Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Lo… (NCT04024488) | Clinical Trial Compass
TerminatedNot Applicable
Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings
Stopped: The study was closed early due to funding issue
Botswana, Malawi, South Africa484 participantsStarted 2024-04-06
Plain-language summary
IMPAACT 2016 was a multi-site, two-arm, individually randomized, controlled study to evaluate whether an Indigenous Leader Outreach Model (ILOM) of trauma-informed cognitive behavioral therapy (TI-CBT) delivered by Indigenous Youth Leaders (IYL) is associated with improved mental health outcomes and ART adherence among youth living with HIV in resource-limited settings. The intervention was adapted to the local context through advance conduct of focus groups and pilot testing.
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 Participants:
* If of legal age to provide independent informed consent as determined by site Standard Operating Procedures (SOPs) and consistent with site IRB/EC policies and procedures: potential youth participant is willing and able to provide written informed consent for study participation.
* If not of legal age to provide independent informed consent: Parent or guardian is willing and able to provide written informed consent for study participation and potential youth participant is willing and able to provide written informed assent for study participation.
* Confirmed HIV-infection based on documented testing of two samples collected at different time points as documented in medical records or by confirmatory testing.
* Age limit 15-19 years
* At screening, aware of his or her HIV infection, as confirmed by Investigator of Record or designee.
* At screening, has been prescribed ART for a minimum of 24 weeks prior to screening based on medical record documentation.
* At screening, meets at least one of the following indicators of moderate to severe mental health symptomology:
* Patient Health Questionnaire-9 (PHQ-9) score ≥ 10
* General Anxiety Disorder-7 (GAD-7) score ≥ 10
* UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) score \>= 35
Inclusion Criteria - For Caregiver Participants:
* Caregiver, defined as a biological parent, legal guardian, or person who provides emotional, psychological and/or informational…
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
Group-level Mean General Anxiety Disorder-7 (GAD-7) at 6 Months
Timeframe: at 6 months
2
Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA-PTSD-RI) at 6 Months
Timeframe: at 6 months
3
Group-level Mean Composite Mental Health Measure at 6 Months
Timeframe: at 6 months
4
Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at 6 Months
Timeframe: at 6 months
Trial details
NCT IDNCT04024488
SponsorInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group