RecruitingNot ApplicableNCT07064785

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


Sponsor

Baylor College of Medicine

Enrollment

1,800 participants

Start Date

Jul 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 10 Years

Inclusion Criteria8

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

Exclusion Criteria1

  • Treatment supporters

Interventions

BEHAVIORALVideo-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

BEHAVIORALStandard 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

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