Clinical trial NCT05600621: Suubi+Adherence4Youth
Official title: Suubi+Adherence4Youth: Optimizing the Suubi Intervention for Adherence to HIV Treatment for Youth Living with HIV in Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of California, San Francisco
First posted: 2022-10-31
Enrollment: 576
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The factorial experiment is guided by the Multiphase Optimization Strategy (MOST).

The 4 intervention components are:

Component 1. Financial Literacy Training (FLT); Component 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); Component 3. A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon); Component 4. Engagement with HIV treatment-experienced role models who share their lived experiences of HIV.

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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Achievement of Viral Suppression
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Cost-Effectiveness Analyses
timeFrame: Baseline 12, 24 and 36 month follow-up
Secondary outcomes:
measure: Financial Literacy
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Financial management skills
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Engagement with financial institutions
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Change in confidence to save
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Change in motivation to save
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Change in savings amount and Investment in IGA
timeFrame: Baseline 12, 24 and 36 month follow-up
Other outcomes:
measure: Change in ART knowledge and ART adherence
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Reductions in internalized stigma
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Sexual negotiation and communication skills
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Change in mental health-hopelessness symptoms
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Change in depressive symptoms
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Change in HIV Stigma
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Positive HIV Identity
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Problem solving of HIV care logistics
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Self-esteem
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Social support
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Engagement and retention of HIV care metrics
timeFrame: Baseline 12, 24 and 36 month follow-up
Locations:
city: Masaka
country: Uganda
facility: International Center for Child Health and Development
Study officials:
References: