Integrating Project YES! With WHO-Endorsed Mental Health Approaches Among Youth Living With HIV (NCT07221201) | Clinical Trial Compass
RecruitingNot Applicable
Integrating Project YES! With WHO-Endorsed Mental Health Approaches Among Youth Living With HIV
Zambia400 participantsStarted 2025-10-25
Plain-language summary
The proposed study will address the intersecting stigmas of HIV, violence and depression among adolescents and young adults (15-24) living with HIV (AYALHIV) in Zambia. The study will integrate a WHO-endorsed mental health approach into an existing HIV-stigma-reducing intervention, and refine measures of internalized and intersecting stigmas, to create and test the feasibility of Project YES+- a combined youth peer mentoring and lay mental health intervention. This research aims to shift HIV care and treatment for AYALHIV by addressing the multiple internalized and intersecting stigmas that impeded antiretroviral adherence and HIV viral suppression.
Who can participate
Age range
15 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:
For youth
* Be between ages 15-21
* living within 30-minutes, by personal transportation, of the clinic by self-report,
* and being available to attend sessions and data collection over a 4-8 month time period On ART for at least 6 months
* On first-line ART
* Speaks Bemba
For caregivers
* Being 25 years of age or older
* Caring for an AYALHIV who meets the study eligibility criteria
* Speaks Bemba
* Living within 30-minutes, by personal transportation, of the clinic by self-report
* Being available to attend sessions and data collection over a 4-8 month time period
Exclusion Criteria:
For youth,
* only one youth per household may join.
* Also participants will be excluded from joining the RCT if they are at imminent risk of suicide based on WHO guidance on the Self Help plus program.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Feasibility of intervention as assessed by percentage of sessions attended
Timeframe: Up to 4 months
2
Number of intervention participants who report they would recommend Project YES+ to their peers
Timeframe: up to 4 months
3
Number of intervention participants who would recommend Project YES+ for caregivers
Timeframe: up to four months
Trial details
NCT IDNCT07221201
SponsorJohns Hopkins Bloomberg School of Public Health