IMPAACT 2016 - Evaluating a Group-Based Intervention to Improve Mental Health and Antiretroviral Therapy (ART) Adherence Among Youth Living With HIV in Low Resource Settings
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 484
- 试验地点
- 8
- 主要终点
- Group-level Mean General Anxiety Disorder-7 (GAD-7) at 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 19 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Exclusion Criteria - For Caregiver Participants:
- •Prior participation in an IMPAACT 2016 Focus Group or Pilot Test.
研究组 & 干预措施
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).
干预措施: Youth TI-CBT Intervention Arm (Behavioral)
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).
干预措施: Youth Discussion Control Arm (Behavioral)
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).
干预措施: Caregiver TI-CBT Intervention Arm (Behavioral)
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).
干预措施: Caregiver Discussion Control Arm (Behavioral)
结局指标
主要结局
Group-level Mean General Anxiety Disorder-7 (GAD-7) at 6 Months
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Viral Load at 6 Months(at 6 months)
- 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))
- 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))
- 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))
- 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))
- Group-level Mean ART Adherence at 6 Months(at 6 months)
- Group-level Mean ART Adherence at IPL (Immediately Post-Last Group Session).(After initial treatment completion (initial treatment lasted an average of 6 weeks).)
- Viral Load at IPL (Immediately Post-Last Group Session)(After initial treatment completion (initial treatment lasted an average of 6 weeks))