Li Li, Nguyen Tuan Anh, Liang Li-Jung, Lin Chunqing, Pham Thang Hong, Nguyen Ha Thi Thanh, Kha Steven
University of California, Los Angeles, Los Angeles, CA, United States.
National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
JMIR Res Protoc. 2023 Mar 22;12:e44219. doi: 10.2196/44219.
A chronic condition, drug addiction, requires long-term multipronged health care and treatment services. Community-based approaches can offer the advantages of managing integrated care along the care continuum and improving clinical outcomes. However, scant rigorous research focuses on sustainable, community-based care and service delivery.
This protocol describes a study aiming to develop and test an intervention that features the alliance of community health workers and family members to provide integrated support and individualized services and treatment for people who use drugs (PWUD) in community settings.
Based on the National Institute on Drug Abuse's Seek-Test-Treat-Retain (STTR) framework, an intervention that provides training to community health workers will be developed and piloted before an intervention trial. Trained community health workers will conduct home visits and provide support for PWUD and their families. The intervention trial will be conducted in 3 regions in Vietnam, with 60 communities (named communes). These communes will be randomized to either an intervention or control condition. Intervention outcomes will be evaluated at baseline and at 3, 6, 9, and 12 months. The primary outcome measure is PWUD's STTR fulfillment, consisting of multiple individual fulfillment indicators across 5 domains: Seek, Test, Treat, Retain, and Health. The secondary outcomes of interest are the community health workers' service provision and family members' support. The primary analysis will follow an intention-to-treat approach. Generalized mixed-effects regression models will be used to compare changes in the outcome measures from baseline between intervention and control conditions.
During the first year of the project, we conducted formative studies, including in-depth interviews and focus groups, to identify service barriers and intervention strategies. The intervention and assessment pilots are scheduled in 2023 before commencing the trial. Reports based on the baseline data will be distributed in early 2024. The intervention outcome results will be available within 6 months of the final data collection date, that is, the main study findings are expected to be available in early 2026.
This study will inform the establishment of community health workers and family members alliance, a locally available infrastructure, to support addiction services and care for PWUD. The methodology, findings, and lessons learned are expected to shed light on the addiction service continuum's implementation and demonstrate a community-based addiction service delivery model that can be transferable to other countries.
ClinicalTrials.gov NCT05315492; https://clinicaltrials.gov/ct2/show/NCT05315492.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44219.
药物成瘾是一种慢性病，需要长期的多方面医疗保健和治疗服务。基于社区的方法可以提供在整个护理连续过程中管理综合护理并改善临床结果的优势。然而，很少有严谨的研究关注可持续的、基于社区的护理和服务提供。
本方案描述了一项旨在开发和测试一种干预措施的研究，该干预措施的特点是社区卫生工作者与家庭成员结成联盟，为社区环境中使用毒品的人（PWUD）提供综合支持和个性化服务及治疗。
基于美国国立药物滥用研究所的“寻求-检测-治疗-留住”（STTR）框架，将在干预试验之前开发并试点一项为社区卫生工作者提供培训的干预措施。经过培训的社区卫生工作者将进行家访，并为PWUD及其家人提供支持。干预试验将在越南的3个地区进行，涉及60个社区（称为公社）。这些公社将被随机分为干预组或对照组。将在基线以及3个月、6个月、9个月和12个月时评估干预结果。主要结局指标是PWUD的STTR实现情况，由5个领域的多个个体实现指标组成：寻求、检测、治疗、留住和健康。感兴趣的次要结局是社区卫生工作者的服务提供情况和家庭成员的支持情况。主要分析将采用意向性分析方法。将使用广义混合效应回归模型来比较干预组和对照组之间从基线开始的结局指标变化。
在项目的第一年，我们进行了形成性研究，包括深入访谈和焦点小组讨论，以确定服务障碍和干预策略。干预和评估试点计划于2023年进行，然后开始试验。基于基线数据的报告将于2024年初发布。干预结果将在最终数据收集日期后的6个月内得出，也就是说，主要研究结果预计将于2026年初得出。
本研究将为建立社区卫生工作者与家庭成员联盟（一种本地可用的基础设施）提供信息，以支持针对PWUD的成瘾服务和护理。该方法、研究结果和经验教训有望为成瘾服务连续过程的实施提供启示，并展示一种可推广到其他国家的基于社区的成瘾服务提供模式。
ClinicalTrials.gov NCT05315492；https://clinicaltrials.gov/ct2/show/NCT05315492。
国际注册报告识别码（IRRID）：DERR1-10.2196/44219。
