The over 14 million African children who are HIV-exposed but uninfected (CHEU) are at risk for poor health outcomes, including neurodevelopmental conditions such as autism; however, no study to date has examined autism in CHEU in Africa, where the vast majority of these children live. Scalable diagnostic and neurobehavioural tools, including powerful, low-cost approaches such as eye-tracking, for detection and study of mechanistic neural processes are necessary to advance autism research in these settings. The objective of this study is to examine autism diagnostic outcomes and eye-tracking biomarkers in relation to CHEU while at the same time building capacity for neuro-health research in Kenya.

This study will leverage a longitudinally assessed cohort of CHEU and children who are HIV-unexposed and uninfected (CHUU) with well characterised HIV-related and contextual exposures. We will first determine and compare autism diagnostic outcomes between young CHEU and CHUU across a large cohort (n=850) of Kenyan children using research-grade autism assessment tools, and, second, determine whether neurobehavioural eye-tracking markers predict autism outcomes across this cohort.

Human subjects approvals have been obtained from Moi University Institutional Review and Ethics Committee (IREC; IREC/909/2024; Approval #0004835), Kenya’s National Commission for Science, Technology and Innovation (NACOSTI; Reference #NACOSTI/P/25/415028), the Institutional Review Board of the Indiana University School of Medicine (Protocol #23171), with reliance agreements executed with Purdue University and Boston University. Dissemination of findings will occur through multiple channels within the research and clinical community, including peer-reviewed journal publications and conference abstracts and presentations. As part of capacity building efforts, the research team will also communicate study results to policy makers, the lay public and other health systems involved in the care of young children with disabilities via study-hosted workshops and conferences.

Each year, an estimated 1700 children should be diagnosed with cancer in western Kenya, with leukaemia making up nearly one-third of cases. However, far fewer are actually diagnosed, highlighting significant delays or errors in diagnosis. Flow cytometry, which the WHO considers essential for leukaemia diagnosis, remains underused across sub-Saharan Africa due to high costs, outdated equipment and a lack of trained personnel. In Kenya, decades-old cytometers have been adapted for leukaemia detection, but these systems are now outdated. Newer platforms, such as simplified single-tube multiparametric assays, provide a scalable and sustainable alternative. This study presents a protocol to evaluate the accuracy of diagnosis and the potential for implementing a streamlined flow cytometry assay using peripheral blood, supported by a regional educational initiative.

This prospective, mixed-methods implementation study has three aims: (1) to assess the concordance between the Beckman Coulter ClearLLab 10C gold standard 4-tube assay and the streamlined ClearLLab LS 1-tube assay using paired bone marrow and peripheral blood samples; (2) to evaluate the feasibility of peripheral facility referrals and transport logistics with couriered peripheral blood samples from referring sites across western Kenya; and (3) to measure training effectiveness and knowledge gain through a multimodal educational programme using the Project ECHO (Extension for Community Healthcare Outcomes) model. Up to 300 patients at Moi Teaching and Referral Hospital in Eldoret, Kenya, will be enrolled in Aim 1. A separate sample of 100 patients from peripheral facilities will be included in Aim 2. Surveys, knowledge assessments and structured interviews will be used to evaluate training impact under Aim 3. Diagnostic concordance, sensitivity, specificity and knowledge gain will be measured through appropriate quantitative and qualitative methods.

The protocol has received approval from institutional ethics committees at Moi University, MTRH and Indiana University. De-identified data will be analysed and shared through peer-reviewed publications, stakeholder presentations and educational platforms.

Providing care management, treatment and support to patients with Alzheimer’s Disease and Related Dementias (ADRD) is a difficult task for health systems. Over the past 20 years, interventions designed to improve outcomes for patients living in the community with dementia and their care partners have moved progressively, but separately, from large scale trials and pragmatic models of collaborative care. Given the projected increase in the number of people living with dementia coupled with the realignment of payment for services to be value-based and provided in the community, system-level approaches are needed to address the complex needs of patients with a dementia diagnosis and their care partners. We designed a statewide, pragmatic trial to evaluate virtual delivery of an evidence-based dementia collaborative care program on patient healthcare utilization and medication use.

The Aging Brain Care Virtual (ABCV) program is a 12-month embedded, cluster randomized, usual care controlled trial designed to test the effectiveness of a virtual dementia collaborative care program in 24 Indiana University Health primary care clinics (12 intervention, 12 control) across the state of Indiana, enrolling 860 persons living with dementia (430 intervention, 430 control) and their care partners. ABCV relies on a tailored approach in which dyad needs are identified during virtual visits and addressed with standardized protocols previously tested in a randomized controlled trial delivered in person. The ABCV trial will measure emergency department utilization (primary outcome) and appropriate medication use (secondary outcome) at 12 months using electronic medical record data. Additionally, this study will use semi-structured interviews with care partners and clinicians to explore the implementation context, process and outcomes of the ABCV program.

Ethics approval was obtained from the Indiana University Institutional Review Board (20249). Research findings will be published in peer-reviewed journals and presented at scientific conferences.

NCT06245499.