Integrating iSYV Within HIV Clinical Care for Youth Living With HIV in Tanzania
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: iSYV (integrated Sauti ya Vijana; The Voice of Youth), mHealth, eSOC.
- Who it may be relevant to
- Registry conditions: HIV -1 Infection, Mental Health Issue. Basic parameters: 15 years — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Tanzania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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. - Other eSOC
mental health screening and referral within the standard of care for moderate to severe symptoms
Primary outcome measures
- viral load [Time frame: at 6-months]
- retention in care [Time frame: at 6-months]
Secondary outcome measures (10)
- changes in self-reported antiretroviral therapy (ART) regarding adherence [Time frame: 6-months, 12-months, 18-months]
- change in self-reported mental health difficulties related to depression [Time frame: 6-months, 12-months, 18-months]
- change in self-reported mental health difficulties related to 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 [Time frame: 6-months, 12-months, 18-months]
- viral load [Time frame: 12-months, 18-months as drawn per standard of care]
- retention in care [Time frame: 12-months and 18-months]
- change in coping and self efficacy on the Coping and Self-Efficacy Scale (CSES) [Time frame: 6-months, 12-months, 18-months]
- change in resilience on People Living with HIV (PLHIV) Resilience Scale [Time frame: 6-months, 12-months, 18-months]
- SYV risk behaviors scale [Time frame: 6-months, 12-months, 18-months]
- interpersonal violence on the World Health Organization intimate partner violence (WHO IPV) scale [Time frame: 6-months, 12-months, 18-months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Tanzania · 1 center
- Elizabeth Glaser Pediatric AIDS Foundation implementing partner sites in Tanzania — Moshi
Identifiers
NCT: NCT07621510 · Pro00119752