Bridges2Scale: Testing Implementation Strategies

HIV/AIDS Clinical Trial

Official title: Bridges2Scale: Testing Implementation Strategies for an Economic Empowerment Intervention Among Young People Orphaned by AIDS

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to compare two multifaceted strategies (standard vs enhanced) for scaling Bridges in a two-arm Hybrid III effectiveness-implementation cluster randomized controlled trial (RCT) in adolescent and youths affected by AIDS [AYaAIDS] (ages 13-17 years) from 48 schools in the Greater Masaka region of Uganda. The main aims of the clinical trial are: Aim 1. Compare the implementation effectiveness of the standard implementation strategy vs. an enhanced implementation strategy. The investigators will assess fidelity to Bridges (primary implementation outcome) and sustainment of Bridges (exploratory implementation outcome).

Aim 2. Determine the clinical effectiveness of Bridges implemented via a standard vs. enhanced implementation strategy. Aim 3: Explore implementation processes, mechanisms, and determinants. Aim 4. Compare the cost and cost-effectiveness of the two implementation strategies. Using an activity-based ingredients approach, the investigators will examine how much each strategy costs to achieve a unit of effect.

Clinical Trial Description

Economic empowerment (EE) interventions have demonstrated substantial promise in reducing HIV-related risk-taking behaviors, and improving ART treatment adherence and mental health outcomes. Our group has demonstrated the effectiveness of a multi-component EE intervention, Bridges, in four NIH-funded randomized control trials (RCT) in Uganda. Bridges involves: 1) financial literacy training (FLT) and mentorship; 2) family income-generating activities (IGA); and 3) incentivized savings via a matched Youth Development Account (YDA) for education, family small business investment, and/or health-related expenses. Bridges has demonstrated robust effects on HIV-related risk-taking behaviors, antiretroviral therapy (ART) adherence, mental health, psychosocial outcomes, educational achievement, family economics, and family cohesion. Yet, scaling EE interventions has been a challenge, signaling the need to identify and test implementation strategies and examine determinants of implementation and sustainment. In Bridges2Scale, the goal of this clinical trial is to compare two multifaceted strategies (standard vs enhanced) for scaling Bridges in a two-arm Hybrid III effectiveness-implementation cluster RCT in adolescent and youths affected by AIDS [AYaAIDS] (ages 13-17 years) from 48 schools in the Greater Masaka region of Uganda. The main aims of the clinical trial are:

Aim 1. Compare the implementation effectiveness of the standard implementation strategy vs. an enhanced implementation strategy. The investigators will assess fidelity to Bridges (primary implementation outcome) and sustainment of Bridges (exploratory implementation outcome).

Aim 2: Determine the clinical effectiveness of Bridges implemented via a standard vs. enhanced implementation strategy. The investigators will assess HIV prevalence (primary outcome measured via participants' HIV status). In exploratory analyses, the investigators will assess economic stability, school attendance and attainment, sexual risk-taking behavior, mental health functioning, viral suppression (for AYLHIV), and pre-exposure prophylaxis (PrEP) use (for HIV-negative adolescents). Participants from each of the 48 schools will be randomly assigned to one of the two study conditions (n=720 participants; n=24 schools per study condition) such that all selected children from a particular school will receive the same intervention to reduce contamination. After the baseline assessment, data will be collected at 4 follow-up time points (12 months, 24 months, 36 months, and 48 months). The investigators will compare the implementation effectiveness (mean levels of fidelity) of the standard implementation strategy to the enhanced strategy and compare whether adolescents in the enhanced implementation strategy will have a lower odds of HIV prevalence at the final measurement point (48 months). The investigators will also compare the superiority of the enhanced implementation strategy to the standard implementation strategy group in lowering sexual risk-taking behavior, improving economic stability, education related outcomes (school attendance and attainment), and mental health functioning (for all adolescents), viral suppression (for AYLHIV), and PrEP use (for HIV negative adolescents).

Aim 3: Explore implementation processes, mechanisms, and determinants. Using mixed methods, the investigators will apply standardized measures and semi-structured interviews with implementing teams to explore any modifications to the two implementation strategies, perceptions of the implementation strategies (acceptability, appropriateness, feasibility), the mechanisms through which they may operate, and determinants (barriers and facilitators) of implementation that will inform future efforts to scale Bridges and other EE interventions.

Aim 4: Compare the cost and cost-effectiveness of the two implementation strategies. Using an activity-based ingredients approach, the investigators will examine how much each strategy costs to achieve a unit of effect. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

• NCT number: NCT06347146
• Study type: Interventional
• Source: Washington University School of Medicine
• Contact: Fred Ssewamala, PhD
• Phone: 314-935-8521
• Email: fms1@wustl.edu
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2024
• Completion date: July 31, 2028