Family Connections program for adolescents with HIV 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)
This study is testing a program in Zambia that helps young people with HIV and their families build support and skills to better manage their health and stick to their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1400 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins Bloomberg School of Public Health Academic / other |
| Locations | 1 site (Ndola, Copperbelt) |
| Trial ID | NCT05358795 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Family Connections intervention, which is designed to support adolescents and young adults living with HIV and their caregivers in Zambia. The program aims to enhance HIV self-management by fostering social and family support while reducing self-stigma among participants aged 15 to 21. By providing a structured environment for skill-building and peer support, the intervention seeks to improve medication adherence and achieve undetectable viral loads. The findings will contribute valuable evidence for effective interventions targeting HIV-positive youth in sub-Saharan Africa.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents and young adults aged 15 to 21 who are HIV positive, on antiretroviral therapy, and live within a reasonable distance from the clinic.
Not a fit: Patients who are not HIV positive or those who do not have access to the study clinic may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the health outcomes and quality of life for adolescents living with HIV.
How similar studies have performed: Other studies have shown success with family-based interventions for chronic illness management, indicating potential for this approach in the context of HIV.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: The only exclusion criteria are not fulfilling the inclusion criteria. -
Where this trial is running
Ndola, Copperbelt
- Copperbelt Province Clinics — Ndola, Copperbelt, Zambia (Recruiting)
Study contacts
- Principal investigator: Julie A. Denison, PhD — Johns Hopkins Bloomberg School of Public Health
- Study coordinator: Julie A. Denison, PhD
- Email: jdenison@jhu.edu
- Phone: 443-287-2704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.