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

项目总结与摘要 到2045年，大多数新的糖尿病病例将发生在低收入和中等收入国家，如印度、 但50%的患者不会知道。改进妊娠期妇女产后糖尿病筛查 糖尿病(GDM)--进展为2型糖尿病(T2 DM)的高危标记物--可以帮助结束这种情况 诊断差距。这在印度尤其重要，因为在印度，很少有妊娠期糖尿病的女性会在产后患上T2 DM 筛查，即使25%的妊娠期糖尿病妇女在产后一年内发展为T2 DM。改进 在妊娠和产后的关键生命阶段进行T2 DM筛查将有助于预防后遗症 未经治疗的糖尿病，包括心血管疾病，是印度妇女死亡的主要原因。 与深格里哈协会和爱德华国王纪念医院研究中心合作，我们建议 一项混合型II型有效性-实施整群随机试验评估社区卫生工作者 (CHW)可以改善印度浦那城市贫民窟的产后T2 DM筛查。我们将对孕妇进行筛查 生活在印度贫民窟的妇女在怀孕期间接受妊娠期糖尿病的治疗。贫民窟社区将成为 随机分为两个研究组之一：(1)基于家庭的测试组，其中女性 妊娠期糖尿病患者将接受世界卫生组织推荐的口服葡萄糖耐量试验，以便在家中筛查T2 DM； 和(2)转诊臂，患有妊娠期糖尿病的妇女将被转诊为基于临床的产后T2 DM筛查。 通过混合方法，我们将确定CHW提供的服务对采用 产后2型糖尿病检测及影响干预实施的因素。我们的具体目标是： 1.确定家庭测试与转诊组中产后T2 DM筛查的接受度 在印度浦那患有妊娠期糖尿病的妇女中。主要结果是产后T2 DM的摄取 对妊娠期糖尿病妇女进行筛查。我们假设70%的家庭检测机构的女性会接受 产后一年内进行T2 DM筛查，转诊组的筛查比例为45% 2.使用汇聚、混合方法研究评估CHW提供的方案的执行情况 设计和实施研究综合框架。我们会收集 来自两个研究分支中患有GDM的Aim 1参与者以及来自 CHW、临床工作人员和卫生部官员系统地评估CFIR领域。 这将是第一次确定受过培训的CHW是否可以改善城市中产后T2 DM筛查的研究 印度贫民窟。这项研究的结果将提高产后T2 DM筛查的摄入量，识别低收入者 印度产后2型糖尿病风险最高的女性，并可能找到改善的新方法 根据NIH PAR-22-132，在低收入和中等收入国家进行其他疾病的产后筛查。

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.