Study protocol for the: HIV enhanced access testing in emergency department program using a systems analysis and improvement approach (HEATED-SAIA) cluster randomized trial

In Kenya, incident and undiagnosed HIV infections are concentrated among populations who are inadequately reached by existing HIV services. These difficult-to-reach populations include men, adolescents and young adults, people who engage in sex work, and people who use substances, populations which also frequently access unscheduled emergency care. Though Kenya’s guidelines recommend evaluation of HIV testing and prevention services (HTS) needs during outpatient emergency encounters, emergency departments have not been well leveraged for HIV testing and prevention programming. This cluster randomized trial will evaluate the Systems Analysis and Improvement Approach (SAIA) as an implementation strategy to improve HIV screening, testing, and linkage to treatment and prevention from emergency care settings in the three counties in the Coast region of Kenya. SAIA is a multicomponent strategy for continuous care enhancement that empowers frontline healthcare personnel to improve services in their clinical settings. Ten public facilities will be cluster-randomized in a 1:1 ratio, with half exposed to the SAIA implementation strategy and the other half following usual procedures. The trial will be evaluated across Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) domains through quantitative systems-level data, qualitative insights from key stakeholders, and micro-costing data. Analyses will utilize Poisson regression and mixed-effect models to compare inter-arm HIV testing and prevention services (HTS) cascade outcomes. Framework matrix and coincidence analyses will be used to understand determinants of program success. Cost-effectiveness of the SAIA strategy will be assessed using incremental cost-effectiveness ratios and scale-up modeling. Emergency care interactions represent an underutilized opportunity to deliver evidence-based HIV testing and prevention services to difficult-to-reach populations. This trial will robustly assess the potential of the SAIA implementation strategy to improve and expand HTS from emergency care settings, and generate key data relevant to program effectiveness, feasibility and scalability in the Kenya context to inform public health programming. This study is registered with ClinicalTrials.gov (NCT06747221). Registration date: December 18, 2024.