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
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 10
Healthy Volunteers: t
View:
• 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).
• \>18 years old
• named as a treatment supporter of an adolescent study participant
• willing to provide informed consent for oneself
Locations
Other Locations
Malawi
Balaka District Hospital
RECRUITING
Balaka
Balaka OPD Health Centre
NOT_YET_RECRUITING
Balaka
Chiendausiku Health Centre
NOT_YET_RECRUITING
Balaka
Kalembo Health Centre
NOT_YET_RECRUITING
Balaka
Kwitanda Health Centre
NOT_YET_RECRUITING
Balaka
Mbera health Centre
RECRUITING
Balaka
Namanolo Health Centre
RECRUITING
Balaka
Nandumbo Health Centre
NOT_YET_RECRUITING
Balaka
Phalula Health Centre
RECRUITING
Balaka
Phimbi Health Centre
NOT_YET_RECRUITING
Balaka
Ulongwe Health Centre
RECRUITING
Balaka
Utale 2 Health Centre
RECRUITING
Balaka
Chamba Health Centre
NOT_YET_RECRUITING
Machinga
Chikweo Health Centre
NOT_YET_RECRUITING
Machinga
Gawanani Health Centre
RECRUITING
Machinga
Kawinga Dispensary
RECRUITING
Machinga
Machinga Disctrict Hospital
RECRUITING
Machinga
Machinga Health Centre
RECRUITING
Machinga
Mangamba Health Centre
NOT_YET_RECRUITING
Machinga
Mbonechela Dispensary
NOT_YET_RECRUITING
Machinga
Mkwepere Health Centre
NOT_YET_RECRUITING
Machinga
Mpiri Health Centre
NOT_YET_RECRUITING
Machinga
Mposa Health Centre
NOT_YET_RECRUITING
Machinga
Namandanje Health Centre
NOT_YET_RECRUITING
Machinga
Namanja Health Centre
RECRUITING
Machinga
Nayinunje Health Centre
NOT_YET_RECRUITING
Machinga
Nayuchi Health Centre
NOT_YET_RECRUITING
Machinga
Ngokwe Health Centre
NOT_YET_RECRUITING
Machinga
Nsanama Health Centre
RECRUITING
Machinga
Ntaja Health Centre
RECRUITING
Machinga
Nthorowa Health Centre
NOT_YET_RECRUITING
Machinga
Nyambi Health Centre
NOT_YET_RECRUITING
Machinga
Contact Information
Primary
Saeed Ahmed, MD, MSc
saeeda@bcm.edu
+13474971049
Backup
Tapiwa Tembo, MSc
ttembo@tingathe.org
+265 999 970 033
Time Frame
Start Date:2025-07-25
Estimated Completion Date:2027-03-28
Participants
Target number of participants:1800
Treatments
Experimental: Video-Based ART Adherence Counseling