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

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Status: Active, not recruiting

Conditions: HIV-1-infection

Treatments: Behavioral: TI-CBT Intervention Arm; Behavioral: Discussion Control Arm

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT04024488

IMPAACT 2016

DAIDS ID #38506 (Other Identifier)

Details and patient eligibility

About

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) 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 is adapted to the local context through advance conduct of focus groups and pilot testing.

Full 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) 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. To adapt the intervention for the local context, the trial will be preceded by an adaption of the TI-CBT intervention at each site using the "ADAPT-ITT" model, which includes focus groups and pilot tests. In the randomized study, youth will be individually randomized to either the TI-CBT Intervention Arm or the Discussion Control Arm. Participants will meet as a group within their randomized arm and receive multiple group sessions within an eight-week period. Each group will include an average of eight youth for an approximate total of 192-256 youth in the Randomized Trial (96-128 youth per arm). TI-CBT and Discussion Control groups in each arm will be mixed-gender unless it is determined necessary to have single-gender groups during the focus group. Caregivers (as available and with youth permission) will be assigned to the same study arm as their youth. Caregivers will meet as a group for two caregiver-specific sessions on two separate weeks and separate from their youth group sessions. Youth and caregivers will complete a follow-up visit immediately after their last group session and two additional follow-up visits at six and 12 months. Youth and caregivers will also receive one two-hour booster group session consistent with their assigned study arm immediately after the six-month evaluations. The booster sessions are intended to enhance treatment effects and increase sustainability. Once all participants have completed their six-month evaluations, data from these evaluations will be analyzed to determine the short-term effects of the intervention. Additional analyses to assess the longer-term effects of the intervention, including the effects of the booster group session, will be performed after the completion of follow-up.

Enrollment: 256 estimated patients

Sex: All

Ages: 15 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

TI-CBT Intervention Arm

Experimental group

Description:

In the Randomized Trial, youth participants will be randomized in a 1:1 ratio with their caregivers to one of two study arms. One arm is the TI-CBT intervention arm consisting of: six 2-hour TI-CBT group sessions lead by Indigenous Youth Leaders (IYL) during weeks 1 - 6 and one 2-hour booster group session at 6-months. The caregivers (willing to participate with youth permission) for youth who are enrolled into the TI-CBT arm will be enrolled onto the same arm, and receive two 2-hour group sessions led by adult study staff during weeks 1-6 and one 2-hour booster group session at 6-months. The youth and caregiver sessions are held separately.

Treatment:

Behavioral: TI-CBT Intervention Arm

Discussion Control Arm

Active Comparator group

Description:

Arm two is the discussion control arm consisting of: six 2 hour discussion group sessions lead by IYL during weeks 1-6 and one 2-hour booster discussion group session at 6 months. The caregivers (willing to participate with youth permission) for youth randomized to the discussion control arm will have two 2-hour discussion group sessions led by adult study staff during weeks 1-6 and one 2-hour booster discussion group session at 6 months. The youth and caregiver sessions are held separately.

Treatment:

Behavioral: Discussion Control Arm