Bridges2Scale: Testing Implementation Strategies

Not Applicable

Recruiting

• Conditions: HIV/AIDS
• Interventions: Behavioral: Financial Literacy Training (FLT) workshops; Behavioral: Mentorship; Behavioral: Income Generation Activity (IGA); Behavioral: Youth Development Accounts (YDA)

• Registration Number: NCT06347146
• Lead Sponsor: Washington University School of Medicine

Brief 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 th...

Detailed 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 involve...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-04
• Study Start: 2024-06-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Primary Completion: 2028-03-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1440

Inclusion Criteria

Adolescent inclusion criteria:

1. Ages 13-17
2. a student at one of the 48 public primary schools included in the study-schools located in high HIV/AIDS prevalence areas in the greater Masaka region
3. living within a family and not an institution/orphanage

Caregiver inclusion criteria:

1. self-identified and confirmed by the adolescent and youth as primary caregiver of the adolescent and youth
2. capable of providing informed consent

Youth-serving NGOs inclusion criteria:

1. registered with the government of Uganda
2. willing to work with the study team
3. have a history of implementing micro-finance economic empowerment interventions.

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Exclusion Criteria

1. anyone with a significant cognitive impairment that interferes with their understanding of the informed consent process, or is unable/unwilling to consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard implementation strategy condition	Mentorship	The Standard Implementation strategy condition is one that has been applied in our prior randomized controlled trials (RCTs). In applying this strategy, the investigators will meet with both non-governmental organizations (NGO) and school staff to gauge NGOs interest in partnering on study implementation and describe roles and responsibilities.
Standard implementation strategy condition	Youth Development Accounts (YDA)	The Standard Implementation strategy condition is one that has been applied in our prior randomized controlled trials (RCTs). In applying this strategy, the investigators will meet with both non-governmental organizations (NGO) and school staff to gauge NGOs interest in partnering on study implementation and describe roles and responsibilities.
Enhanced Implementation strategy condition	Mentorship	The Enhanced Implementation strategy condition will be developed using Implementation Mapping, a systematic protocol for developing implementation strategies using theory, evidence, and stakeholder input. This will ensure that known determinants of implementation, scale-up, and sustainment are addressed by strategies designed collaboratively with the community partners from a public-private partnership of government-funded public schools and non-government organizations (NGOs).
Standard implementation strategy condition	Income Generation Activity (IGA)	The Standard Implementation strategy condition is one that has been applied in our prior randomized controlled trials (RCTs). In applying this strategy, the investigators will meet with both non-governmental organizations (NGO) and school staff to gauge NGOs interest in partnering on study implementation and describe roles and responsibilities.
Enhanced Implementation strategy condition	Financial Literacy Training (FLT) workshops	The Enhanced Implementation strategy condition will be developed using Implementation Mapping, a systematic protocol for developing implementation strategies using theory, evidence, and stakeholder input. This will ensure that known determinants of implementation, scale-up, and sustainment are addressed by strategies designed collaboratively with the community partners from a public-private partnership of government-funded public schools and non-government organizations (NGOs).
Standard implementation strategy condition	Financial Literacy Training (FLT) workshops	The Standard Implementation strategy condition is one that has been applied in our prior randomized controlled trials (RCTs). In applying this strategy, the investigators will meet with both non-governmental organizations (NGO) and school staff to gauge NGOs interest in partnering on study implementation and describe roles and responsibilities.
Enhanced Implementation strategy condition	Income Generation Activity (IGA)	The Enhanced Implementation strategy condition will be developed using Implementation Mapping, a systematic protocol for developing implementation strategies using theory, evidence, and stakeholder input. This will ensure that known determinants of implementation, scale-up, and sustainment are addressed by strategies designed collaboratively with the community partners from a public-private partnership of government-funded public schools and non-government organizations (NGOs).
Enhanced Implementation strategy condition	Youth Development Accounts (YDA)	The Enhanced Implementation strategy condition will be developed using Implementation Mapping, a systematic protocol for developing implementation strategies using theory, evidence, and stakeholder input. This will ensure that known determinants of implementation, scale-up, and sustainment are addressed by strategies designed collaboratively with the community partners from a public-private partnership of government-funded public schools and non-government organizations (NGOs).

Primary Outcome Measures

Name	Time	Method
Intervention Fidelity	Throughout intervention delivery (2 years (Baseline, 12 months, 24 months))	The proportion of research assistants/facilitators that achieve 85% agreement on at least 3 of the fidelity assessment checklists.; ...
HIV prevalence	4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)	Prevalence of adolescents positive for HIV among the sample determined from biomarker data

Secondary Outcome Measures

Name	Time	Method
Proportion of adolescents living with HIV who are virally suppressed	4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)	Viral suppression will be assessed using biological assay
Sexual risk-taking behavior	4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)	Sexual risk-taking behavior will be measured using the Risk Behavior Survey. scores range from 0-20, with higher total scores indicating higher risk to engage in sexual risk behaviors.
Self-concept	4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)	Self-concept was assessed using the Tennessee Self-Concept Scale. Scale scores range from 20 to 100 with higher scores indicative of higher self-concept.
Hopelessness	4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)	Hopelessness was assessed using the Beck Hopelessness Scale The total score range between 0 and 20 with a high score indicating higher levels of Hopelessness.
Economic stability	4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)	Economic stability will be assessed via Bank statements
School attainment	4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)	School attainment will be assessed using the Adapted Monitoring the Future scale and the Primary Leaving Examinations (PLE) Results
Proportion of HIV negative adolescents who use PrEP	4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)	PrEP use will be assessed using biological assay
Self-Esteem	4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)	Self-esteem was assessed using the Rosenberg Self-Esteems Scale. Scale scores range from 0 to 30 with higher scores indicative of higher self-esteem.
Depressive Symptoms	4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)	Depressive symptoms was assessed using the Adapted Child Depression Inventory. The total score range between 0 and 28 with a high score indicating higher levels of depressive symptoms.

Trial Locations

Locations (1)

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