A type 2 hybrid effectiveness-implementation trial of Community Health Workers to improve screening for postpartum diabetes in urban slums of India

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PROJECT SUMMARY & ABSTRACT By 2045, most of the new cases of diabetes will occur in low- and middle- income countries (LMIC) like India, but 50% of those afflicted will not know. Improving postpartum diabetes screening for women with gestational diabetes (GDM) – a marker of high risk for progression to type 2 diabetes (T2DM) – can help close this diagnostic gap. This is particularly important in India, where few women with GDM receive postpartum T2DM screening, even though 25% of women with GDM develop T2DM within the first year postpartum. Improving T2DM screening during the critical life stages of pregnancy and postpartum will help prevent the sequelae of untreated diabetes, including cardiovascular disease, the leading cause of death among Indian women. In partnership with the Deep Griha Society and King Edward Memorial Hospital Research Center, we propose a hybrid type II effectiveness-implementation cluster randomized trial to evaluate if community health workers (CHW) can improve postpartum T2DM screening in the urban slums of Pune, India. We will screen pregnant women living in slum communities in India for GDM during pregnancy. The slum communities will be randomized in equal number to one of two study arms: (1) the home-based testing arm, where women with GDM will be offered the WHO-recommended oral glucose tolerance test for T2DM screening in their homes; and (2) the referral arm, where women with GDM will be referred for clinic-based postpartum T2DM screening. Through a mixed-methods approach, we will determine the impact of CHW-delivered services on the uptake of postpartum T2DM testing as well as factors pertaining to intervention implementation. Our specific aims are to: 1. Determine the uptake of postpartum T2DM screening in home testing versus referral arms among women with GDM in Pune, India. The primary outcome is uptake of postpartum T2DM screening in women with GDM. We hypothesize that 70% of women in the home testing arm will accept screening for T2DM within one-year postpartum compared to 45% in the referral arm 2. Evaluate implementation of the CHW-delivered programs using a convergent, mixed methods study design and the Consolidated Framework for Implementation Research (CFIR). We will collect qualitative and quantitative data from Aim 1 participants with GDM in both study arms, as well as from CHW, clinical staff, and Ministry of Health Officials to systematically evaluate CFIR Domains. This will be the first study to determine if trained CHW can improve postpartum T2DM screening in urban Indian slums. The results of this study will improve uptake of postpartum T2DM screening, identify low-income women at the highest risk of postpartum T2DM in India, and potentially identify novel approaches for improving postpartum screening for other diseases in low- and middle-income countries, in line with the NIH PAR-22-132.