Shorter Treatment Regimen Implementation Evaluation Study

NCT07747792 | Completed DMC

• 2 other identifiers: Ev STR 5558-2024GH002251
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  Mixed methods data collection including qualitative interviews and expert review panels

  March 2023 to August 2024

• 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.

  Immediate end of treatment outcomes

  March 2023 to August 2024

• To determine the 1-year post treatment outcomes of children initiated on the STR in order to ascertain the relapse/re-infection free rates.

  Outcomes after 1 year of treatment

  March 2023 to August 2024

Eligibility Criteria

• Age: 3 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The evaluation population for objective 1 consist of children and adolescents who are recipients of care (RoC), caregivers of children on STR, service providers of STR and decision-makers (e.g., policy makers) relevant to STR. Evaluation Population Under objective 2 and 3 the study population will consist of all children and adolescents aged between 3 months to \< 15 years diagnosed with TB between initial rollout of the STR through the first 6 months of the evaluation period in the selected facilities for assessment of the assignment of children to the STR or six-month treatment regimen (fidelity to eligibility criteria and guidance). Those children initiated on STR will also be followed quarterly for 12 months to assign post treatment follow up.

You may qualify if:

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

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead

Study Sites (1)

CIDRZ

Lusaka, Lusaka Province, 10101, Zambia

Location

MeSH Terms

Conditions

Tuberculosis; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Monde Muyoyeta, MBChB PhD

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 17 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: March 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)