NCT06017843

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

August 21, 2023

Last Update Submit

July 24, 2024

Conditions

Keywords

Active case findingArtificial IntelligenceHotspots

Outcome Measures

Primary Outcomes (1)

  • Camp positivity yield

    Counts of bacteriologically confirmed TB (B+) cases diagnosed in each camp

    12 months

Secondary Outcomes (3)

  • Camp positivity rate

    12 months

  • Camp All-Forms yield

    12 months

  • Camp All-Forms TB rate

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Camps site selection for active case finding for TB using MATCH-AI

Other: Camps site selection for active case finding for TB using MATCH-AI

Control

NO INTERVENTION

Camps site selection for active case finding for TB using existing approaches.

Interventions

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.

Intervention

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All individuals \>15 years of age presenting to camp sites
  • Individuals with previous history of TB disease

You may not qualify if:

  • Children and adolescents \<15 years of age
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy Corps Pakistan

Islamabad, Pakistan

RECRUITING

Related Publications (1)

  • Zaidi SMA, Mahfooz A, Latif A, Nawaz N, Fatima R, Rehman FU, Reza TE, Emmanuel F. Geographical targeting of active case finding for tuberculosis in Pakistan using hotspots identified by artificial intelligence software (SPOT-TB): study protocol for a pragmatic stepped wedge cluster randomised control trial. BMJ Open Respir Res. 2024 Jul 11;11(1):e002079. doi: 10.1136/bmjresp-2023-002079.

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Faran Emmanuel

    Centre for Global Public Health Pakistan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Individuals visiting camps will be masked to the intervention status.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 30, 2023

Study Start

September 1, 2023

Primary Completion

October 31, 2024

Study Completion

June 30, 2025

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

At the conclusion of the trial, aggregate, summary data used for the final analysis will be stored on a public repository for archiving.

Locations