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.

项目总结/摘要 虽然家庭在青少年慢性病管理、艾滋病毒护理和治疗方面发挥着关键作用， 计划很少让年龄较大的青少年和年轻人（AYA）与他们的家庭照顾者接触。创新 然而，由于AYA的艾滋病毒相关结果始终比成人更差， 联合国艾滋病规划署95-95-95目标。自2000年以来，青少年中与艾滋病毒有关的死亡人数增加了两倍， 仍然是撒哈拉以南非洲AYA死亡的主要原因，世界上大多数艾滋病毒+青年 live.这一R 01回应了艾滋病毒相关死亡率在AYA和令人信服的 来自我们的R34试点研究的证据，该研究是关于AYA/护理人员群体干预的可行性和可接受性的 叫做家庭联系R 01的目的是测试家庭联系对AYA的影响 达到不可检测的病毒载量（VL）。这一干预措施借鉴了青年积极发展的原则 (PYD)和社会认知理论（SCT），以增加社会和家庭的支持，减少自我耻辱 因此，他们可以提高他们的药物依从性，并实现检测不到的病毒载量。阿雅 和护理人员将一起参加研究。参与者将与护理人员一起参加小组会议 和AYA分开开会，然后在会议结束时聚在一起分享信息， 学到的技能。 经过培训的主持人将领导小组会议：1）提高AYA对艾滋病毒的了解， 护理人员; 2）帮助AYA制定健康生活策略，包括坚持ART; 3）建立能力 4）建立能力， 护理人员支持AYA;以及5）帮助AYA培养生活技能，以传达他们的艾滋病毒诊断结果 有效地规划他们的未来。该研究设计是一项针对20名艾滋病毒感染者的整群随机对照试验 赞比亚卢萨卡和铜带省的诊所。这个设计可以让我们比较200对 10个干预诊所的AYA和护理人员与10个对照诊所的200对（共n=800：400 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/mL）; 2）评估家庭关系对照顾者负担和社会 照顾者参与者之间的支持;和3）检查家庭关系对AYAs病毒的影响 状态是由通过认知测量评估的青年之间的发展差异调节的。 执行功能，冲动控制和情绪调节。