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: 10013574
• 负责人: Julie Anne Denison
• 金额: $ 65.76万
• 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/10013574
• 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; antiretroviral therapy; arm; base; caregiver interventions; cognitive function; comparison group; design; emotion regulation; executive function; family support; 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; 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; antiretroviral therapy; arm; base; caregiver interventions; cognitive function; comparison group; design; emotion regulation; executive function; family support; 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.

项目摘要 /摘要 虽然家庭在慢性疾病的青少年管理中发挥着关键作用，但艾滋病毒护理和治疗 计划很少与年长的青少年和年轻人（AYA）与他们的家庭护理人员。创新的 但是，需要方法，因为AYA始终比成年人更糟糕的HIV相关结果 所有UNAID 95-95-95目标。自2000年以来，青少年与HIV相关的死亡人数增加了三倍，艾滋病毒 仍然是撒哈拉以南非洲Aya中死亡的主要原因 居住。该R01对AYA和引人注目的HIV相关死亡率的不同烧伤做出了反应 我们R34试点研究的证据 称为家庭联系。 R01的目的是测试家庭联系对AYA的影响 达到无法检测到的病毒载荷（VL）。这种干预借鉴了积极的青年发展原则 （PYD）和社会认知理论（SCT）增加社会和家庭支持并减少自我污名 在AYA中，他们可以改善其药物依从性并达到无法检测到的病毒载量。嗯 照顾者对将一起参加研究。参与者将与照顾者参加小组会议 Aya分开进行会议，然后在会议结束时汇集在一起​​，以共享信息和 学到的技能。 受过训练的主持人将领导小组会议：1）提高对Aya和Aya艾滋病毒的了解 照顾者； 2）帮助AYA的健康生活策略，包括遵守艺术； 3）建立能力 艾亚（Aya）做出有关其性和生殖健康的明智决定； 4）建立能力 护理人员支持AYA； 5）帮助AYA发展生活技能，以传达其HIV诊断 有效地计划自己的未来。研究设计是一项群集随机对照试验，具有20 HIV 卢萨卡和赞比亚铜带省的诊所。该设计将使我们能够比较200对 10个干预诊所的AYA和护理人员在10个控制诊所对200对（n = 800总计：400 Aya，400） 照顾者）。我们的具体目的是：1）评估家庭联系对实现无法检测的影响 AYA中的VL（<20份/ml）； 2）评估家庭联系对看护人伯恩和社会的影响 照顾者参与者之间的支持； 3）检查家庭联系对AYAS病毒的影响是否 通过认知措施评估的年轻人之间的发展差异来调节状态 功能，执行功能，冲动控制和情绪调节。