NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings

TerminatedNA

Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Conditions: HIV-1-infection

Interventions: Youth TI-CBT Intervention Arm, Youth Discussion Control Arm, Caregiver TI-CBT Intervention Arm, Caregiver Discussion Control Arm

Countries: Botswana, Malawi, South Africa, Zimbabwe

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.

Eligibility overview

Sex: ALL

Age: 15 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 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.
* 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:

Prior participation in an IMPAACT 2016 Focus Group or Pilot Test.

Locations (8)

Gaborone, Botswana
Molepolole, Botswana
Blantyre, Malawi
Lilongwe, Malawi
Soweto, South Africa
Chitungwiza, Zimbabwe
Harare, Zimbabwe
Harare, Zimbabwe