Bridging Income Generation with Group Integrated Care (BIGPIC)

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 DESCRIPTION (provided by applicant): Bridging Income Generation with Group Integrated Care (BIGPIC) Cardiovascular disease (CVD) is the leading cause of mortality in the world. Diabetes, a major risk factor for CVD, is increasingly prevalent and responsible for substantial cardiovascular morbidity and mortality. Elevated blood pressure (BP) increases CVD risk among individuals with diabetes and pre-diabetes; BP control is therefore a powerful way to reduce CVD risk. Cost-effective, context-specific, and culturally appropriate interventions are critical, and both group medical visits and microfinance have the potential to achieve this. In partnership with the Government of Kenya, the Academic Model Providing Access to Healthcare Partnership has expanded its clinical scope of work in rural western Kenya to include diabetes and hypertension, and has piloted group care and microfinance initiatives with promising early results. However, the effectiveness of these strategies individually, and in combination, on improving CVD risk is not known. Thus, the overall objective of this proposal is to utilize a transdisciplinary implementation research approach to address the challenge of reducing CVD risk in low-resource settings. Specifically, we propose to test the hypothesis that group medical visits integrated into microfinance groups will be effective and cost-effective in reducing CVD risk among individuals with diabetes and at increased risk for diabetes in western Kenya. We further hypothesize that changes in social network characteristics may mediate the impact of these interventions, and that baseline social network characteristics may moderate the impact. Aim 1 is to identify contextual factors, facilitators, and barriers that may impact integration of group medical visits and microfinance groups in this setting, using novel qualitative research techniques. We will then design a contextually and culturally appropriate integrated group medical visit-microfinance model for CVD risk reduction. Aim 2 is to evaluate the effectiveness of group medical visits and microfinance groups for CVD risk reduction among individuals with diabetes or at increased risk of diabetes, by conducting a four-arm cluster randomized trial comparing: 1) usual clinical care; 2) usual clinical care plus microfinance groups only; 3) group medical visits only; and 4) group medical visits integrated into microfinance groups. The primary outcome will be one-year change in systolic BP, and a key secondary outcome will be change in QRISK2 CVD risk score. We will also conduct mediation analysis and moderation analysis to evaluate the influence of social network characteristics on intervention outcomes. Aim 3 is to evaluate the incremental cost-effectiveness of each intervention arm of the trial. The research will be accomplished by an Early Stage Principal Investigator with extensive experience in implementation research in low-resource settings, supported by a transdisciplinary team of investigators with diverse and complementary expertise. Our goal is to add to the existing knowledge base of innovative, scalable, and sustainable strategies to reduce CVD risk in diabetes and other chronic diseases in low-resource settings worldwide.