Suubi+Adherence4Youth: Optimizing the Suubi Intervention for Adherence to HIV Treatment for Youth Living with HIV in Uganda

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study will test four economic empowerment intervention components to identify the combination that best enhance viral suppression. The study design is a 2-to-the 4 factorial experiment. The 2 represents the level of each component:0 (receive) or (don't receive) four components: 1) Financial Literacy Training (FLT); 2) Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); 3) A manualized intervention for ART adherence and stigma reduction (Suubi Cartoon); and 4) Engagement with HIV treatment-experienced role models who share their lived experiences of HIV. Guided by the MOST framework, the study will test each of the four components' performance and their combinations on the primary outcome, viral suppression. Resulting in 16 unique conditions representing all possible combinations of the 4 components. The study will randomize at the level of health clinics (N=48). Clinics will be randomized to provide one of the 16 conditions, with 12 ALHIV (aged 11-17 years) enrolled per clinic, yielding main effects and interaction effects for the 4 components on sustained viral suppression. Sustained viral suppression is defined as an undetectable viral load on all 12-, 24- and 36-month follow-up assessments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 17
Healthy Volunteers: f
View:

⁃ Adolescent:

• living with HIV (confirmed by medical report and aware of status)

• living within a family

• being 11-17 years of age (at enrollment)

• prescribed ART

• enrolled in ART care at one of the 48 health clinics in the study districts.

⁃ Health clinics would be eligible if they:

• have existing procedures tailored to adolescent adherence (including adolescent-specific clinic days and peer counselling)

• Accredited by the Uganda Ministry of Health as a provider of ART within the study districts.

Locations
Other Locations
Uganda
International Center for Child Health and Development
RECRUITING
Masaka
Contact Information
Primary
Fred M Ssewamala, PhD
fms1@wustl.edu
3149358521
Time Frame
Start Date: 2023-06-26
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 576
Treatments
Experimental: Condition 1: Components 1, 2,3 and 4
Participants will be assigned to receive all of the four intervention programs:~1. Financial Literacy Training (FLT) Workshops~2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)~3. A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)~4. Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Experimental: Condition 2: Components 1, 2 and 3
1. Financial Literacy Training (FLT) Workshops~2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)~3. A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
Experimental: Condition 3: Components 1, 2 and 4
1. Financial Literacy Training (FLT) Workshops~2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)~4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Experimental: Condition 4: Components 1 and 2
1. Financial Literacy Training (FLT) Workshops~2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
Experimental: Condition 5: Components 1,3 and 4
1.Financial Literacy Training (FLT) Workshops~3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)~4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Experimental: Condition 6: Components 1 and 3
1.Financial Literacy Training (FLT) Workshops~3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
Experimental: Condition 7: Components 1 and 4
1.Financial Literacy Training (FLT) Workshops~4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Experimental: Condition 8: Components 1
1.Financial Literacy Training (FLT) Workshops
Experimental: Condition 9: Components 2,3 and 4
2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)~3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)~4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Experimental: Condition 10: Components 2 and 3
2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)~3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
Experimental: Condition 11: Components 2 and 4
2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)~4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Experimental: Condition 12: Components 2
2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
Experimental: Condition 13: Components 3 and 4
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)~4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Experimental: Condition 14: Components 3
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
Experimental: Condition 15: Components 4
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Experimental: Condition 16: No Components
Participants not assigned to any of the 4 components
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: National Institute of Mental Health (NIMH), University of California, San Francisco

This content was sourced from clinicaltrials.gov