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Video-Intervention to Inspire Treatment Adherence for Life for Adolescents

NCT07064785 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Saeed Ahmed, MD, MSc · Baylor College of Medicine, Houston Texas

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-25
Primary Completion
2026-09-30
Completion
2027-03-28

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07064785 on ClinicalTrials.gov