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NCT Number: NCT06017843

Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mercy Corps Pakistan

Islamabad, Pakistan

Location status: Recruiting

Location contact

Abdullah Latif

PRINCIPAL_INVESTIGATOR

Nainan Nawaz

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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 outcomes

  1. Camp positivity yield

    Time frame: 12 months

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

Secondary outcomes

  1. Camp positivity rate

    Time frame: 12 months

    Bacteriologically confirmed TB (B+) cases per population screened

  2. Camp All-Forms yield

    Time frame: 12 months

    Counts of All-Forms TB (AF-TB) cases diagnosed in each camp

  3. Camp All-Forms TB rate

    Time frame: 12 months

    All-Forms TB (AF-TB) cases per population screened

Study contacts

Contact information is provided by the study sponsor or research team.

Amna Mahfooz, MS(PH)

CONTACT

[email protected]

+923438101441

Faheem Baig

CONTACT

[email protected]

+923345379004

Sponsors and collaborators

Lead sponsor

Centre for Global Public Health Pakistan

Other

Collaborators

  • Mercy Corps Pakistan

Registry information

Official study 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

Acronym: SPOT-TB

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 30, 2023
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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