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Video-Intervention to Inspire Treatment Adherence for Life for Adolescents
Sponsor: Baylor College of Medicine
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
10 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1800
Start Date
2025-07-25
Completion Date
2027-03-28
Last Updated
2025-07-25
Healthy Volunteers
Yes
Conditions
Interventions
Video-based ART adherence counseling
* Clinical visit which includes ART provision at 0, 12 and 24 weeks * Two one-hour video-based sessions with associated activities at 0 and 12 weeks * Enhanced/Intensive adherence counselling with video component between 24-35 weeks for those with high viral load
Standard of Care (SOC)
* Clinical visit which includes ART provision at 0, 12 and 24 weeks * Basic adherence counselling between 24-35 weeks for those with high viral load
Locations (32)
Balaka District Hospital
Balaka, Malawi
Balaka OPD Health Centre
Balaka, Malawi
Chiendausiku Health Centre
Balaka, Malawi
Kalembo Health Centre
Balaka, Malawi
Kwitanda Health Centre
Balaka, Malawi
Mbera health Centre
Balaka, Malawi
Namanolo Health Centre
Balaka, Malawi
Nandumbo Health Centre
Balaka, Malawi
Phalula Health Centre
Balaka, Malawi
Phimbi Health Centre
Balaka, Malawi
Ulongwe Health Centre
Balaka, Malawi
Utale 2 Health Centre
Balaka, Malawi
Chamba Health Centre
Machinga, Malawi
Chikweo Health Centre
Machinga, Malawi
Gawanani Health Centre
Machinga, Malawi
Kawinga Dispensary
Machinga, Malawi
Machinga Disctrict Hospital
Machinga, Malawi
Machinga Health Centre
Machinga, Malawi
Mangamba Health Centre
Machinga, Malawi
Mbonechela Dispensary
Machinga, Malawi
Mkwepere Health Centre
Machinga, Malawi
Mpiri Health Centre
Machinga, Malawi
Mposa Health Centre
Machinga, Malawi
Namandanje Health Centre
Machinga, Malawi
Namanja Health Centre
Machinga, Malawi
Nayinunje Health Centre
Machinga, Malawi
Nayuchi Health Centre
Machinga, Malawi
Ngokwe Health Centre
Machinga, Malawi
Nsanama Health Centre
Machinga, Malawi
Ntaja Health Centre
Machinga, Malawi
Nthorowa Health Centre
Machinga, Malawi
Nyambi Health Centre
Machinga, Malawi