Trial Outcomes & Findings for Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings (NCT NCT04024488)

Last Updated: 2026-05-22

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

484 participants

Primary outcome timeframe

at 6 months

Results posted on

2026-05-22

Participant Flow

Accrual occurred between April 2024 and October 2024 in Botswana, Malawi, South Africa, and Zimbabwe at 8 different sites. The first participant was enrolled on 6 April 2024 and the trial closed to accrual on 7 October 2024.

No data for focus groups or pilot tests is reported because participant data was not collected by focus groups and the pilot consent form stated that collected data would not be analyzed. The data reported for all group-level measures reflect an aggregate of the 15 groups in each arm, instead of the individual participants in each arm.

Participant milestones

Participant milestones
Measure	Youth TI-CBT Intervention Arm 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).	Youth Discussion Control Arm 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).	Caregiver TI-CBT Intervention Arm 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).	Caregivers Discussion Control Arm 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).
Overall Study STARTED	128	126	116	114
Overall Study COMPLETED	128	126	115	113
Overall Study NOT COMPLETED	0	0	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This baseline characteristic was not collected for caregivers.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Youth TI-CBT Intervention Arm n=128 Participants 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).	Youth Discussion Control Arm n=126 Participants 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).	Caregiver TI-CBT Intervention Arm n=116 Participants 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).	Caregiver Discussion Control Arm n=114 Participants 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).	Total n=484 Participants Total of all reporting groups
Age, Continuous	17.3 Years STANDARD_DEVIATION 1.3 • n=128 Participants	17.3 Years STANDARD_DEVIATION 1.4 • n=126 Participants	42.6 Years STANDARD_DEVIATION 11.5 • n=116 Participants	41.9 Years STANDARD_DEVIATION 11.1 • n=114 Participants	29.1 Years STANDARD_DEVIATION 14.7 • n=484 Participants
Sex: Female, Male Female	72 Participants n=128 Participants	72 Participants n=126 Participants	104 Participants n=116 Participants	95 Participants n=114 Participants	343 Participants n=484 Participants
Sex: Female, Male Male	56 Participants n=128 Participants	54 Participants n=126 Participants	12 Participants n=116 Participants	19 Participants n=114 Participants	141 Participants n=484 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=128 Participants	0 Participants n=126 Participants	0 Participants n=116 Participants	0 Participants n=114 Participants	0 Participants n=484 Participants
Race (NIH/OMB) Asian	0 Participants n=128 Participants	0 Participants n=126 Participants	0 Participants n=116 Participants	0 Participants n=114 Participants	0 Participants n=484 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=128 Participants	0 Participants n=126 Participants	0 Participants n=116 Participants	0 Participants n=114 Participants	0 Participants n=484 Participants
Race (NIH/OMB) Black or African American	128 Participants n=128 Participants	126 Participants n=126 Participants	116 Participants n=116 Participants	114 Participants n=114 Participants	484 Participants n=484 Participants
Race (NIH/OMB) White	0 Participants n=128 Participants	0 Participants n=126 Participants	0 Participants n=116 Participants	0 Participants n=114 Participants	0 Participants n=484 Participants
Race (NIH/OMB) More than one race	0 Participants n=128 Participants	0 Participants n=126 Participants	0 Participants n=116 Participants	0 Participants n=114 Participants	0 Participants n=484 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=128 Participants	0 Participants n=126 Participants	0 Participants n=116 Participants	0 Participants n=114 Participants	0 Participants n=484 Participants
Region of Enrollment Zimbabwe	60 Participants n=128 Participants	58 Participants n=126 Participants	59 Participants n=116 Participants	58 Participants n=114 Participants	235 Participants n=484 Participants
Region of Enrollment Malawi	32 Participants n=128 Participants	34 Participants n=126 Participants	31 Participants n=116 Participants	28 Participants n=114 Participants	125 Participants n=484 Participants
Region of Enrollment Botswana	26 Participants n=128 Participants	24 Participants n=126 Participants	21 Participants n=116 Participants	20 Participants n=114 Participants	91 Participants n=484 Participants
Region of Enrollment South Africa	10 Participants n=128 Participants	10 Participants n=126 Participants	5 Participants n=116 Participants	8 Participants n=114 Participants	33 Participants n=484 Participants
Group-level mean age	17.3 Years STANDARD_DEVIATION 0.5 • n=128 Participants	17.3 Years STANDARD_DEVIATION 0.6 • n=126 Participants	43 Years STANDARD_DEVIATION 4.1 • n=116 Participants	41.7 Years STANDARD_DEVIATION 4.4 • n=114 Participants	29.8 Years STANDARD_DEVIATION 13.0 • n=484 Participants
Highest level of education attained Some primary	44 Participants n=128 Participants	44 Participants n=126 Participants	39 Participants n=116 Participants	28 Participants n=114 Participants	155 Participants n=484 Participants
Highest level of education attained Some secondary	81 Participants n=128 Participants	78 Participants n=126 Participants	68 Participants n=116 Participants	75 Participants n=114 Participants	302 Participants n=484 Participants
Highest level of education attained Vocational	2 Participants n=128 Participants	2 Participants n=126 Participants	5 Participants n=116 Participants	3 Participants n=114 Participants	12 Participants n=484 Participants
Highest level of education attained University	1 Participants n=128 Participants	2 Participants n=126 Participants	4 Participants n=116 Participants	8 Participants n=114 Participants	15 Participants n=484 Participants
Enrolled in school	20 Participants n=128 Participants • This baseline characteristic was not collected for caregivers.	17 Participants n=126 Participants • This baseline characteristic was not collected for caregivers.	—	—	37 Participants n=254 Participants • This baseline characteristic was not collected for caregivers.
Working outside of home	16 Participants n=128 Participants	18 Participants n=126 Participants	47 Participants n=116 Participants	44 Participants n=114 Participants	125 Participants n=484 Participants
Owns a cellphone	78 Participants n=128 Participants • This baseline characteristic was not collected for the caregivers.	69 Participants n=126 Participants • This baseline characteristic was not collected for the caregivers.	—	—	147 Participants n=254 Participants • This baseline characteristic was not collected for the caregivers.
Housing with electricity	76 Participants n=128 Participants • This baseline characteristic was not collected for caregivers.	83 Participants n=126 Participants • This baseline characteristic was not collected for caregivers.	—	—	159 Participants n=254 Participants • This baseline characteristic was not collected for caregivers.
Housing with pipe water	39 Participants n=128 Participants • This baseline characteristic was not collected for caregivers.	41 Participants n=126 Participants • This baseline characteristic was not collected for caregivers.	—	—	80 Participants n=254 Participants • This baseline characteristic was not collected for caregivers.
Group-level percentage of female participants	56 Percentage STANDARD_DEVIATION 7 • n=128 Participants	58.1 Percentage STANDARD_DEVIATION 13.8 • n=126 Participants	89.1 Percentage STANDARD_DEVIATION 10.8 • n=116 Participants	81 Percentage STANDARD_DEVIATION 18.7 • n=114 Participants	71.1 Percentage STANDARD_DEVIATION 19.4 • n=484 Participants
Group-level percentage of participants enrolled in school	17.4 Percentage STANDARD_DEVIATION 17.1 • n=128 Participants • This baseline characteristic was not collected for caregivers.	14.5 Percentage STANDARD_DEVIATION 11.9 • n=126 Participants • This baseline characteristic was not collected for caregivers.	—	—	16 Percentage STANDARD_DEVIATION 14.5 • n=254 Participants • This baseline characteristic was not collected for caregivers.
Group-level percentage of participants with some secondary education	64.9 Percentage STANDARD_DEVIATION 20.9 • n=128 Participants	64.4 Percentage STANDARD_DEVIATION 20.6 • n=126 Participants	60.5 Percentage STANDARD_DEVIATION 19.2 • n=116 Participants	64.8 Percentage STANDARD_DEVIATION 17.6 • n=114 Participants	63.6 Percentage STANDARD_DEVIATION 19.2 • n=484 Participants
Group-level percentage of participants working outside home	12 Percentage STANDARD_DEVIATION 11.8 • n=128 Participants	15 Percentage STANDARD_DEVIATION 13.1 • n=126 Participants	41.9 Percentage STANDARD_DEVIATION 16.7 • n=116 Participants	38.7 Percentage STANDARD_DEVIATION 21.5 • n=114 Participants	26.9 Percentage STANDARD_DEVIATION 20.9 • n=484 Participants
Group-level percentage of participants virally suppressed (<200 copies/mL)	91.2 Percentage STANDARD_DEVIATION 8.3 • n=128 Participants • This baseline characteristic was not collected for the caregivers.	87.8 Percentage STANDARD_DEVIATION 11.5 • n=126 Participants • This baseline characteristic was not collected for the caregivers.	—	—	89.5 Percentage STANDARD_DEVIATION 10 • n=254 Participants • This baseline characteristic was not collected for the caregivers.
HIV-1 RNA (copies/mL) <40	110 Participants n=128 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.	107 Participants n=126 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.	—	—	217 Participants n=254 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.
HIV-1 RNA (copies/mL) 40 to <200	7 Participants n=128 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.	3 Participants n=126 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.	—	—	10 Participants n=254 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.
Group-level mean ART adherence score	72.7 Score STANDARD_DEVIATION 7.6 • n=128 Participants • The adherence score was not collected for the caragivers.	76.4 Score STANDARD_DEVIATION 7.2 • n=126 Participants • The adherence score was not collected for the caragivers.	—	—	74.6 Score STANDARD_DEVIATION 7.5 • n=254 Participants • The adherence score was not collected for the caragivers.
Group-level mean UCLA PTSD-RI score	41.1 Score STANDARD_DEVIATION 7.8 • n=128 Participants • Three youth participants in the Discussion Control arm did not endorse any trauma and were excluded from calculation of the group-level mean. UCLA PTSD-RI score was not collected for the caregivers.	42.4 Score STANDARD_DEVIATION 6.8 • n=123 Participants • Three youth participants in the Discussion Control arm did not endorse any trauma and were excluded from calculation of the group-level mean. UCLA PTSD-RI score was not collected for the caregivers.	—	—	41.7 Score STANDARD_DEVIATION 7.2 • n=251 Participants • Three youth participants in the Discussion Control arm did not endorse any trauma and were excluded from calculation of the group-level mean. UCLA PTSD-RI score was not collected for the caregivers.
Group-level mean PHQ-9 score	12.2 Score STANDARD_DEVIATION 2.0 • n=128 Participants • The PHQ-9 score was not collected for caregivers.	12.6 Score STANDARD_DEVIATION 2.3 • n=126 Participants • The PHQ-9 score was not collected for caregivers.	—	—	12.4 Score STANDARD_DEVIATION 2.1 • n=254 Participants • The PHQ-9 score was not collected for caregivers.
Group-level mean GAD-7 score	9.9 Score STANDARD_DEVIATION 1.8 • n=128 Participants • The GAD-7 score was not collected for the caregivers.	10.1 Score STANDARD_DEVIATION 1.3 • n=126 Participants • The GAD-7 score was not collected for the caregivers.	—	—	10 Score STANDARD_DEVIATION 1.6 • n=254 Participants • The GAD-7 score was not collected for the caregivers.
Group-level mean Composite score	-0.1 Score STANDARD_DEVIATION 1.1 • n=128 Participants • Three youth participants in the Discussion Control arm did not endorse any trauma, and were excluded from calculation of the group-level mean. The composite score was not collected for the caregivers.	0.2 Score STANDARD_DEVIATION 0.8 • n=123 Participants • Three youth participants in the Discussion Control arm did not endorse any trauma, and were excluded from calculation of the group-level mean. The composite score was not collected for the caregivers.	—	—	0.1 Score STANDARD_DEVIATION 0.9 • n=251 Participants • Three youth participants in the Discussion Control arm did not endorse any trauma, and were excluded from calculation of the group-level mean. The composite score was not collected for the caregivers.
Group-level mean HIV stigma score	15 Score STANDARD_DEVIATION 7.4 • n=128 Participants • One youth in the Discussion Control arm completed the survey but selected "prefer not to answer" for all items and was excluded from calculation of the group-level mean.	15.6 Score STANDARD_DEVIATION 7.0 • n=125 Participants • One youth in the Discussion Control arm completed the survey but selected "prefer not to answer" for all items and was excluded from calculation of the group-level mean.	10.2 Score STANDARD_DEVIATION 5.5 • n=116 Participants • One youth in the Discussion Control arm completed the survey but selected "prefer not to answer" for all items and was excluded from calculation of the group-level mean.	7.6 Score STANDARD_DEVIATION 4.9 • n=114 Participants • One youth in the Discussion Control arm completed the survey but selected "prefer not to answer" for all items and was excluded from calculation of the group-level mean.	12.1 Score STANDARD_DEVIATION 7.0 • n=483 Participants • One youth in the Discussion Control arm completed the survey but selected "prefer not to answer" for all items and was excluded from calculation of the group-level mean.
Composite score	-0.2 Score STANDARD_DEVIATION 2.2 • n=128 Participants • The composite score was not collected for the caregivers.	0.2 Score STANDARD_DEVIATION 2.4 • n=126 Participants • The composite score was not collected for the caregivers.	—	—	0.0 Score STANDARD_DEVIATION 2.3 • n=254 Participants • The composite score was not collected for the caregivers.
UCLA PTSD-RI score	40.3 Score STANDARD_DEVIATION 15.6 • n=128 Participants • Three youth participants did not endorse any trauma. UCLA PTSD-RI score was not collected for the caregivers.	42.1 Score STANDARD_DEVIATION 17.5 • n=123 Participants • Three youth participants did not endorse any trauma. UCLA PTSD-RI score was not collected for the caregivers.	—	—	42.1 Score STANDARD_DEVIATION 17.5 • n=251 Participants • Three youth participants did not endorse any trauma. UCLA PTSD-RI score was not collected for the caregivers.
PHQ-9 score	12.1 Score STANDARD_DEVIATION 4.7 • n=128 Participants • The PHQ-9 score was not collected for the caregivers.	12.8 Score STANDARD_DEVIATION 5.4 • n=126 Participants • The PHQ-9 score was not collected for the caregivers.	—	—	12.4 Score STANDARD_DEVIATION 5.1 • n=254 Participants • The PHQ-9 score was not collected for the caregivers.
GAD-7 score	9.8 Score STANDARD_DEVIATION 4.9 • n=128 Participants • The GAD-7 score was not collected for the caregivers.	10.1 Score STANDARD_DEVIATION 4.1 • n=126 Participants • The GAD-7 score was not collected for the caregivers.	—	—	9.9 Score STANDARD_DEVIATION 4.5 • n=254 Participants • The GAD-7 score was not collected for the caregivers.
Virally suppressed (< 200 copies/mL)	117 Participants n=128 Participants • The viral load was not collected from the caregivers.	110 Participants n=126 Participants • The viral load was not collected from the caregivers.	—	—	227 Participants n=254 Participants • The viral load was not collected from the caregivers.
ART adherence score	73.6 Score STANDARD_DEVIATION 19 • n=128 Participants • The ART adherence score was not collected for the caregivers.	76.2 Score STANDARD_DEVIATION 17.6 • n=126 Participants • The ART adherence score was not collected for the caregivers.	—	—	74.9 Score STANDARD_DEVIATION 18.3 • n=254 Participants • The ART adherence score was not collected for the caregivers.
HIV stigma score	15 Score STANDARD_DEVIATION 19.4 • n=128 Participants	15.3 Score STANDARD_DEVIATION 16.4 • n=126 Participants	9.5 Score STANDARD_DEVIATION 15.9 • n=116 Participants	7.7 Score STANDARD_DEVIATION 13.4 • n=114 Participants	12.0 Score STANDARD_DEVIATION 16.8 • n=484 Participants
HIV-1 RNA (copies/mL) 200 to <1,000	2 Participants n=128 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.	3 Participants n=126 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.	—	—	5 Participants n=254 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.
HIV-1 RNA (copies/mL) 1,000 to <10,000	6 Participants n=128 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.	5 Participants n=126 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.	—	—	11 Participants n=254 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.
HIV-1 RNA (copies/mL) >=10,000	3 Participants n=128 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.	8 Participants n=126 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.	—	—	11 Participants n=254 Participants • The HIV-1 RNA (copies/mL) count was not collected for the caregivers.

PRIMARY outcome

Timeframe: at 6 months

Population: Youth participants who completed month 6 assessments. GAD-7 scores were not collected for caregivers. Primary outcomes were analyzed with groups as the analytic units due to the presence of intracluster correlation among participants in the same group.

Outcome measures

Outcome measures
Measure	Youth TI-CBT Intervention Arm n=127 Participants 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).	Youth Discussion Control Arm n=124 Participants 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).
Group-level Mean General Anxiety Disorder-7 (GAD-7) at 6 Months	4.51 Score Standard Deviation 2.1	4.29 Score Standard Deviation 1.7

PRIMARY outcome

Timeframe: at 6 months

Population: Youth participants who completed Month 6 assessment and endorsed prior trauma. Thirty-seven percent of youth with a Month 6 assessment did not endorse a trauma and subsequently did not get scored for trauma and were excluded from calculation of the group-level means. UCLA PTSD-RI scores were not collected for caregivers. Primary outcomes were analyzed with groups as the analytic units due to the presence of intracluster correlation among participants in the same group.

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.

Outcome measures

Outcome measures
Measure	Youth TI-CBT Intervention Arm n=75 Participants 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).	Youth Discussion Control Arm n=84 Participants 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).
Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA-PTSD-RI) at 6 Months	21.72 Score Standard Deviation 11.0	15.88 Score Standard Deviation 8.7

PRIMARY outcome

Timeframe: at 6 months

Population: Youth participants that completed Month 6 assessment and endorsed prior trauma. Thirty-seven percent of youth with a Month 6 assessment did not endorse a trauma and subsequently did not get scored for trauma and were excluded from calculation of the group-level means. Composite scores were not collected for caregivers. Primary outcomes were analyzed with groups as the analytic units due to the presence of intracluster correlation among participants in the same group.

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.

Outcome measures

Outcome measures
Measure	Youth TI-CBT Intervention Arm n=75 Participants 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).	Youth Discussion Control Arm n=84 Participants 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).
Group-level Mean Composite Mental Health Measure at 6 Months	-3.23 Score Standard Deviation 1.8	-4.09 Score Standard Deviation 1.4

PRIMARY outcome

Timeframe: at 6 months

Population: Youth participants who completed Month 6 assessment. PHQ-9 scores were not collected for caregivers. Primary outcomes were analyzed with groups as the analytic units due to the presence of intracluster correlation among participants in the same group.

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.

Outcome measures

Outcome measures
Measure	Youth TI-CBT Intervention Arm n=127 Participants 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).	Youth Discussion Control Arm n=124 Participants 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).
Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at 6 Months	5.36 Score Standard Deviation 2.8	5.41 Score Standard Deviation 1.9

SECONDARY outcome

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

Population: Youth participants who completed IPL (Immediately Post-Last Group Session) assessment. GAD-7 scores were not collected for caregivers. Primary outcomes were analyzed with groups as the analytic units due to the presence of intracluster correlation among participants in the same group.

Outcome measures

Outcome measures
Measure	Youth TI-CBT Intervention Arm n=128 Participants 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).	Youth Discussion Control Arm n=124 Participants 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).
Group-level Mean General Anxiety Disorder-7 (GAD-7) at IPL (Immediately Post-Last Group Session)	4.92 Score Standard Deviation 1.8	4.63 Score Standard Deviation 1.6

SECONDARY outcome

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

Population: Youth participants who completed IPL (Immediately Post Last Group Session) assessment. PHQ-9 scores were not collected for caregivers. Primary outcomes were analyzed with groups as the analytic units due to the presence of intracluster correlation among participants in the same group.

Outcome measures

Outcome measures
Measure	Youth TI-CBT Intervention Arm n=128 Participants 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).	Youth Discussion Control Arm n=124 Participants 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).
Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at IPL (Immediately Post Last Group Session)	5.81 Score Standard Deviation 2.2	6.13 Score Standard Deviation 2.4

SECONDARY outcome

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

Population: Youth participants who completed IPL (Immediately Post-Last Group Session) assessment and endorsed prior trauma. Twenty-one percent of youth who completed IPL assessment did not endorse a trauma, and subsequently did not get scored for trauma and were excluded from group-level mean calculation. UCLA PTSD-RI scores were not collected for caregivers. Outcomes were analyzed with groups as the analytic units due to the presence of intracluster correlation among participants in the same group.

Outcome measures

Outcome measures
Measure	Youth TI-CBT Intervention Arm n=102 Participants 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).	Youth Discussion Control Arm n=97 Participants 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).
Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) at IPL (Immediately Post-Last Group Session)	20.32 Score Standard Deviation 9.0	19.0 Score Standard Deviation 7.4

SECONDARY outcome

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

Population: Youth participants who completed IPL (Immediately Post-Last Group Session) assessment and endorsed prior trauma. Twenty-one percent of youth who completed IPL assessment did not endorse a trauma, and subsequently did not get scored for trauma and were excluded from group-level mean calculation Composite scores were not collected for caregivers. Primary outcomes were analyzed with groups as the analytic units due to the presence of intracluster correlation among participants in the same group.

Outcome measures

Outcome measures
Measure	Youth TI-CBT Intervention Arm n=102 Participants 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).	Youth Discussion Control Arm n=97 Participants 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).
Group-level Mean Composite Mental Health Measure at IPL (Immediately Post-Last Group Session)	-3.50 Score Standard Deviation 1.2	-3.76 Score Standard Deviation 1.3

SECONDARY outcome

Timeframe: at 6 months

Population: Youth participants who completed Month 6 assessment. ART adherence scores were not collected for caregivers. Outcomes were analyzed with groups as the analytic units due to the presence of intracluster correlation among participants in the same group.

Average (standard deviation) of the group-level mean antiretroviral therapy (ART) adherence score within arm. The Wilson 3-Item Adherence Scale assessed self-reported ART adherence. Within the past 30 days, the 3 items correspond to missed daily doses (0-30), adherence to medication instructions ("Very poor" to "Excellent"), and frequency of perfect use ("Never" to "Always"). Responses on the three items are transformed linearly to scores between 0 and 100 points and averaged to obtain a single score. Scores range from 0 (worst) possible adherence to 100 (best possible adherence).

Outcome measures

Outcome measures
Measure	Youth TI-CBT Intervention Arm n=128 Participants 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).	Youth Discussion Control Arm n=124 Participants 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).
Group-level Mean ART Adherence at 6 Months	77.89 Score Standard Deviation 5.8	78.28 Score Standard Deviation 4.5

SECONDARY outcome

Timeframe: at 6 months

Population: All youth participants with viral load data at Month 6. Viral load data was not collected for caregivers.

HIV-1 RNA

Outcome measures

Outcome measures
Measure	Youth TI-CBT Intervention Arm n=126 Participants 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).	Youth Discussion Control Arm n=124 Participants 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).
Viral Load at 6 Months < 40 copies/mL	102 copies/mL	104 copies/mL
Viral Load at 6 Months 40 - <200 copies/mL	7 copies/mL	5 copies/mL
Viral Load at 6 Months 200 - < 1,000 copies/mL	4 copies/mL	4 copies/mL
Viral Load at 6 Months 1,000 - < 10,000 copies/mL at month 6	8 copies/mL	6 copies/mL
Viral Load at 6 Months >= 10,000 copies/mL	5 copies/mL	5 copies/mL

SECONDARY outcome

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

Population: Youth participants that completed IPL (Immediately Post-Last Group Session) assessment. ART adherence scores were not collected for caregivers. Outcomes were analyzed with groups as the analytic units due to the presence of intracluster correlation among participants in the same group.

Self-report - Wilson 3-item scale (range 0-100, higher=better)

Outcome measures

Outcome measures
Measure	Youth TI-CBT Intervention Arm n=128 Participants 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).	Youth Discussion Control Arm n=124 Participants 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).
Group-level Mean ART Adherence at IPL (Immediately Post-Last Group Session).	79.09 Score Standard Deviation 6.2	80.81 Score Standard Deviation 4.4

SECONDARY outcome

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

Population: All youth participants with viral load data at IPL (Immediately Post-Last Group Session) assessment. Viral load data was not collected for caregivers.

HIV-1 RNA

Outcome measures

Outcome measures
Measure	Youth TI-CBT Intervention Arm n=128 Participants 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).	Youth Discussion Control Arm n=124 Participants 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).
Viral Load at IPL (Immediately Post-Last Group Session) < 40 copies/mL	112 copies/mL	103 copies/mL
Viral Load at IPL (Immediately Post-Last Group Session) 40 - <200 copies/mL	6 copies/mL	9 copies/mL
Viral Load at IPL (Immediately Post-Last Group Session) 200 - < 1,000 copies/mL	5 copies/mL	4 copies/mL
Viral Load at IPL (Immediately Post-Last Group Session) 1,000 - < 10,000 copies/mL	1 copies/mL	2 copies/mL
Viral Load at IPL (Immediately Post-Last Group Session) >= 10,000 copies/mL	4 copies/mL	6 copies/mL

Adverse Events

TI-CBT Intervention Arm

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Discussion Control Arm

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TI-CBT Intervention Arm n=128 participants at risk 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 6 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).	Discussion Control Arm n=126 participants at risk For youth, the Discussion Control arm consisted of six 2-hour discussion group sessions led by IYL during weeks 1 to 6 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).
Injury, poisoning and procedural complications Hand fracture	0.78% 1/128 • All safety events from study entry to the study completion up to month 12. Adverse events (AEs) were not monitored for focus groups/pilot tests. AEs were only monitored for youth trial participants and defined using the Manual for Expedited Reporting of Adverse Events to DAIDS (V2.0). Targeted AEs were grade 2 or higher suicidal ideation or attempt; grade 3 or higher psychiatric disorders or insomnia; and defined expedited adverse events (EAEs). All serious psychiatric adverse events were considered EAEs. No AEs were treatment-related.	0.00% 0/126 • All safety events from study entry to the study completion up to month 12. Adverse events (AEs) were not monitored for focus groups/pilot tests. AEs were only monitored for youth trial participants and defined using the Manual for Expedited Reporting of Adverse Events to DAIDS (V2.0). Targeted AEs were grade 2 or higher suicidal ideation or attempt; grade 3 or higher psychiatric disorders or insomnia; and defined expedited adverse events (EAEs). All serious psychiatric adverse events were considered EAEs. No AEs were treatment-related.
Psychiatric disorders Suicidal ideation	0.00% 0/128 • All safety events from study entry to the study completion up to month 12. Adverse events (AEs) were not monitored for focus groups/pilot tests. AEs were only monitored for youth trial participants and defined using the Manual for Expedited Reporting of Adverse Events to DAIDS (V2.0). Targeted AEs were grade 2 or higher suicidal ideation or attempt; grade 3 or higher psychiatric disorders or insomnia; and defined expedited adverse events (EAEs). All serious psychiatric adverse events were considered EAEs. No AEs were treatment-related.	0.79% 1/126 • All safety events from study entry to the study completion up to month 12. Adverse events (AEs) were not monitored for focus groups/pilot tests. AEs were only monitored for youth trial participants and defined using the Manual for Expedited Reporting of Adverse Events to DAIDS (V2.0). Targeted AEs were grade 2 or higher suicidal ideation or attempt; grade 3 or higher psychiatric disorders or insomnia; and defined expedited adverse events (EAEs). All serious psychiatric adverse events were considered EAEs. No AEs were treatment-related.
Psychiatric disorders Suicide attempt	0.78% 1/128 • All safety events from study entry to the study completion up to month 12. Adverse events (AEs) were not monitored for focus groups/pilot tests. AEs were only monitored for youth trial participants and defined using the Manual for Expedited Reporting of Adverse Events to DAIDS (V2.0). Targeted AEs were grade 2 or higher suicidal ideation or attempt; grade 3 or higher psychiatric disorders or insomnia; and defined expedited adverse events (EAEs). All serious psychiatric adverse events were considered EAEs. No AEs were treatment-related.	0.00% 0/126 • All safety events from study entry to the study completion up to month 12. Adverse events (AEs) were not monitored for focus groups/pilot tests. AEs were only monitored for youth trial participants and defined using the Manual for Expedited Reporting of Adverse Events to DAIDS (V2.0). Targeted AEs were grade 2 or higher suicidal ideation or attempt; grade 3 or higher psychiatric disorders or insomnia; and defined expedited adverse events (EAEs). All serious psychiatric adverse events were considered EAEs. No AEs were treatment-related.

Other adverse events

Other adverse events
Measure	TI-CBT Intervention Arm n=128 participants at risk 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 6 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).	Discussion Control Arm n=126 participants at risk For youth, the Discussion Control arm consisted of six 2-hour discussion group sessions led by IYL during weeks 1 to 6 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).
Psychiatric disorders Major depression	0.00% 0/128 • All safety events from study entry to the study completion up to month 12. Adverse events (AEs) were not monitored for focus groups/pilot tests. AEs were only monitored for youth trial participants and defined using the Manual for Expedited Reporting of Adverse Events to DAIDS (V2.0). Targeted AEs were grade 2 or higher suicidal ideation or attempt; grade 3 or higher psychiatric disorders or insomnia; and defined expedited adverse events (EAEs). All serious psychiatric adverse events were considered EAEs. No AEs were treatment-related.	0.79% 1/126 • All safety events from study entry to the study completion up to month 12. Adverse events (AEs) were not monitored for focus groups/pilot tests. AEs were only monitored for youth trial participants and defined using the Manual for Expedited Reporting of Adverse Events to DAIDS (V2.0). Targeted AEs were grade 2 or higher suicidal ideation or attempt; grade 3 or higher psychiatric disorders or insomnia; and defined expedited adverse events (EAEs). All serious psychiatric adverse events were considered EAEs. No AEs were treatment-related.
Psychiatric disorders Suicidal ideation	3.1% 4/128 • All safety events from study entry to the study completion up to month 12. Adverse events (AEs) were not monitored for focus groups/pilot tests. AEs were only monitored for youth trial participants and defined using the Manual for Expedited Reporting of Adverse Events to DAIDS (V2.0). Targeted AEs were grade 2 or higher suicidal ideation or attempt; grade 3 or higher psychiatric disorders or insomnia; and defined expedited adverse events (EAEs). All serious psychiatric adverse events were considered EAEs. No AEs were treatment-related.	0.00% 0/126 • All safety events from study entry to the study completion up to month 12. Adverse events (AEs) were not monitored for focus groups/pilot tests. AEs were only monitored for youth trial participants and defined using the Manual for Expedited Reporting of Adverse Events to DAIDS (V2.0). Targeted AEs were grade 2 or higher suicidal ideation or attempt; grade 3 or higher psychiatric disorders or insomnia; and defined expedited adverse events (EAEs). All serious psychiatric adverse events were considered EAEs. No AEs were treatment-related.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place