Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593080
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
The DECIDE-TB Trial Validation of Treatment Decision Algorithms for Childhood Tuberculosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation of Treatment Decision Algorithms for Childhood Tuberculosis At District Health Care Levels in Mozambique and Zambia - the Decide-TB Cluster-randomized Pragmatic Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DTB
Brief Summary:
The Decide-TB project aims to generate evidence for the implementation of a comprehensive Treatment Decision Algorithms TDA based approach for TB in children living in high TB burden and resource-limited countries at District Hospital DH and Primary Health Centre PHC levels and to facilitate the integration of this evidence within practices and policies
This programmatic pilot led by the National TB Programs NTP will test a TDA-based approach integrating TB screening diagnosis treatment decision-making and disease severity assessment for shorter treatment eligibility for use at a lower level of healthcare This TDA-based approach will be evaluated in a hybrid effectiveness implementation study based on a pragmatic stepped wedge cluster-randomized trial The Decide TB project will be implemented at the district level targeting five districts in each country Each cluster in a district will be made up of one district hospital and six primary health centers The study will develop a Clinical Decision Support System CDSS to operationalize the use of TDAs and strengthen District Health Information Systems DHIS2 to collect individual data which will contribute to monitoring and evaluation clinical mentoring and supervision by the countrys NTPs
This programmatic pilot led by the National TB Programs NTP will test a TDA-based approach integrating TB screening diagnosis treatment decision-making and disease severity assessment for shorter treatment eligibility for use at a lower level of healthcare This TDA-based approach will be evaluated in a hybrid effectiveness implementation study based on a pragmatic stepped wedge cluster-randomized trial The Decide TB project will be implemented at the district level targeting five districts in each country Each cluster in a district will be made up of one district hospital and six primary health centers The study will develop a Clinical Decision Support System CDSS to operationalize the use of TDAs and strengthen District Health Information Systems DHIS2 to collect individual data which will contribute to monitoring and evaluation clinical mentoring and supervision by the countrys NTPs
Detailed Description:
The Decide-TB trial is a pragmatic cluster-randomized study utilizing a stepped wedge design to provide scientific evidence on a comprehensive TDA-based approach for TB screening diagnosis and treatment in children under 15 years at low healthcare levels in Zambia and Mozambique
The trials primary objective is to evaluate the effectiveness feasibility implementation acceptability costs cost-effectiveness and adoption of a TDA-based approach for childhood TB screening diagnosis and treatment decision-making under programmatic conditions at District Hospitals DH and Primary Health Centres PHC levels in these countries
There are five specific objectives corresponding to the trials research components
1 To assess the effectiveness of the comprehensive TDA-based approach in increasing TB case detection in children as compared to the Standard of Care SOC and in providing good quality TB diagnosis and treatment decision diagnostic accuracy and reliability of treatment decision for TB and shorter treatment
2 To describe the implementation and the feasibility of using the comprehensive TDA-based approach including associated digital tools and to identify contextual determinants influencing implementation and contribute to improved implementationadaptations throughout intervention delivery
3 To assess preferences acceptability and perceived feasibility of using the comprehensive TDA-based approach including associated digital tools among end-users beneficiaries and key stakeholders
4 To assess the costs from the health system and the beneficiary parentscaregivers of children perspective the cost-effectiveness of using the comprehensive TDA-based approach including associated digital tools and the budget impact of scaling up the intervention
5 To assess the factors and stakeholders that support or constrain the adoption of the comprehensive TDA-based approach as health policy at district level
The intervention will be implemented as a programmatic pilot following the National TB Programs decision in Mozambique and Zambia to adopt a TDA-based approach in line with World Health Organisations WHO conditional recommendations Additionally both the standard of care and the intervention will be implemented in a non-randomized district to document diagnostic accuracy throughout the trial The Decide-TB trial is a hybrid effectiveness-implementation trial type 2 assessing both the clinical interventions effectiveness and the feasibility and utility of the implementation strategy
Diagnostic accuracy of both the standard of care and the intervention will be evaluated in an additional district which will transition to the intervention phase alongside the last district selected per the stepped wedge design Aggregated data will be retrospectively collected over 12 months from all participating districts and health facilities
The Decide-TB trial endpoints include effectiveness acceptability implementation health economics and health policy Effectiveness endpoints include the proportion of children who started TB treatment the time it takes to make a treatment decision and the consistency of TDA results with final treatment decisions among other factors Acceptability endpoints consider user preferences and local social value whereas implementation endpoints evaluate the practicality fidelity contextual aspects and sustainability of the TDA-based method Health economics endpoints include cost assessments cost-effectiveness and budget impact of scaling up the TDA-based approach vs the standard of care while health policy endpoints look at key stakeholders roles practices and policy translation processes
The trials primary objective is to evaluate the effectiveness feasibility implementation acceptability costs cost-effectiveness and adoption of a TDA-based approach for childhood TB screening diagnosis and treatment decision-making under programmatic conditions at District Hospitals DH and Primary Health Centres PHC levels in these countries
There are five specific objectives corresponding to the trials research components
1 To assess the effectiveness of the comprehensive TDA-based approach in increasing TB case detection in children as compared to the Standard of Care SOC and in providing good quality TB diagnosis and treatment decision diagnostic accuracy and reliability of treatment decision for TB and shorter treatment
2 To describe the implementation and the feasibility of using the comprehensive TDA-based approach including associated digital tools and to identify contextual determinants influencing implementation and contribute to improved implementationadaptations throughout intervention delivery
3 To assess preferences acceptability and perceived feasibility of using the comprehensive TDA-based approach including associated digital tools among end-users beneficiaries and key stakeholders
4 To assess the costs from the health system and the beneficiary parentscaregivers of children perspective the cost-effectiveness of using the comprehensive TDA-based approach including associated digital tools and the budget impact of scaling up the intervention
5 To assess the factors and stakeholders that support or constrain the adoption of the comprehensive TDA-based approach as health policy at district level
The intervention will be implemented as a programmatic pilot following the National TB Programs decision in Mozambique and Zambia to adopt a TDA-based approach in line with World Health Organisations WHO conditional recommendations Additionally both the standard of care and the intervention will be implemented in a non-randomized district to document diagnostic accuracy throughout the trial The Decide-TB trial is a hybrid effectiveness-implementation trial type 2 assessing both the clinical interventions effectiveness and the feasibility and utility of the implementation strategy
Diagnostic accuracy of both the standard of care and the intervention will be evaluated in an additional district which will transition to the intervention phase alongside the last district selected per the stepped wedge design Aggregated data will be retrospectively collected over 12 months from all participating districts and health facilities
The Decide-TB trial endpoints include effectiveness acceptability implementation health economics and health policy Effectiveness endpoints include the proportion of children who started TB treatment the time it takes to make a treatment decision and the consistency of TDA results with final treatment decisions among other factors Acceptability endpoints consider user preferences and local social value whereas implementation endpoints evaluate the practicality fidelity contextual aspects and sustainability of the TDA-based method Health economics endpoints include cost assessments cost-effectiveness and budget impact of scaling up the TDA-based approach vs the standard of care while health policy endpoints look at key stakeholders roles practices and policy translation processes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None