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ACTIVE NOT RECRUITING
NCT05374109
NA

SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth

Sponsor: Duke University

View on ClinicalTrials.gov

Summary

The overall objectives of this proposal are to support positive coping strategies that bolster mental health and lead to improved HIV outcomes among Young People Living with HIV (YPLWH). The central hypothesis is that SYV (Sauti ya Vijana, The Voice of Youth) will be effective to improve antiretroviral therapy (ART) adherence and virologic suppression in YPLWH in Tanzania. The rationale for this project is that by targeting mental health, which is strongly associated with medication adherence, that this will effectively improve adherence and thereby HIV viral suppression. The central hypothesis will be tested in three aims in a hybrid type-1 effectiveness-implementation trial.

Key Details

Gender

All

Age Range

10 Years - 24 Years

Study Type

INTERVENTIONAL

Enrollment

690

Start Date

2023-03-01

Completion Date

2026-01-06

Last Updated

2025-01-27

Healthy Volunteers

No

Interventions

BEHAVIORAL

SYV: Sauti ya Vijana (The Voice of Youth intervention)

Mental health is associated with ART adherence and HIV outcomes. SYV was designed to address the specific challenges of young people living (YPLWH) with HIV in Tanzania. SYV includes 10 group sessions (two sessions held jointly with caregivers) lasting approximately 90 minutes and two individual sessions delivered by trained young adult group leaders who use a manualized protocol that is designed to scale in low resource settings. The intervention is applied to the Social Action Theory (SAT), a theoretical framework used to determine factors that influence health behavior. Building off a SAT resilience framework for YPLWH, components of evidence-based treatment models to influence cognitive, self, and social regulation to improve behavioral health outcomes will be strategically used.

Locations (6)

Chronic Disease Clinic of Ifakara Health Institute

Ifakara, Tanzania

Baylor College of Medicine Children's Foundation - Tanzania, Mbeya Centre for Excellence

Mbeya, Tanzania

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

Mawenzi Regional Referral Hospital

Moshi, Tanzania

Baylor College of Medicine Children's Foundation - Tanzania, Mwanza Centre for Excellence

Mwanza, Tanzania

Bugando Medical Centre

Mwanza, Tanzania