Shorter Treatment Regimen Implementation Evaluation Study

"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.

Completed

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Key information

Conditions

Tuberculosis (TB) Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mycobacterium Infections Neoplasms Neoplasms by Histologic Type Tuberculosis Tuberculosis Active Tuberculosis Treatment Effectiveness Tuberculosis in Children

Age range

3 month–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CIDRZ

Lusaka, Lusaka Province, 10101, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children with TB
Children with TB diagnosed between March 2023 to August 2024

Exclusion criteria

Treatment and study plan

Primary outcomes

To explore acceptability, fidelity, and feasibility of implementing STR in real-world settings in order to optimize program implementation.

Time frame: 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.

Time frame: 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.

Time frame: March 2023 to August 2024

Outcomes after 1 year of treatment

Sponsors and collaborators

Lead sponsor

Centre for Infectious Disease Research in Zambia

Other

Registry information

Official study title

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

Acronym: EvSTR

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Aug 5, 2026
Registry last updated: Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed