HIV-1-infection
Conditions
Keywords
Mental Health, Adherence, Trauma-Informed Cognitive Behavioral Therapy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALYouth TI-CBT Intervention 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.
BEHAVIORALYouth Discussion Control Arm
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.
BEHAVIORALCaregiver TI-CBT Intervention Arm
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.
BEHAVIORALCaregiver Discussion Control Arm
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.
Sponsors
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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: * Patient Health Questionnaire-9 (PHQ-9) score ≥ 10 * General Anxiety Disorder-7 (GAD-7) score ≥ 10 * UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) score \>= 35 Inclusion Criteria - For Caregiver Participants: * Caregiver, defined as a biological parent, legal guardian, or person who provides emotional, psychological and/or informational care to a youth taking part in the Randomized Trial, as identified by the youth, and for whom the youth has provided written permission to participate in the study. * Of legal age to provide independent consent and willing and able to provide written informed consent for study participation.
Exclusion criteria
- For Youth Participants: * At entry, participating in a study delivering a mental health or ART adherence intervention. * Prior participation in an IMPAACT 2016 Focus Group or Pilot Test * Any other condition, adverse social situation or cognitive impairment that, in the opinion of the site investigator, would preclude informed assent and informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Group-level Mean General Anxiety Disorder-7 (GAD-7) at 6 Months | 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. |
| Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA-PTSD-RI) at 6 Months | 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. |
| Group-level Mean Composite Mental Health Measure at 6 Months | 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. |
| Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Group-level Mean General Anxiety Disorder-7 (GAD-7) at IPL (Immediately Post-Last Group Session) | After initial treatment completion (initial treatment lasted an average of 6 weeks) | 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. |
| Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at IPL (Immediately Post Last Group Session) | After initial treatment completion (initial treatment lasted an average of 6 weeks) | 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. |
| Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) at IPL (Immediately Post-Last Group Session) | After initial treatment completion (initial treatment lasted an average of 6 weeks) | 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. |
| Group-level Mean Composite Mental Health Measure at IPL (Immediately Post-Last Group Session) | After initial treatment completion (initial treatment lasted an average of 6 weeks) | 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. |
| Group-level Mean ART Adherence at 6 Months | 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). |
| Viral Load at 6 Months | at 6 months | HIV-1 RNA |
| Group-level Mean ART Adherence at IPL (Immediately Post-Last Group Session). | After initial treatment completion (initial treatment lasted an average of 6 weeks). | Self-report - Wilson 3-item scale (range 0-100, higher=better) |
| Viral Load at IPL (Immediately Post-Last Group Session) | After initial treatment completion (initial treatment lasted an average of 6 weeks) | HIV-1 RNA |
Countries
Botswana, Malawi, South Africa, Zimbabwe
Contacts
STUDY_CHAIRDorothy Dow, MD, MSc
Duke University
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.9 Years STANDARD_DEVIATION 11.1 |
| ART adherence score | 74.9 Score STANDARD_DEVIATION 18.3 |
| Composite score | -0.2 Score STANDARD_DEVIATION 2.2 |
| Enrolled in school | 20 Participants |
| GAD-7 score | 9.8 Score STANDARD_DEVIATION 4.9 |
| Group-level mean age | 17.3 Years STANDARD_DEVIATION 0.6 |
| Group-level mean ART adherence score | 76.4 Score STANDARD_DEVIATION 7.2 |
| Group-level mean Composite score | 0.1 Score STANDARD_DEVIATION 0.9 |
| Group-level mean GAD-7 score | 9.9 Score STANDARD_DEVIATION 1.8 |
| Group-level mean HIV stigma score | 15.6 Score STANDARD_DEVIATION 7 |
| Group-level mean PHQ-9 score | 12.6 Score STANDARD_DEVIATION 2.3 |
| Group-level mean UCLA PTSD-RI score | 41.1 Score STANDARD_DEVIATION 7.8 |
| Group-level percentage of female participants | 56 Percentage STANDARD_DEVIATION 7 |
| Group-level percentage of participants enrolled in school | 14.5 Percentage STANDARD_DEVIATION 11.9 |
| Group-level percentage of participants virally suppressed (<200 copies/mL) | 87.8 Percentage STANDARD_DEVIATION 11.5 |
| Group-level percentage of participants with some secondary education | 64.4 Percentage STANDARD_DEVIATION 20.6 |
| Group-level percentage of participants working outside home | 15 Percentage STANDARD_DEVIATION 13.1 |
| Highest level of education attained Some primary | 155 Participants |
| Highest level of education attained Some secondary | 75 Participants |
| Highest level of education attained University | 15 Participants |
| Highest level of education attained Vocational | 3 Participants |
| HIV-1 RNA (copies/mL) >=10,000 | 8 Participants |
| HIV-1 RNA (copies/mL) 1,000 to <10,000 | 11 Participants |
| HIV-1 RNA (copies/mL) 200 to <1,000 | 2 Participants |
| HIV-1 RNA (copies/mL) <40 | 217 Participants |
| HIV-1 RNA (copies/mL) 40 to <200 | 3 Participants |
| HIV stigma score | 7.7 Score STANDARD_DEVIATION 13.4 |
| Housing with electricity | 159 Participants |
| Housing with pipe water | 80 Participants |
| Owns a cellphone | 147 Participants |
| PHQ-9 score | 12.1 Score STANDARD_DEVIATION 4.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 126 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Botswana | 26 Participants |
| Region of Enrollment Malawi | 125 Participants |
| Region of Enrollment South Africa | 5 Participants |
| Region of Enrollment Zimbabwe | 59 Participants |
| Sex: Female, Male Female | 104 Participants |
| Sex: Female, Male Male | 54 Participants |
| UCLA PTSD-RI score | 40.3 Score STANDARD_DEVIATION 15.6 |
| Virally suppressed (< 200 copies/mL) | 110 Participants |
| Working outside of home | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 128 | 0 / 126 |
| other Total, other adverse events | 4 / 128 | 1 / 126 |
| serious Total, serious adverse events | 2 / 128 | 1 / 126 |
Outcome results
None listed