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| ID | Type | Description | Link |
|---|---|---|---|
| DAIDS ID #38506 | Other Identifier | DAIDS/NIAID/NIH |
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The study was closed early due to funding issue
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute of Mental Health (NIMH) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Youth TI-CBT Intervention Arm | Experimental | For youth, the TI-CBT intervention arm consisted of six 2-hour TI-CBT group sessions led by Indigenous Youth Leaders (IYL) during weeks 1 to 8 and one 2-hour booster group session at 6-months. The TI-CBT Intervention was delivered in a group format. The TI-CBT Intervention arm had 15 groups with an average of 8.5 youth per group (range 6-11). |
|
| Youth Discussion Control Arm | Active Comparator | For youth, the Discussion Control arm consisted of six 2-hour discussion group sessions led by IYL during weeks 1 to 8 and one 2-hour booster discussion group session at 6 months. The Discussion Control was delivered in a group format. The Discussion Control arm had 15 groups with an average of 8.4 youth per group (range 5-10). |
|
| Caregiver TI-CBT Intervention Arm | Experimental | For caregivers, the TI-CBT Intervention arm consisted of two 2-hour TI-CBT group sessions on two separate weeks within 8 weeks of their youth's first group session and one 2-hour booster group session at 6-months led by adult study staff. The TI-CBT Intervention was delivered in group format. The TI-CBT Intervention arm had 15 groups with an average of 7.7 caregivers per group (range 5-10). |
|
| Caregivers Discussion Control Arm | Active Comparator | For caregivers, the Discussion Control arm consisted of: two 2-hour discussion group sessions on two separate weeks within 8 weeks of their youth's first group session and one 2-hour booster discussion group session at 6 months led by adult study staff. The Discussion Control intervention was delivered in a group format. The Discussion Control arm had 15 groups with an average of 7.6 caregivers per group (range 3-10). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Youth TI-CBT Intervention Arm | Behavioral | For youth, each TI-CBT group session was led by IYL. TI-CBT teaches techniques and ways to manage distress through psychosocial health education, cognitive restructuring, and "mastery of trauma", which refers to the process by which survivors of psychological trauma work through the traumatic experience in a meaningful way, and are able to move on with life. TI-CBT addresses both the trauma of learning one has HIV and the trauma associated with managing a chronic and stigmatized illness. The intervention highlights links between HIV and traditional gender roles, gender inequities, and gender-based violence. Finally, the relaxation training teaches youth strategies to relax and these are integrated at the beginning and end of each session. TI-CBT Youth Intervention Manuals were distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Group-level Mean General Anxiety Disorder-7 (GAD-7) at 6 Months | Average (standard deviation) of the group-level mean General Anxiety Disorder-7 (GAD-7) score within arm. The GAD-7 features 7 items assessing frequency of anxiety symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day". Responses to the 7 items are summed to obtain a GAD-7 score ranging from 0 (least) to 21 (most severe symptoms). A score of 10 or more points indicates moderate to severe anxiety symptoms. | at 6 months |
| Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA-PTSD-RI) at 6 Months | Average (standard deviation) of the group-level mean UCLA Post Traumatic Stress Disorder-Reaction Index (PTSD-RI) score within arm. The UCLA PTSD-RI assesses DSM-IV criteria for PTSD in youth. If prior trauma is endorsed, assessment asks whether 31 PTSD symptoms have occurred within the past month on a scale from 0="None" to 4="Most of the time". A scoring algorithm is applied to the 31 items to calculate a score ranging from 0 (least) to 80 (most severe symptoms). A score of 35 or more indicates moderate to severe PTSD symptoms. If no trauma is endorsed, no score is calculated. | at 6 months |
| Group-level Mean Composite Mental Health Measure at 6 Months | Average (standard deviation) of the group-level mean Composite score within arm. Composite scores are a study-specific measure of combined mental health symptoms. A participant's PHQ-9, GAD-7, and UCLA PTSD-RI scores at the given timepoint are each standardized according to baseline to get Z scores. The 3 Z scores are summed to obtain a Composite score. Composite scores are not Z scores themselves and can range from -Inf to +Inf, with greater scores reflecting more severe symptoms overall. Composite scores of 0 at baseline represent average symptom levels overall, but otherwise do not have a meaningful central value. | at 6 months |
| Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at 6 Months | Average (standard deviation) of the group-level mean Patient Health Questionnaire-9 (PHQ-9) score within arm. The PHQ-9 features 9 items assessing the frequency of depression symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day". Responses to the 9 items are summed to obtain a PHQ-9 score ranging from 0 (least) to 27 (most severe symptoms). A score of 10 or more points indicates moderate to severe depression symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria - For Youth Participants:
If of legal age to provide independent informed consent as determined by site Standard Operating Procedures (SOPs) and consistent with site IRB/EC policies and procedures: potential youth participant is willing and able to provide written informed consent for study participation.
If not of legal age to provide independent informed consent: Parent or guardian is willing and able to provide written informed consent for study participation and potential youth participant is willing and able to provide written informed assent for study participation.
Confirmed HIV-infection based on documented testing of two samples collected at different time points as documented in medical records or by confirmatory testing.
Age limit 15-19 years
At screening, aware of his or her HIV infection, as confirmed by Investigator of Record or designee.
At screening, has been prescribed ART for a minimum of 24 weeks prior to screening based on medical record documentation.
At screening, meets at least one of the following indicators of moderate to severe mental health symptomology:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy Dow, MD, MSc | Duke University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaborone Prevention/Treatment Trials CRS 12701 | Gaborone | Botswana | ||||
| Molepolole Prevention/Treatment Trials CRS 12702 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Dow DE, Libous J, Ponatshego PL, Masheto G, Mvalo T, Payesa C, Buckley J, Stranix-Chibanda L, Nematadzira T, Vhembo T, Ace A, Warshaw M, Townley E, Lee S, Allison S, Donenberg G and the IMPAACT 2016 Team. High levels of mental distress among youth with HIV in Southern Africa: A description of enrollment into IMPAACT 2016, a randomized controlled trial of a peer-led, group-based mental health intervention. Presented at IAS, Kigali, Rwanda, 15 July 2025. | ||
| Result | Libous J, Jeffrey R, George K, Montañez N, Warshaw M, Shakes Raesi M, Ponatshego PL, Maliwichi L, Vhembo T, Mutasa T, Bere CT, Galvin L, Townley E, Varechtchouk O, Dow D, Donenberg G, and the IMPAACT 2016 Team. IMPAACT 2016: The ADAPT-ITT Framework Leveraging Youth and Supporter Voices in the Adaptation of a Trauma-Informed Cognitive Behavioral Therapy Group-Based Intervention for Youth Living with HIV and Mental Health Distress. Presented at Fast Track Cities, Paris, France, 13-15 October 2024. | ||
| Result | Vhemo T, Mhembere T, Mbengeranwa T, Bere TC, Mutasa T, Katsande R, Gumbo J, Mudzonga N, Nematadzira T, Maturure SJ, Mandima PF, Maonera S, Stranix-Chibanda L. High Prevalence of Common Mental Health Disorders Amongst Adolescents With HIV in Zimbabwe: IMPAACT 2016; Presented at International Workshop on Pediatrics & HIV, Munich, Germany, 19-20 July 2024. | ||
| Result | Libous JL, Montañez N, Donenberg G, Kapetanovic S, Dow D. IMPAACT 2016: Operationalizing the ADAPT-ITT Model to drive local adaptation of an intervention to improve mental health and medication adherence in youth living with HIV. Presented at Society for Clinical Research Associates 29th Annual Conference, Virtual, 23-26 September 2020. | ||
| Label | URL |
|---|---|
| IMPAACT 2016 web page | View source |
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Individual participant data that underlie results in the publication, after deidentification.
Beginning three months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
Data will be shared with researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.
Types of Analyses: Specifically for the types of analyses needed to achieve aims in the proposal approved by the IMPAACT Network.
Mechanism: Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jan 13, 2023 |
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In the Randomized Trial, youth participants were randomized in a 1:1 ratio to one of two study arms: TI-CBT Intervention or Discussion Control. Participating caregivers were assigned to the same arm as their youth.
For youth, the TI-CBT Intervention arm consisted of six 2-hour TI-CBT group sessions led by Indigenous Youth Leaders (IYL) during weeks 1 to 8 and one 2-hour booster group session at 6 months. The caregivers of youth who were enrolled in the TI-CBT Intervention arm received two 2-hour group sessions led by adult study staff during weeks 1 to 8 and one 2-hour booster group session at 6 months. The Youth Discussion Control arm consisted of six 2-hour discussion group sessions led by IYL during weeks 1 to 8 and one 2-hour booster discussion group session at 6 months. The caregivers of youth randomized to the Discussion Control arm had two 2-hour discussion group sessions led by adult study staff during weeks 1 to 8 and one 2-hour booster discussion group session at 6 months.
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|
|
| Youth Discussion Control Arm | Behavioral | For youth, each discussion group session was led by IYL. Discussion topics were selected by youth in the group. Discussion Control sessions took place at a separate time from TI-CBT Intervention sessions to minimize contamination. Youth and caregiver group sessions were also held separately. |
|
| Caregiver TI-CBT Intervention Arm | Behavioral | For caregivers, each TI-CBT group session was led by adult study staff. TI-CBT teaches techniques and ways to manage distress through psychosocial health education, cognitive restructuring, and "mastery of trauma", which refers to the process by which survivors of psychological trauma work through the traumatic experience in a meaningful way, and are able to move on with life. TI-CBT addresses both the trauma of learning one has HIV and the trauma associated with managing a chronic and stigmatized illness. The intervention highlights links between HIV and traditional gender roles, gender inequities, and gender-based violence. Finally, the relaxation training teaches strategies to relax and these are integrated at the beginning and end of each session. TI-CBT Caregiver Intervention Manuals were distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial. |
|
| Caregiver Discussion Control Arm | Behavioral | For caregivers, each discussion group session was led by adult study staff. Discussion topics were selected by caregivers in the group. Discussion Control sessions took place at a separate time from TI-CBT Intervention sessions to minimize contamination. Youth and caregiver group sessions were also held separately. |
|
| at 6 months |
| 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. | 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. | 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. | 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). | at 6 months |
| Viral Load at 6 Months | HIV-1 RNA | 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) | After initial treatment completion (initial treatment lasted an average of 6 weeks). |
| Viral Load at IPL (Immediately Post-Last Group Session) | HIV-1 RNA | After initial treatment completion (initial treatment lasted an average of 6 weeks) |
| Molepolole |
| Botswana |
| College of Medicine CRS 30301 | Blantyre | Malawi |
| University of North Carolina Lilongwe CRS 12001 | Lilongwe | Malawi |
| Soweto IMPAACT CRS 8052 | Soweto | South Africa |
| St. Mary's CRS 30303 | Chitungwiza | Zimbabwe |
| Harare Family Care CRS 31890 | Harare | Zimbabwe |
| Seke North CRS 30306 | Harare | Zimbabwe |
| Warshaw M, Dow D, Kapetanovic S, Libous J, Reding C, Montañez , Donenberg G. IMPAACT 2016: Interdisciplinary Collaboration at Multiple Levels. Society for Clinical Trials 41st Annual Meeting, Baltimore, MD (Virtual), 2020. |
| 36303985 | Result | Libous JL, Montanez NA, Dow DE, Kapetanovic S, Buckley J, Kakhu TJ, Kamthunzi P, Maliwichi LA, Vhembo T, Chawana TD, Nematadzira T, Donenberg GR. IMPAACT 2016: Operationalizing HIV Intervention Adaptations to Inform the Science and Outcomes of Implementation. Front Reprod Health. 2021 May 28;3:662912. doi: 10.3389/frph.2021.662912. eCollection 2021. |
| The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1 (July 2017) | View source |
| Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010 | View source |
| FG001 | 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). |
| FG002 | 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). |
| FG003 | 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). |
| COMPLETED |
|
| NOT COMPLETED |
|
Limited sociodemographic characteristics were collected from caregivers at baseline.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | Caregiver 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). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years | Mean | Standard Deviation | Years |
| |||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Country of Enrollment | Number | Participants |
| ||||||||||
| Group-level mean age | Group-level mean age, Continuous | Mean | Standard Deviation | Years |
| |||||||||
| Highest level of education attained | Count of Participants | Participants |
| |||||||||||
| Enrolled in school | This baseline characteristic was not collected for caregivers. | Count of Participants | Participants |
| ||||||||||
| Working outside of home | Count of Participants | Participants |
| |||||||||||
| Owns a cellphone | This baseline characteristic was not collected for the caregivers. | Count of Participants | Participants |
| ||||||||||
| Housing with electricity | This baseline characteristic was not collected for caregivers. | Count of Participants | Participants |
| ||||||||||
| Housing with pipe water | This baseline characteristic was not collected for caregivers. | Count of Participants | Participants |
| ||||||||||
| Group-level percentage of female participants | Average (standard deviation) of the group-level percentage of females within arm | Mean | Standard Deviation | Percentage |
| |||||||||
| Group-level percentage of participants enrolled in school | Average (standard deviation) of the group-level percentage of youth enrolled in school within arm. | This baseline characteristic was not collected for caregivers. | Mean | Standard Deviation | Percentage |
| ||||||||
| Group-level percentage of participants with some secondary education | Average (standard deviation) of the group-level percentage of participants with some secondary education within arm. | Mean | Standard Deviation | Percentage |
| |||||||||
| Group-level percentage of participants working outside home | Average (standard deviation) of the group-level percentage of participants working outside home within arm. | Mean | Standard Deviation | Percentage |
| |||||||||
| Group-level percentage of participants virally suppressed (<200 copies/mL) | Average (standard deviation) of the group-level percentage of participants virally suppressed (<200 copies/mL) within arm. | This baseline characteristic was not collected for the caregivers. | Mean | Standard Deviation | Percentage |
| ||||||||
| Group-level mean ART adherence score | 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). | The adherence score was not collected for the caragivers. | Mean | Standard Deviation | Score |
| ||||||||
| Group-level mean UCLA PTSD-RI score | 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. | 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. | Mean | Standard Deviation | Score |
| ||||||||
| Group-level mean PHQ-9 score | 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. | The PHQ-9 score was not collected for caregivers. | Mean | Standard Deviation | Score |
| ||||||||
| Group-level mean GAD-7 score | 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. | The GAD-7 score was not collected for the caregivers. | Mean | Standard Deviation | Score |
| ||||||||
| Group-level mean Composite score | Average (SD) of the group-level mean Composite score. 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. | 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. | Mean | Standard Deviation | Score |
| ||||||||
| Group-level mean HIV stigma score | Average (standard deviation) of the group-level mean HIV stigma score within arm. The HIV-Related Stigma Scale asks respondents to agree or disagree with 9 beliefs about people with HIV. The scale was modified to include a third response option: "Prefer not to answer" for this study. A single stigma score was obtained as the proportion of beliefs endorsed ranging from 0 (least) to 100 (most severe stigma). "Prefer not to answer" responses are not considered endorsements. If a participant selected "Prefer not to answer" for all items, no score was calculated. | 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. | Mean | Standard Deviation | Score |
| ||||||||
| Composite score | 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. | The composite score was not collected for the caregivers. | Mean | Standard Deviation | Score |
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| UCLA PTSD-RI score | 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. | Three youth participants did not endorse any trauma. UCLA PTSD-RI score was not collected for the caregivers. | Mean | Standard Deviation | Score |
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| PHQ-9 score | 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. | The PHQ-9 score was not collected for the caregivers. | Mean | Standard Deviation | Score |
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| GAD-7 score | 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. | The GAD-7 score was not collected for the caregivers. | Mean | Standard Deviation | Score |
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| Virally suppressed (< 200 copies/mL) | The viral load was not collected from the caregivers. | Count of Participants | Participants |
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| ART adherence score | 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). | The ART adherence score was not collected for the caregivers. | Mean | Standard Deviation | Score |
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| HIV stigma score | Mean HIV stigma score within arm. The HIV-Related Stigma Scale asks respondents to agree or disagree with 9 beliefs about people with HIV. The scale was modified to include a third response option: "Prefer not to answer" for this study. A single stigma score was obtained as the proportion of beliefs endorsed ranging from 0 (least) to 100 (most severe stigma). "Prefer not to answer" responses are not considered endorsements. If a participant selected "Prefer not to answer" for all items, no score was calculated. | Mean | Standard Deviation | Score |
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| HIV-1 RNA (copies/mL) | The HIV-1 RNA (copies/mL) count was not collected for the caregivers. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Score | at 6 months |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Score | at 6 months |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Score | at 6 months |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Score | After initial treatment completion (initial treatment lasted an average of 6 weeks) |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Score | After initial treatment completion (initial treatment lasted an average of 6 weeks) |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Score | After initial treatment completion (initial treatment lasted an average of 6 weeks) |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Score | After initial treatment completion (initial treatment lasted an average of 6 weeks) |
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| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | Score | at 6 months |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Score | at 6 months |
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| Secondary | Viral Load at 6 Months | HIV-1 RNA | All youth participants with viral load data at Month 6. Viral load data was not collected for caregivers. | Posted | Number | copies/mL | at 6 months |
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| Secondary | Group-level Mean ART Adherence at IPL (Immediately Post-Last Group Session). | Self-report - Wilson 3-item scale (range 0-100, higher=better) | 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. | Posted | Mean | Standard Deviation | Score | After initial treatment completion (initial treatment lasted an average of 6 weeks). |
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| Secondary | Viral Load at IPL (Immediately Post-Last Group Session) | HIV-1 RNA | All youth participants with viral load data at IPL (Immediately Post-Last Group Session) assessment. Viral load data was not collected for caregivers. | Posted | Number | copies/mL | After initial treatment completion (initial treatment lasted an average of 6 weeks) |
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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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | 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 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). | 0 | 128 | 2 | 128 | 4 | 128 |
| EG001 | Discussion Control Arm | 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). | 0 | 126 | 1 | 126 | 1 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Major depression | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| IMPAACT Clinicaltrials.gov Coordinator | Family Health International (FHI 360) | (919) 405-1429 | IMPAACT.ctgov@fstrf.org |
| Dec 19, 2025 |
| Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2025 | Dec 22, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
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| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| South Africa |
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| Among females only, unadjusted mean difference in paired group-level means (TI-CBT Intervention minus Discussion Control). A negative treatment effect estimate suggests benefit of the TI-CBT Intervention compared to the Discussion Control at the group-level. | t-test, 2 sided | 0.71 | Mean Difference (Final Values) | 0.36 | 2-Sided | 95 | -1.62 | 2.34 | A pair was defined as the TI-CBT Intervention and Discussion Control group within the same site and randomization wave. Youth responses were averaged within-group, and the mean difference in paired group-level means was assessed using a t-test. | Superiority |
| Among males only, unadjusted mean difference in paired group-level means (TI-CBT Intervention minus Discussion Control). A negative treatment effect estimate suggests benefit of the TI-CBT Intervention compared to the Discussion Control at the group-level. | t-test, 2 sided | 0.94 | Mean Difference (Final Values) | 0.07 | 2-Sided | 95 | -1.88 | 2.01 | A pair was defined as the TI-CBT Intervention and Discussion Control group within the same site and randomization wave. Youth responses were averaged within-group, and the mean difference in paired group-level means was assessed using a t-test. | Superiority |
| 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 |
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| 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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