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友谊长椅干预措施以解决马拉维感染艾滋病毒青少年的抑郁症并提高其对艾滋病毒护理的参与度:一项试点随机对照试验的研究方案

Friendship Bench intervention to address depression and improve HIV care engagement among adolescents living with HIV in Malawi: Study protocol for a pilot randomized controlled trial.

作者信息

Dao Thuy Thi Dieu, Gaynes Bradley N, Pence Brian W, Mphonda Steven M, Kulisewa Kazione, Udedi Michael, Stockton Melissa A, Kramer Jack, Waddell Katherine Grace, Faidas Maria, Mortensen Hillary, Bhushan Nivedita L

机构信息

Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Center for Research and Training on Substance Abuse and HIV, Hanoi Medical University, Hanoi, Vietnam.

出版信息

PLoS One. 2025 Mar 19;20(3):e0302666. doi: 10.1371/journal.pone.0302666. eCollection 2025.


DOI:10.1371/journal.pone.0302666
PMID:40106412
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11922207/
Abstract

BACKGROUND: Adolescents in Sub-Saharan Africa are disproportionately affected by the HIV epidemic. Comorbid depression is prevalent among adolescents living with HIV (ALWH) and poses numerous challenges to HIV care engagement and retainment. We present a pilot trial designed to investigate feasibility, fidelity, and acceptability of an adapted and an enhanced Friendship Bench intervention (henceforth: AFB and EFB) in reducing depression and improving engagement in HIV care among ALWH in Malawi. METHODS: Design: Participants will be randomized to one of three conditions: the Friendship Bench intervention adapted for ALWH (AFB, n = 35), the Friendship Bench intervention enhanced with peer support (EFB, n = 35), or standard of care (SOC, n = 35). Recruitment is planned for early 2024 in four clinics in Malawi. Participants: Eligibility criteria (1) aged 13-19; (2) diagnosed with HIV (vertically or horizontally); (3) scored ≥  13 on the self-reported Beck's Depression Inventory (BDI-II); (4) living in the clinic's catchment area with intention to remain for at least 1 year; and (5) willing to provide informed consent. Interventions: AFB includes 6 counseling sessions facilitated by young, trained non-professional counselors. EFB consists of AFB plus integration of peer support group sessions to facilitate engagement in HIV care. SOC for mental health in public facilities in Malawi includes options for basic supportive counseling, medication, referral to mental health clinics or psychiatric units at tertiary care hospitals for more severe cases. Outcomes: The primary outcomes are feasibility, acceptability, and fidelity of the AFB and EFB assessed at 6 months and 12 months and compared across 3 arms. The secondary outcome is to assess preliminary effectiveness of the interventions in reducing depressive symptoms and improving HIV viral suppression at 6 months and 12 months. DISCUSSION: This pilot study will provide insights into youth-friendly adaptations of the Friendship Bench model for ALWH in Malawi and the value of adding group peer support for HIV care engagement. The information gathered in this study will lead to a R01 application to test our adapted intervention in a large-scale cluster randomized controlled trial to improve depression and engagement in HIV care among ALWH. TRIAL REGISTRATION: ClinicalTrials.gov (NCT06173544).

摘要

背景:撒哈拉以南非洲的青少年受艾滋病疫情的影响尤为严重。合并抑郁症在感染艾滋病毒的青少年(ALWH)中很普遍,给艾滋病毒护理的参与和留存带来了诸多挑战。我们开展了一项试点试验,旨在调查一种经过调整和强化的友谊长椅干预措施(以下简称:AFB和EFB)在减少马拉维ALWH的抑郁症并提高其对艾滋病毒护理的参与度方面的可行性、保真度和可接受性。 方法:设计:参与者将被随机分配到三种情况之一:为ALWH调整的友谊长椅干预措施(AFB,n = 35)、通过同伴支持强化的友谊长椅干预措施(EFB,n = 35)或标准护理(SOC,n = 35)。计划于2024年初在马拉维的四家诊所进行招募。参与者:纳入标准(1)年龄在13 - 19岁;(2)被诊断感染艾滋病毒(垂直或水平传播);(3)在自我报告的贝克抑郁量表(BDI-II)上得分≥13;(4)居住在诊所服务区域且打算至少停留1年;(5)愿意提供知情同意书。干预措施:AFB包括由年轻的、经过培训的非专业咨询师进行的6次咨询会话。EFB包括AFB以及整合同伴支持小组会话以促进对艾滋病毒护理的参与。马拉维公共设施中针对心理健康的标准护理包括基本支持性咨询、药物治疗、转介至心理健康诊所或三级护理医院的精神科病房以处理更严重的病例等选项。结果:主要结果是在6个月和12个月时评估AFB和EFB的可行性、可接受性和保真度,并在三个组之间进行比较。次要结果是评估干预措施在6个月和12个月时减少抑郁症状和提高艾滋病毒病毒抑制率方面的初步效果。 讨论:这项试点研究将为马拉维针对ALWH的友谊长椅模式的青少年友好型调整以及增加同伴群体支持以促进艾滋病毒护理参与的价值提供见解。本研究收集的信息将促成一项R01申请,以在大规模整群随机对照试验中测试我们调整后的干预措施,以改善ALWH的抑郁症并提高其对艾滋病毒护理的参与度。 试验注册:ClinicalTrials.gov(NCT06173544)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/045c/11922207/ae7f43652fb5/pone.0302666.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/045c/11922207/ae7f43652fb5/pone.0302666.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/045c/11922207/ae7f43652fb5/pone.0302666.g001.jpg

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