Implementation strategies to integrate HIV and hypertension care in Kampala and Wakiso districts, Uganda: study protocol for a stepped wedge cluster randomized trial (PULESA-Uganda).

backgroundHypertension (HTN) is the leading cause of cardiovascular morbidity and mortality among people living with HIV (PLWH) in Africa, yet integration of hypertension treatment in HIV clinics is sub-optimal. Cost-effective strategies to implement evidence-based hypertension care for this population are urgently needed to preserve the life-expectancy gains of antiretroviral therapy.

methodsBuilding on insights gained from a comprehensive mixed-methods formative assessment, we used a human-centered design approach to develop a multi-component HIV-HTN integration (HTN-PLUS) strategy. In a stepped-wedge cluster randomized trial, we are assessing the effectiveness, costs, and implementation of HTN-PLUS as well as a less resource intensive strategy of providing HTN medication and blood pressure cuffs (HTN-BASIC) free of charge to clinics. The trial is being conducted in 16 public and private not-for-profit HIV clinics in Kampala and Wakiso districts in Uganda. The co-primary effectiveness outcomes are population BP control (screened and documented BP < 140/90 mmHg) and HTN patient BP control [BP < 140/90 mmHg among PLWH with HTN]. The trial is designed to have > 80% power to detect a 12%-point increase in both outcomes compared to the pre-implementation control period across a range of scenarios of baseline hypertension prevalence and temporal improvements in the control period. At two pre-specified time points, we are conducting a Learn-As-You-Go optimization analysis and will adapt the HTN-PLUS strategy accordingly. To assess implementation outcomes, we have enrolled a prospective longitudinal mixed-methods cohort study of clinic health workers and PLWH with HTN. An extensive economic evaluation will include time and motion studies, facility-based costing, and out-of-pocket cost surveys to determine costs and cost-effectiveness from a societal perspective. DISCUSSION: Innovative implementation strategies to integrate evidence-based hypertension care for PLWH in Africa must be informed by the health workers and PLWH who are cared for across diverse HIV clinics. These clinics currently provide high quality HIV care as evidenced by high rates of HIV viral suppression but often lack the knowledge, skills and resources to provide HTN care. Funders and policymakers critically need to know both the effectiveness and costs to scale these strategies and potentially expand them to include other non-AIDS comorbidities.

trial registrationClinicalTrials.gov NCT05609513. Registered on November 11, 2022.