Exploring the consequences of food insecurity and harnessing the power of peer navigation and mHealth to reduce food insecurity and cardiometabolic comorbidities among persons with HIV: protocol for development and implementation trial of weCare/Secure.

Exploring the consequences of food insecurity and harnessing the power of peer navigation and mHealth to reduce food insecurity and cardiometabolic comorbidities among persons with HIV: protocol for development and implementation trial of weCare/Secure.
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DOI:
10.1186/s13063-022-06924-3
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发表时间:
2022-12-12
期刊:
影响因子:
2.5
通讯作者:
Rhodes, Scott D.
Rhodes, Scott D.
中科院分区:
医学4区
文献类型:
--
作者:
Tanner, Amanda E.;Palakshappa, Deepak;Morse, Caryn G.;Mann-Jackson, Lilli;Alonzo, Jorge;Garcia, Manuel;Wright, Elena;Dharod, Ajay;Isom, Scott;Sucaldito, Ana D.;Aviles, Lucero Refugio;Rhodes, Scott D.

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粮食不安全,或缺乏持续获得营养充足和安全的食物,影响了美国高达50%的艾滋病毒感染者(PWH)。粮食不安全的PWH患者抗逆转录病毒依从性较低,不太可能实现病毒抑制,并且患严重疾病的风险增加,包括心脏代谢合并症。本研究的目的是更好地了解食物不安全如何促进PWH中心脏代谢合并症的发展,并测试一种新的双语同伴导航-移动健康干预(weCare/Secure),旨在减少食物不安全PWH与糖尿病前期或2型糖尿病(T2 DM)的合并症。在目标1中,我们将从我们的临床人群中招募1800名成人(≥18岁)PWH的纵向队列,以确定食物安全和食物不安全PWH之间心脏代谢合并症的患病率和发生率的差异。将每年从该队列中收集食物不安全筛查、心脏代谢合并症指标和电子健康记录(EHR)中记录的其他特征,持续长达3年。在目标2中,我们将在患有前驱糖尿病或T2 DM的食物不安全的PWH样本中进行随机对照试验,以比较weCare/Secure参与者和接受常规护理的参与者之间6个月内胰岛素敏感性的变化。在目标3中,我们将进行半结构化的个人深入访谈,以探讨干预参与者之间的干预效果,不同的胰岛素敏感性结果。目标1(纵向队列)招募于2022年5月开始,目前正在进行中。目标2(干预)招募计划于2023年春季进行,预计将于2024年春季完成。目标3(过程评价)数据收集将在充分完成目标2中的6个月评估后进行。最终结果预计将于2025年秋季公布。这项研究旨在促进我们对粮食不安全如何影响PWH中心脏代谢合并症的发展以及粮食不安全干预措施如何缓解相关合并症的理解。鉴于卫生系统对解决粮食不安全问题的兴趣日益增加,如果发现干预措施有效,就可以在艾滋病毒临床护理环境中广泛推广。ClinicalTrials.gov NCT 04943861。于2021年6月29日注册。
Food insecurity, or the lack of consistent access to nutritionally adequate and safe foods, effects up to 50% of people living with HIV (PWH) in the United States (US). PWH who are food insecure have lower antiretroviral adherence, are less likely to achieve viral suppression, and are at increased risk developing of serious illnesses, including cardiometabolic comorbidities. The objectives of this study are to better understand how food insecurity contributes to the development of cardiometabolic comorbidities among PWH and to test a novel bilingual peer navigation-mHealth intervention (weCare/Secure) designed to reduce these comorbidities in food-insecure PWH with prediabetes or Type 2 diabetes (T2DM). In Aim 1, we will recruit a longitudinal cohort of 1800 adult (≥18 years) PWH from our clinic-based population to determine the difference in the prevalence and incidence of cardiometabolic comorbidities between food-secure and food-insecure PWH. Food insecurity screening, indicators of cardiometabolic comorbidities, and other characteristics documented in the electronic health record (EHR) will be collected annually for up to 3 years from this cohort. In Aim 2, we will conduct a randomized controlled trial among a sample of food-insecure PWH who have prediabetes or T2DM to compare changes in insulin sensitivity over 6 months between participants in weCare/Secure and participants receiving usual care. In Aim 3, we will conduct semi-structured individual in-depth interviews to explore the effect of the intervention among intervention participants with varying insulin sensitivity outcomes. Aim 1 (longitudinal cohort) recruitment began in May 2022 and is ongoing. Aim 2 (intervention) recruitment is planned for spring 2023 and is expected to be completed in spring 2024. Aim 3 (process evaluation) data collection will occur after sufficient completion of the 6-month assessment in Aim 2. Final results are anticipated in fall 2025. This research seeks to advance our understanding of how food insecurity impacts the development of cardiometabolic comorbidities among PWH and how food insecurity interventions may alleviate relevant comorbidities. Given the growing interest among health systems in addressing food insecurity, if the intervention is found to be efficacious, it could be broadly disseminated across HIV clinical care settings. ClinicalTrials.gov NCT04943861. Registered on June 29, 2021.
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