Post-Trial Tuberculosis Case Finding: A Substudy of CoVPN 3008

RecruitingOBSERVATIONAL
Enrollment

6,000

Participants

Timeline

Start Date

October 21, 2024

Primary Completion Date

October 4, 2025

Study Completion Date

October 5, 2025

Conditions
Tuberculosis
Interventions
DIAGNOSTIC_TEST

Clinical Evaluation at Day 4

Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Trial Locations (41)

Unknown

RECRUITING

Gaborone CRS, Gaborone

RECRUITING

Eswatini Prevention Center CRS, Mbabane

RECRUITING

Moi University Clinical Research Centre, Eldoret

RECRUITING

Kisumu Crs, Kisumu

RECRUITING

Kombewa Clinical Research Center, Kisumu

RECRUITING

Blantyre CRS, Blantyre

RECRUITING

Malawi CRS, Lilongwe

RECRUITING

Synergy Biomed Research Institute, East London

RECRUITING

Nelson Mandela Academic Research Unit CRS, Mthatha

RECRUITING

PHOENIX Pharma (Pty) Ltd, Port Elizabeth

RECRUITING

Josha Resarch CRS, Bloemfontein

RECRUITING

MeCRU CRS, Ga-Rankuwa

RECRUITING

Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS, Johannesburg

RECRUITING

Newtown Clinical Research, Johannesburg

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Soweto - Bara CRS, Johannesburg

RECRUITING

Wits RHI Ward 21 CRS, Johannesburg

RECRUITING

Tembisa Clinic 4 CoVPN CRS, Tembisa

RECRUITING

CAPRISA eThekwini CRS, Durban

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Tongaat CRS, Durban

RECRUITING

Vulindlela CRS, Durban

RECRUITING

Isipingo CRS, Isipingo

RECRUITING

Qhakaza Mbokodo Research Clinic CRS, Ladysmith

RECRUITING

Aurum Institute Klerksdorp CRS, Klerksdorp

RECRUITING

Rustenburg CRS, Rustenburg

RECRUITING

Emavundleni CRS, Cape Town

RECRUITING

FAM-CRU (Family Clinical Research Unit), Cape Town

RECRUITING

Groote Schuur HIV CRS, Cape Town

RECRUITING

Masiphumelele Clinical Research Site (MASI) CRS, Cape Town

RECRUITING

TASK Central, Cape Town

RECRUITING

Univeristy of Cape Town Lung CRS Institute, Cape Town

RECRUITING

TASK Eden, George

RECRUITING

Kliptown Soweto CRS, Johannesburg

RECRUITING

PHRU Matlosana CRS, Klerksdorp

RECRUITING

UVRI-IAVI HIV Vaccine Program LTD. CRS, Entebbe

RECRUITING

Baylor-Uganda CRS, Kampala

RECRUITING

Joint Clinical Research Centre, Kampala

RECRUITING

MU-JHU Research Collaboration CRS, Kampala

RECRUITING

Cfhrz Crs, Lusaka

RECRUITING

Matero Reference Clinic CRS, Lusaka

RECRUITING

UNC Global Projects / Kamwala District Health Centre, Lusaka

RECRUITING

Zambia Emory HIV Research Project - Ndola CoVPN CRS, Ndola

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Medical Research Council, South Africa

OTHER

lead

COVID-19 Prevention Network

NETWORK