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

项目摘要/摘要 虽然家庭在青少年慢性病管理中发挥着关键作用，但艾滋病毒的护理和治疗 项目很少让年长的青少年和年轻人(Aya)与他们的家庭照顾者接触。创新型 然而，方法是必要的，因为Aya总是比成年人更糟糕的艾滋病毒相关结果，并滞后 所有联合国艾滋病规划署的95-95-95目标。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人死亡的主要原因，在那里，世界上大多数艾滋病毒+青年 活着。这一R01反应了不同负担的艾滋病毒相关的死亡率在阿亚和引人注目的 来自我们的R34试点研究的证据，关于AYA/照顾者团体干预的可行性和可接受性 被称为家族关系。R01的目的是测试家庭关系对Aya的影响 实现无法检测的病毒载量(VL)。这项干预借鉴了积极青年发展的原则 (PYD)和社会认知理论(SCT)，以增加社会和家庭支持，减少自我污名 因此，他们可能会改善他们的服药依从性，实现无法检测到的病毒载量。阿雅 护理者对将一起参加这项研究。参与者将与照顾者一起参加小组会议 和Aya分开进行会议，然后在会议结束时聚集在一起分享信息和 学到的技能。 训练有素的促进者将领导小组会议：1)提高阿亚和阿亚对艾滋病毒的了解 照顾者；2)帮助阿雅制定健康生活战略，包括坚持艺术；3)建设能力 就其性健康和生殖健康作出明智的决定；4)建设 照顾者支持Aya；以及5)帮助Aya培养生活技能，以交流他们的艾滋病毒诊断 并有效地规划他们的未来。研究设计为20例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。这一设计将允许我们比较200双 10个干预诊所的Aya和照顾者，而10个对照诊所的200对(n=800总计：400 Aya，400 照顾者)。我们的具体目标是：1)评估家庭关系对实现不可检测的影响 VL(20拷贝/毫升)；2)评估家庭关系对照顾者负担和社会的影响 在照顾者参与者中的支持；以及3)检查家庭关系是否对AYA病毒的影响 通过认知测量评估青年之间的发展差异，从而缓和了地位 功能、执行功能、冲动控制和情绪调节。

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.