An implementation science study to enhance cardiovascular disease prevention in Mukono and Buikwe districts in Uganda: a stepped-wedge design.

Background: Uganda is experiencing a shift in major causes of death with cases of stroke, heart attack, and heart failure reportedly on the rise. In a study in Mukono and Buikwe in Uganda, more than one in four adults were reportedly hypertensive. Moreover, very few (36.5%) reported to have ever had a blood pressure measurement. The rising burden of CVD is compounded by a lack of integrated primary health care for early detection and treatment of people with increased risk. Many people have less access to effective and equitable health care services which respond to their needs. Capacity gaps in human resources, equipment, and drug supply, and laboratory capabilities are evident. Prevention of risk factors for CVD and provision of effective and affordable treatment to those who require it prevent disability and death and improve quality of life. The aim of this study is to improve health profiles for people with intermediate and high risk factors for CVD at the community and health facility levels. The implementation process and effectiveness of interventions will be evaluated.

Methods: The overall study is a type 2-hybrid stepped-wedge (SW) design. The design employs mixed methods evaluations with incremental execution and adaptation. Sequential crossover take place from control to intervention until all are exposed. The study will take place in Mukono and Buikwe districts in Uganda, home to more than 1,000,000 people at the community and primary healthcare facility levels. The study evaluation will be guided by; 1) RE-AIM an evaluation framework and 2) the CFIR a determinant framework. The primary outcomes are implementation - acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, coverage, and sustainability.

Discussion: The study is envisioned to provide important insight into barriers and facilitators of scaling up CVD prevention in a low income context. This project is registered at the ISRCTN Registry with number ISRCTN15848572. The trial was first registered on 03/01/2019.