NCT07064785Active, not recruiting
Video-Intervention to Inspire Treatment Adherence for Life for Adolescents
VITAL Start (Video-Intervention to Inspire Treatment Adherence for Life) for Adolescents, a Randomized Controlled Trial of a Video Intervention to Improve Adherence, Retention, and Viral Load Suppression Among Adolescents Living With HIV
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
This a two-arm randomized controlled trial whose objective is to explore the impact of VITAL Start for Adolescents (VS4A), a video-based antiretroviral treatment (ART) adherence intervention, on a range of implementation and effectiveness outcomes. The study will be conducted in health facilities which provide HIV care to teens/adolescents in the Machinga and Balaka districts of Malawi with approximately 900 teens living with HIV and their treatment supporters (dyads). Dyads will be individually randomized on a 1:1 ratio to receive either the intervention or the standard of care. The VS4A intervention is designed to support Information, Motivation, and Behavioral skills (IMB) around adolescent ART adherence as well as strategies for enhancing treatment supporter social support. The intervention consists of: 1) a two-session video package with associated activities that both the adolescent and their treatment supporter will be asked to watch and participate in; 2) ART refill for the adolescent; 3) and intensive adherence counselling for those with a high viral load. The primary outcomes are adoption of the intervention and adolescent viral load suppression. The overall hypothesis is that VS4A will achieve high adoption and improve adolescent viral suppression.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1800 (estimated)
- First submitted
- 7 Jul 2025
- Start date
- 25 Jul 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Baylor College of Medicine
- Diseases
- HIV
- NCT number
- NCT07064785
What you commit to
- Study type: Interventional
- Planned participants: 1800
- From 25 Jul 2025 to the primary completion date, 30 Sept 2026
- 32 sites 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.
Who the study is looking for
- 10-19 years of age
- In care at the health facility
- Aware of their HIV status
- Provide informed consent (if aged 18+ years) or assent and guardian informed consent (if aged 10-17 years).
- Exclusion Criteria: if their ability to provide informed consent or assent is impaired
- Treatment supporters
- \>18 years old
- named as a treatment supporter of an adolescent study participant
- willing to provide informed consent for oneself
- Exclusion Criteria: if their ability to provide informed consent is impaired
Criteria the registry did not label
- Adolescents
Age in the registry: 10 years to - · Sex: All · Accepts healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mbera health Centre Coordinator of this site? Confirm its status | Balaka | Malawi | Unknown status |
| Chiendausiku Health Centre Coordinator of this site? Confirm its status | Balaka | Malawi | Unknown status |
| Kalembo Health Centre Coordinator of this site? Confirm its status | Balaka | Malawi | Unknown status |
| Nandumbo Health Centre Coordinator of this site? Confirm its status | Balaka | Malawi | Unknown status |
| Kwitanda Health Centre Coordinator of this site? Confirm its status | Balaka | Malawi | Unknown status |
| Balaka OPD Health Centre Coordinator of this site? Confirm its status | Balaka | Malawi | Unknown status |
| Ulongwe Health Centre Coordinator of this site? Confirm its status | Balaka | Malawi | Unknown status |
| Phimbi Health Centre Coordinator of this site? Confirm its status | Balaka | Malawi | Unknown status |
| Phalula Health Centre Coordinator of this site? Confirm its status | Balaka | Malawi | Unknown status |
| Utale 2 Health Centre Coordinator of this site? Confirm its status | Balaka | Malawi | Unknown status |
| Balaka District Hospital Coordinator of this site? Confirm its status | Balaka | Malawi | Unknown status |
| Namanolo Health Centre Coordinator of this site? Confirm its status | Balaka | Malawi | Unknown status |
| Nsanama Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Ntaja Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Kawinga Dispensary Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Gawanani Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Machinga Disctrict Hospital Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Nayinunje Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Mkwepere Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Mpiri Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Namandanje Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Namanja Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Nyambi Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Mposa Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Nthorowa Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Mbonechela Dispensary Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Mangamba Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Nayuchi Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Chikweo Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Chamba Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Machinga Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
| Ngokwe Health Centre Coordinator of this site? Confirm its status | Machinga | Malawi | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.