Despite major global gains in the HIV response, children in sub-Saharan Africa continue to have poorer outcomes than adults. Malawi has expanded testing and treatment and progressed toward the UNAIDS targets, yet disparities persist: by the end of 2023 viral suppression among adults was approximately 87% while suppression among children remained about 55%. Children in this context experience lower diagnosis rates, delayed initiation of antiretroviral therapy, suboptimal retention, poorer adherence, and lower viral suppression across the HIV care continuum. These gaps threaten Malawi’s ability to achieve and sustain epidemic control and to meet the 95-95-95 goals for children.
Improving paediatric access to HIV services requires interventions that address more than service availability. Access encompasses timely, equitable, acceptable, affordable, and continuous provision of services including testing, linkage, ART initiation, retention, and viral load monitoring. Existing health-system strategies—decentralisation, task shifting, integration with maternal and child health, point-of-care diagnostics, differentiated service delivery, and community-based programmes—have shown promise but evidence is fragmented and context-specific. National routine data analyses that identify where children are lost in the cascade are limited in Malawi, and there is insufficient synthesis of which interventions best improve paediatric access in the sub-Saharan context. This study uses an integrated approach to combine epidemiological analysis, literature synthesis, stakeholder prioritisation and local feasibility testing to develop a contextually appropriate intervention package.
The primary aim is to identify and develop feasible strategies to enhance access to HIV services for children in Malawi. The study is informed by the Socio-Ecological Model, which frames determinants of access at multiple levels (individual, interpersonal, facility, community, policy), and by the HIV care cascade framework to locate points of attrition and opportunity across diagnosis, linkage, treatment initiation, retention, and viral suppression.
The first sub-study will perform secondary analyses of routine national HIV programme data and Spectrum estimates from 2012–2023 to assess trends and quantify progress toward the 95-95-95 targets for children. The analysis will identify stages of the care cascade where children are disproportionately lost (for example, diagnosis, linkage, ART initiation, retention, viral suppression) and will characterise temporal trends. The protocol specifies use of existing national datasets and modelling estimates; specific analytic methods and variable definitions are described in the full protocol. No new primary datasets are reported at this stage.
A scoping review will map and synthesise health system interventions implemented in sub-Saharan Africa between 2015 and 2025 that aim to improve paediatric access to HIV services. Interventions of interest include decentralisation of services, task shifting and task sharing, integration of paediatric HIV with maternal and child health, differentiated service delivery models, community-based approaches, and point-of-care diagnostics. The review will identify the types of interventions evaluated, implementation contexts, reported outcomes relevant to paediatric access (uptake, retention, viral suppression), and evidence gaps. The scoping review will inform the candidate interventions considered in subsequent stakeholder prioritisation.
A modified electronic Delphi (e-Delphi) process will convene 15–30 experts to prioritise and adapt interventions identified from the programme data and the scoping review into a context-appropriate package for Malawi. The e-Delphi will iteratively solicit expert ratings and achieve consensus on intervention components, delivery modalities, and implementation considerations. The process aims to produce a feasible, evidence-informed intervention package tailored to Malawian health-system constraints and priorities.
The final sub-study will pilot the proposed intervention package at Kabudula Community Hospital in Lilongwe. The assessment will involve healthcare workers, community health workers and caregivers and will use structured questionnaires and qualitative interviews to evaluate feasibility, acceptability, and operational challenges. Findings will inform refinement of the package and highlight implementation barriers and enablers in a real-world facility setting.
The study will obtain ethical approval from the Stellenbosch University Health Research Ethics Committee and the Malawi National Health Sciences Research Ethics Committee. Written informed consent procedures and confidentiality safeguards will be implemented for all primary data collection in the feasibility assessment. The protocol notes that data generated by the study will be made available on study completion. At the time of protocol publication, no specific funding was reported and the authors declared no competing interests.
The integrated approach is designed to produce: (1) a national-level description of where children are lost in the HIV care cascade; (2) a synthesis of health system interventions with potential to improve paediatric access; (3) a stakeholder-prioritised, context-adapted intervention package; and (4) empirical feasibility and acceptability data from a Malawian facility. Together these outputs aim to provide policymakers and programme managers with actionable, context-specific evidence to strengthen paediatric HIV service delivery and accelerate progress toward the UNAIDS 95-95-95 targets for children.
The protocol recognises that evidence on effective paediatric HIV interventions is fragmented and context-dependent. Combining routine data analysis, literature synthesis, expert consensus and local feasibility testing is intended to bridge evidence gaps and increase the likelihood that recommended strategies will be implementable in Malawi. The authors acknowledge that findings from a single facility feasibility assessment may have limited generalisability and that the scoping review and e-Delphi outcomes will be influenced by available published evidence and expert selection. Specific limitations of the datasets and analytic approaches are described in the full protocol.
This multifaceted research protocol aims to identify gaps in paediatric HIV care in Malawi, synthesise evidence on effective health system interventions, and develop a feasible, context-specific intervention package. The project seeks to strengthen children’s access to HIV services and contribute to Malawi’s progress toward achieving sustained epidemic control among children.