Evaluation of the Implementation of the Shorter Treatment Regimen for Children and Adolescents With Non-Severe Tuberculosis in Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- To explore acceptability, fidelity, and feasibility of implementing STR in real-world settings in order to optimize program implementation.
研究概览
简要总结
"Evaluation of the implementation of the shorter treatment regimen for children and adolescents with non-severe TB in Zambia" is a parallel and convergent mixed methods evaluation study of implementation and clinical outcomes of STR in real-world settings. The study enrolled caregivers and children who were recepients of care on STR, health workers providing STR services, facilities leadership and policy makers.
This study aimed to explore acceptability, fidelity, and feasibility of implementing STR in real-world settings in order to optimize program implementation. Additionally, the study aimed to determine the clinical outcomes of patients initiated on the STR in order to ascertain the performance of the regimen in a programmatic setting and contribute to the evidence base for using STR in clinical practice.
详细描述
As the Zambia National TB program adopts the pediatric short treatment regimen (STR) and scales to different levels of care with variable infrastructural and human resource capacity, it is crucial to evaluate the nature and quality of its implementation, the contextual factors that affect implementation as well as the treatment response of children initiated on STR. This evaluation will provide insights into programmatic strengths and weaknesses in relation to STR implementation, allowing for ongoing program optimization. By identifying implementation gaps, barriers, and facilitators, Zambia can refine its roll out strategies, enhance healthcare provider training and mentorship, and develop targeted interventions to improve the delivery of STR to children. Further, this evaluation will provide useful information on the potential differences between STR performance in research and under programmatic conditions and implications for its use in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 3 Months 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with TB
- •Children with TB diagnosed between March 2023 to August 2024
排除标准
- 未提供
结局指标
主要结局
To explore acceptability, fidelity, and feasibility of implementing STR in real-world settings in order to optimize program implementation.
时间窗: March 2023 to August 2024
Mixed methods data collection including qualitative interviews and expert review panels
To determine the clinical outcomes of children and adolescents aged 3 months to <15 years initiated on the STR in order to ascertain the performance of the regimen in a programmatic setting.
时间窗: March 2023 to August 2024
Immediate end of treatment outcomes
To determine the 1-year post treatment outcomes of children initiated on the STR in order to ascertain the relapse/re-infection free rates.
时间窗: March 2023 to August 2024
Outcomes after 1 year of treatment
次要结局
未报告次要终点
