Status:
ACTIVE_NOT_RECRUITING
Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings
Lead Sponsor:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV-1-infection
Eligibility:
All Genders
15-19 years
Phase:
NA
Brief Summary
IMPAACT 2016 is 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)...
Detailed Description
IMPAACT 2016 is 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)...
Eligibility Criteria
Inclusion
- Inclusion Criteria - For Youth Participants:
- At screening, 15-19 years old.
- 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.
- 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 care to a youth taking part in the Randomized Trial, as identified by the youth, and for whom the youth has provided written permission to participate in the study.
- Of legal age to provide independent consent and willing and able to provide written informed consent for study participation.
- Exclusion Criteria - For Youth Participants:
- At entry, participating in a study delivering a mental health or ART adherence intervention.
- Has prior participation in an IMPAACT 2016 Focus Group or Pilot Test
- Any other condition, adverse social situation or cognitive impairment that, in the opinion of the site investigator, would preclude informed assent and informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
- Exclusion Criteria - For Caregiver Participants:
- Has prior participation in an IMPAACT 2016 Focus Group or Pilot Test.
Exclusion
Key Trial Info
Start Date :
November 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2025
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT04024488
Start Date
November 11 2023
End Date
October 15 2025
Last Update
April 22 2025
Active Locations (8)
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1
Gaborone Prevention/Treatment Trials CRS 12701
Gaborone, Botswana
2
Molepolole Prevention/Treatment Trials CRS 12702
Molepolole, Botswana
3
College of Medicine CRS 30301
Blantyre, Malawi
4
University of North Carolina Lilongwe CRS 12001
Lilongwe, Malawi