Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347146
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-03-17
Brief Title:
Bridges2Scale Testing Implementation Strategies
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Bridges2Scale Testing Implementation Strategies for an Economic Empowerment Intervention Among Young People Orphaned by AIDS
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 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 andor 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 n720 participants n24 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
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 n720 participants n24 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD112323 | NIH | None | httpsreporternihgovquickSearchR01HD112323 |