Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline assessment
Participants undergo initial assessments to identify bacteriologically-confirmed asymptomatic and symptomatic TB cases.
1 visit (in-person)
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
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
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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