Post-Trial Tuberculosis Case Finding: A Substudy of CoVPN 3008
NCT ID: NCT06585683
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5694 participants
OBSERVATIONAL
2024-09-13
2025-05-21
Brief Summary
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Detailed Description
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The study has two main groups. Group 1 includes participants with confirmed TB, and Group 2 includes participants without TB who will act as controls.
Participants with confirmed TB will start treatment and have a first follow-up visit on Day 4 to reassess TB symptoms and collect blood samples. A second follow-up visit will take place at week 26 to evaluate their treatment progress, clinical outcomes, and TB status, ensuring they receive the necessary care.
Participants without TB will have a single follow-up visit on Day 4 to reassess TB symptoms and collect blood samples. The study aims to identify potential biomarkers of TB by analyzing blood samples from both cases and controls, focusing on gene expression linked to TB, including hidden (subclinical) TB.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Confirmed TB
Participants with confirmed TB will start treatment and have a follow-up visit soon after to check their TB symptoms again and collect blood samples. They will also have a second follow-up visit at week 26 to assess their treatment progress and TB status.
Clinical Evaluation at Day 4
Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB
Laboratory Evaluation at Day 4
Peripheral blood samples, including serum, PBMC, and whole blood, are collected from participants. A tongue swab is also collected from each participant.
Clinical Evaluation at week 26
Participants will undergo another complete physical exam and have their medical (including TB) history, potential TB signs/symptoms, and concomitant medications reassessed. Chest radiography will be obtained for all participants. An assessment of TB outcomes will also be performed.
Laboratory Evaluation at week 26
Peripheral blood samples, including serum, PBMC, and whole blood, will be collected. Participants not previously identified as living with HIV will undergo HIV diagnostic testing, while participants living with HIV will have their HIV viral load and CD4+ T-cell count measured.
no TB (control)
Participants without TB will have a single follow-up visit to reassess TB symptoms and collect blood samples.
Clinical Evaluation at Day 4
Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB
Laboratory Evaluation at Day 4
Peripheral blood samples, including serum, PBMC, and whole blood, are collected from participants. A tongue swab is also collected from each participant.
Interventions
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Clinical Evaluation at Day 4
Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB
Laboratory Evaluation at Day 4
Peripheral blood samples, including serum, PBMC, and whole blood, are collected from participants. A tongue swab is also collected from each participant.
Clinical Evaluation at week 26
Participants will undergo another complete physical exam and have their medical (including TB) history, potential TB signs/symptoms, and concomitant medications reassessed. Chest radiography will be obtained for all participants. An assessment of TB outcomes will also be performed.
Laboratory Evaluation at week 26
Peripheral blood samples, including serum, PBMC, and whole blood, will be collected. Participants not previously identified as living with HIV will undergo HIV diagnostic testing, while participants living with HIV will have their HIV viral load and CD4+ T-cell count measured.
Eligibility Criteria
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Inclusion Criteria
* Able and willing to complete the informed consent process: Volunteer demonstrates an understanding of this substudy.
* Willingness to discuss TB status, undergo related testing/monitoring labs, and receive referrals for TB care.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Medical Research Council, South Africa
OTHER
COVID-19 Prevention Network
NETWORK
Responsible Party
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Principal Investigators
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Nigel Garrett
Role: STUDY_CHAIR
eThekwini CRS / Centre for the AIDS Programme of Research in South Africa (CAPRISA)
Philip Kotze
Role: STUDY_CHAIR
Qhakaza Mbokodo Research Clinic
Sufia Dadabhai
Role: STUDY_CHAIR
Blantyre CRS / Johns Hopkins Research Project
Nyaradzo Mgodi
Role: STUDY_CHAIR
University of Zimbabwe Clinical Trials Research Centre
Locations
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Gaborone CRS
Gaborone, , Botswana
Eswatini Prevention Center CRS
Mbabane, , Eswatini
Moi University Clinical Research Centre
Eldoret, , Kenya
Kisumu Crs
Kisumu, , Kenya
Kombewa Clinical Research Center
Kisumu, , Kenya
Blantyre CRS
Blantyre, , Malawi
Malawi CRS
Lilongwe, , Malawi
Synergy Biomed Research Institute
East London, Eastern Cape, South Africa
Nelson Mandela Academic Research Unit CRS
Mthatha, Eastern Cape, South Africa
PHOENIX Pharma (Pty) Ltd
Port Elizabeth, Eastern Cape, South Africa
Josha Resarch CRS
Bloemfontein, Free State, South Africa
MeCRU CRS
Ga-Rankuwa, Gauteng, South Africa
Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS
Johannesburg, Gauteng, South Africa
Newtown Clinical Research
Johannesburg, Gauteng, South Africa
Soweto - Bara CRS
Johannesburg, Gauteng, South Africa
Wits RHI Ward 21 CRS
Johannesburg, Gauteng, South Africa
Tembisa Clinic 4 CoVPN CRS
Tembisa, Gauteng, South Africa
CAPRISA eThekwini CRS
Durban, KwaZulu-Natal, South Africa
Tongaat CRS
Durban, KwaZulu-Natal, South Africa
Vulindlela CRS
Durban, KwaZulu-Natal, South Africa
Isipingo CRS
Isipingo, KwaZulu-Natal, South Africa
Qhakaza Mbokodo Research Clinic CRS
Ladysmith, KwaZulu-Natal, South Africa
Aurum Institute Klerksdorp CRS
Klerksdorp, North West, South Africa
Rustenburg CRS
Rustenburg, North West, South Africa
Emavundleni CRS
Cape Town, Western Cape, South Africa
FAM-CRU (Family Clinical Research Unit)
Cape Town, Western Cape, South Africa
Groote Schuur HIV CRS
Cape Town, Western Cape, South Africa
Masiphumelele Clinical Research Site (MASI) CRS
Cape Town, Western Cape, South Africa
TASK Central
Cape Town, Western Cape, South Africa
Univeristy of Cape Town Lung CRS Institute
Cape Town, Western Cape, South Africa
TASK Eden
George, Western Cape, South Africa
Kliptown Soweto CRS
Johannesburg, , South Africa
PHRU Matlosana CRS
Klerksdorp, , South Africa
UVRI-IAVI HIV Vaccine Program LTD. CRS
Entebbe, , Uganda
Baylor-Uganda CRS
Kampala, , Uganda
Joint Clinical Research Centre
Kampala, , Uganda
MU-JHU Research Collaboration CRS
Kampala, , Uganda
Cfhrz Crs
Lusaka, , Zambia
Matero Reference Clinic CRS
Lusaka, , Zambia
UNC Global Projects / Kamwala District Health Centre
Lusaka, , Zambia
Zambia Emory HIV Research Project - Ndola CoVPN CRS
Ndola, , Zambia
Countries
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Other Identifiers
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CoVPN 3008 TB substudy
Identifier Type: -
Identifier Source: org_study_id
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