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Clinical Trials/NCT06017843
NCT06017843RecruitingNot Applicable

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

Centre for Global Public Health Pakistan1 site in 1 country180,000 target enrollmentStarted: September 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
180,000
Locations
1
Primary Endpoint
Camp positivity yield

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
Single (Participant)

Masking Description

Individuals visiting camps will be masked to the intervention status.

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Intervention

Experimental

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

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

Control

No Intervention

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

Outcomes

Primary Outcomes

Camp positivity yield

Time Frame: 12 months

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

Secondary Outcomes

  • Camp positivity rate(12 months)
  • Camp All-Forms yield(12 months)
  • Camp All-Forms TB rate(12 months)

Investigators

Sponsor
Centre for Global Public Health Pakistan
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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