for an HIV care transition visit in the intervention compared to control facilities. We assessed uncertainty in costing estimates via Monte Carlo simulations. Results: The average cost of an adolescent HIV care visit was 29.8USD (95%CI 27.5, 33.4) in the standard of care arm and 32.9USD (95%CI 30.5, 36.8) in the ATP intervention arm, yielding an incremental cost of 3.1USD (95%CI 3.0, 3.4) for the ATP intervention. The majority of the intervention cost (2.8USD) was due ATP booklet discussion with the adolescent. Conclusion: The ATP can be feasibly implemented in HIV care clinics at a modest increase in overall clinic visit cost. Our cost estimates can be used to inform economic evaluations or budgetary planning of adolescent HIV care interventions in Kenya. [ABSTRACT FROM AUTHOR]

Objectives: With optimized antiretroviral treatment youth living with HIV (YLH) now spend most of their time in schools, making schools an important venue to optimize outcomes. We evaluated school support for YLH. Methods: We conducted surveys with public secondary/high schools in 3 Kenyan counties (Nairobi, Homa Bay, and Kajiado) to determine policies and training related to HIV. Chi‐squared tests and Poisson regression were used to compare policy availability and staff training by county HIV prevalence and school type. Results: Of 512 schools in the 3 counties, we surveyed 100. The majority (60%) of schools surveyed had boarding facilities. The median student population was 406 (IQR: 200, 775). Only half (49%) of schools had medication use policies; more in boarding than day schools (65% vs 30%, p =.003). While most schools (82%) had clinic attendance policies; policy availability was higher in higher HIV prevalence counties (Homa Bay [100%], Nairobi [82%], Kajiado [56%], p <.05). Overall, 64% had confidentiality policies with higher policy availability in higher HIV prevalence regions (p <.05). Few schools had staff trained in HIV‐related topics: HIV prevention (37%), HIV treatment (18%), HIV stigma reduction (36%). Few were trained in confidentiality (41%), psychosocial support (40%), or mental health (26%). Compared to day schools, boarding school were more likely to have staff trained in HIV prevention (prevalence ratio: 2.1 [95% confidence interval 1.0, 4.0], p =.037). Conclusion: In this survey of Kenyan schools, there were notable gaps in HIV care policy availability and training, despite high HIV burden. Development and implementation of national school HIV policies and staff training as well as strengthening clinic and family support may improve outcomes for YLH. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic resulted in disruptions to routine HIV services for youth living with HIV (YLH), provoking rapid adaptation to mitigate interruptions in care. The Adolescent Transition to Adult Care for HIV-infected adolescents (ATTACH) study (NCT03574129) was a hybrid I cluster randomized trial testing the effectiveness of a healthcare worker (HCW)-delivered disclosure and transition intervention — the Adolescent Transition Package (ATP). During the pandemic, HCWs leveraged phone delivery of the ATP and were supported to make adaptations. We characterized real-time, provider-driven adaptations made to support phone delivery of the ATP. Methods: We conducted continuous quality improvement (CQI) meetings with HCWs involved in phone delivery of the ATP at 10 intervention sites. CQI meetings used plan-do-study-act (PDSA) cycles and were audio-recorded. Adaptations were coded by two-independent coders using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS). Adaptation testing outcomes (adopt, retest, or abandon) and provider experience implementing the adaptations were also recorded. We summarized adaptation characteristics, provider experience, and outcomes. Results: We identified 72 adaptations, 32 were unique. Overall, adaptations included modification to context (53%, n = 38), content (49%, n = 35), and evaluation processes (13%, n = 9). Context adaptations primarily featured changes to personnel, format, and setting, while content and evaluation adaptations were frequently achieved by simple additions, repetition, and tailoring/refining of the phone delivery strategy. Nine adaptations involved abandoning, then returning to phone delivery. HCWs sought to increase reach, improve fidelity, and intervention fit within their context. Most adaptations (96%, n = 69) were perceived to increase the feasibility of phone delivery when compared to before the changes were introduced, and HCWs felt 83% (n = 60) of adaptations made phone delivery easier. Most adaptations were either incorporated into routine workflows (47%) or tested again (47%). Conclusion: Adaptation of phone delivery was a feasible and effective way of addressing challenges with continuity of care for YLH during the COVID-19 pandemic. Adaptations were primarily context adaptions. While FRAME-IS was apt for characterizing adaptations, more use cases are needed to explore the range of its utility. Trial registration: Trial registered on ClinicalTrial.gov as NCT03574129. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Mortality and loss to follow-up (LTFU) among adolescents and youth living with HIV (AYLHIV) remain high. We evaluated mortality and LTFU during the test and treat era. We abstracted medical records of AYLHIV for 10–24 years between January 2016 and December 2017 in 87 HIV clinics in Kenya. Using competing risk survival analysis, we compared incidence rates and determined correlates of mortality and LTFU among newly enrolled [<2 years since antiretroviral therapy (ART) initiation] and AYLHIV on ART for ≥2 years. Among 4201 AYLHIV, 1452 (35%) and 2749 (65%) were new enrollments and on ART for ≥2 years, respectively. AYLHIV on antiretroviral therapy (ART) for ≥2 years were younger and more likely to have perinatally acquired HIV (p < 0.001). Incidence of mortality and LTFU per 100 person-years were 2.32 [95% confidence interval (CI): 1.64–3.28] and 37.8 (95% CI: 34.7–41.3), respectively, among new enrollments and 1.22 (95% CI: 0.94–1.59) and 10.2 (95% CI: 9.3–11.1), respectively, among those on ART for ≥2 years. New enrollments had almost twice higher risk of mortality [subdistribution hazard ratio (sHR) 1.92 (1.30, 2.84), p = 0.001] and sevenfold higher risk of LTFU [sHR 7.71 (6.76, 8.79), p < 0.001] than those on ART for ≥2 years. Among new enrollments, mortality was higher in males and those with World Health Organization (WHO) stage III/IV disease at enrollment, and LTFU was associated with pregnancy, older age, and nonperinatal acquisition. Female sex and WHO stage (I/II) were associated with LTFU among those on ART for ≥2 years. During the study period from January 1, 2016, to December 31, 2017, the mortality incidence observed did not demonstrate improvement from earlier studies despite universal test and treat and better ART regimens. This trial was registered with ClinicalTrials.gov, NCT03574129. [ABSTRACT FROM AUTHOR]

Objective: HIV stigma and discrimination is widespread in sub‐Saharan Africa and is associated with poor clinical outcomes. Schools play a critical role in the life of youth and have been identified as a potentially stigmatising environment. We sought to explore school HIV stigma drivers, facilitators, manifestations and outcomes among youth living with HIV (YLH) as well as potential stigma reduction interventions in Kenya. Methods: Semi‐structured in‐depth qualitative interviews with 28 school‐attending YLH aged 14–19 years and 24 caregivers of YLH were analysed using directed content analysis. Results were summarised using the Health and Stigma Framework. Results: Drivers and facilitators of HIV stigma in the school environment included misconceptions about HIV transmission, HIV treatment outcomes and long‐term overall health of people living with HIV. HIV stigma manifested largely as gossip, isolation and loss of friendships. Fear of HIV stigma or experienced stigma resulted in poor adherence to antiretroviral treatment—particularly among YLH in boarding schools—and poor mental health. Stigma also impacted school choice (boarding vs. day school) and prevented HIV disclosure to schools which was necessary for optimal support for care. Proposed interventions to address HIV stigma in schools included HIV education, psychosocial support for YLH, support for HIV disclosure to schools while ensuring confidentiality and building YLH resilience. Conclusion: There is an urgent need to develop interventions to address HIV stigma in schools to ensure optimised health and social outcomes for YLH. Future studies to understand the most effective and efficient interventions are needed. [ABSTRACT FROM AUTHOR]

HIV self-testing (HIVST) can improve testing completion among adolescents and young adults (AYA), although its influence on sexual behaviors is unclear. We evaluated whether HIVST was associated with changes in talking with sexual partners about HIVST, condom use, and HIV risk perception among AYA ages 15–24 years in a study of HIVST distribution through homes, pharmacies, and nightclubs in Nairobi, Kenya. All participants had negative HIVST results. Regression models were used to evaluate changes between pre-HIVST and 4 months post-HIVST. Overall, there was a significant increase in talking with sexual partners about HIVST. There was a significant reduction in number of condomless sex acts among AYA recruited through pharmacies and homes. Unexpectedly, among females, there was a significant decrease in consistent condom use with casual partners. HIVST services for AYA may benefit from including strategies to support condom use and partner communication about self-testing adapted to specific populations and partnerships. [ABSTRACT FROM AUTHOR]

The health care transition (HCT) from pediatric to adult care is a potential contributor to poor clinical outcomes among adolescents living with HIV (ALHIV). In sub-Saharan Africa (SSA), there is limited information on effective tools and processes to prepare and support ALHIV through this transition. This study elicited perspectives of policy-makers regarding barriers and facilitators to successful HCT among ALHIV in Kenya. Twenty in-depth interviews (IDIs) were conducted with policy-makers using a semi-structured guide. Using the socio-ecological model (SEM) as an organizing framework, directed content and thematic network analyses methods were used to characterize themes related to key influences on HCT processes and to describe actionable recommendations for improved tools and resources. Policy-makers identified multilevel support, including the development of a triadic relationship between the caregiver, healthcare worker (HCW) and adolescent, as an essential strategy for improved HCT success. Across the SEM, policy-makers described the importance of actively engaging adolescents in their care to promote increased ownership and autonomy over health decisions. At the structural level, the need for more comprehensive HCT guidelines and improved HCW training was highlighted. Expanded HCT tools and guidelines, that emphasize supportive relationships and intensified adolescent engagement, may improve HCT processes and outcomes. [ABSTRACT FROM AUTHOR]

Background: The impact of human immunodeficiency virus (HIV) on pregnancy outcomes for women on antiretroviral therapy (ART) in sub-Saharan Africa remains unclear.Methods: Pregnant women in Kenya were enrolled in the second trimester and followed up to delivery. We estimated effects of treated HIV with 3 pregnancy outcomes: loss, premature birth, and low birth weight and factors associated with HIV-positive status.Results: Of 2113 participants, 311 (15%) were HIV infected and on ART. Ninety-one of 1762 (5%) experienced a pregnancy loss, 169/1725 (10%) a premature birth (<37 weeks), and 74/1317 (6%) had a low-birth-weight newborn (<2500 g). There was no evidence of associations between treated HIV infection and pregnancy loss (adjusted relative risk [aRR], 1.19; 95% confidence interval [CI], .65-2.16; P = .57), prematurity (aRR, 1.09; 95% CI, .70-1.70; P = .69), and low birth weight (aRR, 1.36; 95% CI, .77-2.40; P = .27). Factors associated with an HIV-positive status included older age, food insecurity, lower education level, higher parity, lower gestation at first antenatal clinic, anemia, and syphilis. Women who were overweight or underweight were less likely to be HIV infected compared to those with normal weight.Conclusions: Currently treated HIV was not significantly associated with adverse pregnancy outcomes. HIV-infected women, however, had a higher prevalence of other factors associated with adverse pregnancy outcomes. [ABSTRACT FROM AUTHOR]

Oral HIV self-testing (HIVST) may expand access to testing among hard-to-reach reach adolescents and young adults (AYA). We evaluated community-based HIVST services for AYA in an urban settlement in Kenya. Peer-mobilizers recruited AYA ages 15–24 through homes, bars/clubs, and pharmacies. Participants were offered oral HIVST, optional assistance and post-test counseling. Outcomes were HIVST acceptance and completion (self-report and returned kits). Surveys were given at enrollment, post-testing, and 4 months. Log-binomial regression evaluated HIVST preferences by venue. Among 315 reached, 87% enrolled. HIVST acceptance was higher in bars/clubs (94%) than homes (86%) or pharmacies (75%). HIVST completion was 97%, with one confirmed positive result. Participants wanted future HIVST at multiple locations, include PrEP, and cost ≤ $5USD. Participants from bars/clubs and pharmacies were more likely to prefer unassisted testing and peer-distributers compared to participants from homes. This differentiated community-based HIVST strategy could facilitate engagement in HIV testing and prevention among AYA. [ABSTRACT FROM AUTHOR]

We examined patterns of disclosure among youth living with HIV (YLHIV) in Kenya, and the association between self-disclosure and antiretroviral therapy adherence, stigma, depression, resilience, and social support. Of 96 YLHIV, 78% were female, 33% were ages 14–18, and 40% acquired HIV perinatally. Sixty-three (66%) YLHIV had self-disclosed their HIV status; 67% to family and 43% to non-family members. Older YLHIV were 75% more likely to have self-disclosed than those 14–18 years. Of the 68 either married or ever sexually active, 45 (66%) did not disclose to their partners. Those who had self-disclosed were more likely to report internalized stigma (50% vs. 21%, prevalence ratio [PR] 2.3, 1.1–4.6), experienced stigma (26% vs. 3%, PR 11.0, 1.4–86), and elevated depressive symptoms (57% vs. 30%, PR 1.8, 1.0–3.1). The association with stigma was stronger with self-disclosure to family than non-family. Support should be provided to YLHIV during self-disclosure to mitigate psychosocial harms. [ABSTRACT FROM AUTHOR]

Stakeholder engagement between researchers, policymakers and practitioners is critical for the successful translation of research into policy and practice. The Counseling and Testing for Children at Home (CATCH) study evaluated a paediatric index case testing model, targeting the children of HIV-infected adults in care in Kenya. Researchers collaborated with stakeholders in the planning, execution and evaluation, and dissemination phases of CATCH. They included a community advisory board, the national HIV programme, County health departments, institutional ethics review bodies, a paediatric bioethics group, facility heads and frontline healthcare workers . Stakeholder analysis considered the power and interest of each stakeholder in the study. All stakeholders had some power to influence the success of the project in the different phases. However, support from institutions with higher hierarchical power increased acceptance of the study by stakeholders lower in the hierarchy. During the planning, execution and evaluation, and dissemination phases, the study benefitted from deliberate stakeholder engagement. Through engagement, changes were made in the approach to recruitment to ensure high external validity, placing recruitment optimally within existing clinic flow patterns. Choices in staffing home visits were made to include the appropriate cadre of staff. Adaptations were made to the consenting process that balanced the child's evolving autonomy and risks of HIV disclosure. Dissemination involved delivering site-specific results in each HIV clinic, local and international conferences and sharing of study tools, resulting in the study approach being scaled up nationally. The deliberate engagement of stakeholders early in intervention development optimized study validity and accelerated adoption of the CATCH approach in nationwide HIV testing campaigns by the Ministry of Health and inclusion of paediatric index-case testing in national HIV testing guidelines. Involving policymakers and frontline healthcare workers throughout the study cycle builds capacity in the implementing team for quick adoption and scale-up of the evidence-based practice. [ABSTRACT FROM AUTHOR]

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Poor retention in HIV care remains a major problem for Adolescents and Young Adults (AYA). A Standardized Patient (SP) clinical training intervention was developed to improve healthcare worker (HCW) "adolescent-friendly" competencies in Kenya. Professional actors were trained to portray HIV-infected AYA according to standardized scripts. HCWs completed a 2-day SP training that included didactic sessions, 7 video-recorded SP encounters, and group debriefing. AYA health experts rated HCWs by reviewing the video recordings. All HCWs (10/10) reported high satisfaction with the intervention and overall improvement in self-rated competency in caring for HIV-infected AYA. Cases were reported to be realistic and relevant by between 7 and 10 of 10 HCWs. The case on disclosure and adherence was rated as most challenging in communication and making medical decisions by HCWs. Areas identified by SPs for improvement by HCWs included allowing patients time to ask questions, and enabling SP to share sensitive information. The overall ICC by experts was low 0.27 (95% CI: −0.79 to 0.95), however, ICCs in assessment of HIV disclosure 0.78 (95% CI: 0.17–0.98), and sexual behavior 0.97 (95% CI: 0.89–0.99) were high. This intervention was acceptable for Kenyan HCWs and improved self-rated competency in caring for HIV-infected AYA. [ABSTRACT FROM AUTHOR]

HIV incidence and mortality are high among adolescents and young adults (AYA) in sub-Saharan Africa, but testing rates are low. Understanding how support people (SP), such as peers, partners, or parents, influence AYA may improve HIV testing uptake. AYA aged 14-24 seeking HIV testing at a referral hospital in Nairobi, Kenya completed a post-test survey assessing the role of SP. Among 1062 AYA, median age was 21. Overall, 12% reported their decision to test was influenced by a parent, 20% by a partner, and 22% by a peer. Young adults (20-24 years old) were more likely than adolescents (14-19 years old) to be influenced to test by partners (23% vs. 12%, p < .001), and less likely by parents (6.6% vs. 27%, p < .001), healthcare workers (11% vs. 16%, p < .05), or counselors (9.4% vs. 19%, p < .001). Half of AYA were accompanied for testing (9.9% with parent, 10% partner, 23% peer, 4.3% others, and 2.1% multiple types). Young adults were more likely than adolescents to present alone (58% vs. 32%, p < .001) or with a partner (12% vs. 6.7%, p < .05), and less likely with a parent (1.6% vs. 31%, p < .001). Similar proportions of adolescents and young adults came with a peer or in a group. Correlates of presenting with SP included: younger age (aRR = 1.55 [95%CI = 1.30-1.85]), female sex (aRR = 1.45 [95%CI = 1.21-1.73]), and school enrollment (aRR = 1.41 [95%CI = 1.05-1.88]). SP play an important role in AYAs' HIV testing and varies with age. Leveraging SP may promote uptake of HIV testing and subsequent linkage care for AYA. [ABSTRACT FROM AUTHOR]

Expansion of access to diagnosis and treatment for human immunodeficiency virus (HIV) and a high incidence of HIV infection in adolescence has resulted in a growing population of adolescents and young adults living with HIV. The prevalence of poor retention in care, insufficient viral suppression and loss to follow-up are higher among adolescents and young adults compared with other age groups. Poor outcomes could be attributed to psychosocial changes during adolescence, but also to poor transitional care from paediatric to adult HIV services. In many countries, transition processes remain poorly defined and unstructured, which may jeopardize treatment adherence and retention. We describe existing definitions of transition and transition frameworks, and key elements of transition as proposed by key national stakeholders in Kenya. Our consensus definition of transition is "a planned process by which adolescents and young adults living with HIV, and their caregivers, are empowered with knowledge and skills to enable them to independently manage their health." Transition should begin soon after disclosure of HIV status until an adolescent gains the necessary knowledge and skills and is willing to move to adult services, or by 25 years of age. Proposed key elements of transition are: target ages for milestone achievement; readiness assessment; caregiver involvement and communication with adult clinics; flexibility to return to adolescent or paediatric clinics; group transition; and considerations for adolescents with special needs. Retention in care, linkage to care and viral suppression are important markers of transition success. Proposed definitions and key elements could provide a framework for structuring transition programmes in other countries. [ABSTRACT FROM AUTHOR]

Objective: Evaluate effects of tuberculosis (TB)-HIV co-treatment on clinical and growth outcomes in children with HIV (CHIV)., Design: Longitudinal study among Kenyan hospitalized ART-naive CHIV in the PUSH trial (NCT02063880)., Methods: CHIV started ART within 2 weeks of enrollment; Anti-TB therapy was initiated based on clinical and TB diagnostics. Children were followed for 6 months with serial viral load, CD4%, and growth assessments [weight-for-age z -score (WAZ), height-for-age z -score (HAZ), and weight-for-height z -score (WHZ)]. TB-ART treated and ART-only groups were compared at 6 months post-ART for undetectable viral load (<40 c/ml), CD4% change, and growth using generalized linear models, linear regression, and linear mixed-effects models, respectively., Result: Among 152 CHIV, 40.8% (62) were TB-ART treated. Pre-ART, median age was 2.0 years and growth was significantly lower, and viral load significantly higher in the TB-ART versus ART-only group. After 6 months on ART, 37.2% of CHIV had undetectable viral load and median CD4% increased by 7.2% (IQR 2.0-11.6%) with no difference between groups. The TB-ART group had lower WAZ and HAZ over 6 month follow-up [WAZ -0.81 (95% CI: -1.23 to -0.38], P  < 0.001; HAZ -0.15 (95% CI: -0.29 to -0.01), P  = 0.030] and greater rate of WAZ increase in analyses unadjusted and adjusted for baseline WAZ [unadjusted 0.62 (95% CI: 0.18-1.07, P  = 0.006) or adjusted 0.58 (95% CI: 0.12-1.03, P  = 0.013)]., Conclusion: TB-HIV co-treatment did not adversely affect early viral suppression and CD4 + recovery post-ART. TB-ART-treated CHIV had more rapid growth reconstitution, but growth deficits persisted, suggesting need for continued growth monitoring., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Women infected during pregnancy with TORCH (Toxoplasmosis, Other, Rubella, Cytomegalovirus, and Herpes simplex viruses) pathogens have a higher risk of adverse birth outcomes including stillbirth / miscarriage because of mother-to-child transmission. To investigate these risks in pregnant women in Kenya, we analyzed serum specimens from a pregnancy cohort study at three healthcare facilities. A sample of 481 participants was selected for TORCH pathogen antibody testing to determine seroprevalence. A random selection of 285 from the 481 participants was selected to measure seroconversion. These sera were tested using an IgG enzyme-linked immunosorbent assay against 10 TORCH pathogens. We found that the seroprevalence of all but three of the 10 TORCH pathogens at enrollment was >30%, except for Bordetella pertussis (3.8%), Treponema pallidum (11.4%), and varicella zoster virus (0.5%). Conversely, very few participants seroconverted during their pregnancy and were herpes simplex virus type 2 ( n  = 24, 11.2%), parvovirus B19 ( n  = 14, 6.2%), and rubella ( n  = 12, 5.1%). For birth outcomes, 88% of the participant had live births and 12% had stillbirths or miscarriage. Cytomegalovirus positivity at enrolment had a statistically significant positive association with a live birth outcome ( p  = 0.0394). Of the 10 TORCH pathogens tested, none had an association with adverse pregnancy outcome.

Introduction: Disclosure of HIV status to adolescents living with HIV has been associated with improved treatment outcomes. However, there are limited data regarding the experiences of, perceptions of, and preferences for the process of disclosure of HIV status among adolescents and young adults living with HIV (AYLH), especially in sub-Saharan Africa., Methods: Young adults living with HIV from 20 HIV clinics in Kenya who participated in a clinical trial evaluating the effectiveness of a disclosure and transition package completed an anonymous survey in 2019. We described their experiences and preferences using counts and proportions and assessed factors associated with satisfaction with the disclosure process using linear regression, reporting age-adjusted mean differences (aMD), and 95% confidence intervals (95%CIs)., Results: Of the 375 enrolled AYLH, 265 (71%) had perinatally acquired HIV, of whom 162 (61%) were female. The median age of the enrolled AYLH was 16 years (IQR: 14-19 years), and all of them were on antiretroviral therapy (ART). For over half (55%) of the participants, caregivers disclosed their HIV status, and 57% preferred that their caregivers disclose the status to them. Most (78%) of the participants preferred full disclosure by 12 years of age. The majority (69%) believed the disclosure was planned, and 11% suspected being HIV positive before the disclosure. Overall, 198 (75%) AYLH reported that they were ready for disclosure when it happened, and 86% were satisfied with the process. During both pre-disclosure (67 and 70%, respectively) and post-disclosure (>75% for each), AYLH felt supported by the clinic and caregivers. Factors associated with higher satisfaction with the disclosure process were pre-disclosure clinic support (aMD: 0.19 [95%CI: 0.05-0.33]) and pre-disclosure (aMD: 0.19 [0.06-0.31]) and post-disclosure (aMD: 0.17 [0.03-0.31]) caregiver support. AYLH who suspected they were HIV positive before they were disclosed to tended to have lower satisfaction when compared to those who never suspected (aMD: -0.37 [-0.74-(-0.01)]). Overall, they reported that disclosure positively influenced their ART adherence (78%), clinic attendance (45%), and communication with caregivers (20%), and 40% reported being happier after disclosure., Conclusion: Young adults living with HIV advocated for an appropriately timed disclosure process with the involvement of caregivers and healthcare workers (HCWs). Support from caregivers and HCWs before and during disclosure is key to improving their disclosure experience., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Mugo, Njuguna, Beima-Sofie, Mburu, Onyango, Itindi, Richardson, Oyiengo, John-Stewart and Wamalwa.)

Introduction: Disclosure of one's HIV status to others is often difficult due to the fear of stigma. However, disclosure may facilitate receiving social support. Many youth living with HIV (YLH) are enrolled in school as better treatments have improved the health and survival of children with HIV. There is no structured process for disclosure at school for YLH and their caregivers. We sought to understand school disclosure experiences among YLH and their caregivers and assess the need for the development of a structured disclosure intervention tailored to school settings., Methods: We conducted in-depth qualitative interviews with 28 school-going YLH aged 14-19 years and 24 caregivers of YLH. Interviews were conducted in English and Swahili, transcribed, and translated. The transcripts were uploaded to Atlas.ti 9 for thematic analysis., Results: YLH and caregivers clearly articulated the benefits of disclosing to school staff. Disclosure to school staff was seen as the first step to receiving support for medication storage, adherence, and clinic attendance. However, disclosure was also perceived to be a very complicated and stressful process. Fear of stigma drove caregivers and YLH toward careful planning of when and to whom to disclose. Distrust of school staff was a significant barrier to disclosure, even among those who clearly articulated the benefits of disclosure. Disclosure to school staff largely resulted in positive experiences; the immediate reactions were positive or somewhat neutral and confidentiality was upheld. The anticipated benefits of practical and emotional support were demonstrated by the school staff to whom the HIV information was disclosed., Conclusion: Disclosure of HIV status to someone at school is necessary to receive support for medication adherence. Stigma and the lack of structured support for the disclosure process at school often hinder YLH and their caregivers from disclosing. YLH would benefit from better support at schools, including policies to facilitate disclosure that address the caregiver and YLH's fear of stigma and loss of confidentiality. School policies could also provide guidance on whom to disclose to and available post-disclosure support., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Moraa, Njuguna, Mugo, Mbwayo, Nyapara, Aballa, Wagner, Wamalwa, John-Stewart, Inwani and O'Malley.)

Background: There is mixed evidence on the influence of self-disclosure of one's HIV status on mental health, health behaviours and clinical outcomes. We studied the patterns of self-disclosure among parents living with HIV, and factors that influence parental disclosure., Methods: This mixed-methods study was among adults in HIV care participating in a study assessing the uptake of pediatric index-case testing. They completed a survey to provide demographic and HIV-related health information, and assess self-disclosure to partners, children and others. We ran generalized linear models to determine factors associated with disclosure and reported prevalence ratios (PR). Eighteen participants also participated in in-depth interviews to explore perceived barriers and facilitators of self-disclosure to one's child. A content analysis approach was used to analyze interview transcripts., Results: Of 493 caregivers, 238 (48%) had a child ≥ 6 years old who could potentially be disclosed to about their parent's HIV status. Of 238 participants, 205 (86%) were female, median age was 35 years, and 132 (55%) were in a stable relationship. Among those in a stable relationship, 96 (73%) knew their partner's HIV status, with 79 (60%) reporting that their partner was living with HIV. Caregivers had known their HIV status for a median 2 years, and the median age of their oldest child was 11 years old. Older caregiver age and older first born child's age were each associated with 10% higher likelihood of having disclosed to a child (PR: 1.10 [1.06-1.13] and PR: 1.10 [1.06-1.15], per year of age, respectively). The child's age or perceived maturity and fear of causing anxiety to the child inhibited disclosure. Child's sexual activity was a motivator for disclosure, as well as the belief that disclosing was the "right thing to do". Caregivers advocated for peer and counseling support to gain insight on appropriate ways to disclose their status., Conclusions: Child's age is a key consideration for parents to disclose their own HIV status to their children. While parents were open to disclosing their HIV status to their children, there is a need to address barriers including anticipated stigma, and fear that disclosure will cause distress to their children., (© 2023. The Author(s).)

Background: Tuberculosis is the leading cause of death among adolescents and young adults living with HIV (YWHIV) and their heightened risk warrants deeper understanding of utilization of tuberculosis-prevention measures within HIV care., Setting: Retrospective study using clinic surveys and medical record data from 86 Kenyan HIV clinics., Methods: Clinic surveys obtained information on tuberculosis preventive therapy (TPT) services. Medical records of YWHIV were abstracted. Bivariate and multivariate analyses used generalized linear models to determine individual-level and clinic-level cofactors of TPT initiation and completion., Results: Among 10,328 eligible YWHIV, 4337 (42.0%) initiated TPT. Of 3295 with ≥6 months follow-up, 1774 (53.8%) completed TPT. A lower patient-to-staff ratio was a clinic-level cofactor of TPT initiation ( P = 0.044) and completion ( P = 0.004); designated adolescent areas were associated with TPT initiation {prevalence ratio 2.05 [95% confidence interval (CI): 1.46 to -2.88]}. Individual cofactors of TPT initiation included younger age at HIV-care enrollment [relative risk (RR) 0.85 (95% CI: 0.80 to 0.90)] and antiretroviral therapy (ART) duration [1-2 vs. <1 year RR 1.31 (95% CI: 1.18 to 1.45)]. TPT completion was associated with younger age [RR 0.91 (95% CI: 0.85 to 0.98)] and ART duration [2-5 vs. <1 year RR 1.27 (95% CI: 1.03 to 1.57)]. In multivariate models, TPT initiation was associated with younger age and ART duration [1-2 vs. 1 year; adjusted RR 1.30 (95% CI: 1.16 to 1.46)] and TPT completion with ART duration [2-5 vs. 1 year adjusted RR 1.23 (95% CI: 0.99 to 1.52)]., Conclusion: Over half of YWHIV did not initiate and >40% did not complete TPT, with distinct clinic-level and individual-level cofactors. Approaches to enhance adolescent-friendly infrastructure and support older YWHIV are necessary to improve TPT use., Competing Interests: D.A.B. is a Predoctoral Fellow funded by the NIH-supported University of Washington STD and AIDS Research Training Program under Award 5T32AI007140-44. D.A.B. is employed by Merative, a healthcare analytics company. Her work with Merative does not involve any products or competing products that play a role in this manuscript. The parent study was funded by the National Institutes of Health (NIH) under Award 5R01HD089850-05. For the remaining authors, no funding or conflicts of interest were declared., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Social support is a critical component of achieving positive health outcomes for youth living with HIV (YLWH). Mobile health (mHealth) has significant potential for providing social support to YLWH. However, little is known about the domains of social support most needed by YLWH which mHealth interventions might address. Drawing on the spontaneous creation of WhatsApp support groups by YLWH in Nairobi, Kenya, we characterized Kenyan YLWH's social support needs and potential roles of social media groups in meeting them. We conducted interviews and focus-groups with 68 YLWH, 24 caregivers and 20 healthcare workers, and observed two YLWH-led WhatsApp groups for 6 weeks. Youth reported that existing support systems, including family and healthcare workers, already provided informational and instrumental support. However, they emphasized unmet companionship and emotional support needs, leading to isolation, hopelessness, and medication adherence challenges. Participants identified connection with other YLWH as a unique source of emotional and companionship support that allowed them to feel more secure and less isolated. Interviews and observed WhatsApp chats demonstrated that WhatsApp groups were a desirable medium for companionship support that overcame barriers to in-person connection.

Background: Transitioning youth living with HIV to adult care is a crucial step in the HIV care continuum; however, tools to support transition in sub-Saharan Africa are insufficient. We assessed the effectiveness of an adolescent transition package (ATP) to improve youth readiness for transition to independent HIV care., Methods: In this hybrid type 1, multicentre, cluster randomised clinical trial, we assessed the effectiveness of an ATP (administered by routine clinic staff, which included standardised assessments and chapter books to guide discussions at scheduled clinic visits) in four counties in Kenya, with HIV clinics randomly assigned 1:1 to ATP or control (standard-of-care practice). Clinics were eligible to participate if they had at least 50 youth (aged 10-24 years) living with HIV enrolled in care. We used restricted randomisation to achieve cluster balance and an independent biostatistician used computer-generated random numbers to assign clinics. We excluded very large clinics with more than 1000 youth, clinics with fewer than 50 youth, paediatric-only clinics, clinics with logistical challenges, and the smallest clinics in Homa Bay county. Youth were eligible for the transition intervention if they were enrolled in participating clinics, were aged 15-24 years, and were aware of their positive HIV diagnosis. Study staff assessed transition readiness scores overall and by four domains (HIV literacy, self-management, communication, and support) in youth with HIV, which were then compared between groups by use of mixed-effects linear regression models. Analysis was by intention-to-treat and was adjusted for multiple comparisons. This trial is registered with ClinicalTrials.gov, NCT03574129., Findings: We identified 35 clinics in four counties; of these, ten were assigned to the intervention group and ten to the control group. Of 1066 youth with HIV enrolled between Nov 1, 2019, and March 18, 2020, 578 (54%) were in intervention and 488 (46%) in control sites. Mean baseline transition readiness score was 12·1 (SD 3·4) in ATP sites and 11·4 (3·7) in control sites. At 1 year, adjusting for baseline scores, age, and months since HIV disclosure, participants in the ATP group had significantly higher overall transition readiness scores (adjusted mean difference 1·7, 95% CI 0·3-3·1, p=0·024), and higher scores in HIV literacy domain (adjusted mean difference 1·0, 0·2-1·7, p=0·011). At 12 months, 15 serious adverse events were recorded, none of which were thought to be related to study participation., Interpretation: Integrating ATP approaches could enhance long-term HIV care in youth with HIV as they age into adulthood., Funding: US National Institutes of Health., Competing Interests: Declaration of interests BAR reports payments from Gilead for participation in data safety monitoring boards. GJ-S reports support from the US National Institutes of Health (NIH) and IMPAACT. INN reports support from NIH, Gilead Sciences, and the UW Center for AIDS Research. The other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: The World Health Organization (WHO) recommends tuberculosis (TB) diagnostic evaluation for children with HIV (CHIV) who have history of TB contact, poor weight gain, cough, or fever. These screening criteria were developed based on studies of symptomatic CHIV with incomplete microbiologic confirmation. We performed routine TB microbiologic evaluation of hospitalized CHIV with and without symptoms to develop a data-driven TB symptom screen., Methods: Among hospitalized antiretroviral therapy-naive Kenyan CHIV enrolled in the Pediatric Urgent Start of Highly Active Antiretroviral Therapy (PUSH) trial, we performed Xpert MTB/RIF and mycobacterial culture of respiratory and stool specimens independent of TB symptoms. We evaluated performance of WHO and other published pediatric TB screening criteria and derived optimized criteria using a combination of symptoms., Results: Of 168 CHIV who underwent TB microbiologic evaluation, 13 (8%) had confirmed TB. WHO TB symptom screening had 100% sensitivity and 4% specificity to detect confirmed TB. Published TB screening criteria that relied on prolonged symptoms missed cases of confirmed TB (sensitivity 85%-92%). An optimized symptom screen including weight loss, cough, anorexia, or TB contact had 100% sensitivity and improved specificity (31%) compared with the WHO pediatric TB symptom screen., Conclusions: The WHO TB symptom screen was highly sensitive but resulted in a high proportion of hospitalized CHIV who would require TB diagnostic evaluation. Other published TB screening criteria missed CHIV with confirmed TB. Our optimized screening tool increased specificity while preserving sensitivity. Future multicenter studies are needed to improve TB screening tools for CHIV in both inpatient and outpatient settings., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Zika virus (ZIKV), first discovered in Uganda in 1947, re-emerged globally in 2013 and was later associated with microcephaly and other birth defects. We determined the incidence of ZIKV infection and its association with adverse pregnancy and fetal outcomes in a pregnancy cohort in Kenya., Methods: From October 2017 to July 2019, we recruited and followed up women aged ≥ 15 years and ≤ 28 weeks pregnant in three hospitals in coastal Mombasa. Monthly follow-up included risk factor questions and a blood sample collected for ZIKV serology. We collected anthropometric measures (including head circumference), cord blood, venous blood from newborns, and any evidence of birth defects. Microcephaly was defined as a head circumference (HC) < 2 standard deviations (SD) for sex and gestational age. Severe microcephaly was defined as HC < 3 SD for sex and age. We tested sera for anti-ZIKV IgM antibodies using capture enzyme-linked immunosorbent assay (ELISA) and confirmed positives using the plaque reduction neutralization test (PRNT 90 ) for ZIKV and for dengue (DENV) on the samples that were ZIKV neutralizing antibody positive. We collected blood and urine from participants reporting fever or rash for ZIKV testing., Results: Of 2889 pregnant women screened for eligibility, 2312 (80%) were enrolled. Of 1916 recorded deliveries, 1816 (94.6%) were live births and 100 (5.2%) were either stillbirths or spontaneous abortions (< 22 weeks of gestation). Among 1236 newborns with complete anthropometric measures, 11 (0.9%) had microcephaly and 3 (0.2%) had severe microcephaly. A total of 166 (7.2%) participants were positive for anti-ZIKV IgM, 136 of whom became seropositive during follow-up. Among the 166 anti-ZIKV IgM positive, 3 and 18 participants were further seropositive for ZIKV and DENV neutralizing antibodies, respectively. Of these 3 and 18 pregnant women, one and 13 (72.2%) seroconverted with antibodies to ZIKV and DENV, respectively. All 308 samples (serum and urine samples collected during sick visits and samples that were anti-ZIKV IgM positive) tested by RT-PCR were negative for ZIKV. No adverse pregnancy or neonatal outcomes were reported among the three participants with confirmed ZIKV exposure. Among newborns from pregnant women with DENV exposure, four (22.2%) were small for gestational age and one (5.6%) had microcephaly., Conclusions: The prevalence of severe microcephaly among newborns in coastal Kenya was high relative to published estimates from facility-based studies in Europe and Latin America, but little evidence of ZIKV transmission. There is a need for improved surveillance for microcephaly and other congenital malformations in Kenya., (© 2022. The Author(s).)

Expanding index and family-based testing (HBT) is a priority for identifying children living with HIV. Our study characterizes predictors that drive testing location choice for children of parents living with HIV. Kenyan adults living with HIV were offered a choice of HBT or clinic-based testing (CBT) for any of their children (0-12 years) of unknown HIV status. Multilevel generalized linear models were used to identify correlates of choosing HBT or CBT for children and testing all versus some children within a family, including caregiver demographics, HIV history, social support, cost, and child demographics and HIV prevention history. Among 244 caregivers living with HIV and their children of unknown HIV status, most (72%) caregivers tested children using CBT. In multivariate analysis, female caregivers [aRR 0.52 (95% CI 0.34-0.80)] were less likely to choose HBT than male caregivers. Caregivers with more children requiring testing [aRR 1.23 (95% CI 1.05-1.44)] were more likely to choose HBT than those with fewer children requiring testing. In subgroup univariate analysis, female caregivers with a known HIV negative spouse were significantly more likely to choose HBT over CBT than those with a known HIV positive spouse [RR 2.57 (95% CI 1.28-5.14), p = 0.008], no association was found for male caregivers. Child demographics and clinical history was not associated with study outcomes. Caregiver-specific factors were more influential than child-specific factors in caregiver choice of pediatric HIV testing location. Home-based testing may be preferable to families with higher child care needs and may encourage pediatric HIV testing if offered as an alternative to clinic testing., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Abstract: Sustained viral suppression in adolescents and young adults living with HIV (AYALWH) is necessary for epidemic control. We evaluated facility and individual correlates of viral suppression using programmatic data from AYALWH between ages 10 and 24 years at 24 HIV clinics in Kenya. Binomial regression was used to evaluate correlates of viral load (VL) suppression (<1,000 copies/ml). Of 5,316 AYALWH on antiretroviral therapy ≥6 months, 2,081 (39%) had VLs available in the medical record, of which 76% were virally suppressed. In multivariable analyses, antiretroviral therapy initiation among AYALWH older than 10 years was associated with higher viral suppression than initiation younger than 10 years (adjusted risk ratio [aRR] 10-14 = 1.03, 95% confidence interval [CI] 0.97-1.10; aRR 15-19 = 1.30, 95% CI 1.19-1.41; aRR 20-24 = 1.43, 95% CI 1.24-1.63). Facilities with both youth-friendly services (YFS) and trained providers had significantly higher VL suppression compared with facilities without YFS or trained providers (adjusted odds ratio: 2.07, 95% CI: 1.71-2.52). Viral suppression remains suboptimal among AYALWH. YFS and trained providers plus greater use of VL data may help increase viral suppression among AYALWH., (Copyright © 2021 Association of Nurses in AIDS Care.)

Background: How can we fast-track the global agenda of integrated mental healthcare in low- and middle-income countries (LMICs) such as Kenya? This is a question that has become increasingly important for individuals with lived experiences, policymakers, mental health advocates and health care providers at the local and international levels. Discussion: This narrative synthesis and perspective piece encompasses an overview of mental health care competencies, best practices and capacity building needed to fast track patient responsive services. In that vein we also review key policy developments like UHC to make a case for fast-tracking our four-step framework. Results: While there is an increasingly global impetus for integrated mental healthcare, there is a lack of clarity around what patient-responsive mental healthcare services should look like and how to measure and improve provider readiness appropriately. Here, our collaborative team of local and international experts proposes a simple four-step approach to integrating responsive mental healthcare in Kenya. Our recommended framework prioritizes a clear understanding and demonstration of multidimensional skills by the provider. The four steps are (1) provider sensitization , (2) continuous supervision , (3) continuous professional training , and (4) leadership empowerment . Conclusion: Our proposed framework can provide pointers to embracing patient-centered and provider empowerment focused quality of care improvements. Though elements of our proposed framework are well-known, it has not been sufficiently intertwined and therefore not been integrated. We think in the current times our integrated framework offers an opportunity to "building back better" mental health for all., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Kumar, Osborn, Mugo, Akbarialiabad, Warfa, Mbuthia, Wambugu, Ngunu, Gohar, Mwaniga, Njuguna and Saxena.)

Competing Interests: The authors have no conflicts of interest to disclose.

Background: Financial incentives can motivate desirable health behaviors, including adult HIV testing. Data regarding the effectiveness of financial incentives for HIV testing in children, who require urgent testing to prevent mortality, are lacking., Methods: In a five-arm unblinded randomized controlled trial, adults living with HIV attending 19 HIV clinics in Western Kenya, with children 0-12 years of unknown HIV status, were randomized with equal allocation to $0, $1.25, $2.50, $5 or $10. Payment was conditional on child HIV testing within 2 months. Block randomization with fixed block sizes was used; participants and study staff were unblinded at randomization. Primary analysis was intent-to-treat, with predefined primary outcomes of completing child HIV testing and time to testing., Results: Of 452 caregivers, 90, 89, 93, 92 and 88 were randomized to $0, $1.25, $2.50, $5.00, and $10.00, respectively. Of those, 31 (34%), 31 (35%), 44 (47%), 51 (55%), and 54 (61%) in the $0, $1.25, $2.50, $5.00, and $10.00 arms, respectively, completed child testing. Compared with the $0 arm, and adjusted for site, caregivers in the $10.00 arm had significantly higher uptake of testing [relative risk: 1.80 (95% CI 1.15--2.80), P = 0.010]. Compared with the $0 arm, and adjusted for site, time to testing was significantly faster in the $5.00 and $10.00 arms [hazard ratio: 1.95 (95% CI 1.24--3.07) P = 0.004, 2.42 (95% CI 1.55--3.79), P < 0.001, respectively)., Conclusion: Financial incentives are effective in improving pediatric HIV testing among caregivers living with HIV., Registration: NCT03049917.

Background: Repeat HIV viral load (VL) testing is required after unsuppressed VL to confirm treatment failure. We assessed proportion of adolescents and young adults living with HIV (AYALHIV) in Kenya with a confirmatory VL test and time to repeat testing., Design: A retrospective analysis of longitudinal data abstracted from Kenya's national VL database., Methods: VL data for AYALHIV who were 10-24 year old between April 2017 and May 2019 were abstracted from 117 HIV care clinics. Records were eligible if at least one VL test was performed ≥6 months after antiretroviral therapy (ART) initiation. The proportion of unsuppressed AYALHIV (≥1000 copies/mL) and time in months between first unsuppressed VL and repeat VL was determined., Results: We abstracted 40,928 VL records for 23,969 AYALHIV; of whom, 17,092 (71%) were eligible for this analysis. Of these, 12,122 (71%) were women, median age of 19 years [interquartile range (IQR): 13-23], and median ART duration of 38 months (IQR: 16-76). Among eligible AYALHIV, 4010 (23%) had an unsuppressed VL at first eligible measurement. Only 316 (8%) of the unsuppressed AYALHIV had a repeat VL within 3 months and 1176 (29%) within 6 months. Among 2311 virally unsuppressed AYALHIV with a repeat VL, the median time between the first and the repeat VL was 6 months (IQR: 4-8), with 1330 (58%) having confirmed treatment failure., Conclusions: One-quarter of AYALHIV on ART had unsuppressed VL, with less than a third receiving a repeat VL within 6 months. Strategies to improve VL testing practices are needed to improve AYALHIV's outcomes.

Introduction: Gaps in HIV testing of children persist, particularly among older children born before the expansion of the prevention of mother-to-child transmission of HIV programs., Methods: The Counseling and Testing for Children at Home study evaluated an index-case pediatric HIV testing approach. Caregivers receiving HIV care at 7 health facilities in Kenya (index cases), who had children of unknown HIV status aged 0-12 years, were offered the choice of clinic-based testing (CBT) or home-based testing (HBT). Testing uptake and HIV prevalence were compared between groups choosing HBT and CBT; linkage to care, missed opportunities, and predictors of HIV-positive diagnosis were identified., Results: Among 493 caregivers, 70% completed HIV testing for ≥1 child. Most caregivers who tested children chose CBT (266/347, 77%), with 103 (30%) agreeing to same-day testing of an untested accompanying child. Overall HIV prevalence among 521 tested children was 5.8% (CBT 6.8% vs HBT 2.4%; P = 0.07). Within 1 month of diagnosis, 88% of 30 HIV-positive children had linked to care, and 54% had started antiretroviral treatment. For 851 children eligible for testing, the most common reason for having an unknown HIV status was that the child's mother was not tested for HIV or had tested HIV negative during pregnancy (82%)., Conclusion: Testing uptake and HIV prevalence were moderate with nonsignificant differences between HBT and CBT. Standardized offer to test children accompanying caregivers is feasible to scale-up with little additional investment. Linkage to care for HIV-positive children was suboptimal. Lack of peripartum maternal testing contributed to gaps in pediatric testing.

Introduction: Successfully transitioning adolescents to adult HIV care is critical for optimising outcomes. Disclosure of HIV status, a prerequisite to transition, remains suboptimal in sub-Saharan Africa. Few interventions have addressed both disclosure and transition. An adolescent transition package (ATP) that combines disclosure and transition tools could support transition and improve outcomes., Methods and Analysis: In this hybrid type 1 effectiveness-implementation cluster randomised controlled trial, 10 HIV clinics with an estimated ≥100 adolescents and young adults age 10-24 living with HIV (ALWHIV) in Kenya will be randomised to implement the ATP and compared with 10 clinics receiving standard of care. The ATP includes provider tools to assist disclosure and transition. Healthcare providers at intervention clinics will receive training on ATP use and support to adapt it through continuous quality improvement cycles over the initial 6 months of the study, with continued implementation for 1 year. The primary outcome is transition readiness among ALWHIV ages 15-24 years, assessed 6 monthly using a 22-item readiness score. Secondary outcomes including retention and viral suppression among ALWHIV at the end of the intervention period (month 18), implementation outcomes (acceptability, feasibility, fidelity, coverage and penetration) and programme costs complement effectiveness outcomes. The primary analysis will be intent to treat, using mixed-effects linear regression models to compare transition readiness scores (overall and by domain (HIV literacy, self-management, communication, support)) over time in control and intervention sites with adjustment for multiple testing, accounting for clustering by clinic and repeated assessments. We will estimate the coefficients and 95% CIs with a two- sided α=0.05., Ethics and Dissemination: The study was approved by the University of Washington Institutional Review Board and the Kenyatta National Hospital Ethics and Research Committee. Study results will be shared with participating facilities, county and national policy-makers., Trials Registration Number: NCT03574129; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Newly diagnosed HIV positive children may be unique index cases to identify undiagnosed parents. Data was used from the Pediatric Urgent Start of HAART (NCT02063880) trial, which enrolled hospitalized, ART-naïve, HIV positive children ages 0-12 years in Kenya. Exact McNemar's tests were used to compare proportions of mothers and fathers tested for HIV, linked to care, and on ART at baseline and 6 months. This analysis included 87 newly diagnosed children with HIV who completed 6 months of follow-up. Among 83 children with living mothers, there were improvements in maternal linkage to care and treatment comparing baseline to 6 months (36% vs. 78%; p  < 0.0001 and 22% vs. 52%; p  < 0.0001). Among 80 children with living fathers, there were increases from baseline to 6 months in the number of fathers who knew the child's HIV status (34% vs. 78%; p  < 0.0001), fathers ever tested for HIV (43% vs. 65%; p  < 0.0001), fathers ever tested HIV positive (21% vs. 43%; p  < 0.0001), fathers ever linked to care (15% vs. 35%; p  < 0.0001), and fathers ever initiated on ART (11% vs. 23%; p  = 0.0039). Newly diagnosed HIV positive children can be important index cases to identify parents with undiagnosed HIV or poor engagement in care.

Objectives: To determine clinic-level and individual-level correlates of viral suppression among HIV-positive adolescents and young adult (AYA) aged 10-24 years receiving antiretroviral treatment (ART)., Design: Multilevel cross-sectional analysis using viral load data and facility surveys from HIV treatment programs throughout Kenya., Methods: We abstracted medical records of AYA in HIV care, analyzed the subset on ART for more than 6 months between January 2016 and December 2017, and collected information on services at each clinic. Multilevel logistic regression models were used to determine correlates of viral suppression at most recent assessment., Results: In 99 HIV clinics, among 10 096 AYA on ART more than 6 months, 2683 (27%) had unsuppressed viral load at last test. Among 16% of clinics, more than 80% of AYA were virally suppressed. Clinic-level correlates of individual viral suppression included designated adolescent spaces [aOR: 1.32, 95% CI (1.07-1.63)] and faster viral load turnaround time [aOR: 1.06 (95% CI 1.03-1.09)]. Adjusting for clinic-level factors, AYA aged 10-14 and 15-19 years had lower odds of viral suppression compared with AYA aged 20-24 years [aOR: 0.61 (0.54-0.69) and 0.59 (0.52-0.67], respectively. Compared with female patients, male patients had lower odds of viral suppression [aOR: 0.69 (0.62-0.77)]. Compared with ART duration of 6-12 months, ART for 2-5, above 5-10 or more than 10 years was associated with poor viral suppression (P < 0.001)., Conclusion: Dedicated adolescent space, rapid viral load turnaround time, and tailored approaches for male individuals and perinatally infected AYA may improve viral suppression. Routine summarization of viral load suppression in clinics could provide benchmarking to motivate innovations in clinic-AYA and individual-AYA care strategies.

Lack of health care worker (HCW) training is a barrier to implementing youth-friendly services. We examined training coverage and self-reported competence, defined as knowledge, abilities, and attitudes, of HCWs caring for adolescents living with HIV (ALWH) in Kenya. Surveys were conducted with 24 managers and 142 HCWs. Competence measures were guided by expert input and Kalamazoo II Consensus items. Health care workers had a median of 3 (interquartile range [IQR]: 1-6) years of experience working with ALWH, and 40.1% reported exposure to any ALWH training. Median overall competence was 78.1% (IQR: 68.8-84.4). In multivariable linear regression analyses, more years caring for ALWH and any prior training in adolescent HIV care were associated with significantly higher self-rated competence. Training coverage for adolescent HIV care remains suboptimal. Targeting HCWs with less work experience and training exposure may be a useful and efficient approach to improve quality of youth-friendly HIV services.

Objectives: Adolescents and young adults (AYA) have poorer retention, viral suppression, and survival than other age groups. We evaluated correlates of initial AYA engagement in HIV care at facilities participating in a randomized trial in Kenya., Design: Retrospective cohort study., Methods: Electronic medical records from AYA ages 10-24 attending 24 HIV care facilities in Kenya were abstracted. Facility surveys assessed provider trainings and services. HIV provider surveys assessed AYA training and work experience. Engagement in care was defined as return for first follow-up visit within 3 months among newly enrolled or recently re-engaged (returning after >3 months out of care) AYA. Multilevel regression estimated risk ratios and 95% confidence intervals (CIs), accounting for clustering by facility. Final models adjusted for AYA individual age and median AYA age and number enrolled per facility., Results: Among 3662 AYA records at first eligible visit, most were female (75.1%), older (20-24 years: 54.5%), and on antiretroviral therapy (79.5%). Overall, 2639 AYA returned for care (72.1%) after enrollment or re-engagement visit. Engagement in care among AYA was significantly higher at facilities offering provider training in adolescent-friendly care (85.5 vs. 67.7%; adjusted risk ratio (aRR) 1.11, 95% CI: 1.01-1.22) and that used the Kenyan government's AYA care checklist (88.9 vs. 69.2%; aRR 1.14, 95% CI: 1.06-1.23). Engagement was also significantly higher at facilities where providers reported being trained in AYA HIV care (aRR 1.56, 95% CI: 1.13-2.16)., Conclusion: Adolescent-specific health provider training and tools may improve quality of care and subsequent AYA engagement. Health provider interventions are needed to achieve the '95-95-95' targets for AYA.

Objectives: Identifying factors associated with mortality among acutely ill HIV-infected children presenting with advanced HIV disease may help clinicians optimize care for those at highest risk of death., Design: Using data from a randomized controlled trial (NCT02063880), we determined baseline sociodemographic, clinical, and laboratory cofactors of mortality among HIV-infected children in Kenya., Methods: We enrolled hospitalized, HIV-infected, antiretroviral therapy-naive children (0-12 years), initiated antiretroviral therapy, and followed up them for 6 months. We used Cox proportional hazards regression to estimate hazard ratios (HRs) for death and 95% confidence intervals (CIs)., Results: Of 181 enrolled children, 39 (22%) died. Common diagnoses at death were pneumonia or suspected pulmonary tuberculosis [23 (59%)] and gastroenteritis [7 (18%)]. Factors associated with mortality in univariate analysis included age <2 years [HR 3.08 (95% CI: 1.50 to 6.33)], orphaned or vulnerable child (OVC) [HR 2.05 (95% CI: 1.09 to 3.84)], weight-for-age Z score <-2 [HR 2.29 (95% CI: 1.05 to 5.00)], diagnosis of pneumonia with hypoxia [HR 5.25 (95% CI: 2.00 to 13.84)], oral thrush [HR 2.17 (95% CI: 1.15 to 4.09)], persistent diarrhea [HR 3.81 (95% CI: 1.89 to 7.69)], and higher log10 HIV-1 viral load [HR 2.16 (95% CI: 1.35 to 3.46)] (all P < 0.05). In multivariable analysis, age <2 years and OVC status remained significantly associated with mortality., Conclusions: Young age and OVC status independently predicted mortality. Hypoxic pneumonia, oral thrush, and persistent diarrhea are important clinical features that predict mortality. Strategies to enhance early diagnosis in children and improve hospital management of critically ill HIV-infected children are needed.

Background: Prompt child HIV testing and treatment is critical; however, children are often not diagnosed until symptomatic. Understanding factors that influence pediatric HIV testing can inform strategies to increase testing., Methods: A mixed-methods study was conducted at a tertiary hospital in Nairobi, Kenya. Three focus group discussions with health care workers (HCWs) and 18 in-depth interviews with HIV-infected adults with children of unknown status were analyzed using thematic analysis. A structured questionnaire was administered to 116 HIV-infected caregivers of children of unknown status to triangulate qualitative findings., Results: Analysis revealed 3 key periods of the pediatric HIV testing process: decision to test, test visit, and posttest. Key issues included: decision to test: inaccurate HIV risk perception for children, challenges with paternal consent, lack of caregiver HIV status disclosure to partners or older children; test experience: poor understanding of child consent/assent and disclosure guidelines, perceived costs of testing and care, school schedules, HCW discomfort with pediatric HIV testing; and posttest: pessimism regarding HIV-infected children's prognosis, caregiver concerns about their own emotional health if their child is positive, and challenges communicating about HIV with children. Concerns about all 3 periods influenced child testing decisions. In addition, 3 challenges were unique to pediatric HIV: inaccurate HIV risk perception for children; disclosure, consent, and permission; and costs and scheduling., Conclusions: Pediatric HIV testing barriers are distinct from adult barriers. Uptake of pediatric HIV testing may be enhanced by interventions to address misconceptions, disclosure services, psychosocial support addressing concerns unique to pediatric testing, child-focused HCW training, and alternative clinic hours.

Background: Tuberculosis (TB) causes substantial morbidity and mortality in HIV-infected children. Sample collection and the paucibacillary nature of TB in children makes diagnosis challenging. Rapid diagnostic tools using easily obtained specimens are urgently needed., Methods: Hospitalized, HIV-infected children aged 12 years or less enrolled in a randomized controlled trial (NCT02063880) comparing urgent to post-stabilization antiretroviral therapy initiation in Kenya underwent TB evaluation. At enrollment, sputum or gastric aspirates were collected for TB culture and Xpert, stool for Xpert, and urine for lipoarabinomannan (LAM). When possible, a second sputum/gastric aspirate for culture was obtained. Stool Xpert and urine LAM performance were compared to reference sputum/gastric aspirate culture., Results: Among 165 HIV-infected children, median age was 24 months [interquartile range (IQR) 13-58], median CD4% was 14.3 (IQR 8.9-22.0%), and 114 (69.5%) had severe immunosuppression. Thirteen (7.9%) children had confirmed TB (positive culture and/or Xpert). Sputum/gastric aspirate Xpert, stool Xpert, and urine LAM sensitivities were 60% [95% confidence interval (CI) 26-88%], 63% (95% CI 25-92%), and 43% (95% CI 10-82%), respectively. Specificity was 98% (95% CI 94-100%) for sputum/gastric aspirate Xpert, 99% (95% CI 95-100%) for stool Xpert, and 91% (95% CI 84-95%) for urine LAM. Stool Xpert and urine LAM sensitivity increased among children with severe immunosuppression [80% (95% CI 28-100) and 60% (95% Cl 15-95%)]., Conclusion: Stool Xpert had similar performance compared with sputum/gastric aspirate Xpert to detect TB. Urine LAM had lower sensitivity and specificity, but increased among children with severe immunosuppression. Stool Xpert and urine LAM can aid rapid detection of TB in HIV-infected children using easily accessible samples.

Background: Adolescent-friendly policies aim to tailor HIV services for adolescents and young adults aged 10-24 years (AYA) to promote health outcomes and improve retention in HIV care and treatment. However, few interventions focus on improving healthcare worker (HCW) competencies and skills for provision of high-quality adolescent care. Standardized patients (SPs) are trained actors who work with HCWs in mock clinical encounters to improve clinical assessment, communication, and empathy skills. This stepped-wedge randomized controlled trial will evaluate a clinical training intervention utilizing SPs to improve HCW skills in caring for HIV-positive AYA, resulting in increased retention in care., Methods/design: The trial will utilize a stepped-wedge design to evaluate a training intervention using SPs to train HCWs in assessment, communication, and empathy skills for AYA HIV care. We will recruit 24 clinics in Kenya with an active electronic medical record (EMR) system and at least 40 adolescents enrolled in HIV care per site. Stratified randomization by county will be used to assign clinics to one of four waves - time periods when they receive the intervention - with each wave including six clinics. From each clinic, up to 10 HCWs will participate in the training intervention. SP training includes didactic sessions in adolescent health, current guidelines, communication skills, and motivational interviewing techniques. HCW participants will rotate through seven standardized SP scenarios, followed by SP feedback, group debriefing, and remote expert evaluation. AYA outcomes will be assessed using routine clinic data. The primary outcome is AYA retention in HIV care, defined as returning for first follow-up visit within 6 months of presenting to care, or returning for a first follow-up visit after re-engagement in care in AYA with a previous history of being lost to follow-up. Secondary outcomes include HCW competency scores, AYA satisfaction with care, and AYA clinical outcomes including CD4 and viral load. Additional analyses will determine cost-effectiveness of the intervention., Discussion: This trial will contribute valuable information to HIV programs in Kenya and other low-resource settings, providing a potentially scalable strategy to improve quality of care and retention in critical HIV services in this population., Trial Registration: ClinicalTrials.gov, ID: NCT02928900. Registered 26 August 2016.