Impact of a youth and caregiver intervention on HIV self-management among youth living with HIV: a protocol for the Family Connections cluster RCT in Zambia

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BACKGROUND: Families play a critical role in adolescent management of chronic illnesses; however, 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. To address this gap, a family-based group intervention called Family Connections, was pilot tested for feasibility and acceptability in Zambia from April to November 2016. Family Connections consists of 10 group sessions every other week, for AYAs and their caregivers, to improve HIV disease management, decrease HIV stigma, and to promote health behaviors. Building on the successfully pilot, this study evaluates the intervention's impact on AYA's HIV self-management. METHODS: This study is a parallel-group, two-arm, pair-matched cluster randomized controlled trial. The clusters are the health facilities where AYAs receive their HIV care. A total of 800 participants, comprising 400 AYA and 400 caregivers from 20 clinics (10 intervention, 10 control), will be enrolled. AYA-caregiver pairs will be included if the AYA has a detectable viral load or high self-stigma at baseline. Clinics in a matched-pair will be randomized, after completion of enrollment at both sites, to either the 6-month intervention or the standard of care comparison arm. The primary outcome, assessed immediately post-intervention, is AYA's HIV self-management, defined as a composite score of undetectable viral load and low self-stigma. DISCUSSION: Family Connections aims to equip AYAs and their caregivers with skills that enhance AYA's HIV self-management and lessen caregiver burden. If successful, this intervention will provide a valuable approach for AYA, a group for whom there are limited proven effective interventions. TRIAL REGISTRATION: National Clinical Trial (NCT) Identifier Number: NCT05358795. Registered 2022-05-02.

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