Bridges2Scale: Testing Implementation Strategies for an Economic Empowerment Intervention Among Young People Orphaned by AIDS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,440
- 试验地点
- 2
- 主要终点
- Intervention Fidelity
研究概览
简要总结
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.
详细描述
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 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. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescent inclusion criteria:
- •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.
排除标准
- •1. anyone with a significant cognitive impairment that interferes with their understanding of the informed consent process, or is unable/unwilling to consent.
研究组 & 干预措施
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.
干预措施: Youth Development Accounts (YDA) (Behavioral)
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).
干预措施: Income Generation Activity (IGA) (Behavioral)
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.
干预措施: Financial Literacy Training (FLT) workshops (Behavioral)
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.
干预措施: Mentorship (Behavioral)
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.
干预措施: Income Generation Activity (IGA) (Behavioral)
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).
干预措施: Financial Literacy Training (FLT) workshops (Behavioral)
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).
干预措施: Mentorship (Behavioral)
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).
干预措施: Youth Development Accounts (YDA) (Behavioral)
结局指标
主要结局
Intervention Fidelity
时间窗: 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. Field research assistants will be trained on using fidelity tools to track: (a) content of the intervention (e.g., saving), (b) process (e.g., mentoring skills), (c) activities (e.g., workshops). The team will practice fidelity assessment in pairs until they reach at least 85% agreement on at least 3 fidelity assessment checklists. In the field, independent fidelity observations will be conducted by research staff for 25% of Bridges sessions. Fidelity data will be used to assess the relationship between planned and actual implementation, and will be catalogued using FRAME-IS as a guide.
HIV prevalence
时间窗: 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
次要结局
- Proportion of adolescents living with HIV who are virally suppressed(4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline))
- Sexual risk-taking behavior(4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline))
- Self-concept(4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline))
- Hopelessness(4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline))
- School attainment(4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline))
- Economic stability(4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline))
- Proportion of HIV negative adolescents who use PrEP(4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline))
- Self-Esteem(4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline))
- Depressive Symptoms(4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline))
研究者
Fred Ssewamala
Professor
Washington University School of Medicine