Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07312266

Questioning the Epidemiology of Asymptomatic Tuberculosis in High HIV Burden Areas

Led by Barcelona Institute for Global Health · Updated on 2025-12-31

6770

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Tuberculosis (TB) remains a leading cause of illness and death worldwide. This research investigates the role of asymptomatic TB—where individuals carry the bacteria without symptoms—in spreading the disease. The study aims to provide direct proof of TB transmission from asymptomatic cases to their close contacts and to better understand this stage in the natural course of TB infection. It is an observational, epidemiological field study conducted in a high TB and HIV burden district in Mozambique. The study enrolls both asymptomatic and symptomatic TB patients and their close contacts. Initial screening identifies bacteriologically confirmed TB cases among people living with HIV during routine care visits. Two groups of close contacts exposed to either asymptomatic or symptomatic TB cases will be followed for 12 months to observe new infections and secondary TB cases. Additional longitudinal assessments will monitor symptom development, clinical progression, and the characteristics of non-infectious asymptomatic TB. Participants will undergo regular evaluations including symptom tracking, microbiological and radiological tests, and clinical examinations over the study period. Researchers will measure the proportion of secondary TB cases linked to index patients and assess symptom presence and disease progression among asymptomatic individuals. The study will generate important evidence to inform TB control strategies and improve understanding of TB transmission dynamics over a 12-month follow-up.

CONDITIONS

Brief Title

Questioning the Epidemiology of Asymptomatic TB

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Documented HIV infection
  • Presenting at a health facility for routine HIV care
  • Close contacts of TB patients of any age or HIV status
Not Eligible

You will not qualify if you...

  • 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
  • Plans to migrate in the next 12 months
  • Currently taking anti-tuberculosis treatment or preventive TB treatment
  • Contacts with co-prevalent TB identified at baseline

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline assessment

Participants undergo initial assessments to identify bacteriologically-confirmed asymptomatic and symptomatic TB cases.

1 visit (in-person)

Long-term Monitoring

Duration - 12 months

Close contacts of TB index cases are followed periodically to observe secondary TB infections and disease progression over time.

Periodic visits over 12 months

Surveillance

Duration - Up to 12 months

Participants with asymptomatic TB undergo additional longitudinal assessments to monitor symptom presence and clinical trajectory.

Multiple follow-up visits during 12 months

Trial Site Locations

Total: 1 location

1

Centro de Investigação em Saúde de Manhiça (CISM)

Manhiça, Maputo Province, Mozambique

Actively Recruiting

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Research Team

A

Alberto L. Garcia-Basteiro, MD

J

Joanna Ehrlich

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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