跳至主要内容
临床试验/NCT07747792
NCT07747792已完成不适用

Evaluation of the Implementation of the Shorter Treatment Regimen for Children and Adolescents With Non-Severe Tuberculosis in Zambia

Centre for Infectious Disease Research in Zambia1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2025年3月1日最近更新:
适应症

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

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

研究者

发起方
Centre for Infectious Disease Research in Zambia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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