An interventional study of iSYV (integrated Sauti ya Vijana; The Voice of Youth) and mHealth in HIV -1 Infection and Mental Health Issue, sponsored by Duke University. Not yet recruiting at 1 site in Tanzania. Open to participants aged 15 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
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.
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.
Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
A gamified version of iSYV that can be played via SMS or Whatsapp messaging.
mental health screening and referral within the standard of care for moderate to severe symptoms
viral load
HIV RNA \<50 copies/mL considered suppression (per National guidelines)
Time frame: at 6-months
retention in care
clinical follow up as prescribed within 30 days of scheduled 6-month appointment
Time frame: at 6-months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6-months, 12-months, 18-months
viral load
HIV RNA
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 6-months, 12-months, 18-months
Plan to share: Yes — de-identified data
Supporting information: Study protocol, Statistical analysis plan, 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.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Mar 2029, 26 months later.
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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