Cohort profile: longitudinal and population comparison of children who are HIV-exposed uninfected and children who are HIV unexposed in Kenya (HOPE study).

PURPOSE: Globally, the number of children/adolescents exposed to HIV but uninfected (HIV-exposed uninfected, HEU) is growing. The HEU outcomes: population-evaluation and screening strategies study was designed to provide population-level evidence of the impact of HIV and recent antiretroviral therapy regimen exposure on neurodevelopmental, hearing and mental health outcomes from infancy to adolescence. PARTICIPANTS: The study includes a prospective mother-infant cohort and cross-sectional child/youth-caregiver cohorts conducted in Kenya.Between 2021 and 2022, the study enrolled 2000 mother-infant pairs (1000 HEU and 1000 HIV-unexposed uninfected (HUU)) for longitudinal follow-up. Infants were eligible if they were aged 4-10 weeks and healthy. Mothers were eligible if their HIV status was known and were ≥18 years. Study visits are 6 monthly until the child reaches age 3 years.Cross-sectional cohorts spanning ages 3-18 years started enrolment in 2022. Target enrolment is 4400 children/youth (4000 HEU and 400 HUU). Children and youth are eligible if they are HIV negative, maternal HIV status and timing of diagnosis is known, and caregivers are ≥18 years.Data on infant/child/youth growth, neurodevelopment, mental health, morbidity and hearing are collected at enrolment using standardised tools. Dry blood spots samples are collected for telomere length assessment at baseline and yearly for the longitudinal cohort. Growth z-scores, neurodevelopmental scores, telomere length and prevalence of developmental and hearing problems will be compared between HEU/HUU populations. FINDINGS TO DATE: Full cohort enrolment for the longitudinal cohort is complete and participants are in follow-up. At 1 year of age, comparing HEU to HUU neurodevelopment using the Malawi developmental assessment tool, we found that HEU infants had higher language scores and comparable scores in fine motor, gross motor and social scores. The cross-sectional cohort has enrolled over 2000 participants and recruitment is ongoing. FUTURE PLANS: Longitudinal cohort follow-up and enrolment to the cross-sectional study will be completed in June 2024.

Pilot evaluation of a standardized patient actor training intervention to improve HIV care for adolescents and young adults in Kenya.

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.

Decay of HIV DNA in the Reservoir and the Impact of Short Treatment Interruption in Kenyan Infants.

We compared change in HIV reservoir DNA following continued antiretroviral therapy (ART) vs short treatment interruption (TI) in early ART-treated Kenyan infants. While HIV DNA in the reservoir decayed with continued ART, HIV DNA levels were similar to pre-TI HIV DNA reservoir levels in most children after short TI.

Simulated patient encounters to improve adolescent retention in HIV care in Kenya: study protocol of a stepped-wedge randomized controlled trial.

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.

"At our age, we would like to do things the way we want: " a qualitative study of adolescent HIV testing services in Kenya.

OBJECTIVES: Adolescents in Africa have low HIV testing rates. Better understanding of adolescent, provider, and caregiver experiences in high-burden countries such as Kenya could improve adolescent HIV testing programs. DESIGN: We conducted 16 qualitative interviews with HIV-positive and HIV-negative adolescents (13-18 years) and six focus group discussions with Healthcare workers (HCWs) and caregivers of adolescents in Nairobi, Kenya. METHODS: Semi-structured interviews and focus groups were recorded and transcribed. Analysis employed a modified constant comparative approach to triangulate findings and identify themes influencing testing experiences and practices. RESULTS: All groups identified that supportive interactions during testing were essential to the adolescent's positive testing experience. HCWs were a primary source of support during testing. HCWs who acted respectful and informed helped adolescents accept results, link to care, or return for repeat testing, whereas HCWs who acted dismissive or judgmental discouraged adolescent testing. Caregivers universally supported adolescent testing, including testing with the adolescent to demonstrate support. Caregivers relied on HCWs to inform and encourage adolescents. Although peers played less significant roles during testing, all groups agreed that school-based outreach could increase peer demand and counteract stigma. All groups recognized tensions around adolescent autonomy in the absence of clear consent guidelines. Adolescents valued support people during testing but wanted autonomy over testing and disclosure decisions. HCWs felt pressured to defer consent to caregivers. Caregivers wanted to know results regardless of adolescents' wishes. CONCLUSION: Findings indicate that strengthening HCW, caregiver, and peer capacities to support adolescents while respecting their autonomy may facilitate attaining '90-90-90' targets for adolescents.

Treatment interruption after 2-year antiretroviral treatment initiated during acute/early HIV in infancy.

OBJECTIVE: Treatment interruption has been well tolerated and durable in some pediatric studies but none have compared treatment interruption with continued antiretroviral treatment (ART) following ART initiation in early HIV. The objective of this study was to compare outcomes in treatment interruption versus continued ART among early-treated infants. DESIGN: Randomized trial (OPH-03; NCT00428116). METHODS: The trial included HIV-infected infants who initiated ART at less than 13 months of age, received ART for 24 months, and, if eligible (CD4% >25%, normal growth), were randomized to treatment interruption versus continued ART. Children in the treatment interruption group restarted ART if they met WHO ART-eligibility criteria. During 18-months postrandomization, primary outcomes were incidence of serious adverse events and growth. CD4%, viral load, morbidity, and growth were compared. RESULTS: Of 140 infants enrolled, 121 started ART, of whom 75 completed at least 24 months ART and 42 were randomized (21 per arm). ART was initiated at median age 5 months and randomization at 30 months. Among 21 treatment interruption children, 14 met ART restart criteria within 3 months. Randomization was discontinued by Data and Safety Monitoring Board due to low treatment interruption durability. At 18 months postrandomization, growth and serious adverse events were comparable between arms; hypercholesteremia incidence was higher in the continued arm (P = 0.03). CD4% and viral load did not differ between arms [CD4% 35% and median viral load undetectable (<150 copies/ml) in both arms, P = 0.9 for each comparison]. No infants had post-treatment viral control. CONCLUSION: Short treatment interruption did not compromise 18-month CD4%, viral control, growth, or morbidity compared with continued ART among infants who started ART in early HIV infection.