Family Connections cluster RCT in Zambia: Impact of a youth and caregiver intervention on virologic status among HIV-positive youth (ages 15-21)

赞比亚家庭联系集群随机对照试验：青年和护理人员干预对艾滋病毒阳性青年（15-21 岁）病毒学状态的影响

• 批准号: 10246290
• 负责人: Julie Anne Denison
• 金额: $ 62.44万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10246290
• 关键词: AIDS prevention; Address; Adherence; Adolescent; Adolescent and Young Adult; Adult; Africa South of the Sahara; Age; Behavior; Caregiver Burden; Caregivers; Caring; Cause of Death; Cessation of life; Chronic Disease; Clinic; Data; Data Collection; Development; Enrollment; Ensure; Event; Evidence based intervention; Failure; Family; Family Caregiver; Feeling; Future; Group Meetings; HIV; HIV Seropositivity; HIV diagnosis; Health; Individual; Intervention; Lead; Life; Measures; Medical; Monitor; Outcome; Participant; Pediatric Hospitals; Personal Satisfaction; Persons; Pilot Projects; Play; Population; Prevention; Province; Randomized; Randomized Controlled Trials; Reproductive Health; Research; Research Design; Role; Self Management; Sexual Health; Shame; Signal Transduction; Social support; Stress; System; Testing; Training; United States National Institutes of Health; Viral; Viral Load result; Work; Youth; Zambia; acceptability and feasibility; antiretroviral therapy; arm; base; caregiver interventions; cognitive function; comparison group; design; emotion regulation; executive function; family support; feasibility testing; group intervention; improved; innovation; medication compliance; mortality; peer; positive youth development; programs; response; skills; social cognitive theory; social stigma; statistics; success; therapy adherence; therapy design; treatment arm; treatment program; virology

PROJECT SUMMARY / ABSTRACT While families play a critical role in adolescent management of chronic illnesses, HIV care and treatment programs rarely engage older adolescents and young adults (AYA) with their family caregivers. Innovative approaches are needed though, as AYA consistently have worse HIV-related outcomes than adults and lag on all the UNAIDS 95-95-95 targets. With a tripling in HIV-related deaths among adolescents since 2000, HIV remains a leading cause of death among AYA in sub-Saharan Africa where most of the world’s HIV+ youth live. This R01 responds to the disparate burden of HIV-related mortality among AYA and the compelling evidence from our R34 pilot study on the feasibility and acceptability of an AYA/caregiver group intervention called Family Connections. The purpose of the R01 is to test the impact of Family Connections on AYA achieving undetectable viral loads (VL). This intervention draws upon principles of Positive Youth Development (PYD) and Social Cognitive theory (SCT) to increase social and family support and decrease self-stigma among AYA, so they may improve their medication adherence and achieve an undetectable viral load. AYA and caregiver pairs will enroll into the study together. Participants will attend group sessions, with caregivers and AYA separated for sessions and then brought together at the end of the sessions to share information and skills learned. Trained facilitators will lead the group sessions to: 1) improve understanding of HIV among AYA and caregivers; 2) help AYA develop strategies for healthy living including adherence to ART; 3) build the capacity of AYA to make informed decisions about their sexual and reproductive health; 4) build the capacity of caregivers to support AYA; and 5) help AYA develop life skills to communicate their HIV diagnosis effectively and to plan for their futures. The study design is a cluster randomized controlled trial with 20 HIV clinics in the Lusaka and Copperbelt Provinces in Zambia. The design will allow us to compare 200 pairs of AYA and caregivers at 10 intervention clinics versus 200 pairs at 10 control clinics (n=800 total: 400 AYA, 400 caregivers). Our specific aims are to: 1) assess the impact of Family Connections on achieving undetectable VL (<20 copies/mL) among AYAs; 2) assess the impact of Family Connections on caregiver burden and social support among the caregiver participants; and 3) examine if the impact of Family Connections on AYAs’ viral status is moderated by developmental differences among youth assessed through measures of cognitive functioning, executive functioning, impulse control, and emotional regulation.

项目概要/摘要 虽然家庭在青少年慢性病管理中发挥着关键作用，但艾滋病毒护理和治疗 项目很少让年龄较大的青少年和年轻人 (AYA) 与其家庭护理人员互动。 但需要采取一些方法，因为 AYA 的艾滋病毒相关结果始终比成人差，并且滞后于成人 自 2000 年以来，青少年中与艾滋病毒相关的死亡人数增加了两倍，艾滋病毒 仍然是撒哈拉以南非洲 AYA 死亡的主要原因，那里世界上大多数艾滋病毒阳性青年 R01 旨在应对 AYA 中艾滋病毒相关死亡率的不同负担和引人注目的问题。 来自我们 R34 试点研究的证据，证明 AYA/护理人员团体干预的可行性和可接受性 R01 的目的是测试 Family Connections 对 AYA 的影响。 该干预措施借鉴了积极青少年发展的原则。 （PYD）和社会认知理论（SCT）以增加社会和家庭支持并减少自我耻辱 AYA 中，因此他们可以提高药物依从性并实现不可检测的 AYA 病毒载量。 参与者将与护理人员一起参加小组会议。 和 AYA 分开进行会议，然后在会议结束时聚在一起分享信息和 学到的技能。 训练有素的协调员将主持小组会议，以： 1) 提高 AYA 和 AYA 之间对艾滋病毒的了解 护理人员；2) 帮助 AYA 制定健康生活策略，包括遵守 ART；3) 建设能力； AYA 就其性健康和生殖健康做出明智的决定； 4) 建设以下方面的能力： 护理人员支持 AYA；以及 5) 帮助 AYA 发展生活技能以传达他们的艾滋病毒诊断结果 该研究设计是一项针对 20 名 HIV 患者的整群随机对照试验。 赞比亚卢萨卡省和铜带省的诊所该设计将使我们能够比较 200 双。 10 个干预诊所的 AYA 和护理人员与 10 个对照诊所的 200 对（n=800 总计：400 AYA、400 我们的具体目标是：1) 评估家庭联系对实现不可检测的影响。 AYA 中的 VL（<20 拷贝/mL）2) 评估家庭联系对护理人员负担和社交的影响 照顾者参与者之间的支持；3) 检查家庭联系是否对 AYA 的病毒式传播产生影响 青年人的地位是由通过以下措施评估的青年人的发展差异来调节的： 功能、执行功能、冲动控制和情绪调节。