Post-Trial Tuberculosis Case Finding: A Substudy of CoVPN 3008
- Conditions
- Tuberculosis
- Interventions
- Diagnostic Test: Clinical Evaluation at Day 4Diagnostic Test: Laboratory Evaluation at Day 4Diagnostic Test: Clinical Evaluation at week 26Diagnostic Test: Laboratory Evaluation at week 26
- Registration Number
- NCT06585683
- Lead Sponsor
- COVID-19 Prevention Network
- Brief Summary
This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6000
- Enrollment into the CoVPN 3008 clinical trial.
- 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.
- Investigator's concern for difficulty with venous access based on clinical history and physical examination.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Confirmed TB Clinical Evaluation at Day 4 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. Confirmed TB Laboratory Evaluation at Day 4 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. Confirmed TB Clinical Evaluation at week 26 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. Confirmed TB Laboratory Evaluation at week 26 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. no TB (control) Clinical Evaluation at Day 4 Participants without TB will have a single follow-up visit to reassess TB symptoms and collect blood samples. no TB (control) Laboratory Evaluation at Day 4 Participants without TB will have a single follow-up visit to reassess TB symptoms and collect blood samples.
- Primary Outcome Measures
Name Time Method Proportion of participants with TB Measured at Day 1, Day 4 and week 26 The 95% confidence interval on the proportion of participants with TB will be estimated using the "score" method
Association parameters of each demographic variable with confirmed TB. Measured at Day 1, Day 4 and week 26 Proportions and 95% CIs will be estimated using the score method. A multivariate analysis will also be conducted using generalized linear regression models with TB as the outcome.
Proportion of participants with confirmed TB at the six-month follow visit out of the total number of participants that are screened at the six-month visit and who had confirmed TB at their enrollment visit. Measured at Day 1, Day 4 and week 26 Proportion and 95% CI will be estimated using the score method.
Peripheral blood biomarkers associated with diagnosis of TB, including subclinical TB. Measured at Day 1, Day 4 and week 26 TB risk scores will be computed from RNA sequencing data generated from each participant's baseline whole-blood sample (Tempus tube) provided upon enrollment into CoVPN 3008. Association of each score with confirmed TB will be assessed using cross-validated ROC curve analysis with area under curve (AUC) 95% CI estimated using the Delong method.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
Moi University Clinical Research Centre
🇰🇪Eldoret, Kenya
Malawi CRS
🇲🇼Lilongwe, Malawi
MeCRU CRS
🇿🇦Ga-Rankuwa, Gauteng, South Africa
Univeristy of Cape Town Lung CRS Institute
🇿🇦Cape Town, Western Cape, South Africa
Zambia Emory HIV Research Project - Ndola CoVPN CRS
🇿🇲Ndola, Zambia
Wits RHI Ward 21 CRS
🇿🇦Johannesburg, Gauteng, South Africa
Gaborone CRS
🇧🇼Gaborone, Botswana
Eswatini Prevention Center CRS
🇸🇿Mbabane, Eswatini
Kisumu Crs
🇰🇪Kisumu, Kenya
Nelson Mandela Academic Research Unit CRS
🇿🇦Mthatha, Eastern Cape, South Africa
Tembisa Clinic 4 CoVPN CRS
🇿🇦Tembisa, Gauteng, South Africa
Rustenburg CRS
🇿🇦Rustenburg, North West, South Africa
FAM-CRU (Family Clinical Research Unit)
🇿🇦Cape Town, Western Cape, South Africa
UVRI-IAVI HIV Vaccine Program LTD. CRS
🇺🇬Entebbe, Uganda
Baylor-Uganda CRS
🇺🇬Kampala, Uganda
MU-JHU Research Collaboration CRS
🇺🇬Kampala, Uganda
Blantyre CRS
🇲🇼Blantyre, Malawi
Synergy Biomed Research Institute
🇿🇦East London, Eastern Cape, 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
Isipingo CRS
🇿🇦Isipingo, KwaZulu-Natal, South Africa
Qhakaza Mbokodo Research Clinic CRS
🇿🇦Ladysmith, KwaZulu-Natal, South Africa
Joint Clinical Research Centre
🇺🇬Kampala, Uganda
Matero Reference Clinic CRS
🇿🇲Lusaka, Zambia
Kombewa Clinical Research Center
🇰🇪Kisumu, Kenya
PHOENIX Pharma (Pty) Ltd
🇿🇦Port Elizabeth, Eastern Cape, South Africa
Josha Resarch CRS
🇿🇦Bloemfontein, Free State, South Africa
CAPRISA eThekwini CRS
🇿🇦Durban, KwaZulu-Natal, South Africa
Tongaat CRS
🇿🇦Durban, KwaZulu-Natal, South Africa
Emavundleni CRS
🇿🇦Cape Town, Western Cape, South Africa
Groote Schuur HIV CRS
🇿🇦Cape Town, Western Cape, South Africa
TASK Central
🇿🇦Cape Town, Western Cape, South Africa
PHRU Matlosana CRS
🇿🇦Klerksdorp, South Africa
Cfhrz Crs
🇿🇲Lusaka, Zambia
Vulindlela CRS
🇿🇦Durban, KwaZulu-Natal, South Africa
Aurum Institute Klerksdorp CRS
🇿🇦Klerksdorp, North West, South Africa
Masiphumelele Clinical Research Site (MASI) CRS
🇿🇦Cape Town, Western Cape, South Africa
TASK Eden
🇿🇦George, Western Cape, South Africa
Kliptown Soweto CRS
🇿🇦Johannesburg, South Africa
UNC Global Projects / Kamwala District Health Centre
🇿🇲Lusaka, Zambia