Tuberculosis Active, Tuberculosis in Children, Tuberculosis (TB), Tuberculosis Treatment Effectiveness
Conditions
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
Study design
Eligibility
Inclusion criteria
* Children with TB * Children with TB diagnosed between March 2023 to August 2024
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To explore acceptability, fidelity, and feasibility of implementing STR in real-world settings in order to optimize program implementation. | 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. | 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. | March 2023 to August 2024 | Outcomes after 1 year of treatment |
Countries
Zambia
Contacts
Centre for Infectious Disease Research in Zambia