Suubi+Adherence4Youth

HIV Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• HIV

• NCT number: NCT05600621
• Study type: Interventional
• Source: Washington University School of Medicine
• Contact: Fred M Ssewamala, PhD
• Phone: 3149358521
• Email: fms1@wustl.edu
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2023
• Completion date: July 31, 2027