- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05307250
M-Suubi: A Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma
M-Suubi: A Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma on HIV Treatment Outcomes Among Adolescents Living With HIV in Uganda
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fred M Ssewamala, PhD
- Phone Number: 3149358521
- Email: fms1@wustl.edu
Study Contact Backup
- Name: Ozge Sensoy Bahar, PhD
- Phone Number: 3149359403
- Email: ozge.sensoybahar@wustl.edu
Study Locations
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Masaka, Uganda
- Recruiting
- International Center for Child Health and Development Field Office
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Contact:
- Flavia Namuwonge, BA
- Phone Number: +256 793888706
- Email: flavia.namuwonge9@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- HIV-positive adolescents confirmed by medical report
- Prescribed antiretroviral therapy
- Enrolled in primary and secondary schools in a boarding section
- Caregivers of ALHIV who agree to participate in the study
- Teachers, school nurses, and administrators in the target schools who agree to participate in the study
Exclusion Criteria:
- A significant cognitive impairment that interferes with the participant's understanding of the informed consent process, or inability/unwillingness to commit to completing the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm 1
Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE
|
In addition to the BSOC, ALHIV and their caregivers will participate in a family strengthening intervention plus a family economic empowerment intervention. MFG is an evidence-based family-centered, group-delivered, evidence-informed, strength-based 10-session (weekly) intervention for children whose families struggle with poverty. Six additional sessions covering HIV stigma stigma-related issues will be added. ALHIV will receive a YDA with a 1:1 matched savings program at a financial institution accredited by the Bank of Uganda. Each YDA will be opened in the name of the adolescent, with their primary caregiver as a co-signer, until the adolescent turns 18 years. The account will then be matched with money from the program on 1:1 rate.
All participants (in control and treatment arms) will receive medical and psychosocial support as part of the BSOC. 1) Medical SOC: All public clinics, including our study sites, follow procedures for pediatric ART initiation and monitoring, as outlined in the National Department of Health Guidelines for pediatric HIV care in Uganda.
Specifically, immediately after initiation, or if clinically unstable, ALHIV are seen more frequently (weekly to monthly).
Laboratory data (VL and CD4 counts) are collected every six months until the patient is stabilized and then annually, using the National Health Laboratory Service standardized protocol.
A
|
Experimental: Treatment Arm 2
Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR)
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All participants (in control and treatment arms) will receive medical and psychosocial support as part of the BSOC. 1) Medical SOC: All public clinics, including our study sites, follow procedures for pediatric ART initiation and monitoring, as outlined in the National Department of Health Guidelines for pediatric HIV care in Uganda.
Specifically, immediately after initiation, or if clinically unstable, ALHIV are seen more frequently (weekly to monthly).
Laboratory data (VL and CD4 counts) are collected every six months until the patient is stabilized and then annually, using the National Health Laboratory Service standardized protocol.
A
In addition to BSOC and MFG-HIVSR+FEE, ALHIV in this arm will receive the school-level HIV stigma reduction intervention targeting teachers, school nurses, matrons, and administrators (headteachers, director of studies) in their schools.
GED-HIVSR seeks to impart educators in the intervention schools with HIV related knowledge, provide a safe space for educators to explore their personal values and bias that may promote or hinder their role of supportive individuals and systems for ALHIV, and empower them with knowledge and skills to act as change agents within their schools.
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Other: Control Arm
Bolstered Standard of Care (BSOC)
|
All participants (in control and treatment arms) will receive medical and psychosocial support as part of the BSOC. 1) Medical SOC: All public clinics, including our study sites, follow procedures for pediatric ART initiation and monitoring, as outlined in the National Department of Health Guidelines for pediatric HIV care in Uganda.
Specifically, immediately after initiation, or if clinically unstable, ALHIV are seen more frequently (weekly to monthly).
Laboratory data (VL and CD4 counts) are collected every six months until the patient is stabilized and then annually, using the National Health Laboratory Service standardized protocol.
A
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change HIV viral suppression
Time Frame: Baseline 12, 24 and 36 month follow-up
|
Change in viral suppression will be assessed using viral load (VL) data collected from health clinic records.
VL will be dichotomized between undetectable /suppression (VL< 40 copies/ml) and detectable/failed viral suppression (VL > =40 copies/ml) levels at each assessment time.
|
Baseline 12, 24 and 36 month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Adherence and retention in care
Time Frame: Baseline 12, 24 and 36 month follow-up
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Change in adolescent Self reported medication adherence.
This will be measured using the Adherence and retention in care questionnaire focusing on the pharmacy refills, pill counts and missed appointments at each assessment time.
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Baseline 12, 24 and 36 month follow-up
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HIV Stigma Measure for Children
Time Frame: Baseline 12, 24 and 36 month follow-up
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HIV-associated stigma for children will be measured using the HIV Stigma Measure.
We will measure the mean score over time.
The total score range between 40- 160 with a high score indicating higher levels of perceived HIV-associated stigma.
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Baseline 12, 24 and 36 month follow-up
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The Shame Questionnaire for Children
Time Frame: Baseline 12, 24 and 36 month follow-up
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Shame related to living with HIV will be measured using the Shame Questionnaire.
We will measure the mean score over time.
The total score range between 0 and 16 with a higher score indicating higher levels of HIV-associated shame.
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Baseline 12, 24 and 36 month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Depression Inventory (CDI)
Time Frame: Baseline 12, 24 and 36 month follow-up
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Depressive Symptoms will be measured using the Child Depression Inventory (CDI) scale.
We will measure the mean score on the CDI scale over time.
The total score range between 0 and 28 with a high score indicating higher levels of depressive symptoms.
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Baseline 12, 24 and 36 month follow-up
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Post-Traumatic Stress Disorder (PTSD)
Time Frame: Baseline 12, 24 and 36 month follow-up
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Post-Traumatic Stress Disorder (PTSD) will be measured using the Child PTSD Reaction Scale.
We will measure the mean score on the Child PTSD Reaction Scale over time.
The total score range between 0 and 120, with a high score indicating higher levels of PTSD.
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Baseline 12, 24 and 36 month follow-up
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Tennessee Self-Concept Scale (TSCS)
Time Frame: Baseline 12, 24 and 36 month follow-up
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Self concept will be measured using the Tennessee Self-Concept Scale (TSCS).
We will measure the mean score on the TSCS over time.
The total score range between 20 and 100 with a high score indicating higher levels of self-concept.
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Baseline 12, 24 and 36 month follow-up
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Beck Hopelessness Scale (BHS)
Time Frame: Baseline 12, 24 and 36 month follow-up
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Hopelessness will be measured using the Beck Hopelessness Scale (BHS).
We will measure the mean score on the BHS over time.
The total score range between 0 and 20 with a high score indicating higher levels of hopelessness.
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Baseline 12, 24 and 36 month follow-up
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HIV Adherence Self-Efficacy Scale
Time Frame: Baseline 12, 24 and 36 month follow-up
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Self reported medication adherence will be measured by the number of times a child missed taking medication in the past 30 days, and number of days took medication the way they were supposed to. HIV Adherence Self-Efficacy Scale (HIV-ASES) |
Baseline 12, 24 and 36 month follow-up
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Family relations
Time Frame: Baseline 12, 24 and 36 month follow-up
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Change in family relations will be measured by Family Environment Scale
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Baseline 12, 24 and 36 month follow-up
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Social Support Behaviors Scale
Time Frame: Baseline 12, 24 and 36 month follow-up
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Social support from family members and friends will be measured using the Social Support Behaviors Scale (SSBS).
We will measure the mean score on the SSBS over time.
The total score ranges between 45-225, with higher score indicating higher levels of social support.
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Baseline 12, 24 and 36 month follow-up
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Rosenberg Self-Esteem Scale
Time Frame: Baseline 12, 24 and 36 month follow-up
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Self- Esteem will be measured using the Rosenberg Self-Esteem Scale.
The total score range 0-30 where a score less than 15 may indicate a problematic low self esteem.
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Baseline 12, 24 and 36 month follow-up
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Savings Deposits
Time Frame: Baseline 12, 24 and 36 month follow-up
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Change in savings will be measured by Bank statements and financial diaries.
Minimum savings will be 0.
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Baseline 12, 24 and 36 month follow-up
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Financial Literacy
Time Frame: Baseline 12, 24 and 36 month follow-up
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Change in Financial Literacy knowledge
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Baseline 12, 24 and 36 month follow-up
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Caregiver mental health
Time Frame: Baseline 12, 24 and 36 month follow-up
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Hopkins Symptom Checklists will be used to measure symptoms of anxiety and depression.
We will measure the mean score of the Hopkins Symptoms Checklists over time.
High score indicates severe levels of anxiety and depression.
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Baseline 12, 24 and 36 month follow-up
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Collaborators and Investigators
Collaborators
Publications and 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
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- R01MH126892 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
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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