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

项目概要和摘要 到2045年，大多数糖尿病新发病例将发生在印度等中低收入国家， 但50%的受害者不会知道改善妊娠合并糖尿病妇女的产后糖尿病筛查 糖尿病（GDM）-进展为2型糖尿病（T2 DM）的高风险标志物-可以帮助关闭这个 诊断差距这在印度尤其重要，因为很少有GDM女性接受产后T2 DM 筛查，即使25%的GDM妇女在产后第一年内发展为T2 DM。改善 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，这是印度妇女死亡的主要原因。 与Deep Griha Society和King Edward Memorial Hospital Research Center合作，我们建议 一项混合II型有效性-实施群集随机试验，以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。我们会筛查孕妇 生活在印度贫民窟社区的妇女在怀孕期间进行GDM。贫民窟社区将成为 随机分为两个研究组：（1）以家庭为基础的测试组， GDM将在其家中接受WHO推荐的口服葡萄糖耐量试验进行T2 DM筛查; 和（2）转诊组，其中GDM女性将被转诊进行基于临床的产后T2 DM筛查。 通过混合方法，我们将确定CHW提供的服务对以下方面的影响： 产后T2 DM检测以及与干预实施有关的因素。我们的具体目标是： 1.确定产后T2 DM筛查在家庭检测与转诊组中的使用情况 在印度浦那的GDM妇女中。主要结局是产后T2 DM的摄取 筛查GDM女性。我们假设70%的家庭测试组女性会接受 产后1年内筛查T2 DM，而转诊组为45% 2.使用融合的混合方法研究评估CHW提供的项目的实施情况 实施研究综合框架（CFIR）。我们将收集 来自两个研究组中目标1 GDM参与者的定性和定量数据，以及来自 CHW、临床工作人员和卫生部官员系统地评估CFIR域。 这将是第一个研究，以确定是否训练有素的CHW可以改善产后T2 DM筛查在城市 印第安贫民窟。这项研究的结果将提高产后T2 DM筛查的利用率，识别低收入人群， 印度产后T2 DM风险最高的妇女，并可能发现改善产后T2 DM的新方法。 根据NIH PAR-22-132，在低收入和中等收入国家进行产后其他疾病筛查。

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.