Tushirikiane-4-Uthabiti（相互支持以增强韧性）：一项心理健康、HIV 自我检测和生计的随机对照试验研究方案，旨在提高乌干达坎帕拉城市难民青年的 HIV 预防效果。

Tushirikiane-4-Uthabiti (Supporting Each Other For Resilience): study protocol of a mental health, HIV self-testing and livelihoods randomised controlled trial for advancing HIV prevention outcomes among urban refugee youth in Kampala, Uganda.

机构信息

Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada

Women's College Research Institute, Women's College Hospital, Toronto, Ontario, Canada.

出版信息

BMJ Open. 2024 Nov 24;14(11):e087470. doi: 10.1136/bmjopen-2024-087470.

DOI:10.1136/bmjopen-2024-087470

PMID:39581739

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11590822/

Abstract

INTRODUCTION

Research with urban refugee youth in Uganda has documented co-occurring social (e.g., poverty) and health (e.g., depression) disparities associated with HIV vulnerabilities. Benefits of HIV self-testing (HIVST) in increasing HIV testing uptake among youth are well established, yet limited interventions have examined if combining HIVST with mental health promotion, or with mental health promotion alongside poverty reduction, is associated with greater improvements in HIV prevention and testing outcomes.

METHODS AND ANALYSIS

The aim is to evaluate the effectiveness of: (1) HIVST alone (standard of care); (2) mobile health (mHealth) and graphic medicine (comic) programme for mental health alongside HIVST; and (3) the combination of HIVST, a livelihoods programme, and mHealth mental health programme, in advancing the primary outcome of HIV testing uptake and secondary outcomes (HIV status knowledge, linkage to confirmatory testing and HIV care, HIV knowledge, consistent condom use, condom use self-efficacy, sexual risk) with urban refugee youth in Kampala, Uganda. A three-arm randomised controlled trial will be implemented from 8 April 2024 to 31 October 2024 with youth across five informal settlements in Kampala, grouped into three sites based on proximity, and randomised in a 1:1:1 design. Approximately 330 participants (110 per arm) are enrolled and data collection will occur at three time points (baseline enrolment, 3-month follow-up and 6-month follow-up).

ETHICS AND DISSEMINATION

The study received ethical approval from the University of Toronto (#37496), Mildmay Uganda Research Ethics Committee (#MUREC-2021-41) and Uganda National Council for Science & Technology (#SS1021ES). The trial is registered at ClinicalTrials.gov (NCT06270160). Study findings will produce new knowledge of the impacts of a mental health programme, and a combined mental health and livelihoods programme, on improving HIV prevention outcomes among urban refugee youth in Kampala. Findings will be shared in peer-reviewed publications, conference presentations and in community dissemination.

TRIAL REGISTRATION NUMBER

NCT06270160 (date of registration: 13 February 2024).

TRIAL SPONSOR

Dr. Carmen Logie, carmen.logie@utoronto.ca.

摘要

介绍

在乌干达，对城市难民青年的研究记录了与 HIV 易感性相关的社会（例如贫困）和健康（例如抑郁）方面的并存差异。HIV 自我检测（HIVST）在增加青年人群 HIV 检测率方面的益处已得到充分证实，但很少有干预措施研究 HIVST 是否与心理健康促进相结合，或者与心理健康促进和减贫相结合，是否会对 HIV 预防和检测结果的改善产生更大的影响。

方法与分析

本研究旨在评估以下三种干预措施的有效性：（1）单独进行 HIVST（标准护理）；（2）在 HIVST 基础上结合移动健康（mHealth）和图形医学（漫画）心理健康方案；（3）将 HIVST、生计方案和 mHealth 心理健康方案相结合，以推进城市难民青年在乌干达坎帕拉的主要结局 HIV 检测率以及次要结局（HIV 感染状况知识、确证检测和 HIV 护理的衔接、HIV 知识、持续使用安全套、安全套使用自我效能、性风险）的改善。该三臂随机对照试验将于 2024 年 4 月 8 日至 2024 年 10 月 31 日实施，招募来自坎帕拉五个非正规住区的青年，根据临近程度将他们分为三个地点，并按 1:1:1 的比例进行随机分组。大约有 330 名参与者（每组 110 名）入组，数据收集将在三个时间点进行（基线入组、3 个月随访和 6 个月随访）。

伦理与传播

该研究已获得多伦多大学（#37496）、米德玛乌干达研究伦理委员会（#MUREC-2021-41）和乌干达国家科学与技术委员会（#SS1021ES）的伦理批准。该试验已在 ClinicalTrials.gov 注册（NCT06270160）。研究结果将产生关于心理健康方案以及心理健康和生计相结合方案对改善坎帕拉城市难民青年 HIV 预防结果的影响的新知识。研究结果将在同行评议的出版物、会议演讲和社区传播中分享。