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Integrated Stigma Reduction Interventions for HIV/AIDS

N/A
Recruiting
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prescribed antiretroviral therapy
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline 12, 24 and 36 month follow-up
Awards & highlights

Study Summary

This trial will study the effects of different interventions on HIV viral suppression among 840 adolescents living with HIV. The investigators will test the effects of a group-based HIV stigma reduction intervention for educators, multiple family groups with HIV stigma reduction combined with family economic empowerment, or Bolstered Standard of Care.

Who is the study for?
This trial is for adolescents living with HIV who are on antiretroviral therapy and enrolled in boarding schools. Their caregivers, as well as school staff like teachers and nurses willing to participate, can join. It's not for those with cognitive impairments that affect understanding of the study or who can't commit to finishing it.Check my eligibility
What is being tested?
The M-Suubi study compares three approaches: Bolstered Standard of Care (BSOC), Multiple Family Groups plus economic empowerment (MFG-HIVSR plus FEE), and these two combined with a stigma reduction program for educators (GED-HIVSR). Schools will be randomly assigned one of these methods.See study design
What are the potential side effects?
Since this trial focuses on social interventions rather than medications, traditional side effects aren't expected. However, participants may experience emotional or psychological impacts from discussions around HIV stigma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on antiretroviral therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline 12, 24 and 36 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 12, 24 and 36 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change HIV viral suppression
Secondary outcome measures
Change in Adherence and retention in care
HIV Stigma Measure for Children
The Shame Questionnaire for Children
Other outcome measures
Beck Hopelessness Scale (BHS)
Caregiver mental health
Child Depression Inventory (CDI)
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment Arm 2Experimental Treatment3 Interventions
Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR)
Group II: Treatment Arm 1Experimental Treatment2 Interventions
Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE
Group III: Control ArmExperimental Treatment1 Intervention
Bolstered Standard of Care (BSOC)

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,296,129 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,777 Previous Clinical Trials
2,673,532 Total Patients Enrolled

Media Library

Bolstered Standard of Care (BSOC) Clinical Trial Eligibility Overview. Trial Name: NCT05307250 — N/A
HIV/AIDS Research Study Groups: Treatment Arm 1, Treatment Arm 2, Control Arm
HIV/AIDS Clinical Trial 2023: Bolstered Standard of Care (BSOC) Highlights & Side Effects. Trial Name: NCT05307250 — N/A
Bolstered Standard of Care (BSOC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05307250 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any additional participants being sought for the trial?

"As of current, this clinical trial is open for enrollment. The first posting was made on March 15th 2022 and the latest update occurred June 4th 2022 as per data from clinicaltrials.gov."

Answered by AI

What is the upper limit of participants in this experiment?

"Affirmative, according to clinicaltrials.gov this medical trial has a call for participants open and running. This research was first listed on March 15th 2022 and its most recent update was June 4th 2022; 840 patients are being recruited from 1 site."

Answered by AI

Is this research study open to individuals 85 years or older?

"This trial is reaching out to individuals aged between 10 and 17."

Answered by AI

For whom is this clinical research most advantageous?

"This clinical trial seeks to recruit 840 HIV-positive adolescents between 10 and 17 years of age, verifying their diagnosis with a medical report. Moreover, these individuals must be treated with antiretroviral therapy, enrolled in primary or secondary school programs requiring boarding accommodation. Furthermore, the caregivers of ALHIVs who agree to participate in this study are also eligible for inclusion as well as teachers, school nurses and administrators from target institutions consenting to take part on the research."

Answered by AI
~452 spots leftby Jul 2026