Video-Intervention to Inspire Treatment Adherence for Life for Adolescents

NCT07064785 | Active Not Recruiting DMC

• 2 other identifiers: H-539635UG1MD019436-02
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 32

Brief 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

HIV/AIDS

Keywords

Adolescents; Children; Teens; Viral Suppression; Retention; Video; Intervention; Antiretroviral treatment; Counseling; Human Immunodeficiency Virus; Adherence; Health Education; Patient Compliance; Malawi; Self-efficacy; Social Support

Outcome Measures

Primary Outcomes (2)

• Adolescent Viral Load Measure

  Adolescents will have their viral load assessed via dried blood spot. Results will be analyzed and those with a result of \<1000 copies/ml will be considered virally suppressed. All others will be considered non-suppressed: \>=1000 copies/ml or having no viral load measurement, lost, or died.

  By 47 weeks

• Adoption of VS4 intervention at teen club

  Proportion of health facilities in the experimental arm that participated in implementation strategy.

  By Week 24

Secondary Outcomes (3)

• Adolescent behavioral adherence

  By Week 36

• Reach

  By Week 12

• Implementation fidelity

  By Week 24

Study Arms (2)

Video-Based ART Adherence Counseling

EXPERIMENTAL

Behavioral: Video-based ART adherence counseling

Standard of Care

ACTIVE COMPARATOR

Behavioral: Standard of Care (SOC)

Interventions

Video-based ART adherence counseling BEHAVIORAL

* 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

Video-Based ART Adherence Counseling

Standard of Care (SOC) BEHAVIORAL

* 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

Standard of Care

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Treatment supporters
• \>18 years old
• named as a treatment supporter of an adolescent study participant
• willing to provide informed consent for oneself

Sponsors & Collaborators

• Baylor College of Medicine: lead
• University of North Carolina, Chapel Hill: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (32)

Balaka District Hospital

Balaka, Malawi

Location

Balaka OPD Health Centre

Balaka, Malawi

Location

Chiendausiku Health Centre

Balaka, Malawi

Location

Kalembo Health Centre

Balaka, Malawi

Location

Kwitanda Health Centre

Balaka, Malawi

Location

Mbera health Centre

Balaka, Malawi

Location

Namanolo Health Centre

Balaka, Malawi

Location

Nandumbo Health Centre

Balaka, Malawi

Location

Phalula Health Centre

Balaka, Malawi

Location

Phimbi Health Centre

Balaka, Malawi

Location

Ulongwe Health Centre

Balaka, Malawi

Location

Utale 2 Health Centre

Balaka, Malawi

Location

Chamba Health Centre

Machinga, Malawi

Location

Chikweo Health Centre

Machinga, Malawi

Location

Gawanani Health Centre

Machinga, Malawi

Location

Kawinga Dispensary

Machinga, Malawi

Location

Machinga Disctrict Hospital

Machinga, Malawi

Location

Machinga Health Centre

Machinga, Malawi

Location

Mangamba Health Centre

Machinga, Malawi

Location

Mbonechela Dispensary

Machinga, Malawi

Location

Mkwepere Health Centre

Machinga, Malawi

Location

Mpiri Health Centre

Machinga, Malawi

Location

Mposa Health Centre

Machinga, Malawi

Location

Namandanje Health Centre

Machinga, Malawi

Location

Namanja Health Centre

Machinga, Malawi

Location

Nayinunje Health Centre

Machinga, Malawi

Location

Nayuchi Health Centre

Machinga, Malawi

Location

Ngokwe Health Centre

Machinga, Malawi

Location

Nsanama Health Centre

Machinga, Malawi

Location

Ntaja Health Centre

Machinga, Malawi

Location

Nthorowa Health Centre

Machinga, Malawi

Location

Nyambi Health Centre

Machinga, Malawi

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Health Education; Patient Compliance

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Adherence Interventions; Medication Adherence; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Saeed Ahmed, MD, MSc

  Baylor College of Medicine, Houston Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts and the study biostatistician will be masked to randomization arm until they have a locked dataset.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, Principal Investigator

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 15, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 28, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 months after publication and continuing through 36 months of publication
• Access Criteria: A repository will be selected that has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations. The researcher will need approval form an Institutional Review Board and an executed data use/sharing agreement with Baylor College of Medicine investigators.

Locations

MA (32)