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Youth-Focused Economic Empowerment Approach
Economic Empowerment for HIV Treatment Adherence
Masaka, Uganda
N/A
Waitlist Available
Led By Fred M Ssewamala, MSW, PhD
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
10-16 years of age at the time of enrollment
Must not have
Not HIV-positive
HIV-positive but not prescribed antiretroviral therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every year in years 6 to 10
Awards & highlights
No Placebo-Only Group
Summary
This trial is examining whether an innovative intervention that includes an economic empowerment component can increase adherence to HIV treatment among adolescents in Uganda.
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Who is the study for?
This trial is for HIV-positive adolescents aged 10-16 in southern Uganda, who are on antiretroviral therapy and enrolled at one of the specified 40 medical clinics. They must be living within a family setting, but not necessarily with biological parents.Check my eligibility
What is being tested?
The study tests Suubi+Adherence, an economic empowerment intervention aimed to improve HIV treatment adherence among youth. It includes savings-led income generation to promote stability and applies it to their HIV treatment regimen.See study design
What are the potential side effects?
Since this trial focuses on economic empowerment rather than medication, traditional side effects related to drugs aren't applicable. However, there may be social or psychological impacts due to changes in financial status or responsibilities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on antiretroviral therapy.
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I am between 10 and 16 years old.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have HIV.
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I am HIV-positive and not on antiretroviral therapy.
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I am between 10 and 16 years old.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every year in years 6 to 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every year in years 6 to 10
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline to follow-up assessments of adherence to HIV treatment
Secondary study objectives
Cognitive functioning
Cost-Effectiveness Analyses
HIV stigma
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Suubi+AdherenceExperimental Treatment1 Intervention
Suubi+Adherence intervention arm provides:
* Matched savings accounts/child development accounts (CDAs) for the adolescents held in a local bank.
* Financial education and workshops on asset-building, future planning, and protection from risks
* Mentorship from a young adult/near-peer
* Family-based microenterprise development training
Bolstered Standard of Care: Adherence Counseling Practices
-Four to six counseling sessions to review HIV, ART, resistance, and adherence.
Medical Standard of Care:
-Pediatric ART initiation and monitoring followed by all public clinics, and outlined in National Department of Health Guidelines for pediatric HIV care in Uganda
Psychosocial Standard of Care:
-Psychosocial support provided by lay counselors trained in standardized ART adherence counseling
Group II: Bolstered Standard of CareActive Control1 Intervention
Bolstered Standard of Care: Adherence Counseling Practices
-Four to six counseling sessions to review HIV, ART, resistance, and adherence.
Medical Standard of Care:
-Pediatric ART initiation and monitoring followed by all public clinics, and outlined in National Department of Health Guidelines for pediatric HIV care in Uganda
Psychosocial Standard of Care:
-Psychosocial support provided by lay counselors trained in standardized ART adherence counseling
Find a Location
Closest Location:Washington University in St. Louis· Saint Louis, MO· 332 miles
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
2,021 Previous Clinical Trials
2,349,191 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,098 Previous Clinical Trials
2,748,614 Total Patients Enrolled
Fred M Ssewamala, MSW, PhDPrincipal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have HIV.I am HIV-positive and not on antiretroviral therapy.I am on antiretroviral therapy.I am between 10 and 16 years old.I am between 10 and 16 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Bolstered Standard of Care
- Group 2: Suubi+Adherence
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.