Globally, there are ~38 million people living with HIV (PLH), with the majority in low-and middle-income countries (LMICs), where the UNAIDS 95-95-95 HIV targets are at risk of not being achieved. Data show that incident infections are concentrated in sub-Saharan Africa (SSA) and focused in difficult to reach populations for HIV services. These persons also often have higher-risk profiles for HIV making them priority populations to receive HIV Testing Services (HTS). Among target populations, men, adolescents and young adults (AYAs) aged 15-24 years, and persons from key populations (KPs), are crucial groups which must be regularly reached for HTS to achieve global control targets.
In LMICs, emergency departments (ED) provide care to large numbers of persons that often do not otherwise access health services. Injuries among men, AYA and KPs are frequent reasons for ED care. Data from Africa show that persons seeking emergency care have high HIV burdens, and desire ED-HTS. Furthermore, as EDs are status-neutral care settings, ED-HTS may have fewer stigmatization barriers than conventional service delivery points (SDPs) to support testing provision. However, data from multiple SSA studies show that ED HIV testing is infrequent, with <25% of patients engaged for HTS during emergency care. EDs in LMICs represent a waiting strategic and pragmatic opportunity to deliver evidence-based HTS to higher-risk persons already frequently in contact with health facilities.
While Kenya has reduced its HIV prevalence to ~4.0%, incidence reduction targets have not been met, and in 2021 there was an 7.8% increase in new infections. In Kenya, one in five people with HIV disease are undiagnosed, less than half of men are reached for HIV testing at appropriate frequencies, AYAs account for 42% of new infections and KPs contribute to hyper-endemic transmission. Kenya's national guidelines call for utilizing facilities-based care to deliver HTS for difficult to reach populations where the HIV epidemic is concentrated. While the guidelines include EDs as SDPs, emergency care HTS is still evolving in Kenya and best practice evidence is in early development. The HIV Enhanced Access Testing in Emergency Departments (HEATED) program in Nairobi, Kenya was developed by a collaborative team led by Principal Investigator (PI) Dr. Aluisio (K23AI145411). The program was a status neutral systems intervention, using the Capability-Opportunity-Motivation Behavioral model to enhance ED-HTS, through data-driven, setting-specific, feasible systems adaptations designed to address modifiable barriers (micro-strategies). The HEATED program significantly improved likelihood of ED-HTS for the overall population by 31%, and significantly increased testing for men, AYA and KP. In addition, stakeholders affirmed that the program was acceptable.
Although evaluation of the HEATED program demonstrated improved HTS more robust understanding of optimal implementation strategies, impacts on linkage to HIV care and costing data are needed to inform ED-HTS advancement in Kenya. To address this, the current proposal builds upon the HEATED program by utilizing and evaluating the Systems Analysis and Improvement Approach (SAIA) implementation strategy (HEATED-SAIA) to enhance HTS delivery in a cluster randomized trial of all public facilities with EDs in Kilifi, Mombasa and Kwale Counties of the Coast region of Kenya. SAIA is a multi-component implementation strategy that utilizes cascade analysis, process flow mapping and micro-strategy development and testing in plan-do-study-act cycles to improve care delivery.46 SAIA implementation has been shown to improve HTS integration in family planning (FP) clinics in Mombasa County by the study team previously. Application of SAIA to ED settings in the Coast region has substantial potential to improve delivery of evidence-based HTS for higher-risk persons already in contact with care, while also expanding the evidence-base for SAIA via application in a novel clinical space. This will be studied through the following aims:
Aim 1: Evaluate impacts of the HEATED-SAIA program as compared to standard care (control) in a cluster randomized trial of all ten public ED facilities in three counties in the Coast region of Kenya, to improve HIV screening, testing, and linkage to treatment and prevention, among persons receiving emergency care with a focus on target populations of men, AYA and KPs.
Approach: This cluster parallel trial, with a baseline measurement period, will randomize all ten public EDs in Kilifi, Mombasa and Kwale Counties (1:1) to control (usual care) or intervention (SAIA implementation strategy) and use the Reach, Effectiveness, Adoption, Implementation and Maintenance (REAIM) framework in trial assessment. Quantitative systems level data and qualitative participant level data, based on the Consolidated Framework for Implementation Research and the Implementation Research Logic Model will be used to inform appropriate use of the results in the study setting and larger public health context of Kenya.
Aim 2: Assess the cost of ED-HTS and implementation of the HEATED-SAIA program using micro-costing and time-and-motion costing methods to inform public health programming and future scale-up.
