NCT05358795Completed
Family Connections Cluster RCT in Zambia
Family Connections Cluster RCT in Zambia: Impact of a Youth and Caregiver Intervention on HIV Management Among HIV-positive Youth (Ages 15-21)
Source: ClinicalTrials.gov · Last updated 22 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1386 (actual)
- First submitted
- 28 Apr 2022
- Start date
- 1 Apr 2023
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Diseases
- HIV
- NCT number
- NCT05358795
What you commit to
- Study type: Interventional
- Participants enrolled: 1386
- From 1 Apr 2023 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- The only exclusion criteria are not fulfilling the inclusion criteria.
- \-
Who the study is looking for
- 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,
- being available over the next 14 months,
- and speaks one of the study languages English or Bemba.
- Being a biological parent or family member is not an eligibility criterion.
Age in the registry: 15 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Copperbelt Province Clinics Coordinator of this site? Confirm its status | Ndola | Zambia | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.