A community-based intervention for primary prevention of cardiovascular diseases in the slums of Nairobi: the SCALE UP study protocol for a prospective quasi-experimental community-based trial.

BACKGROUND: The burden of cardiovascular disease is rising in sub-Saharan Africa with hypertension being the main risk factor. However, context-specific evidence on effective interventions for primary prevention of cardiovascular diseases in resource-poor settings is limited. This study aims to evaluate the feasibility and cost-effectiveness of one such intervention--the "Sustainable model for cardiovascular health by adjusting lifestyle and treatment with economic perspective in settings of urban poverty". DESIGN: A prospective quasi-experimental community-based intervention study. SETTING: Two slum settlements (Korogocho and Viwandani) in Nairobi, Kenya. STUDY POPULATION: Adults aged 35 years and above in the two communities. INTERVENTION: The intervention community (Korogocho) will be exposed to an intervention package for primary prevention of cardiovascular disease that comprises awareness campaigns, household screening for cardiovascular diseases risk factors, and referral and treatment of people with high cardiovascular diseases risk at a primary health clinic. The control community (Viwandani) will continue accessing the usual standard of care for primary prevention of cardiovascular diseases in Kenya. DATA: Demographic and socioeconomic data; anthropometric and clinical measurements including blood pressure. Population-based data will be collected at the baseline and endline--12 months after implementing the intervention. These data will be collected from a random sample of 1,610 adults aged 35 years and above in the intervention and control sites at both baseline and endline. Additionally, operational (including cost) and clinic-based data will be collected on an ongoing basis. MAIN OUTCOMES: (1) A positive difference in the change in the proportion of the intervention versus control study populations that are at moderate or high risk of cardiovascular disease; (2) a difference in the change in mean systolic blood pressure in the intervention versus control study populations; (3) the net cost of the complete intervention package per disability-adjusted life year gained. ANALYSIS: Primary outcomes comparing pre- and post-, and operational data will be analyzed descriptively and "impact" of the intervention will be calculated using double-difference methods. We will also conduct a cost-effectiveness analysis of the intervention using World Health Organization guidelines. DISCUSSION: The outcomes of the study will be disseminated to local policy makers and health planners. TRIAL REGISTRATION: Current controlled trials ISRCTN84424579.