Support for adolescents living with HIV in South Africa
Interactive Transition Support for Adolescents Living With HIV Comparing Virtual and In-person Delivery Through a Stepped-wedge Cluster Randomized Clinical Trial in South Africa
This study tests if in-person and mobile health support can help teenagers with HIV in South Africa better transition to adult healthcare services and stay healthy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 15 Years to 19 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Congella) |
| Trial ID | NCT06035445 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of in-person and mobile health interventions designed to assist adolescents living with HIV in transitioning from pediatric to adult healthcare services. It focuses on adolescents aged 15 to 19 in KwaZulu-Natal, South Africa, who have low readiness for this transition. The study compares these interventions against standard care to determine their impact on retention in care and viral suppression. Given the high number of adolescents living with HIV in South Africa, this research aims to address a critical gap in healthcare support during a vulnerable transition period.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 15 to 19 years who are living with perinatally-acquired HIV and have been on antiretroviral therapy for at least six months.
Not a fit: Patients who are unable to read or speak English or Zulu, or those with severe mental or physical illnesses that prevent informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve retention in care and health outcomes for adolescents living with HIV.
How similar studies have performed: Other studies have shown success with similar transition interventions for adolescents living with HIV, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Adolescent Participants: * Aged 15 to 19 years at enrollment * Living with perinatally-acquired HIV * Receiving ART for at least 6 months * Aware of their HIV status * Scoring low to intermediate on transition readiness assessment (intervention cohort only) Inclusion Criteria for Healthcare Providers: * Profession as a healthcare provider * Working at one of the designated clinics * Involvement with adolescents before, during or after transition to adult care Exclusion Criteria for all participants: * Inability to read and/or speak English or Zulu * Severe mental or physical illness preventing participation in informed consent activities * Anticipated move out of clinic area in the next 12 months
Where this trial is running
Congella
- King Edward VIII Hospital — Congella, South Africa (Recruiting)
Study contacts
- Principal investigator: Brian C Zanoni, MD, MPH — Emory University
- Study coordinator: Brian C Zanoni, MD, MPH
- Email: brian.christopher.zanoni@emory.edu
- Phone: 404-727-0284
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.