Suubi+Adherence4Youth

Not Applicable

Recruiting

• Conditions: HIV
• Interventions: Behavioral: Financial Literacy Training (FLT) Workshops; Other: Standard of Care (SOC); Behavioral: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); Behavioral: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).; Behavioral: Engagement with HIV treatment-experienced role models who share lived experiences of HIV

• Registration Number: NCT05600621
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

The number of adolescents living with HIV (ALHIV) in Uganda is over 170,000 and growing. Ugandan ALHIV are a priority due to social and structural inequities that make them highly vulnerable to HIV infection and sub-optimal access and adherence to antiretroviral therapy (ART). Less than 50% of ALHIV in Uganda are ART-adherent leading to low rates of viral suppression and high rates of attrition from HIV care. In response to the call for expanding differentiated care approaches for ALHIV and new forms of combination HIV interventions, we seek to intervene on social and structural inequities as economic and psychosocial hardships exacerbate the risk for viral load non-suppression. Addressing these hardships can improve the livelihoods of ALHIV and give them the knowledge and resources to sustainably manage HIV.

With 15+ years of intervention research combining 1) economic empowerment (EE) and 2) psychosocial components for HIV prevention, care and support for adolescents in SSA, we have demonstrated the effectiveness of Suubi (Hope), our multi-component combination intervention tested in four RCTs in Uganda (R01HD070727, R01HD074949, R34MH081763, R01MH113486) and one foundation-funded study in Kenya. With EE components to address economic hardships and psychosocial components to address ART non-adherence and HIV stigma, we have improved viral suppression and psychosocial and mental health functioning. Suubi is evidence-based and theory-informed and has 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. Suubi has shown robust effects on viral suppression and ART adherence, mental health, psychosocial outcomes, and family financial stability and cohesion. However, it is unknown if each component in Suubi had a positive effect, how the components interacted, or if fewer components could have produced equivalent effects. Given our successes and infrastructure, we are well-positioned to unpack and optimize Suubi to identify the most impactful and sustainable components for scale up across Uganda.

The study will use a factorial experiment to unpack, test, and optimize the Suubi intervention to enhance scale up in health systems using the multi-phase optimization strategy (MOST), an engineering-inspired intervention framework. Guided by the MOST framework, the study will test each of the four components' performance and their combinations in a fully powered efficient factorial experiment on the primary outcome, viral suppression. Then a pre-specified optimization objective will be set to create the new "optimized" intervention. We define our "optimization objective" as the most cost-effective components that addresses three real-world constraints (i.e., challenges to implementation): 1) efficiency (do the components work within our existing health systems?), 2) affordability (do observed effect sizes justify costs and labor?), and 3) scalability (do components perform exactly as they would at scale?). The study will evaluate various component combination effect sizes and balance them against real-world constraints and costing data to empirically arrive at optimization. Our goal is to build Suubi 2.0 (hereafter, Suubi+Adherence4Youth), a combination of components for viral suppression that meets standards for being efficient, affordable, and working at scale.

The study will be guided by the following specific aims:

Aim 1. Conduct a factorial experiment (optimization trial) to test the main effects of each of the four Suubi intervention components and combinations of components (interactions) on viral suppression (primary outcome);

Aim 2. Test mediators and explore moderators that explain and modify the relationship between each of the four Suubi intervention components and viral suppression;

Aim 3. Compare the cost and cost-effectiveness of each of the four Suubi intervention components and every combination of components.

Study Timeline

• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Study Start: 2023-06-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

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.

Exclusion Criteria

• Includes an inability to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent or parent.
• If the adolescent or adult caregiver presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Condition 3: Components 1, 2 and 4	Financial Literacy Training (FLT) Workshops	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.
Condition 1: Components 1, 2,3 and 4	Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)	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.
Condition 2: Components 1, 2 and 3	Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)	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)
Condition 1: Components 1, 2,3 and 4	Financial Literacy Training (FLT) Workshops	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.
Condition 2: Components 1, 2 and 3	Financial Literacy Training (FLT) Workshops	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)
Condition 7: Components 1 and 4	Financial Literacy Training (FLT) Workshops	1.Financial Literacy Training (FLT) Workshops 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Condition 1: Components 1, 2,3 and 4	A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).	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.
Condition 3: Components 1, 2 and 4	Engagement with HIV treatment-experienced role models who share lived experiences of HIV	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.
Condition 4: Components 1 and 2	Financial Literacy Training (FLT) Workshops	1. Financial Literacy Training (FLT) Workshops 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
Condition 9: Components 2,3 and 4	A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).	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.
Condition 13: Components 3 and 4	A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).	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.
Condition 14: Components 3	A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).	3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
Condition 1: Components 1, 2,3 and 4	Engagement with HIV treatment-experienced role models who share lived experiences of HIV	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.
Condition 5: Components 1,3 and 4	A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).	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.
Condition 6: Components 1 and 3	Financial Literacy Training (FLT) Workshops	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)
Condition 11: Components 2 and 4	Engagement with HIV treatment-experienced role models who share lived experiences of HIV	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.
Condition 2: Components 1, 2 and 3	A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).	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)
Condition 3: Components 1, 2 and 4	Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)	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.
Condition 7: Components 1 and 4	Engagement with HIV treatment-experienced role models who share lived experiences of HIV	1.Financial Literacy Training (FLT) Workshops 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Condition 8: Components 1	Financial Literacy Training (FLT) Workshops	1.Financial Literacy Training (FLT) Workshops
Condition 9: Components 2,3 and 4	Engagement with HIV treatment-experienced role models who share lived experiences of HIV	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.
Condition 4: Components 1 and 2	Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)	1. Financial Literacy Training (FLT) Workshops 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
Condition 5: Components 1,3 and 4	Financial Literacy Training (FLT) Workshops	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.
Condition 5: Components 1,3 and 4	Engagement with HIV treatment-experienced role models who share lived experiences of HIV	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.
Condition 6: Components 1 and 3	A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).	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)
Condition 9: Components 2,3 and 4	Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)	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.
Condition 10: Components 2 and 3	Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)	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)
Condition 11: Components 2 and 4	Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)	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.
Condition 15: Components 4	Engagement with HIV treatment-experienced role models who share lived experiences of HIV	4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Condition 16: No Components	Standard of Care (SOC)	Participants not assigned to any of the 4 components
Condition 10: Components 2 and 3	A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).	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)
Condition 12: Components 2	Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)	2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
Condition 13: Components 3 and 4	Engagement with HIV treatment-experienced role models who share lived experiences of HIV	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.

Primary Outcome Measures

Name	Time	Method
Achievement of Viral Suppression	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.
Cost-Effectiveness Analyses	Baseline 12, 24 and 36 month follow-up	Cost-effectiveness analyses measuring the cost of achieving an agreed upon benefit, such as cost of staff time, supplies, overhead of IDA's, as measured by admin review and project records.

Secondary Outcome Measures

Name	Time	Method
Financial management skills	Baseline 12, 24 and 36 month follow-up	Change in financial management skills will be measured using the Attitudes about Saving Scale, with higher scores indicating greater financial management skills.
Engagement with financial institutions	Baseline 12, 24 and 36 month follow-up	Change in engagement with financial institutions will be measured using the frequency of deposits and withdrawals by data from bank statements.
Financial Literacy	Baseline 12, 24 and 36 month follow-up	Change in Financial Literacy knowledge will be measured using the Financial Literacy Knowledge item, with higher scores indicating higher financial literacy.
Change in motivation to save	Baseline 12, 24 and 36 month follow-up	Motivation to save will be measured using the Financial Literacy Knowledge item, with higher scores indicating higher motivation to save.
Change in savings amount and Investment in IGA	Baseline 12, 24 and 36 month follow-up	Change in savings amount and investment measured by data from bank statements
Change in confidence to save	Baseline 12, 24 and 36 month follow-up	Change in confidence to save will be measured using the Financial Literacy Knowledge item, with higher scores indicating higher confidence to save.

Trial Locations

Locations (1)

International Center for Child Health and Development; 🇺🇬 Masaka, Uganda