search
Back to results

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
Centre for Global Public Health Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tuberculosis focused on measuring Active case finding, Artificial Intelligence, Hotspots

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 21, 2023
    Last Updated
    September 4, 2023
    Sponsor
    Centre for Global Public Health Pakistan
    Collaborators
    Mercy Corps Pakistan
    search

    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

    We'll reach out to this number within 24 hrs