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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

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mbera health Centre
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BalakaMalawiUnknown status
Chiendausiku Health Centre
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BalakaMalawiUnknown status
Kalembo Health Centre
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BalakaMalawiUnknown status
Nandumbo Health Centre
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BalakaMalawiUnknown status
Kwitanda Health Centre
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BalakaMalawiUnknown status
Balaka OPD Health Centre
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BalakaMalawiUnknown status
Ulongwe Health Centre
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BalakaMalawiUnknown status
Phimbi Health Centre
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BalakaMalawiUnknown status
Phalula Health Centre
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BalakaMalawiUnknown status
Utale 2 Health Centre
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BalakaMalawiUnknown status
Balaka District Hospital
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BalakaMalawiUnknown status
Namanolo Health Centre
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BalakaMalawiUnknown status
Nsanama Health Centre
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MachingaMalawiUnknown status
Ntaja Health Centre
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MachingaMalawiUnknown status
Kawinga Dispensary
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MachingaMalawiUnknown status
Gawanani Health Centre
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MachingaMalawiUnknown status
Machinga Disctrict Hospital
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MachingaMalawiUnknown status
Nayinunje Health Centre
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MachingaMalawiUnknown status
Mkwepere Health Centre
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MachingaMalawiUnknown status
Mpiri Health Centre
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MachingaMalawiUnknown status
Namandanje Health Centre
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MachingaMalawiUnknown status
Namanja Health Centre
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MachingaMalawiUnknown status
Nyambi Health Centre
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MachingaMalawiUnknown status
Mposa Health Centre
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MachingaMalawiUnknown status
Nthorowa Health Centre
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MachingaMalawiUnknown status
Mbonechela Dispensary
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MachingaMalawiUnknown status
Mangamba Health Centre
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MachingaMalawiUnknown status
Nayuchi Health Centre
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MachingaMalawiUnknown status
Chikweo Health Centre
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MachingaMalawiUnknown status
Chamba Health Centre
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MachingaMalawiUnknown status
Machinga Health Centre
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MachingaMalawiUnknown status
Ngokwe Health Centre
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MachingaMalawiUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.