Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding (SPOT-TB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tuberculosis
• Intervention / Treatment: Other: Camps site selection for active case finding for TB using MATCH-AI

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.

• Study Type: Interventional
• Enrollment (Estimated): 180000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amna Mahfooz, MS(PH); Phone Number: +923438101441; Email: amna.mahfooz@cgph.org.pk
• Study Contact Backup: Name: Faheem Baig; Phone Number: +923345379004; Email: faheem@cgph.org.pk

Study Locations

• Pakistan
  • Islamabad, Pakistan
    • Recruiting
    • Mercy Corps Pakistan
    • Contact: Nainan Nawaz; Email: nanawaz@mercycorps.org
    • Principal Investigator: Abdullah Latif

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
No Intervention: Control; Camps site selection for active case finding for TB using existing approaches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Camp positivity yield	Counts of bacteriologically confirmed TB (B+) cases diagnosed in each camp	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Camp positivity rate	Bacteriologically confirmed TB (B+) cases per population screened	12 months
Camp All-Forms yield	Counts of All-Forms TB (AF-TB) cases diagnosed in each camp	12 months
Camp All-Forms TB rate	All-Forms TB (AF-TB) cases per population screened	12 months

Collaborators and Investigators

• Sponsor: Centre for Global Public Health Pakistan
• Collaborators: Mercy Corps Pakistan
• Investigators: Principal Investigator: Faran Emmanuel, Centre for Global Public Health Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Active case finding; Hotspots
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: CGPH-TB2023-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No