Suubi+Adherence4Youth: Optimizing the Suubi Intervention for Adherence to HIV Treatment for Youth Living With HIV in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 576
- 试验地点
- 1
- 主要终点
- Achievement of Viral Suppression
研究概览
简要总结
The study will test four economic empowerment intervention components to identify the combination that best enhance viral suppression.
The study design is a 2-to-the 4 factorial experiment. The 2 represents the level of each component:0 (receive) or (don't receive) four components: 1) Financial Literacy Training (FLT); 2) Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); 3) A manualized intervention for ART adherence and stigma reduction (Suubi Cartoon); and 4) Engagement with HIV treatment-experienced role models who share their lived experiences of HIV. Guided by the MOST framework, the study will test each of the four components' performance and their combinations on the primary outcome, viral suppression. Resulting in 16 unique conditions representing all possible combinations of the 4 components. The study will randomize at the level of health clinics (N=48). Clinics will be randomized to provide one of the 16 conditions, with 12 ALHIV (aged 11-17 years) enrolled per clinic, yielding main effects and interaction effects for the 4 components on sustained viral suppression. Sustained viral suppression is defined as an undetectable viral load on all 12-, 24- and 36-month follow-up assessments.
详细描述
The number of adolescents living with HIV (ALHIV) in Uganda is over 170,000 and growing. Ugandan ALHIV are a priority due to social and structural inequities that make them highly vulnerable to HIV infection and sub-optimal access and adherence to antiretroviral therapy (ART). Less than 50% of ALHIV in Uganda are ART-adherent leading to low rates of viral suppression and high rates of attrition from HIV care. In response to the call for expanding differentiated care approaches for ALHIV and new forms of combination HIV interventions, we seek to intervene on social and structural inequities as economic and psychosocial hardships exacerbate the risk for viral load non-suppression. Addressing these hardships can improve the livelihoods of ALHIV and give them the knowledge and resources to sustainably manage HIV.
With 15+ years of intervention research combining 1) economic empowerment (EE) and 2) psychosocial components for HIV prevention, care and support for adolescents in SSA, we have demonstrated the effectiveness of Suubi (Hope), our multi-component combination intervention tested in four RCTs in Uganda (R01HD070727, R01HD074949, R34MH081763, R01MH113486) and one foundation-funded study in Kenya. With EE components to address economic hardships and psychosocial components to address ART non-adherence and HIV stigma, we have improved viral suppression and psychosocial and mental health functioning. Suubi is evidence-based and theory-informed and has four components: 1) Financial Literacy Training (FLT); 2) Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); 3) A manualized intervention for ART adherence and stigma reduction (Suubi Cartoon); and 4) Engagement with HIV treatment-experienced role models who share their lived experiences of HIV. Suubi has shown robust effects on viral suppression and ART adherence, mental health, psychosocial outcomes, and family financial stability and cohesion. However, it is unknown if each component in Suubi had a positive effect, how the components interacted, or if fewer components could have produced equivalent effects. Given our successes and infrastructure, we are well-positioned to unpack and optimize Suubi to identify the most impactful and sustainable components for scale up across Uganda.
The study will use a factorial experiment to unpack, test, and optimize the Suubi intervention to enhance scale up in health systems using the multi-phase optimization strategy (MOST), an engineering-inspired intervention framework. Guided by the MOST framework, the study will test each of the four components' performance and their combinations in a fully powered efficient factorial experiment on the primary outcome, viral suppression. Then a pre-specified optimization objective will be set to create the new "optimized" intervention. We define our "optimization objective" as the most cost-effective components that addresses three real-world constraints (i.e., challenges to implementation): 1) efficiency (do the components work within our existing health systems?), 2) affordability (do observed effect sizes justify costs and labor?), and 3) scalability (do components perform exactly as they would at scale?). The study will evaluate various component combination effect sizes and balance them against real-world constraints and costing data to empirically arrive at optimization. Our goal is to build Suubi 2.0 (hereafter, Suubi+Adherence4Youth), a combination of components for viral suppression that meets standards for being efficient, affordable, and working at scale.
The study will be guided by the following specific aims:
Aim 1. Conduct a factorial experiment (optimization trial) to test the main effects of each of the four Suubi intervention components and combinations of components (interactions) on viral suppression (primary outcome);
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to the experimental condition that the participant was assigned to.
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent:
- •living with HIV (confirmed by medical report and aware of status)
- •living within a family
- •being 11-17 years of age (at enrollment)
- •prescribed ART
- •enrolled in ART care at one of the 48 health clinics in the study districts.
- •Health clinics would be eligible if they:
- •have existing procedures tailored to adolescent adherence (including adolescent-specific clinic days and peer counselling)
- •Accredited by the Uganda Ministry of Health as a provider of ART within the study districts.
排除标准
- •Includes an inability to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent or parent.
- •If the adolescent or adult caregiver presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation
研究组 & 干预措施
Condition 4: Components 1 and 2
- Financial Literacy Training (FLT) Workshops
- Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
干预措施: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) (Behavioral)
Condition 1: Components 1, 2,3 and 4
Participants will be assigned to receive all of the four intervention programs:
- Financial Literacy Training (FLT) Workshops
- Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
- A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
- Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Financial Literacy Training (FLT) Workshops (Behavioral)
Condition 1: Components 1, 2,3 and 4
Participants will be assigned to receive all of the four intervention programs:
- Financial Literacy Training (FLT) Workshops
- Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
- A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
- Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) (Behavioral)
Condition 1: Components 1, 2,3 and 4
Participants will be assigned to receive all of the four intervention programs:
- Financial Literacy Training (FLT) Workshops
- Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
- A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
- Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). (Behavioral)
Condition 1: Components 1, 2,3 and 4
Participants will be assigned to receive all of the four intervention programs:
- Financial Literacy Training (FLT) Workshops
- Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
- A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
- Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Engagement with HIV treatment-experienced role models who share lived experiences of HIV (Behavioral)
Condition 2: Components 1, 2 and 3
- Financial Literacy Training (FLT) Workshops
- Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
- A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
干预措施: Financial Literacy Training (FLT) Workshops (Behavioral)
Condition 10: Components 2 and 3
2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
干预措施: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). (Behavioral)
Condition 2: Components 1, 2 and 3
- Financial Literacy Training (FLT) Workshops
- Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
- A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
干预措施: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) (Behavioral)
Condition 2: Components 1, 2 and 3
- Financial Literacy Training (FLT) Workshops
- Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
- A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
干预措施: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). (Behavioral)
Condition 3: Components 1, 2 and 4
- Financial Literacy Training (FLT) Workshops
- Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Financial Literacy Training (FLT) Workshops (Behavioral)
Condition 3: Components 1, 2 and 4
- Financial Literacy Training (FLT) Workshops
- Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) (Behavioral)
Condition 3: Components 1, 2 and 4
- Financial Literacy Training (FLT) Workshops
- Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Engagement with HIV treatment-experienced role models who share lived experiences of HIV (Behavioral)
Condition 4: Components 1 and 2
- Financial Literacy Training (FLT) Workshops
- Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
干预措施: Financial Literacy Training (FLT) Workshops (Behavioral)
Condition 16: No Components
Participants not assigned to any of the 4 components
干预措施: Standard of Care (SOC) (Other)
Condition 5: Components 1,3 and 4
1.Financial Literacy Training (FLT) Workshops
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Financial Literacy Training (FLT) Workshops (Behavioral)
Condition 5: Components 1,3 and 4
1.Financial Literacy Training (FLT) Workshops
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). (Behavioral)
Condition 5: Components 1,3 and 4
1.Financial Literacy Training (FLT) Workshops
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Engagement with HIV treatment-experienced role models who share lived experiences of HIV (Behavioral)
Condition 6: Components 1 and 3
1.Financial Literacy Training (FLT) Workshops
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
干预措施: Financial Literacy Training (FLT) Workshops (Behavioral)
Condition 6: Components 1 and 3
1.Financial Literacy Training (FLT) Workshops
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
干预措施: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). (Behavioral)
Condition 7: Components 1 and 4
1.Financial Literacy Training (FLT) Workshops
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Financial Literacy Training (FLT) Workshops (Behavioral)
Condition 7: Components 1 and 4
1.Financial Literacy Training (FLT) Workshops
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Engagement with HIV treatment-experienced role models who share lived experiences of HIV (Behavioral)
Condition 8: Components 1
1.Financial Literacy Training (FLT) Workshops
干预措施: Financial Literacy Training (FLT) Workshops (Behavioral)
Condition 9: Components 2,3 and 4
2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) (Behavioral)
Condition 9: Components 2,3 and 4
2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). (Behavioral)
Condition 9: Components 2,3 and 4
2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Engagement with HIV treatment-experienced role models who share lived experiences of HIV (Behavioral)
Condition 10: Components 2 and 3
2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
干预措施: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) (Behavioral)
Condition 11: Components 2 and 4
2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) (Behavioral)
Condition 11: Components 2 and 4
2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Engagement with HIV treatment-experienced role models who share lived experiences of HIV (Behavioral)
Condition 12: Components 2
2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
干预措施: Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) (Behavioral)
Condition 13: Components 3 and 4
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). (Behavioral)
Condition 13: Components 3 and 4
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Engagement with HIV treatment-experienced role models who share lived experiences of HIV (Behavioral)
Condition 14: Components 3
3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
干预措施: A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon). (Behavioral)
Condition 15: Components 4
4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
干预措施: Engagement with HIV treatment-experienced role models who share lived experiences of HIV (Behavioral)
结局指标
主要结局
Achievement of Viral Suppression
时间窗: Baseline 12, 24 and 36 month follow-up
Change in viral suppression will be assessed using viral load (VL) data collected from health clinic records. VL will be dichotomized between undetectable /suppression (VL\< 40 copies/ml) and detectable/failed viral suppression (VL \> =40 copies/ml) levels at each assessment time.
Cost-Effectiveness Analyses
时间窗: Baseline 12, 24 and 36 month follow-up
Cost-effectiveness analyses measuring the cost of achieving an agreed upon benefit, such as cost of staff time, supplies, overhead of IDA's, as measured by admin review and project records.
次要结局
- Financial Literacy(Baseline 12, 24 and 36 month follow-up)
- Change in motivation to save(Baseline 12, 24 and 36 month follow-up)
- Change in savings amount and Investment in IGA(Baseline 12, 24 and 36 month follow-up)
- Change in confidence to save(Baseline 12, 24 and 36 month follow-up)
- Financial management skills(Baseline 12, 24 and 36 month follow-up)
- Engagement with financial institutions(Baseline 12, 24 and 36 month follow-up)
研究者
Fred Ssewamala
Professor
Washington University School of Medicine