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Shorter Treatment Regimen Implementation Evaluation Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07747792
Acronym
EvSTR
Enrollment
175
Registered
2026-08-05
Start date
2025-03-01
Completion date
2026-01-30
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis Active, Tuberculosis in Children, Tuberculosis (TB), Tuberculosis Treatment Effectiveness

Keywords

Shorter Treatment Regimen, STR, Non-Severe, TB, Severe

Brief summary

"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.

Detailed description

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.

Interventions

None listed

Sponsors

Centre for Infectious Disease Research in Zambia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
3 Months to 14 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
To explore acceptability, fidelity, and feasibility of implementing STR in real-world settings in order to optimize program implementation.March 2023 to August 2024Mixed 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.March 2023 to August 2024Immediate 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.March 2023 to August 2024Outcomes after 1 year of treatment

Countries

Zambia

Contacts

PRINCIPAL_INVESTIGATORMonde Muyoyeta, MBChB PhD

Centre for Infectious Disease Research in Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026