Suubi+Adherence: Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 702
- 试验地点
- 2
- 主要终点
- Change from baseline to follow-up assessments of adherence to HIV treatment
研究概览
简要总结
The goal of Suubi+Adherence is to examine the impact and cost associated with an innovative intervention to increase adherence to HIV treatment for HIV-infected adolescents. Multiple intervention studies by our team in Rakai and Masaka Districts of southern Uganda with AIDS-orphaned adolescents have revealed that if given an opportunity to participate in economic empowerment interventions, youth and their caregivers take full advantage of these interventions to save and invest in their future, show improvements in family financial outcomes, future aspirations, health functioning, sexual-risk taking behaviors, and mental health. The Suubi+Adherence study capitalizes on this prior work, positing that economic empowerment may be a missing, yet critical ingredient to HIV treatment adherence interventions for adolescents and young people. Suubi+Adherence incorporates an economic empowerment design, with a savings-led income generating component, to promote economic stability, and apply it to adherence to HIV treatment regimens for HIV-positive adolescents in a region of southern Uganda with the highest HIV incidence and prevalence in the country.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV-positive adolescents confirmed by medical report
- •Prescribed antiretroviral therapy
- •Enrolled in care at one of 40 medical clinics within study region
- •10-16 years of age at the time of enrollment
- •Living within a family (not necessarily with biological parent(s))
排除标准
- •Not HIV-positive
- •HIV-positive but not prescribed antiretroviral therapy
- •Not enrolled in care at one of 40 medical clinics within study region
- •Younger than 10 years and older than 16 years
- •Not living within a family
研究组 & 干预措施
Suubi+Adherence
Suubi+Adherence intervention arm provides:
- Matched savings accounts/child development accounts (CDAs) for the adolescents held in a local bank.
- Financial education and workshops on asset-building, future planning, and protection from risks
- Mentorship from a young adult/near-peer
- Family-based microenterprise development training
Bolstered Standard of Care: Adherence Counseling Practices
-Four to six counseling sessions to review HIV, ART, resistance, and adherence.
Medical Standard of Care:
-Pediatric ART initiation and monitoring followed by all public clinics, and outlined in National Department of Health Guidelines for pediatric HIV care in Uganda
Psychosocial Standard of Care:
-Psychosocial support provided by lay counselors trained in standardized ART adherence counseling
干预措施: Suubi+Adherence (Behavioral)
Bolstered Standard of Care
Bolstered Standard of Care: Adherence Counseling Practices
-Four to six counseling sessions to review HIV, ART, resistance, and adherence.
Medical Standard of Care:
-Pediatric ART initiation and monitoring followed by all public clinics, and outlined in National Department of Health Guidelines for pediatric HIV care in Uganda
Psychosocial Standard of Care:
-Psychosocial support provided by lay counselors trained in standardized ART adherence counseling
干预措施: Bolstered Standard of Care (Behavioral)
结局指标
主要结局
Change from baseline to follow-up assessments of adherence to HIV treatment
时间窗: Every year for 10 years
Adherence to HIV treatment regimen outcomes for HIV-positive adolescents, including participants' ability to access and refill prescribed HIV antiretroviral therapy and adhere to prescribed daily HIV medication routines.
次要结局
- Cognitive functioning(Every year in years 6 to 10)
- Social transitions(Every year in years 6 to 10)
- Cost-Effectiveness Analyses(Every year for 10 years)
- Protective Health Behaviors(Every year for 10 years)
- Substance misuse(Every year in years 6 to 10)
- HIV stigma(Every year in years 6 to 10)
研究者
Fred Ssewamala
Professor
Washington University School of Medicine