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Family Connections Cluster RCT in Zambia

NCT05358795 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1386

Last updated 2025-09-22

No results posted yet for this study

Summary

This study will evaluate the impact of Family Connections, a family-based group intervention for adolescents and young adults (AYA) living with HIV and their family caregivers, on achieving HIV self-management defined as having an undetectable viral load (VL) and low self-stigma (a score of 1 or less), among older adolescents and young adults (AYA) ages 15-to-21 years. The intervention seeks 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. Findings will fill a critical gap in available evidence-based intervention options for improving the HIV-related outcomes and wellbeing of HIV-positive AYA in sub-Saharan Africa.

Conditions

  • HIV
  • Adolescent Development
  • Adolescent Behavior
  • Caregivers
  • Africa

Interventions

BEHAVIORAL

Family Connections

Family Connections is based on the WHO endorsed Positive Connections manual.

Sponsors & Collaborators

  • FHI 360

    collaborator OTHER

  • Arthur Davison Children's Hospital

    collaborator OTHER

  • Tropical Diseases Research Centre

    collaborator UNKNOWN

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Julie A. Denison, PhD · Johns Hopkins Bloomberg School of Public Health

  • Gershom Chongwe, PhD · Tropical Diseases Research Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • Zambia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05358795 on ClinicalTrials.gov