Tuberculosis (TB)EvSTRNCT07747792
Shorter Treatment Regimen Implementation Evaluation Study
An observational study of Tuberculosis (TB) and Tuberculosis in Children, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 14 years
- Conditions the study is for
- Tuberculosis (TB), Tuberculosis in Children, Tuberculosis Treatment Effectiveness
- How many people
- 175 participants
- Where
- 1 siteZambia
- Study dates
- 1 Mar 2025to 30 Jan 2026
- How long will I take part?
- 17 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 14 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children with TB
- Children with TB diagnosed between March 2023 to August 2024
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Implementation of the Shorter Treatment Regimen for Children and Adolescents With Non-Severe Tuberculosis in Zambia
"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.
Read the 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.
- Conditions
- Tuberculosis (TB), Tuberculosis in Children, Tuberculosis Treatment Effectiveness, Tuberculosis Active
- Keywords
- Shorter Treatment Regimen, STR, Non-Severe, TB, Severe
- Medical subject headings
- Tuberculosis, Lymphoma, Follicular
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: March 2023 to August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Mar 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 175 participants (actual)
- Target duration
- 17 Months
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monde Muyoyeta, MBChB PhD, Principal investigator, Centre for Infectious Disease Research in Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747792
- Sponsor's protocol ID
- Ev STR 5558-2024
- Other IDs
- GH002251
- Acronym
- EvSTR
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation of the Shorter Treatment Regimen for Children and Adolescents With Non-Severe Tuberculosis in Zambia
- ClinicalTrials.gov ID
- NCT07747792
- Acronym / sponsor ID
- EvSTR / Ev STR 5558-2024
- Conditions
- Tuberculosis (TB), Tuberculosis in Children, Tuberculosis Treatment Effectiveness, Tuberculosis Active
- Keywords
- Shorter Treatment Regimen, STR, Non-Severe, TB, Severe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 17 Months
Who may qualify
- Ages
- 3 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Children with TB
- Children with TB diagnosed between March 2023 to August 2024
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monde Muyoyeta, MBChB PhD principal investigator
Centre for Infectious Disease Research in Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis (TB) and Tuberculosis in Children, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.