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Wits RHI

CoVPN 3008 (Ubuntu) TB Substudy

Infectious Diseases

Tuberculosis Case Finding at the Completion of the Ubuntu Clinical Trial: A Substudy to CoVPN 3008 (Ubuntu)

Project Overview

The CoVPN 3008 (Ubuntu) TB Substudy is an observational project aimed at identifying undiagnosed tuberculosis (TB) cases, including subclinical TB, among participants of the CoVPN 3008 (Ubuntu) parent study. This substudy seeks to enhance our understanding of TB prevalence, risk factors, and potential biomarkers within a diverse cohort, primarily people living with HIV, by observing the incidence and progression of both clinical and subclinical TB cases.

Study Rationale

Tuberculosis remains a leading health concern globally, particularly for individuals with HIV. Detecting TB early, especially subclinical forms, can improve patient outcomes and reduce transmission. This substudy addresses a crucial gap by identifying undiagnosed TB cases and analyzing participant characteristics and biomarkers that may predict TB incidence, offering valuable insights for TB prevention and management.

Primary Objectives

  1. Detect previously undiagnosed TB cases, including subclinical TB, among CoVPN 3008 participants.
  2. Examine participant demographics and characteristics associated with TB diagnosis.
  3. Investigate peripheral blood biomarkers linked to TB, including subclinical TB.
  4. Track TB-positive participants over six months to assess TB treatment response and identify those with persistent microbiological positivity.

Study Design

This substudy is a cross-sectional and case-cohort observational study utilizing the CoVPN 3008 (Ubuntu) cohort. The initial cross-sectional assessment will identify undiagnosed TB cases, followed by a case-cohort study for biomarker analysis, with six-month follow-up for TB-positive cases to monitor treatment outcomes.

Study Population

The study includes all participants from the CoVPN 3008 (Ubuntu) parent study, with approximately 6,000 individuals across multiple research sites. Wits RHI Ward 21 CRS expects around 209 participants.

Investigators

  • Principal Investigator, Prof Sinead Delany-Moretlwe
  • Sub-Investigator, Dr Monique Da Fonseca
  • Sub-Investigator, Dr Carrie-Anne Mathew
  • Sub-Investigator, Dr Elizabeth Helena Roos
  • Sub-Investigator, Dr Juliet Vimbai Rundogo

Latest Update

November 2024

For more details about CoVPN 3008 (Ubuntu) TB Substudy please email rhicomms@wrhi.ac.za

Click here for further details regarding the CoVPN 3008 (Ubuntu) TB Substudy.

Research Brief

CoVPN 3008 (Ubuntu) TB Substudy