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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 11-17 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 17
Healthy Volunteers: t
View:

⁃ Adolescent inclusion criteria:

• Ages 11-17

• 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

• living within a family and not an institution/orphanage

⁃ Caregiver inclusion criteria:

• self-identified and confirmed by the adolescent and youth as primary caregiver of the adolescent and youth

• capable of providing informed consent

⁃ Youth-serving NGOs inclusion criteria:

• registered with the government of Uganda

• willing to work with the study team

• have a history of implementing micro-finance economic empowerment interventions.

Locations
Other Locations
Uganda
International Center for Child Health and Development
RECRUITING
Masaka
Contact Information
Primary
Fred Ssewamala, PhD
fms1@wustl.edu
314-935-8521
Time Frame
Start Date: 2024-06-04
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 1440
Treatments
Experimental: Standard implementation strategy condition
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.
Experimental: Enhanced Implementation strategy condition
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).
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov