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

NCT04024488 | Active Not Recruiting DMC

• 2 other identifiers: IMPAACT 2016DAIDS ID #38506
• Study Type: interventional
• Target: 256
• Locations: 4 countries
• Sites: 8

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) 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.

Conditions

HIV-1-infection

Keywords

Mental Health; Adherence; Trauma-Informed Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (4)

• Patient Health Questionnaire-9

  (PHQ-9, measure of depression: range 0-27, higher=worse)

  at 6-months

• General Anxiety Disorder-7

  (GAD-7, measure of anxiety: range 0-21, higher=worse)

  at 6-months

• UCLA Post-Traumatic Stress Disorder-Reaction Index

  (UCLA PTSD-RI, measure of TPSD: range 0-51, higher=worse)

  at 6-months

• Composite mental health measure

  (measure of combined mental health issues: PHQ-9, GAD-7, and UCLA PTSD-RI scores will be standardized to have mean=0, standard deviation=1, and then summed; higher=worse)

  at 6-months

Secondary Outcomes (6)

• Patient Health Questionnaire-9

  after initial treatment completion (an average of 6 weeks)

• General Anxiety Disorder-7

  after initial treatment completion (an average of 6 weeks)

• UCLA Post-Traumatic Stress Disorder-Reaction Index

  after initial treatment completion (an average of 6 weeks)

• Composite mental health measure

  after initial treatment completion (an average of 6 weeks)

• ART Adherence

  after initial treatment completion (an average of 6 weeks), and at 6-months

Study Arms (2)

TI-CBT Intervention Arm

EXPERIMENTAL

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.

Behavioral: TI-CBT Intervention Arm

Discussion Control Arm

ACTIVE COMPARATOR

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.

Behavioral: Discussion Control Arm

Interventions

TI-CBT Intervention Arm BEHAVIORAL

TI-CBT teaches techniques and ways to manage distress through psychosocial health education, cognitive restructuring, and "mastery of trauma", which refers to the process by which survivors of psychological trauma work through the traumatic experience in a meaningful way, and are able to move on with life. TI-CBT addresses both the trauma of learning one has HIV and the trauma associated with managing a chronic and stigmatized illness. The intervention highlights links between HIV and traditional gender roles, gender inequities, and gender based violence. Finally, the relaxation training teaches youth strategies to relax and these are integrated at the beginning and end of each session. TI-CBT Youth and Caregiver Intervention Manuals are distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial.

TI-CBT Intervention Arm

Discussion Control Arm BEHAVIORAL

Each youth discussion control group session will be led by IYL and each caregiver discussion control group will be led by adult study staff. Discussion topics will be selected by youth and caregivers in the group as applicable. Discussion Control group session will take place at a separate time from TI-CBT youth group sessions in attempt to minimize contamination. To note, participant and caregiver group sessions are always held separately.

Discussion Control Arm

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• Has prior participation in an IMPAACT 2016 Focus Group or Pilot Test.

Sponsors & Collaborators

• International Maternal Pediatric Adolescent AIDS Clinical Trials Group: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (8)

Gaborone Prevention/Treatment Trials CRS 12701

Gaborone, Botswana

Location

Molepolole Prevention/Treatment Trials CRS 12702

Molepolole, Botswana

Location

College of Medicine CRS 30301

Blantyre, Malawi

Location

University of North Carolina Lilongwe CRS 12001

Lilongwe, Malawi

Location

Soweto IMPAACT CRS 8052

Soweto, South Africa

Location

St. Mary's CRS 30303

Chitungwiza, Zimbabwe

Location

Harare Family Care CRS 31890

Harare, Zimbabwe

Location

Seke North CRS 30306

Harare, Zimbabwe

Location

Related Links

• IMPAACT 2016 web page

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Geri Donenberg, PhD

  University of Illinois at Chicago

  STUDY CHAIR

• Dorothy Dow, MD, MSc

  Duke University

  STUDY CHAIR

• Suad Kapetanovic, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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: 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 participating for youth who are enrolled into the TI-CBT arm will 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 other arm 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 of 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.

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 18, 2019
• Study Start: November 11, 2023
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning three months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network. Types of Analyses: Specifically for the types of analyses needed to achieve aims in the proposal approved by the IMPAACT Network. Mechanism: Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.

Locations

BO (2); ZI (3); MA (2); ZA (1)