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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Health Issue; HIV -1 Infection
• Intervention / Treatment: Other: eSOC; Behavioral: iSYV (integrated Sauti ya Vijana; The Voice of Youth); Other: mHealth

Detailed Description

SYV incorporates components of existing evidence-based models: Trauma Focused-Cognitive Behavioral Therapy, Interpersonal Psychotherapy, and Motivational Interviewing to address the needs youth described in formative interviews. Preliminary data indicates implementation success with estimated effects towards improved MH, antiretroviral therapy adherence, and a 10% greater increase in viral suppression in the intervention arm compared to standard of care. The central hypothesis here is that the new integrated "i" SYV will be acceptable, feasible, and effective to improve virologic suppression and improve retention in care. The mechanism of change is that improved MH leads to better medication adherence, viral suppression, and care engagement. The rationale is twofold: 1) Tanzania is planning to initiate MH screening in HIV clinical visits, but the MH treatment gap persists; 2) the iSYV stepped-care package could be an effective approach to support integrated MH care for YLWH. The central hypothesis will be tested in a hybrid type-2 effectiveness-implementation trial. The first aim will leverage the Fit to Context Framework, using an iterative Designing for Dissemination and Sustainability approach. Current SYV peer-group leaders with extensive experience delivering SYV will co-design the new iSYV package. The iSYV in-person sessions will be delivered by trained peer youth leaders and be aligned to the Tanzanian differentiated care model: stable youth (those fully suppressed) attend clinic every 6 months; and unstable youth (those with HIV RNA > 50 copies/mL) attend enhanced adherence counseling monthly. Youth with symptoms of MH difficulties on screening (PHQ9-depression, GAD7-anxiety, Trauma-related stress) will join the unstable group. To support engagement between visits, iSYV will explore use of a mHealth gamification strategy. The second aim includes a pilot and a four-arm cluster randomized trial. Two large implementing partners of PEPFAR clinics will support testing of the iSYV care package. The primary outcome is powered to show an increase in viral suppression (HIV RNA <50 copies/mL) in the unstable group and improved retention in care among the stable group. Change in MH is measured as a secondary outcome. The third aim will evaluate implementation determinants and outcomes, including acceptability, feasibility, fidelity, and cost informed by the Consolidated Framework for Implementation Research. The proposal is significant because it is expected to help address the MH gap for YLWH with implications for HIV care in Tanzania and other low income areas.

• Study Type: Interventional
• Enrollment (Estimated): 5000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stuart T Carr, BA; Phone Number: (919) 668-4849; Email: stuart.carr@duke.edu
• Study Contact Backup: Name: Sandy Askew, MPh; Email: sandy.askew@duke.edu

Study Locations

• Tanzania
  • Moshi, Tanzania
    • Elizabeth Glaser Pediatric AIDS Foundation implementing partner sites in Tanzania
    • Principal Investigator: Akwila Temu, MD, MMED

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: eSOC (enhanced Standard of Care); 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; mental health screening and referral within the standard of care for moderate to severe symptoms
Experimental: eSOC (enhanced Standard of Care) + iSYV (integrated Sauti ya Vijana or The voice of youth); iSYV is an intervention that will be peer-led and group based in six monthly sessions.	Other: eSOC; mental health screening and referral within the standard of care for moderate to severe symptoms; Behavioral: iSYV (integrated Sauti ya Vijana; The Voice of Youth); 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.
Experimental: eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health); 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	Other: eSOC; mental health screening and referral within the standard of care for moderate to severe symptoms; Behavioral: iSYV (integrated Sauti ya Vijana; The Voice of Youth); 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.; Other: mHealth; A gamified version of iSYV that can be played via SMS or Whatsapp messaging.
Experimental: eSOC (enhanced Standard of Care) + mHealth (mobile Health); 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: eSOC; mental health screening and referral within the standard of care for moderate to severe symptoms; Other: mHealth; A gamified version of iSYV that can be played via SMS or Whatsapp messaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in self-reported antiretroviral therapy (ART) regarding adherence	Self-reported adherence on a 3 question survey (Wilson) 0-100 range, higher scores indicate greater adherence	6-months, 12-months, 18-months
change in self-reported mental health difficulties related to depression	self-report of the Patient Health Questionnaire-9 (PHQ-9 ) range is 0-27, higher scores indicate greater depression	6-months, 12-months, 18-months
change in self-reported mental health difficulties related to anxiety	self-report on the Generalized Anxiety Disorder-7 (GAD-7) range 0-21 with higher scores indicating greater 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	self reported knowledge on the HIV-KQ18 (HIV Knowledge questionnaire 18) range 0-18. higher score indicates more HIV knowledge	6-months, 12-months, 18-months
viral load	HIV RNA	12-months, 18-months as drawn per standard of care
retention in care	follow up in routine HIV care within 30 days of scheduled 12-month and 18-month appointments	12-months and 18-months
change in coping and self efficacy on the Coping and Self-Efficacy Scale (CSES)	self-reported, 13 questions with scale of 0 to 2 (range 0 to 26), where a higher number is a better outcome, more coping and self-efficacy	6-months, 12-months, 18-months
change in resilience on People Living with HIV (PLHIV) Resilience Scale	10 items, scale 0 to 2 (range 0 to 20), higher number means more resilience and a better outcome	6-months, 12-months, 18-months
SYV risk behaviors scale	5 items assessing sexual activity, number of sexual partners, condom use, consumption of alcohol, cocaine, heroin, or other substances. These are yes/no response with clarification of rate/amount. Higher numbers is higher risk.	6-months, 12-months, 18-months
interpersonal violence on the World Health Organization intimate partner violence (WHO IPV) scale	self report, 15 items with 0=no and 1-yes. More yes (higher scale) means more experience with IPV.	6-months, 12-months, 18-months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Dorothy Dow, MD, MSc, Duke Universtiy

Study record dates

Study Major Dates

• Study Start (Estimated): January 10, 2027
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Cognitive behavioral therapy; Tanzania; Youth
• Additional Relevant MeSH Terms: Health Services Administration; Delivery of Health Care; Patient Care Management; Telemedicine
• Other Study ID Numbers: Pro00119752

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified data
• IPD Sharing Time Frame: at the conclusion of trial analysis
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No