Family Connections Cluster RCT in Zambia

NCT05358795 | Completed

• 1 other identifier: IRB00020325
• Study Type: interventional
• Target: 1,386
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV; Adolescents; Youth; Caregivers; Africa; Intervention

Outcome Measures

Primary Outcomes (1)

• Number of participants with undetectable viral load and low self-stigma

  Defined as having \<20 RNA copies/mL and scoring 1 or less on a 3 point self-stigma scale among adolescent and youth participants

  ~ 6 months from baseline to midline

Secondary Outcomes (4)

• Number of caregivers experiencing caregiver burden measured using the Zarit Burden Interview

  ~ 6 months from baseline to midline

• Number of caregivers with higher social support measured with Medical Outcomes Study Social Support Survey (MOS-SS)

  ~ 6 months from baseline to midline

• Number of adolescent and youth participants with cognitive challenges assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric cognitive function scale

  ~ 6 months from baseline to midline

• Number of adolescent and youth participants with emotional regulation challenges measures using the Difficulties in Emotion Regulation Scale (DERS-SF)

  ~ 6 months from baseline to midline

Study Arms (2)

Family Connections Intervention Arm

EXPERIMENTAL

The intervention group sessions aim to 1) improve understanding of HIV among AYA and caregivers; 2) help AYA develop strategies for healthy living (e.g. ART adherence); 3) build AYA capacity 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. Participants attend group sessions, with caregivers and AYA typically separated for sessions and then brought together sometimes during and sometimes at the end of the sessions, to share information and skills learned. The in-person group intervention will be held twice per month over a period of an estimated 6 months for a total of 10 sessions. Trained facilitators will deliver the intervention at the clinics. Health clinic staff will be available as technical experts to answer clinical questions.

Behavioral: Family Connections

Standard of Care Comparison

NO INTERVENTION

The control group will receive the standard of care during the study for AYA living with HIV in these public health care facilities and communities. The 20 facilities included in the research have been trained to operate under the standard protocols endorsed by the Zambia Ministry of Health. There can be variations in how these standards are adhered to and if special programming is provided for youth, such as youth group meetings and special youth clinic hours. Standard of care services per the 2020 Zambia Consolidated Guidelines include routine clinical care for HIV treatment including laboratory testing (CD4, VL tests); adherence counseling, with enhanced adherence counseling for clients with unsuppressed viral loads; multi-month dispensing of ART including differentiated service delivery for stable clients; screening and treatment of sexually transmitted infections (STIs); prevention and screening for opportunistic infections; and clinical monitoring of kidney and liver function.

Interventions

Family Connections BEHAVIORAL

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

Family Connections Intervention Arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility criteria for AYA include:
• being between 15 and 21 years,
• HIV positive and aware of their HIV status,
• on ART for at least 6 months,
• on first-line ART,
• living within 30-minutes, by personal transportation, of the clinic by self-report,
• being available to attend 10 sessions over 6 months,
• being available for the next 14 months,
• and speaks one of the study languages, English or Bemba
• Eligibility criteria for the caregiver is:
• being 22 years of age or older,
• does not work at the study clinic,
• living within 30-minutes, by personal transportation, of the clinic by self-report,
• caring for an AYA who meets the study eligibility criteria,
• being available to attend 10 sessions over 6 months,

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• FHI 360: collaborator
• Arthur Davison Children's Hospital: collaborator
• Tropical Diseases Research Centre: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Copperbelt Province Clinics

Ndola, Copperbelt, Zambia

Location

Related Publications (1)

• Schue JL, Mainga T, Nonyane BA, Peterson TL, Miti S, Chongwe G, McCarraher DR, Denison JA. 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. Trials. 2026 Jan 28. doi: 10.1186/s13063-026-09455-3. Online ahead of print.

  PMID: 41606621 DERIVED

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Julie A. Denison, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Gershom Chongwe, PhD

  Tropical Diseases Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Randomized Controlled Trial

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: April 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Once the data is de-identified it may be shared in a repository.
• Access Criteria: The team plans to place the data in an open access repository.

Locations

ZA (1)