Integrating iSYV Within HIV Clinical Care for Youth Living With HIV in Tanzania

NCT07621510 | Not Yet Recruiting DMC

• 1 other identifier: Pro00119752
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Youth living with HIV (YLWH) experience mental health (MH) challenges that compromise their HIV care. Though the MH gap is well described, MH service delivery to YLWH is rare, especially in low resource settings. MH professionals are few and interventions tailored to the needs of this population are scarce. This project proposes a way to bridge the gap by streamlining the Sauti ya Vijana (SYV, The Voice of Youth) intervention redesigned to integrate into the differentiated HIV clinical care model in Tanzania. SYV is a peer-led, group-based treatment designed with and for YLWH to address their self-reported MH challenges and stressors living with HIV.

Conditions

HIV -1 Infection; Mental Health Issue

Keywords

Youth; Adolescents; Tanzania; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (2)

• viral load

  HIV RNA \<50 copies/mL considered suppression (per National guidelines)

  at 6-months

• retention in care

  clinical follow up as prescribed within 30 days of scheduled 6-month appointment

  at 6-months

Secondary Outcomes (10)

• changes in self-reported antiretroviral therapy (ART) regarding adherence

  6-months, 12-months, 18-months

• change in self-reported mental health difficulties related to depression

  6-months, 12-months, 18-months

• change in self-reported mental health difficulties related to anxiety

  6-months, 12-months, 18-months

• change in HIV knowledge in the SOC+iSYV intervention arm compared to SOC arm at 6 month follow-up and at all timepoints in the intervention arm compared to SOC arm

  6-months, 12-months, 18-months

• viral load

  12-months, 18-months as drawn per standard of care

Study Arms (4)

eSOC (enhanced Standard of Care)

ACTIVE COMPARATOR

Currently mental health screening is not part of routine care. Youth at all trial clinics who report moderate to severe symptoms will be referred for care within the local standard.

Other: eSOC

eSOC (enhanced Standard of Care) + iSYV (integrated Sauti ya Vijana or The voice of youth)

EXPERIMENTAL

iSYV is an intervention that will be peer-led and group based in six monthly sessions.

Behavioral: iSYV (integrated Sauti ya Vijana; The Voice of Youth); Other: eSOC

eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health)

EXPERIMENTAL

mHealth will be an additional experimental intervention exploring the boosting effect of gamification of intervention content to boost participant knowledge and understanding of iSYV content

Behavioral: iSYV (integrated Sauti ya Vijana; The Voice of Youth); Other: mHealth; Other: eSOC

eSOC (enhanced Standard of Care) + mHealth (mobile Health)

EXPERIMENTAL

mHealth is evaluated as a stand alone experimental intervention in this arm to evaluate if mHealth alone (without in person iSYV content) can improve mental health and/or HIV RNA outcomes.

Other: mHealth; Other: eSOC

Interventions

iSYV (integrated Sauti ya Vijana; The Voice of Youth) BEHAVIORAL

Integrated "i"SYV is a streamlined version of the original intervention SYV that is adapted for integration into routine clinical care. The original SYV intervention included 10 group weekly sessions (2 incorporating caregivers) and 2 individual sessions with adaptation to fit without routine adolescent HIV care based on Tanzanian National HIV Guidelines for HIV care follow up visits.

eSOC (enhanced Standard of Care) + iSYV (integrated Sauti ya Vijana or The voice of youth); eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health)

mHealth OTHER

A gamified version of iSYV that can be played via SMS or Whatsapp messaging.

eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health); eSOC (enhanced Standard of Care) + mHealth (mobile Health)

eSOC OTHER

mental health screening and referral within the standard of care for moderate to severe symptoms

eSOC (enhanced Standard of Care); eSOC (enhanced Standard of Care) + iSYV (integrated Sauti ya Vijana or The voice of youth); eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health); eSOC (enhanced Standard of Care) + mHealth (mobile Health)

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• youth living with HIV (YLWH) 15-24 years;
• have understanding of their HIV status;
• able to attend iSYV sessions if site is randomized to the intervention.

You may not qualify if:

• inability to provide informed consent/assent or participate meaningfully in the intervention due to cognitive impairment, psychosis, or other disability;
• enrollment in any other MH, stigma-related, or adherence intervention research study.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Elizabeth Glaser Pediatric AIDS Foundation implementing partner sites in Tanzania

Moshi, Tanzania

Location

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Dorothy Dow, MD, MSc

  Duke Universtiy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuart T Carr, BA

CONTACT

(919) 668-4849; stuart.carr@duke.edu

Sandy Askew, MPh

CONTACT

sandy.askew@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Trial statisticians
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): January 10, 2027
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): September 30, 2030
• Last Updated: June 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: at the conclusion of trial analysis
• Access Criteria: Data sharing is critical to confirm findings, discover important new associations, and to test new ideas that impact health. Our core quantitative dataset will be archived in the National Institute of Mental Health (NIMH) Data Archive (NDA). To achieve this we will harmonize our data to NDA common data elements (CDE) as much as possible prior to data collection. We will follow the standard practices of the NDA for data uploads, submitting data biannually beginning in the second submission cycle following the Notice of Award. Data will be made publicly available in the data archive at the time of publication.

Locations

TA (1)