Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding (SPOT-TB)
Primary Purpose
Tuberculosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Camps site selection for active case finding for TB using MATCH-AI
Sponsored by
About this trial
This is an interventional health services research trial for Tuberculosis focused on measuring Active case finding, Artificial Intelligence, Hotspots
Eligibility Criteria
Inclusion Criteria: All individuals >15 years of age presenting to camp sites Individuals with previous history of TB disease Exclusion Criteria: Children and adolescents <15 years of age Pregnant women
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Camps site selection for active case finding for TB using MATCH-AI
Camps site selection for active case finding for TB using existing approaches.
Outcomes
Primary Outcome Measures
Camp positivity yield
Counts of bacteriologically confirmed TB (B+) cases diagnosed in each camp
Secondary Outcome Measures
Camp positivity rate
Bacteriologically confirmed TB (B+) cases per population screened
Camp All-Forms yield
Counts of All-Forms TB (AF-TB) cases diagnosed in each camp
Camp All-Forms TB rate
All-Forms TB (AF-TB) cases per population screened
Full Information
NCT ID
NCT06017843
First Posted
August 21, 2023
Last Updated
September 4, 2023
Sponsor
Centre for Global Public Health Pakistan
Collaborators
Mercy Corps Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT06017843
Brief Title
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
Acronym
SPOT-TB
Official Title
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding in Pakistan: a Pragmatic Stepped Wedge Cluster Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Global Public Health Pakistan
Collaborators
Mercy Corps Pakistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this pragmatic, stepped wedge cluster-randomized trial is to measure the comparative yield (number of incident TB cases diagnosed during active case-finding camps) using a site selection approach based on predictions generated via an artificial intelligence software called MATCH-AI (intervention group) versus the conventional approach of camp site selection using field-staff knowledge and experience (control group). The trial will help inform whether a targeted approach towards screening for TB using artificial-intelligence can improve yields of TB cases detected through community-based active case-finding.
Detailed Description
Despite significant progress over the past decades, an estimated 10.6 million individuals fell ill with tuberculosis (TB) in 2021 and the disease caused 1.6 million deaths globally. Pakistan is ranked as the 5th highest TB burden country in the world and TB causes 42,000 deaths annually in the country. A key challenge in the Pakistan's response to TB is ensuring diagnosis and treatment of all individuals with TB. In 2020, out of the 573,000 cases, a total of 276,736 (48%) were notified. Bridging this case-detection gap is a critical objective for the National TB Program (NTP). Active case-finding (ACF), is a potential strategy to increase case-detection by systematic screening of communities for TB. Recent evidence, indicates that ACF can also reduce population-level TB incidence and prevalence through early detection. While ACF interventions have demonstrated effectiveness in community-trials and are now being conducted at scale in Pakistan, concerns remain regarding their yields and cost-effectiveness in programmatic settings.
The primary aim of this study is to investigate whether a targeted approach towards community-based screening using MATCH-AI, an artificial intelligence software that models sub-district TB prevalence, can improve the yield of ACF interventions in Pakistan. In the intervention arm, field-team will conduct community-based ACF activities (called chest camps) primarily in locations predicted by MATCH-AI to have a higher prevalence of TB. In the control arm, field-teams will continue to utilize existing approaches towards camp site-selection. The trial will be conducted in 65 districts of Pakistan in collaboration with implementation partners of the NTP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Active case finding, Artificial Intelligence, Hotspots
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The MATCH-AI evaluation is designed as a stepped-wedge cluster randomized trial. In this study, clusters (mobile X-ray van teams) will successively switch over in groups of 3 to the intervention in a randomly assigned order until all clusters are eventually exposed to the intervention.
In the intervention arm, TB active case finding camps will be conducted primarily in locations guided by MATCH-AI a modelling software that predicts TB hotspots. In the control sites, field-teams will continue to utilize existing approaches such as local knowledge, historical data etc towards camp site-selection.
Masking
Participant
Masking Description
Individuals visiting camps will be masked to the intervention status.
Allocation
Randomized
Enrollment
180000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Camps site selection for active case finding for TB using MATCH-AI
Arm Title
Control
Arm Type
No Intervention
Arm Description
Camps site selection for active case finding for TB using existing approaches.
Intervention Type
Other
Intervention Name(s)
Camps site selection for active case finding for TB using MATCH-AI
Intervention Description
The primary intervention in this study is the roll-out of MATCH-AI, an artificial intelligence software that models sub-district TB prevalence, to guide site selection of ACF camps. The MATCH-AI tool uses a Bayesian modelling approach to predict TB prevalence to a resolution of 10,000 population that are mapped as polygons. The model integrates data from a range of sources including historical TB facility notification data, previous ACF data as well as contextual factors such as demographics, income, population density, health indicators such as vaccination coverage and climate related variables to predict localized TB prevalence. In the intervention arm, camps will be conducted primarily in locations guided by MATCH-AI.
Primary Outcome Measure Information:
Title
Camp positivity yield
Description
Counts of bacteriologically confirmed TB (B+) cases diagnosed in each camp
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Camp positivity rate
Description
Bacteriologically confirmed TB (B+) cases per population screened
Time Frame
12 months
Title
Camp All-Forms yield
Description
Counts of All-Forms TB (AF-TB) cases diagnosed in each camp
Time Frame
12 months
Title
Camp All-Forms TB rate
Description
All-Forms TB (AF-TB) cases per population screened
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All individuals >15 years of age presenting to camp sites
Individuals with previous history of TB disease
Exclusion Criteria:
Children and adolescents <15 years of age
Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amna Mahfooz, MS(PH)
Phone
+923438101441
Email
amna.mahfooz@cgph.org.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Faheem Baig
Phone
+923345379004
Email
faheem@cgph.org.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faran Emmanuel
Organizational Affiliation
Centre for Global Public Health Pakistan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
At the conclusion of the trial, aggregate, summary data used for the final analysis will be stored on a public repository for archiving.
Learn more about this trial
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
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