Clinical trial NCT06347146: Bridges2Scale: Testing Implementation Strategies
Official title: Bridges2Scale: Testing Implementation Strategies for an Economic Empowerment Intervention Among Young People Orphaned by AIDS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-04-04
Enrollment: 1440
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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, 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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Intervention Fidelity
timeFrame: Throughout intervention delivery (2 years (Baseline, 12 months, 24 months))
measure: HIV prevalence
timeFrame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Secondary outcomes:
measure: Sexual risk-taking behavior
timeFrame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
measure: Economic stability
timeFrame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
measure: School attainment
timeFrame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
measure: Depressive Symptoms
timeFrame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
measure: Proportion of adolescents living with HIV who are virally suppressed
timeFrame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
measure: Proportion of HIV negative adolescents who use PrEP
timeFrame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
measure: Hopelessness
timeFrame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
measure: Self-Esteem
timeFrame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
measure: Self-concept
timeFrame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Other outcomes:
Locations:
city: Masaka
country: Uganda
facility: International Center for Child Health and Development
Study officials:
References: