SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth (NCT05374109) | Clinical Trial Compass
CompletedNot Applicable
SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth
Tanzania690 participantsStarted 2023-03-01
Plain-language summary
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.
Who can participate
Age range
10 Years – 24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Youth between the ages of 10 and 24 years of age
* Attending the enrolling adolescent HIV clinic
* Are fully disclosed and aware of their HIV status
* Receiving ART for a minimum of 6 months
* If ≥ 18 years, able to understand the project and provide written informed consent
* If \<18 years, a parent or guardian must provide written permission and participant must be able to assent
* All adolescents must also commit to attending the 10 weekly SYV sessions and 2 individual sessions
Exclusion Criteria:
* Active psychosis
* Developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a mental health intervention alongside HIV treatment for young people in Tanzania — do you think my mental health is affecting how consistently I take my HIV medications, and is there a similar combined approach available to me here?
2Since this trial has already completed and was measuring whether participants achieved an HIV RNA level below 400 copies/mL, have the results been published yet, and what do they suggest about whether addressing mental health actually improved viral suppression in young people?
3The trial was labeled 'Phase NA,' which means it wasn't a standard drug-safety trial but more of a behavioral or program study — does that change how you'd interpret any findings compared to a Phase 2 or Phase 3 medication trial?
4Since this study was done specifically with youth in Tanzania, how confident are you that its approach would translate to my situation, given possible differences in healthcare setting, culture, or support resources?
5If my mental health challenges are making it harder to stick to my HIV medication regimen, what options do you currently offer that combine mental health support with HIV care, and would you recommend trying those before or instead of seeking out a research program?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Virologic Suppression as Measured by Number of Participants With a HIV RNA <400 Copies/mL