Reexamining how asymptomatic tuberculosis spreads

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TB-QUEST is a prospective epidemiological field project that enrolls adults living with HIV who attend routine care and have laboratory-confirmed but self-reported asymptomatic TB, together with their close household and community contacts. The study combines systematic symptom tracking, clinical and radiological assessment, and collection of respiratory and other samples. Advanced whole-genome sequencing and contact tracing will be used to seek direct genomic links between index asymptomatic cases and secondary cases among contacts. Follow-up over time will also characterize the clinical, immunological and radiological features of the asymptomatic stage within the natural history of TB.

Why it matters

Who can join: the full rules

Index cases:

Inclusion Criteria:

1. 18 years of age or older
2. Documented HIV infection
3. Presenting at a health facility for routine HIV care

Exclusion Criteria:

1. History of TB treatment in the last 12 months
2. Pregnant women
3. Refusal to provide consent for study procedures
4. Contra-indication to any sampling procedure required by the study

Study 3 will utilize additional inclusion criteria:

Inclusion criteria:

1. On ART for less than 6 months
2. No evidence of viral suppression
3. Documented CD4 count \>350 copies/ul
4. TB-suggestive x-ray
5. 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:

1. Plans to migrate in the next 12 months
2. Pregnant women
3. Currently taking anti-tuberculosis treatment or preventive TB treatment
4. Contacts with co-prevalent TB identified at baseline

Where it's running

• Centro de Investigação em Saúde de Manhiça (CISM)
  Manhiça, Maputo Province, Mozambique Recruiting

Study contacts

• Study coordinator: Alberto L. Garcia-Basteiro, MD
• Email: alberto.garcia-basteiro@isglobal.org
• Phone: +34 93 227 1806

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.