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

NCT04024488 | Terminated Results DMC

• 2 other identifiers: IMPAACT 2016DAIDS ID #38506
• Study Type: interventional
• Target: 484
• Locations: 4 countries
• Sites: 8

Brief 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.

Conditions

HIV-1-infection

Keywords

Mental Health; Adherence; Trauma-Informed Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (4)

• Group-level Mean General Anxiety Disorder-7 (GAD-7) at 6 Months

  Average (standard deviation) of the group-level mean General Anxiety Disorder-7 (GAD-7) score within arm. The GAD-7 features 7 items assessing frequency of anxiety symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day". Responses to the 7 items are summed to obtain a GAD-7 score ranging from 0 (least) to 21 (most severe symptoms). A score of 10 or more points indicates moderate to severe anxiety symptoms.

  at 6 months

• Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA-PTSD-RI) at 6 Months

  Average (standard deviation) of the group-level mean UCLA Post Traumatic Stress Disorder-Reaction Index (PTSD-RI) score within arm. The UCLA PTSD-RI assesses DSM-IV criteria for PTSD in youth. If prior trauma is endorsed, assessment asks whether 31 PTSD symptoms have occurred within the past month on a scale from 0="None" to 4="Most of the time". A scoring algorithm is applied to the 31 items to calculate a score ranging from 0 (least) to 80 (most severe symptoms). A score of 35 or more indicates moderate to severe PTSD symptoms. If no trauma is endorsed, no score is calculated.

  at 6 months

• Group-level Mean Composite Mental Health Measure at 6 Months

  Average (standard deviation) of the group-level mean Composite score within arm. Composite scores are a study-specific measure of combined mental health symptoms. A participant's PHQ-9, GAD-7, and UCLA PTSD-RI scores at the given timepoint are each standardized according to baseline to get Z scores. The 3 Z scores are summed to obtain a Composite score. Composite scores are not Z scores themselves and can range from -Inf to +Inf, with greater scores reflecting more severe symptoms overall. Composite scores of 0 at baseline represent average symptom levels overall, but otherwise do not have a meaningful central value.

  at 6 months

• Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at 6 Months

  Average (standard deviation) of the group-level mean Patient Health Questionnaire-9 (PHQ-9) score within arm. The PHQ-9 features 9 items assessing the frequency of depression symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day". Responses to the 9 items are summed to obtain a PHQ-9 score ranging from 0 (least) to 27 (most severe symptoms). A score of 10 or more points indicates moderate to severe depression symptoms.

  at 6 months

Secondary Outcomes (8)

• Group-level Mean General Anxiety Disorder-7 (GAD-7) at IPL (Immediately Post-Last Group Session)

  After initial treatment completion (initial treatment lasted an average of 6 weeks)

• Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at IPL (Immediately Post Last Group Session)

  After initial treatment completion (initial treatment lasted an average of 6 weeks)

• Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) at IPL (Immediately Post-Last Group Session)

  After initial treatment completion (initial treatment lasted an average of 6 weeks)

• Group-level Mean Composite Mental Health Measure at IPL (Immediately Post-Last Group Session)

  After initial treatment completion (initial treatment lasted an average of 6 weeks)

• Group-level Mean ART Adherence at 6 Months

  at 6 months

Study Arms (4)

Youth TI-CBT Intervention Arm

EXPERIMENTAL

For youth, the TI-CBT intervention arm consisted of six 2-hour TI-CBT group sessions led by Indigenous Youth Leaders (IYL) during weeks 1 to 8 and one 2-hour booster group session at 6-months. The TI-CBT Intervention was delivered in a group format. The TI-CBT Intervention arm had 15 groups with an average of 8.5 youth per group (range 6-11).

Behavioral: Youth TI-CBT Intervention Arm

Youth Discussion Control Arm

ACTIVE COMPARATOR

For youth, the Discussion Control arm consisted of six 2-hour discussion group sessions led by IYL during weeks 1 to 8 and one 2-hour booster discussion group session at 6 months. The Discussion Control was delivered in a group format. The Discussion Control arm had 15 groups with an average of 8.4 youth per group (range 5-10).

Behavioral: Youth Discussion Control Arm

Caregiver TI-CBT Intervention Arm

EXPERIMENTAL

For caregivers, the TI-CBT Intervention arm consisted of two 2-hour TI-CBT group sessions on two separate weeks within 8 weeks of their youth's first group session and one 2-hour booster group session at 6-months led by adult study staff. The TI-CBT Intervention was delivered in group format. The TI-CBT Intervention arm had 15 groups with an average of 7.7 caregivers per group (range 5-10).

Behavioral: Caregiver TI-CBT Intervention Arm

Caregivers Discussion Control Arm

ACTIVE COMPARATOR

For caregivers, the Discussion Control arm consisted of: two 2-hour discussion group sessions on two separate weeks within 8 weeks of their youth's first group session and one 2-hour booster discussion group session at 6 months led by adult study staff. The Discussion Control intervention was delivered in a group format. The Discussion Control arm had 15 groups with an average of 7.6 caregivers per group (range 3-10).

Behavioral: Caregiver Discussion Control Arm

Interventions

Youth TI-CBT Intervention Arm BEHAVIORAL

For youth, each TI-CBT group session was led by IYL. 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 Intervention Manuals were distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial.

Youth TI-CBT Intervention Arm

Youth Discussion Control Arm BEHAVIORAL

For youth, each discussion group session was led by IYL. Discussion topics were selected by youth in the group. Discussion Control sessions took place at a separate time from TI-CBT Intervention sessions to minimize contamination. Youth and caregiver group sessions were also held separately.

Youth Discussion Control Arm

Caregiver TI-CBT Intervention Arm BEHAVIORAL

For caregivers, each TI-CBT group session was led by adult study staff. 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 strategies to relax and these are integrated at the beginning and end of each session. TI-CBT Caregiver Intervention Manuals were distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial.

Caregiver TI-CBT Intervention Arm

Caregiver Discussion Control Arm BEHAVIORAL

For caregivers, each discussion group session was led by adult study staff. Discussion topics were selected by caregivers in the group. Discussion Control sessions took place at a separate time from TI-CBT Intervention sessions to minimize contamination. Youth and caregiver group sessions were also held separately.

Caregivers Discussion Control Arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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.
• 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 Publications (6)

• Dow DE, Libous J, Ponatshego PL, Masheto G, Mvalo T, Payesa C, Buckley J, Stranix-Chibanda L, Nematadzira T, Vhembo T, Ace A, Warshaw M, Townley E, Lee S, Allison S, Donenberg G and the IMPAACT 2016 Team. High levels of mental distress among youth with HIV in Southern Africa: A description of enrollment into IMPAACT 2016, a randomized controlled trial of a peer-led, group-based mental health intervention. Presented at IAS, Kigali, Rwanda, 15 July 2025.

  RESULT

• Libous J, Jeffrey R, George K, Montañez N, Warshaw M, Shakes Raesi M, Ponatshego PL, Maliwichi L, Vhembo T, Mutasa T, Bere CT, Galvin L, Townley E, Varechtchouk O, Dow D, Donenberg G, and the IMPAACT 2016 Team. IMPAACT 2016: The ADAPT-ITT Framework Leveraging Youth and Supporter Voices in the Adaptation of a Trauma-Informed Cognitive Behavioral Therapy Group-Based Intervention for Youth Living with HIV and Mental Health Distress. Presented at Fast Track Cities, Paris, France, 13-15 October 2024.

  RESULT

• Vhemo T, Mhembere T, Mbengeranwa T, Bere TC, Mutasa T, Katsande R, Gumbo J, Mudzonga N, Nematadzira T, Maturure SJ, Mandima PF, Maonera S, Stranix-Chibanda L. High Prevalence of Common Mental Health Disorders Amongst Adolescents With HIV in Zimbabwe: IMPAACT 2016; Presented at International Workshop on Pediatrics & HIV, Munich, Germany, 19-20 July 2024.

  RESULT

• Libous JL, Montañez N, Donenberg G, Kapetanovic S, Dow D. IMPAACT 2016: Operationalizing the ADAPT-ITT Model to drive local adaptation of an intervention to improve mental health and medication adherence in youth living with HIV. Presented at Society for Clinical Research Associates 29th Annual Conference, Virtual, 23-26 September 2020.

  RESULT

• Warshaw M, Dow D, Kapetanovic S, Libous J, Reding C, Montañez , Donenberg G. IMPAACT 2016: Interdisciplinary Collaboration at Multiple Levels. Society for Clinical Trials 41st Annual Meeting, Baltimore, MD (Virtual), 2020.

  RESULT

• Libous JL, Montanez NA, Dow DE, Kapetanovic S, Buckley J, Kakhu TJ, Kamthunzi P, Maliwichi LA, Vhembo T, Chawana TD, Nematadzira T, Donenberg GR. IMPAACT 2016: Operationalizing HIV Intervention Adaptations to Inform the Science and Outcomes of Implementation. Front Reprod Health. 2021 May 28;3:662912. doi: 10.3389/frph.2021.662912. eCollection 2021.

  PMID: 36303985 RESULT

Related Links

• IMPAACT 2016 web page
• The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1 (July 2017)
• Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Limitations and Caveats

1. Due to gender stratification, 12 youth were assigned five to one arm and seven to another. To meet the requirement of six youth per arm, per protocol, the last youth and their caregiver were reassigned to the Discussion arm 2. Due to funding constraints the study was closed early 3. Thirty-seven percent of youth with a Month 6 assessment and twenty-one percent of youth with an IPL assessment did not endorse a trauma, and subsequently did not receive a UCLA PTSD-RI or Composite score.

Results Point of Contact

• Title: IMPAACT Clinicaltrials.gov Coordinator
• Organization: Family Health International (FHI 360)

IMPAACT.ctgov@fstrf.org

(919) 405-1429

Study Officials

• Dorothy Dow, MD, MSc

  Duke University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 were randomized in a 1:1 ratio to one of two study arms: TI-CBT Intervention or Discussion Control. Participating caregivers were assigned to the same arm as their youth. For youth, the TI-CBT Intervention arm consisted of six 2-hour TI-CBT group sessions led by Indigenous Youth Leaders (IYL) during weeks 1 to 8 and one 2-hour booster group session at 6 months. The caregivers of youth who were enrolled in the TI-CBT Intervention arm received two 2-hour group sessions led by adult study staff during weeks 1 to 8 and one 2-hour booster group session at 6 months. The Youth Discussion Control arm consisted of six 2-hour discussion group sessions led by IYL during weeks 1 to 8 and one 2-hour booster discussion group session at 6 months. The caregivers of youth randomized to the Discussion Control arm had two 2-hour discussion group sessions led by adult study staff during weeks 1 to 8 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: April 6, 2024
• Primary Completion: March 27, 2025
• Study Completion: June 5, 2025
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

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/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.

Locations

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