Validation of Artificial Intelligence Enabled TB Screening and Diagnosis in Zambia

Tuberculosis Clinical Trial

Official title:

Validation of Artificial Intelligence Enabled TB Screening and Diagnosis in Zambia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05139940
• Other study ID #: Google AI
• Status: Recruiting
• Start date: November 22, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2022
• Source: Centre for Infectious Disease Research in Zambia
• Contact: Monde Muyoyeta, MBChB,PhD
• Phone: +260966765615
• Email: monde.muyoyeta[@]cidrz.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tuberculosis (TB) is a global epidemic and for many years has remained a major cause of death throughout the developing world. Zambia is among the top 30 TB/HIV high burden countries. Chest X-ray (CXR) is recommended as a triaging test for TB, and a diagnostic aid when available. However, many high-burden settings lack access to experienced radiologists capable of interpreting these images, resulting in mixed sensitivity, poor specificity, and large inter-observer variation. In recognition of this challenge, the World Health Organization has recommended the use of automated systems that utilize artificial intelligence (AI) to read CXRs for screening and triaging for TB. In this study, we primarily evaluate the performance of our AI algorithm for TB, and secondarily for Abnormal/Normal.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2432
• Est. completion date: November 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants who are 18 years and older with a known HIV status or are willing to undergo HIV testing if unknown HIV status and meet the following criteria will be

included in the study:

• Presumptive TB patients defined as having any of the following:

? Cough, Weight loss, Night sweats, Fever

• Household /close TB contacts regardless of symptoms
• Newly diagnosed HIV regardless of symptoms.

Exclusion Criteria:

• Individuals who do meet the above inclusion criteria will be excluded. In addition, individuals with history of TB treatment within 365 days prior to enrolment will be excluded.

Related Conditions & MeSH terms

• Tuberculosis

Locations

Country	Name	City	State
Zambia	Chainda South Health Facility	Lusaka
Zambia	Chawama first level hospital	Lusaka
Zambia	Kanyama level 1	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Infectious Disease Research in Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pilot Group to calibrate the operating points for AI algorithms	1. Operating point selection for TB AI algorithm and Abnormal/Normal AI algorithm on CXRs for outcomes listed in Main Cross Sectional Group.	2 months
Primary	Main Cross Sectional Group	1. TB AI algorithm sensitivity and specificity in detecting active TB on CXR compared to panel of radiologists	7 months
Secondary	Main Cross Sectional Group:	1. TB AI algorithm sensitivity and specificity in detecting active TB compared to World Health Organisation (WHO) performance guidelines of 90% sensitivity and 70% specificity	7 months
Secondary	Main Cross Sectional Group	2. Abnormal/Normal AI algorithm sensitivity and specificity compared to 90% sensitivity and 50% specificity.	7 months