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

HIV-1-infection Clinical Trial

Official title:

IMPAACT 2016 - Evaluating a Group-Based Intervention to Improve Mental Health and Antiretroviral Therapy (ART) Adherence Among Youth Living With HIV in Low Resource Settings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04024488
• Other study ID #: IMPAACT 2016
• Secondary ID: DAIDS ID #38506
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2024
• Source: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Contact: Nicole Montañez, MSW
• Phone: 919-544-7040
• Email: nmontanez[@]fhi360.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: September 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Behavioral:
• TI-CBT Intervention Arm
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.
• Discussion Control Arm
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.

Locations

Country	Name	City	State
Botswana	Gaborone Prevention/Treatment Trials CRS 12701	Gaborone
Botswana	Molepolole Prevention/Treatment Trials CRS 12702	Molepolole
Malawi	College of Medicine CRS 30301	Blantyre
Malawi	University of North Carolina Lilongwe CRS 12001	Lilongwe
South Africa	Soweto IMPAACT CRS 8052	Soweto
Zimbabwe	St. Mary's CRS 30303	Chitungwiza
Zimbabwe	Harare Family Care CRS 31890	Harare
Zimbabwe	Seke North CRS 30306	Harare

Sponsors (4)

Lead Sponsor	Collaborator
International Maternal Pediatric Adolescent AIDS Clinical Trials Group	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

Botswana,  Malawi,  South Africa,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire-9	(PHQ-9, measure of depression: range 0-27, higher=worse)	at 6-months
Primary	General Anxiety Disorder-7	(GAD-7, measure of anxiety: range 0-21, higher=worse)	at 6-months
Primary	UCLA Post-Traumatic Stress Disorder-Reaction Index	(UCLA PTSD-RI, measure of TPSD: range 0-51, higher=worse)	at 6-months
Primary	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	Patient Health Questionnaire-9	(PHQ-9, measure of depression: range 0-27, higher=worse)	after initial treatment completion (an average of 6 weeks)
Secondary	General Anxiety Disorder-7	(PHQ-9, measure of depression: range 0-27, higher=worse)	after initial treatment completion (an average of 6 weeks)
Secondary	UCLA Post-Traumatic Stress Disorder-Reaction Index	(UCLA PTSD-RI, measure of TPSD: range 0-51, higher=worse)	after initial treatment completion (an average of 6 weeks)
Secondary	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)	after initial treatment completion (an average of 6 weeks)
Secondary	ART Adherence	Self-report - Wilson 3-item scale (range 0-100, higher=better)	after initial treatment completion (an average of 6 weeks), and at 6-months
Secondary	Viral Load	HIV-1 RNA	after initial treatment completion (an average of 6 weeks), and at 6-months

External Links

•   IMPAACT 2016 web page