Clinical trial NCT04024488: Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV-1-infection
Keywords: Mental Health
Adherence
Trauma-Informed Cognitive Behavioral Therapy
Lead sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Mental Health (NIMH)
First posted: 2019-07-18
Enrollment: 256
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: at 6-months
measure: General Anxiety Disorder-7
timeFrame: at 6-months
measure: UCLA Post-Traumatic Stress Disorder-Reaction Index
timeFrame: at 6-months
measure: Composite mental health measure
timeFrame: at 6-months
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: after initial treatment completion (an average of 6 weeks)
measure: General Anxiety Disorder-7
timeFrame: after initial treatment completion (an average of 6 weeks)
measure: UCLA Post-Traumatic Stress Disorder-Reaction Index
timeFrame: after initial treatment completion (an average of 6 weeks)
measure: Composite mental health measure
timeFrame: after initial treatment completion (an average of 6 weeks)
measure: ART Adherence
timeFrame: after initial treatment completion (an average of 6 weeks), and at 6-months
measure: Viral Load
timeFrame: after initial treatment completion (an average of 6 weeks), and at 6-months
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Gaborone Prevention/Treatment Trials CRS 12701
city: Molepolole
country: Botswana
facility: Molepolole Prevention/Treatment Trials CRS 12702
city: Blantyre
country: Malawi
facility: College of Medicine CRS 30301
city: Lilongwe
country: Malawi
facility: University of North Carolina Lilongwe CRS 12001
city: Soweto
country: South Africa
facility: Soweto IMPAACT CRS 8052
city: Chitungwiza
country: Zimbabwe
facility: St. Mary's CRS 30303
city: Harare
country: Zimbabwe
facility: Harare Family Care CRS 31890
city: Harare
country: Zimbabwe
facility: Seke North CRS 30306
Study officials:
affiliation: University of Illinois at Chicago
name: Geri Donenberg, PhD
role: STUDY_CHAIR
affiliation: Duke University
name: Dorothy Dow, MD, MSc
role: STUDY_CHAIR
affiliation: University of Southern California
name: Suad Kapetanovic, MD
role: PRINCIPAL_INVESTIGATOR
References: