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

Last updated: February 7, 2025
Sponsor: COVID-19 Prevention Network
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Lung Disease

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: 6000
Treatment Group(s): 4
Primary Treatment: Laboratory Evaluation at week 26
Phase:
Study Start date:
October 21, 2024
Estimated Completion Date:
October 05, 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

    Active - Recruiting

  • Eswatini Prevention Center CRS

    Mbabane,
    Eswatini

    Active - Recruiting

  • Moi University Clinical Research Centre

    Eldoret,
    Kenya

    Active - Recruiting

  • Kisumu Crs

    Kisumu,
    Kenya

    Active - Recruiting

  • Kombewa Clinical Research Center

    Kisumu,
    Kenya

    Active - Recruiting

  • Blantyre CRS

    Blantyre,
    Malawi

    Active - Recruiting

  • Malawi CRS

    Lilongwe,
    Malawi

    Active - Recruiting

  • Synergy Biomed Research Institute

    East London, Eastern Cape
    South Africa

    Active - Recruiting

  • Nelson Mandela Academic Research Unit CRS

    Mthatha, Eastern Cape
    South Africa

    Active - Recruiting

  • PHOENIX Pharma (Pty) Ltd

    Port Elizabeth, Eastern Cape
    South Africa

    Active - Recruiting

  • Josha Resarch CRS

    Bloemfontein, Free State
    South Africa

    Active - Recruiting

  • MeCRU CRS

    Ga-Rankuwa, Gauteng
    South Africa

    Active - Recruiting

  • 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

    Active - Recruiting

  • 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

    Active - Recruiting

  • Isipingo CRS

    Isipingo, KwaZulu-Natal
    South Africa

    Active - Recruiting

  • Qhakaza Mbokodo Research Clinic CRS

    Ladysmith, KwaZulu-Natal
    South Africa

    Active - Recruiting

  • Aurum Institute Klerksdorp CRS

    Klerksdorp, North West
    South Africa

    Active - Recruiting

  • Rustenburg CRS

    Rustenburg, North West
    South Africa

    Active - Recruiting

  • 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

    Active - Recruiting

  • 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

    Active - Recruiting

  • Kliptown Soweto CRS

    Johannesburg,
    South Africa

    Active - Recruiting

  • PHRU Matlosana CRS

    Klerksdorp,
    South Africa

    Active - Recruiting

  • UVRI-IAVI HIV Vaccine Program LTD. CRS

    Entebbe,
    Uganda

    Active - Recruiting

  • Baylor-Uganda CRS

    Kampala,
    Uganda

    Active - Recruiting

  • Joint Clinical Research Centre

    Kampala,
    Uganda

    Active - Recruiting

  • MU-JHU Research Collaboration CRS

    Kampala,
    Uganda

    Active - Recruiting

  • Cfhrz Crs

    Lusaka,
    Zambia

    Active - Recruiting

  • Matero Reference Clinic CRS

    Lusaka,
    Zambia

    Active - Recruiting

  • UNC Global Projects / Kamwala District Health Centre

    Lusaka,
    Zambia

    Active - Recruiting

  • Zambia Emory HIV Research Project - Ndola CoVPN CRS

    Ndola,
    Zambia

    Active - Recruiting

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