Who is sponsoring NCT05374109?

NCT05374109 is sponsored by Duke University.

What drugs are being tested in NCT05374109?

Interventions in NCT05374109: SYV: Sauti ya Vijana (The Voice of Youth intervention).

What condition does NCT05374109 study?

NCT05374109 studies HIV-1-infection, Mental Health Issue, Adherence, Medication.

Is NCT05374109 still recruiting?

NCT05374109 is currently active, enrolled. Last updated 27 January 2025.

Last reviewed 2025-01-27 · How we verify

NCT05374109

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled NA Last updated 27 January 2025

What this trial tests

NA trial testing SYV: Sauti ya Vijana (The Voice of Youth intervention) in HIV-1-infection in 690 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 March 2023

Primary endpoint
11 January 2025

6 January 2026

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	690
Start date	1 March 2023
Primary completion	11 January 2025
Estimated completion	6 January 2026
Sites	6 locations across Tanzania

Drugs / interventions tested

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

Conditions studied

HIV-1-infection — all drugs for HIV-1-infection →
Mental Health Issue — all drugs for Mental Health Issue →
Adherence, Medication — all drugs for Adherence, Medication →

Sponsor

Duke University

Who can join

Adults 10 to 24, any sex, with HIV-1-infection or Mental Health Issue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Integrating Adolescent Mental Health into HIV Prevention and Treatment Programs: Can Implementation Science Pave the Path Forward?
Boshe J, Brtek V, Beima-Sofie K, Braitstein P, et al · · 2023 · cited 6× · PMID 36322219 · DOI 10.1007/s10461-022-03876-2
Study protocol for Sauti ya Vijana (The Voice of Youth): A hybrid-type 1 randomized trial to evaluate effectiveness and implementation of a mental health and life skills intervention to improve health outcomes for Tanzanian youth living with HIV.
Mollel GJ, Ketang'enyi E, Komba L, Mmbaga BT, et al · · 2024 · cited 3× · PMID 39186768 · DOI 10.1371/journal.pone.0305471
Peer-led interventions: Exploring the peer group leader experience of delivering Sauti ya Vijana, a group-based mental health intervention for youth living with HIV in Tanzania.
Agina C, Nasuwa F, Mosha J, Abdul N, et al · · 2026 · PMID 41662108 · DOI 10.1371/journal.pmen.0000512

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05374109 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 27 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05374109.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing