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

Last updated: January 23, 2026
Sponsor: COVID-19 Prevention Network
Overall Status: Completed

Phase

N/A

Condition

Lung Disease

Hiv

Treatment

Laboratory Evaluation at week 26

Clinical Evaluation at week 26

Laboratory Evaluation at Day 4

Clinical Study ID

NCT06585683
CoVPN 3008 TB substudy
UM1AI068614
  • Ages > 18
  • All Genders

Study Summary

This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Enrollment into the CoVPN 3008 clinical trial.

  • Able and willing to complete the informed consent process: Volunteer demonstrates anunderstanding of this substudy.

  • Willingness to discuss TB status, undergo related testing/monitoring labs, andreceive referrals for TB care.

Exclusion

Exclusion Criteria:

  • Investigator's concern for difficulty with venous access based on clinical historyand physical examination.

Study Design

Total Participants: 5694
Treatment Group(s): 4
Primary Treatment: Laboratory Evaluation at week 26
Phase:
Study Start date:
September 13, 2024
Estimated Completion Date:
May 21, 2025

Study Description

This observational substudy will involve participants from the CoVPN 3008 trial, regardless of their HIV status, to study tuberculosis (TB). At the start, all participants will be screened for TB, even if they have no symptoms. They will receive chest x-rays and provide sputum samples for TB testing using Xpert Ultra, smear microscopy, and culture.

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.

Connect with a study center

  • Gaborone CRS

    Gaborone,
    Botswana

    Site Not Available

  • Gaborone CRS

    Gaborone 933773,
    Botswana

    Site Not Available

  • Eswatini Prevention Center CRS

    Mbabane,
    Eswatini

    Site Not Available

  • Eswatini Prevention Center CRS

    Mbabane 934985,
    Eswatini

    Site Not Available

  • Moi University Clinical Research Centre

    Eldoret,
    Kenya

    Site Not Available

  • Moi University Clinical Research Centre

    Eldoret 198629,
    Kenya

    Site Not Available

  • Kisumu Crs

    Kisumu,
    Kenya

    Site Not Available

  • Kombewa Clinical Research Center

    Kisumu,
    Kenya

    Active - Recruiting

  • Kisumu Crs

    Kisumu 191245,
    Kenya

    Site Not Available

  • Kombewa Clinical Research Center

    Kisumu 191245,
    Kenya

    Site Not Available

  • Blantyre CRS

    Blantyre,
    Malawi

    Site Not Available

  • Blantyre CRS

    Blantyre 931755,
    Malawi

    Site Not Available

  • Malawi CRS

    Lilongwe,
    Malawi

    Site Not Available

  • Malawi CRS

    Lilongwe 927967,
    Malawi

    Site Not Available

  • Synergy Biomed Research Institute

    East London, Eastern Cape
    South Africa

    Site Not Available

  • Nelson Mandela Academic Research Unit CRS

    Mthatha, Eastern Cape
    South Africa

    Site Not Available

  • PHOENIX Pharma (Pty) Ltd

    Port Elizabeth, Eastern Cape
    South Africa

    Site Not Available

  • Synergy Biomed Research Institute

    East London 1006984, Eastern Cape 1085593
    South Africa

    Site Not Available

  • Nelson Mandela Academic Research Unit CRS

    Mthatha 946058, Eastern Cape 1085593
    South Africa

    Site Not Available

  • PHOENIX Pharma (Pty) Ltd

    Port Elizabeth 964420, Eastern Cape 1085593
    South Africa

    Site Not Available

  • Josha Resarch CRS

    Bloemfontein, Free State
    South Africa

    Site Not Available

  • Josha Resarch CRS

    Bloemfontein 1018725, Free State 967573
    South Africa

    Site Not Available

  • Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS

    Johannesburg, Gauteng
    South Africa

    Active - Recruiting

  • Newtown Clinical Research

    Johannesburg, Gauteng
    South Africa

    Active - Recruiting

  • Soweto - Bara CRS

    Johannesburg, Gauteng
    South Africa

    Active - Recruiting

  • Wits RHI Ward 21 CRS

    Johannesburg, Gauteng
    South Africa

    Active - Recruiting

  • Tembisa Clinic 4 CoVPN CRS

    Tembisa, Gauteng
    South Africa

    Site Not Available

  • MeCRU CRS

    Ga-Rankuwa, Gauteng 1085594
    South Africa

    Site Not Available

  • Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS

    Johannesburg 993800, Gauteng 1085594
    South Africa

    Site Not Available

  • Newtown Clinical Research

    Johannesburg 993800, Gauteng 1085594
    South Africa

    Site Not Available

  • Soweto - Bara CRS

    Johannesburg 993800, Gauteng 1085594
    South Africa

    Site Not Available

  • Wits RHI Ward 21 CRS

    Johannesburg 993800, Gauteng 1085594
    South Africa

    Site Not Available

  • Tembisa Clinic 4 CoVPN CRS

    Tembisa 949879, Gauteng 1085594
    South Africa

    Site Not Available

  • CAPRISA eThekwini CRS

    Durban, KwaZulu-Natal
    South Africa

    Active - Recruiting

  • Tongaat CRS

    Durban, KwaZulu-Natal
    South Africa

    Active - Recruiting

  • Vulindlela CRS

    Durban, KwaZulu-Natal
    South Africa

    Site Not Available

  • Isipingo CRS

    Isipingo, KwaZulu-Natal
    South Africa

    Site Not Available

  • Qhakaza Mbokodo Research Clinic CRS

    Ladysmith, KwaZulu-Natal
    South Africa

    Site Not Available

  • CAPRISA eThekwini CRS

    Durban 1007311, KwaZulu-Natal 972062
    South Africa

    Site Not Available

  • Tongaat CRS

    Durban 1007311, KwaZulu-Natal 972062
    South Africa

    Site Not Available

  • Vulindlela CRS

    Durban 1007311, KwaZulu-Natal 972062
    South Africa

    Site Not Available

  • Isipingo CRS

    Isipingo 994493, KwaZulu-Natal 972062
    South Africa

    Site Not Available

  • Qhakaza Mbokodo Research Clinic CRS

    Ladysmith 984998, KwaZulu-Natal 972062
    South Africa

    Site Not Available

  • Aurum Institute Klerksdorp CRS

    Klerksdorp, North West
    South Africa

    Site Not Available

  • Rustenburg CRS

    Rustenburg, North West
    South Africa

    Site Not Available

  • Aurum Institute Klerksdorp CRS

    Klerksdorp 989921, North West 1085598
    South Africa

    Site Not Available

  • Rustenburg CRS

    Rustenburg 958724, North West 1085598
    South Africa

    Site Not Available

  • Emavundleni CRS

    Cape Town, Western Cape
    South Africa

    Active - Recruiting

  • FAM-CRU (Family Clinical Research Unit)

    Cape Town, Western Cape
    South Africa

    Active - Recruiting

  • Groote Schuur HIV CRS

    Cape Town, Western Cape
    South Africa

    Active - Recruiting

  • Masiphumelele Clinical Research Site (MASI) CRS

    Cape Town, Western Cape
    South Africa

    Site Not Available

  • TASK Central

    Cape Town, Western Cape
    South Africa

    Active - Recruiting

  • Univeristy of Cape Town Lung CRS Institute

    Cape Town, Western Cape
    South Africa

    Active - Recruiting

  • TASK Eden

    George, Western Cape
    South Africa

    Site Not Available

  • Emavundleni CRS

    Cape Town 3369157, Western Cape 1085599
    South Africa

    Site Not Available

  • FAM-CRU (Family Clinical Research Unit)

    Cape Town 3369157, Western Cape 1085599
    South Africa

    Site Not Available

  • Groote Schuur HIV CRS

    Cape Town 3369157, Western Cape 1085599
    South Africa

    Site Not Available

  • Masiphumelele Clinical Research Site (MASI) CRS

    Cape Town 3369157, Western Cape 1085599
    South Africa

    Site Not Available

  • TASK Central

    Cape Town 3369157, Western Cape 1085599
    South Africa

    Site Not Available

  • Univeristy of Cape Town Lung CRS Institute

    Cape Town 3369157, Western Cape 1085599
    South Africa

    Site Not Available

  • TASK Eden

    George 1002145, Western Cape 1085599
    South Africa

    Site Not Available

  • Kliptown Soweto CRS

    Johannesburg,
    South Africa

    Site Not Available

  • Kliptown Soweto CRS

    Johannesburg 993800,
    South Africa

    Site Not Available

  • PHRU Matlosana CRS

    Klerksdorp,
    South Africa

    Active - Recruiting

  • PHRU Matlosana CRS

    Klerksdorp 989921,
    South Africa

    Site Not Available

  • UVRI-IAVI HIV Vaccine Program LTD. CRS

    Entebbe,
    Uganda

    Site Not Available

  • UVRI-IAVI HIV Vaccine Program LTD. CRS

    Entebbe 233508,
    Uganda

    Site Not Available

  • Baylor-Uganda CRS

    Kampala,
    Uganda

    Active - Recruiting

  • Joint Clinical Research Centre

    Kampala,
    Uganda

    Active - Recruiting

  • MU-JHU Research Collaboration CRS

    Kampala,
    Uganda

    Site Not Available

  • Baylor-Uganda CRS

    Kampala 232422,
    Uganda

    Site Not Available

  • Joint Clinical Research Centre

    Kampala 232422,
    Uganda

    Site Not Available

  • MU-JHU Research Collaboration CRS

    Kampala 232422,
    Uganda

    Site Not Available

  • Cfhrz Crs

    Lusaka,
    Zambia

    Site Not Available

  • Matero Reference Clinic CRS

    Lusaka,
    Zambia

    Active - Recruiting

  • UNC Global Projects / Kamwala District Health Centre

    Lusaka,
    Zambia

    Active - Recruiting

  • Cfhrz Crs

    Lusaka 909137,
    Zambia

    Site Not Available

  • Matero Reference Clinic CRS

    Lusaka 909137,
    Zambia

    Site Not Available

  • UNC Global Projects / Kamwala District Health Centre

    Lusaka 909137,
    Zambia

    Site Not Available

  • Zambia Emory HIV Research Project - Ndola CoVPN CRS

    Ndola,
    Zambia

    Site Not Available

  • Zambia Emory HIV Research Project - Ndola CoVPN CRS

    Ndola 901344,
    Zambia

    Site Not Available

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