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The Missing Millions: Identification and infectiousness of undiagnosed tuberculosis cases in the community (the MI-TB study)

Award Number: R01AI147346
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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The Missing Millions: Identification and infectiousness of undiagnosed tuberculosis cases in the community (the MI-TB study) - PROJECT SUMMARY/ABSTRACT A startling 40% of tuberculosis (TB) cases in endemic countries are “missing” (~4.2 million cases globally remain undiagnosed or unreported)! Undiagnosed cases may substantially contribute to disease transmission as ~30% are smear positive while having an asymptomatic or minimally symptomatic presentation. These undiagnosed cases serve as a reservoir in the community and severely undermine TB control efforts. In the recently completed NIH-funded CASS I study we performed cough aerosol sampling on 453 patients with newly diagnosed TB (detected by passive case finding) and found ~30% were highly infectious – containing culturable M. tuberculosis bacilli in their respirable cough aerosols (<10uM infectious inhalable particles that initiate disease). Multivariate analysis revealed relatively healthier, HIV negative patients who were not on TB treatment and had a high bacillary load were more likely to be highly infectious. We have also developed a novel low-cost mobile mini-clinic housing a novel TB diagnostic and HIV/CD4 testing capabilities. Using this mobile mini-clinic we have screened 4700 individuals in the communities of Cape Town and found 475 cases of suspected TB, 54 of which had confirmed TB. By combining these two techniques we found an unsettling ~17% of undiagnosed TB cases are highly infectious. Sizable gaps exist in our knowledge of community-based TB patient infectiousness and transmission. We do not know the ‘bioprofile’ of infectious undiagnosed cases in the community nor their degree of infectiousness, and a chasm remains in our understanding of patient level infectiousness and TB transmission. These have implications for targeting contact tracing investigations and the development of a scalable screening tool to measure infectiousness. In the proposed study we will employ active case finding using a novel mobile-mini clinic to detect ‘missing’ TB cases and establish their degree of infectiousness using cough aerosol sampling (Aim 1), determine a biosignature and bioprofile of infectious but minimally symptomatic undiagnosed individuals (Aim 2), and accurately model the impact of active case finding on disease transmission using estimates generated in the study, thus informing policy. In summary, this project will elucidate the bioprofile of undiagnosed minimally symptomatic active TB cases in the community – ‘the missing millions’, and further our understanding of the fundamental biology of TB transmission, potentially uncovering targets to interrupt disease spread.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	UNIVERSITY OF CAPE TOWN LUNG INSTITUTE (PTY) LTD	GEORGE STREET	CAPE TOWN				ZAF	Allergy and Infectious Diseases Research	000	4	2/12/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $342,146 )
2022	2022	UNIVERSITY OF CAPE TOWN LUNG INSTITUTE (PTY) LTD	GEORGE ST	CAPE TOWN				ZAF	Allergy and Infectious Diseases Research	000	4	9/12/2022	NON-COMPETING CONTINUATION	$342,146
														Subtotal = $342,146

Issue Date FY: 2021 ( Subtotal = $388,431 )
2021	2021	UNIVERSITY OF CAPE TOWN LUNG INSTITUTE (PTY) LTD	GEORGE ST	CAPE TOWN				ZAF	Allergy and Infectious Diseases Research	000	3	9/17/2021	NON-COMPETING CONTINUATION	$388,431
														Subtotal = $388,431

Issue Date FY: 2020 ( Subtotal = $387,291 )
2020	2020	UNIVERSITY OF CAPE TOWN LUNG INSTITUTE (PTY) LTD	GEORGE ST	CAPE TOWN		7700		ZAF	Allergy and Infectious Diseases Research	000	2	9/4/2020	NON-COMPETING CONTINUATION	$387,291
														Subtotal = $387,291

Issue Date FY: 2019 ( Subtotal = $425,645 )
2019	2019	UNIVERSITY OF CAPE TOWN LUNG INSTITUTE (PTY) LTD	GEORGE ST	CAPE TOWN		7700		ZAF	Allergy and Infectious Diseases Research	000	1	8/21/2019	NEW	$425,645
														Subtotal = $425,645

Grand Total All Awards = $1,543,513

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The Missing Millions: Identification and infectiousness of undiagnosed tuberculosis cases in the community (the MI-TB study)

Award Number: R01AI147346

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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