Bolstered Standard of Care (BSOC) for HIV/AIDS

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
HIV/AIDSBolstered Standard of Care (BSOC) - Other
Eligibility
10 - 17
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • HIV/AIDS

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline 12, 24 and 36 month follow-up

Month 36
Beck Hopelessness Scale (BHS)
Caregiver mental health
Change HIV viral suppression
Change in Adherence and retention in care
Child Depression Inventory (CDI)
Family relations
Financial Literacy
HIV Adherence Self-Efficacy Scale
HIV Stigma Measure for Children
Post-Traumatic Stress Disorder (PTSD)
Rosenberg Self-Esteem Scale
Savings Deposits
Social Support Behaviors Scale
Tennessee Self-Concept Scale (TSCS)
The Shame Questionnaire for Children

Trial Safety

Trial Design

2 Treatment Groups

Treatment Arm 1
1 of 2
Treatment Arm 2
1 of 2

Experimental Treatment

840 Total Participants · 2 Treatment Groups

Primary Treatment: Bolstered Standard of Care (BSOC) · No Placebo Group · N/A

Treatment Arm 1Experimental Group · 2 Interventions: Bolstered Standard of Care (BSOC), Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE · Intervention Types: Other, Behavioral
Treatment Arm 2Experimental Group · 3 Interventions: Bolstered Standard of Care (BSOC), Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR)., Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE · Intervention Types: Other, Behavioral, Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline 12, 24 and 36 month follow-up

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,560 Previous Clinical Trials
1,823,001 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,805 Previous Clinical Trials
2,277,775 Total Patients Enrolled

Eligibility Criteria

Age 10 - 17 · All Participants · 5 Total Inclusion Criteria

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