Questioning the Epidemiology of Asymptomatic TB
Recruiting · NCT07312266 · Observational (researchers observe without assigning treatment) · Lead sponsor: Barcelona Institute for Global Health
View the official record on ClinicalTrials.gov →What this trial is about
Tuberculosis (TB) remains one of the world's leading causes of morbidity and mortality. Current TB control strategies focus largely on the binary paradigm of TB, which tackle Mtb infection and the symptomatic stages of the disease as the major drivers of the TB epidemic. However, prevalence surveys have shown that about 50% of cases in which Mycobacterium tuberculosis is isolated from sputum but do not report having symptoms. Therefore, asymptomatic TB may play an important role in TB transmission. However, no field study has demonstrated direct transmission from a subclinical TB case to a confirmed secondary case. TB-QUEST is an ERC-funded epidemiological field study that aims to provide direct evidence of effective transmission from asymptomatic TB cases to their close contacts using advanced genomic methods, and to better characterize the asymptomatic stage of TB within the natural history of disease.
Who can take part
Inclusion criteria
- 18 years of age or older
- Documented HIV infection
- Presenting at a health facility for routine HIV care
Exclusion criteria
- History of TB treatment in the last 12 months
- Pregnant women
- Refusal to provide consent for study procedures
- Contra-indication to any sampling procedure required by the study
- Study 3 will utilize additional inclusion criteria:
- Inclusion criteria:
- On ART for less than 6 months
- No evidence of viral suppression
- Documented CD4 count \>350 copies/ul
- TB-suggestive x-ray
- Verified absence of fever and cough, as ascertained through the symptom trackers
- Contacts:
- Inclusion criteria: All close contacts (household and close community contacts) will be offered to participate in the study, regardless of age or HIV status.
- Exclusion criteria:
- Plans to migrate in the next 12 months
- Pregnant women
- Currently taking anti-tuberculosis treatment or preventive TB treatment
- Contacts with co-prevalent TB identified at baseline
Where it is running
1 location listed.
- Centro de Investigação em Saúde de Manhiça (CISM) - Manhiça, Maputo Province, Mozambique