Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Adolescents Who May Qualify: - 10-19 years of age - In care at the health facility - Aware of their HIV status - Provide willing to sign a consent form (if aged 18+ years) or assent and guardian willing to sign a consent form (if aged 10-17 years). - Who Should NOT Join This Trial: if their ability to provide willing to sign a consent form or assent is impaired Treatment supporters Who May Qualify: - \>18 years old - named as a treatment supporter of an adolescent study participant - willing to provide willing to sign a consent form for oneself - Who Should NOT Join This Trial: if their ability to provide willing to sign a consent form is impaired Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Adolescents Inclusion Criteria: * 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 Inclusion Criteria: * \>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

Treatments Being Tested

BEHAVIORAL

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

BEHAVIORAL

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 (20)

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