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: 10480913
• 负责人: Julie Anne Denison
• 金额: $ 61.58万
• 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/10480913
• 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; HIV-infected adolescents; 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; group intervention; improved; innovation; internalized stigma; medication compliance; mortality; peer; pilot test; positive youth development; programs; response; skills; social cognitive theory; social stigma; statistics; success; therapy adherence; therapy design; treatment arm; treatment program

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