- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04024488
Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicole Montañez, MSW
- Phone Number: 11844 919-544-7040
- Email: nmontanez@fhi360.org
Study Contact Backup
- Name: Jennifer Libous, MS
- Phone Number: 18131 202-884-8131
- Email: jlibous@fhi360.org
Study Locations
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Gaborone, Botswana
- Recruiting
- Gaborone Prevention/Treatment Trials CRS 12701
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Contact:
- Gaerolwe Masheto, MD
- Phone Number: 2673975999
- Email: gmasheto@bhp.org.bw
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Molepolole, Botswana
- Recruiting
- Molepolole Prevention/Treatment Trials CRS 12702
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Contact:
- Gaerolwe Masheto, MD
- Phone Number: 2673975999
- Email: gmasheto@bhp.org.bw
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Blantyre, Malawi
- Recruiting
- College of Medicine CRS 30301
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Contact:
- Limbika Senganimalunje
- Phone Number: 265993662154
- Email: limbika@jhu.medcol.mw
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Lilongwe, Malawi
- Recruiting
- University of North Carolina Lilongwe CRS 12001
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Contact:
- Portia Kamthunzi
- Phone Number: 265999553034
- Email: pkamthunzi@unclilongwe.org
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Soweto, South Africa
- Recruiting
- Soweto IMPAACT CRS 8052
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Contact:
- Janice Buckley, MBChB/FCPsyc
- Email: buckleyj@phru.co.za
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Chitungwiza, Zimbabwe
- Recruiting
- St. Mary's CRS 30303
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Contact:
- Tsungai Chipato, MBChB/MSE
- Phone Number: 2634704890
- Email: tchipato@zol.co.zw
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Harare, Zimbabwe
- Recruiting
- Harare Family Care CRS 31890
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Contact:
- Hilda Mujuru, MBChB/MSc
- Phone Number: 2634791631
- Email: hmujuru@iwayafrica.co.zw; drhamujuru@gmail.com
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Harare, Zimbabwe
- Recruiting
- Seke North CRS 30306
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Contact:
- Tsungai Chipato, MBChB/MSE
- Phone Number: 2634704890
- Email: tchipato@zol.co.zw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria - For Youth Participants:
- At screening, 15-19 years old.
- 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.
- 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.
- Has 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:
Has prior participation in an IMPAACT 2016 Focus Group or Pilot Test.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TI-CBT Intervention Arm
In the Randomized Trial, youth participants will be randomized in a 1:1 ratio with their caregivers to one of two study arms.
One arm is the TI-CBT intervention arm consisting of: six 2-hour TI-CBT group sessions lead by Indigenous Youth Leaders (IYL) during weeks 1 - 6 and one 2-hour booster group session at 6-months.
The caregivers (willing to participate with youth permission) for youth who are enrolled into the TI-CBT arm will be enrolled onto the same arm, and receive two 2-hour group sessions led by adult study staff during weeks 1-6 and one 2-hour booster group session at 6-months.
The youth and caregiver sessions are held separately.
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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 and Caregiver Intervention Manuals are distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial.
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Active Comparator: Discussion Control Arm
Arm two is the discussion control arm consisting of: six 2 hour discussion group sessions lead by IYL during weeks 1-6 and one 2-hour booster discussion group session at 6 months.
The caregivers (willing to participate with youth permission) for youth randomized to the discussion control arm will have two 2-hour discussion group sessions led by adult study staff during weeks 1-6 and one 2-hour booster discussion group session at 6 months.
The youth and caregiver sessions are held separately.
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Each youth discussion control group session will be led by IYL and each caregiver discussion control group will be led by adult study staff.
Discussion topics will be selected by youth and caregivers in the group as applicable.
Discussion Control group session will take place at a separate time from TI-CBT youth group sessions in attempt to minimize contamination.
To note, participant and caregiver group sessions are always held separately.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire-9
Time Frame: at 6-months
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(PHQ-9, measure of depression: range 0-27, higher=worse)
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at 6-months
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General Anxiety Disorder-7
Time Frame: at 6-months
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(GAD-7, measure of anxiety: range 0-21, higher=worse)
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at 6-months
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UCLA Post-Traumatic Stress Disorder-Reaction Index
Time Frame: at 6-months
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(UCLA PTSD-RI, measure of TPSD: range 0-51, higher=worse)
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at 6-months
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Composite mental health measure
Time Frame: at 6-months
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(measure of combined mental health issues: PHQ-9, GAD-7, and UCLA PTSD-RI scores will be standardized to have mean=0, standard deviation=1, and then summed; higher=worse)
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at 6-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire-9
Time Frame: after initial treatment completion (an average of 6 weeks)
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(PHQ-9, measure of depression: range 0-27, higher=worse)
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after initial treatment completion (an average of 6 weeks)
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General Anxiety Disorder-7
Time Frame: after initial treatment completion (an average of 6 weeks)
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(PHQ-9, measure of depression: range 0-27, higher=worse)
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after initial treatment completion (an average of 6 weeks)
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UCLA Post-Traumatic Stress Disorder-Reaction Index
Time Frame: after initial treatment completion (an average of 6 weeks)
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(UCLA PTSD-RI, measure of TPSD: range 0-51, higher=worse)
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after initial treatment completion (an average of 6 weeks)
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Composite mental health measure
Time Frame: after initial treatment completion (an average of 6 weeks)
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(measure of combined mental health issues: PHQ-9, GAD-7, and UCLA PTSD-RI scores will be standardized to have mean=0, standard deviation=1, and then summed; higher=worse)
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after initial treatment completion (an average of 6 weeks)
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ART Adherence
Time Frame: after initial treatment completion (an average of 6 weeks), and at 6-months
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Self-report - Wilson 3-item scale (range 0-100, higher=better)
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after initial treatment completion (an average of 6 weeks), and at 6-months
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Viral Load
Time Frame: after initial treatment completion (an average of 6 weeks), and at 6-months
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HIV-1 RNA
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after initial treatment completion (an average of 6 weeks), and at 6-months
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Geri Donenberg, PhD, University of Illinois at Chicago
- Study Chair: Dorothy Dow, MD, MSc, Duke University
- Principal Investigator: Suad Kapetanovic, MD, University of Southern California
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IMPAACT 2016
- DAIDS ID #38506 (Other Identifier: DAIDS/NIAID/NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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