Community-based Implementation of Hypertension Screening and Telehealth Systems in Kenya (COMPASS) - PROJECT SUMMARY/ABSTRACT Our main goal is to examine the implementation, effectiveness, and cost-effectiveness of two implementation strategies for integrating a community health worker (CHW)-facilitated hypertension telehealth intervention into routine primary health centers operated by Kenya’s Ministry of Health (MoH). Hypertension, a major contributor to global morbidity and mortality and a key driver of cardiovascular diseases, remains inadequately treated in Kenya due to multi-level barriers at the health system, clinic, clinician, and patient levels. We previously showed that CHW-led telehealth interventions, combining CHW home visits and clinician assessment over the phone, can significantly improve control of hypertension by mitigating patient-level barriers like transportation costs to clinics. Despite the evidence supporting CHW telehealth, gaps in knowledge about effective implementation strategies at multiple system levels limit its broader application. This study will assess two approaches aimed at enhancing uptake, effectiveness, sustainability, and cost-effectiveness of CHW hypertension telehealth in MoH primary health centers. Guided by the Consolidated Framework for Implementation Research, we have identified two preliminary sets of implementation strategies: a) core (training, protocol development, MoH leadership engagement for clinic supervision, and medication supply chain improvements) and b) enhanced (core + plus implementation champions among clinicians and CHWs, and practice facilitation). The rationale for these approaches is based on the premise that while core strategies may suffice to address knowledge deficits and ensure effective implementation initially, additional external facilitation and empowering local champions might be necessary to reinforce training, increase motivation, iteratively adapt workflows, troubleshoot challenges, identify ongoing opportunities for improvement, and sustain implementation over time. In Aim 1, we will use Implementation Mapping with stakeholders from community to health system levels to adapt and refine these strategies for broader testing. We will attend to adaptation differences between HIV clinic (existing chronic care infrastructure and electronic medical record (EMR)) and general primary care clinic (current care is generally episodic, no EMR) settings. In Aim 2, we will conduct a type 2 hybrid implementation-effectiveness cluster randomized trial across 16 MoH primary health centers and surrounding communities to compare the impact of core and enhanced strategies on the implementation penetration of CHW telehealth and population-level hypertension control at 18 months. We will also evaluate sustainment during a 12-month maintenance phase following cessation of external support for implementation strategies. We will stratify all analyses by HIV status and sex to understand the role of these factors in implementation and effectiveness. Lastly, Aim 3 will measure cost and determine the cost-effectiveness of these strategies using an established individual-based hypertension model. This study will generate robust evidence for the most effective and cost-effective strategies for implementing CHW-based hypertension treatment, improving BP control and reducing CVD at a population level.
