An interventional study of Youth TI-CBT Intervention Arm and Youth Discussion Control Arm in HIV-1-infection, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group. Terminated at 8 sites in 4 countries. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Not applicable, Interventional, and Supportive care
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.
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 trial was preceded by an adaption of the TI-CBT Intervention at each site using the "ADAPT-ITT" model, which included focus groups and pilot tests. Participant-level data was not collected during the focus group phase, and the pilot phase consent form specified that collected data would not be analyzed. Per protocol, only data from the randomized trial were analyzed. The study was closed early due to the funding constraints.
In the randomized study, youth were individually randomized to either the TI-CBT Intervention arm or the Discussion Control arm. Youth participants met as a group within their randomized arm and received multiple group sessions within an 8-week period. Each arm featured 15 groups with an average of 8.5 youth per group, or a total of 254 youth in the Randomized Trial. TI-CBT Intervention and Discussion Control groups could be mixed-gender, which required at least two participants of each gender. Caregivers (with consent and youth permission) were assigned to the same study arm as their youth. Caregiver participants met as a group within their arm for two caregiver-specific sessions on two separate weeks, separate from their youth's group sessions. Each arm featured 15 groups with an average of 7.7 caregivers per group, or a total of 230 caregivers in the Randomized Trial. Youth and caregivers completed a follow-up assessment immediately after their last group session and two additional follow-up assessments at 6 and 12 months. Youth and caregivers received 1 two-hour booster group session consistent with their assigned study arm immediately after the 6-month assessments. The booster sessions were intended to enhance treatment effects and increase sustainability.
Following completion of 6-month assessments (primary timepoint), data were analyzed to determine the short-term effects of the interventions. Additional analyses to assess long-term effects of the interventions, including the effects of the booster group session, will be performed after the completion of 12-month assessments.
Results are reported for youth participants in the randomized trial only, because limited sociodemographic characteristics and no primary or secondary outcome measures were collected for caregivers. As specified in the protocol and statistical analysis plan, primary outcomes were analyzed with groups as the analytic units due to the presence of intracluster correlation among participants in the same group.
Inclusion Criteria - For Youth Participants:
At screening, meets at least one of the following indicators of moderate to severe mental health symptomology:
Inclusion Criteria - For Caregiver Participants:
Exclusion Criteria - For Youth Participants:
Exclusion Criteria - For Caregiver Participants:
Prior participation in an IMPAACT 2016 Focus Group or Pilot Test.
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
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
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
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
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at 6 months
Group-level Mean General Anxiety Disorder-7 (GAD-7) at IPL (Immediately Post-Last Group Session)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: After initial treatment completion (initial treatment lasted an average of 6 weeks)
Group-level Mean ART Adherence at 6 Months
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).
Time frame: at 6 months
Viral Load at 6 Months
HIV-1 RNA
Time frame: at 6 months
Group-level Mean ART Adherence at IPL (Immediately Post-Last Group Session).
Self-report - Wilson 3-item scale (range 0-100, higher=better)
Time frame: After initial treatment completion (initial treatment lasted an average of 6 weeks).
Viral Load at IPL (Immediately Post-Last Group Session)
HIV-1 RNA
Time frame: After initial treatment completion (initial treatment lasted an average of 6 weeks)
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.
| Milestone | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm | Caregiver TI-CBT Intervention Arm | Caregivers Discussion Control Arm |
|---|---|---|---|---|
| Started | 128 | 126 | 116 | 114 |
| Completed | 128 | 126 | 115 | 113 |
| Not completed | 0 | 0 | 1 | 1 |
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.
| Score | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm |
|---|---|---|
| Group-level Mean General Anxiety Disorder-7 (GAD-7) at 6 Months | 4.51 ± 2.1 | 4.29 ± 1.7 |
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.
| Score | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm |
|---|---|---|
| Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA-PTSD-RI) at 6 Months | 21.72 ± 11.0 | 15.88 ± 8.7 |
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.
| Score | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm |
|---|---|---|
| Group-level Mean Composite Mental Health Measure at 6 Months | -3.23 ± 1.8 | -4.09 ± 1.4 |
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.
| Score | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm |
|---|---|---|
| Group-level Mean General Anxiety Disorder-7 (GAD-7) at IPL (Immediately Post-Last Group Session) | 4.92 ± 1.8 | 4.63 ± 1.6 |
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.
| Score | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm |
|---|---|---|
| Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at IPL (Immediately Post Last Group Session) | 5.81 ± 2.2 | 6.13 ± 2.4 |
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.
| Score | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm |
|---|---|---|
| Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) at IPL (Immediately Post-Last Group Session) | 20.32 ± 9.0 | 19.0 ± 7.4 |
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.
| Score | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm |
|---|---|---|
| Group-level Mean Composite Mental Health Measure at IPL (Immediately Post-Last Group Session) | -3.50 ± 1.2 | -3.76 ± 1.3 |
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).
| Score | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm |
|---|---|---|
| Group-level Mean ART Adherence at 6 Months | 77.89 ± 5.8 | 78.28 ± 4.5 |
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.
| Score | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm |
|---|---|---|
| Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at 6 Months | 5.36 ± 2.8 | 5.41 ± 1.9 |
HIV-1 RNA
| copies/mL | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm |
|---|---|---|
| < 40 copies/mL | 102 | 104 |
| 40 - <200 copies/mL | 7 | 5 |
| 200 - < 1,000 copies/mL | 4 | 4 |
| 1,000 - < 10,000 copies/mL at month 6 | 8 | 6 |
| >= 10,000 copies/mL | 5 | 5 |
Self-report - Wilson 3-item scale (range 0-100, higher=better)
| Score | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm |
|---|---|---|
| Group-level Mean ART Adherence at IPL (Immediately Post-Last Group Session). | 79.09 ± 6.2 | 80.81 ± 4.4 |
HIV-1 RNA
| copies/mL | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm |
|---|---|---|
| < 40 copies/mL | 112 | 103 |
| 40 - <200 copies/mL | 6 | 9 |
| 200 - < 1,000 copies/mL | 5 | 4 |
| 1,000 - < 10,000 copies/mL | 1 | 2 |
| >= 10,000 copies/mL | 4 | 6 |
Collected over All safety events from study entry to the study completion up to month 12.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TI-CBT Intervention Arm | 0/128 (0%) | 2/128 (1.6%) | 4/128 (3.1%) |
| Discussion Control Arm | 0/126 (0%) | 1/126 (0.8%) | 1/126 (0.8%) |
| Event | TI-CBT Intervention Arm | Discussion Control Arm |
|---|---|---|
| Suicidal ideationPsychiatric disorders | 0/128 | 1/126 |
| Hand fractureInjury, poisoning and procedural complications | 1/128 | 0/126 |
| Suicide attemptPsychiatric disorders | 1/128 | 0/126 |
| Event | TI-CBT Intervention Arm | Discussion Control Arm |
|---|---|---|
| Suicidal ideationPsychiatric disorders | 4/128 | 0/126 |
| Major depressionPsychiatric disorders | 0/128 | 1/126 |
Limited sociodemographic characteristics were collected from caregivers at baseline.
| Age, Continuous(Years) | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm | Caregiver TI-CBT Intervention Arm | Caregiver Discussion Control Arm | Total |
|---|---|---|---|---|---|
| Mean | 17.3 ± 1.3 | 17.3 ± 1.4 | 42.6 ± 11.5 | 41.9 ± 11.1 | 29.1 ± 14.7 |
| Sex: Female, Male(Participants) | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm | Caregiver TI-CBT Intervention Arm | Caregiver Discussion Control Arm | Total |
|---|---|---|---|---|---|
| Female | 72 | 72 | 104 | 95 | 343 |
| Male | 56 | 54 | 12 | 19 | 141 |
| Race (NIH/OMB)(Participants) | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm | Caregiver TI-CBT Intervention Arm | Caregiver Discussion Control Arm | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 128 | 126 | 116 | 114 | 484 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm | Caregiver TI-CBT Intervention Arm | Caregiver Discussion Control Arm | Total |
|---|---|---|---|---|---|
| Zimbabwe | 60 | 58 | 59 | 58 | 235 |
| Malawi | 32 | 34 | 31 | 28 | 125 |
| Botswana | 26 | 24 | 21 | 20 | 91 |
| South Africa | 10 | 10 | 5 | 8 | 33 |
| Group-level mean age(Years) | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm | Caregiver TI-CBT Intervention Arm | Caregiver Discussion Control Arm | Total |
|---|---|---|---|---|---|
| Mean | 17.3 ± 0.5 | 17.3 ± 0.6 | 43 ± 4.1 | 41.7 ± 4.4 | 29.8 ± 13.0 |
| Highest level of education attained(Participants) | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm | Caregiver TI-CBT Intervention Arm | Caregiver Discussion Control Arm | Total |
|---|---|---|---|---|---|
| Some primary | 44 | 44 | 39 | 28 | 155 |
| Some secondary | 81 | 78 | 68 | 75 | 302 |
| Vocational | 2 | 2 | 5 | 3 | 12 |
| University | 1 | 2 | 4 | 8 | 15 |
| Enrolled in school(Participants) | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm | Caregiver TI-CBT Intervention Arm | Caregiver Discussion Control Arm | Total |
|---|---|---|---|---|---|
| Count of participants | 20 | 17 | — | — | 37 |
| Working outside of home(Participants) | Youth TI-CBT Intervention Arm | Youth Discussion Control Arm | Caregiver TI-CBT Intervention Arm | Caregiver Discussion Control Arm | Total |
|---|---|---|---|---|---|
| Count of participants | 16 | 18 | 47 | 44 | 125 |
22 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.
Supporting information: Study protocol, Sap
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International Maternal Pediatric Adolescent AIDS Clinical Trials Group