None listed
Conditions
Brief summary
During 2010, 8.8 million people developed TB and 1.45 million people died due to the disease. In this project, which will be conducted in Vietnam, one of the countries in our region with a particularly high prevalence of TB, we will test a new form of an old intervention: community-wide screening for TB, not with x-rays but by testing sputum. If the project is successful it has the potential to lead to a giant leap forward towards the elimination of TB as a global health problem.
Interventions
Adult residents of intervention clusters will be screened for TB once per year for three years.
Eligible residents within each cluster will be persons aged 15 years and over who are capable of giving informed consent and who are resident in the cluster at the time of screening.
Residents will be visited in their home, informed about the study and, if they agree to be screened, will answer questions about symptoms of TB and attempt to produce a single spontaneous sputum specimen for testing. The
Adult residents of intervention clusters will be screened for TB once per year for three years. Eligible residents within each cluster will be persons aged 15 years and over who are capable of giving informed consent and who are resident in the cluster at the time of screening. Residents will be visited in their home, informed about the study and, if they agree to be screened, will answer questions about symptoms of TB and attempt to produce a single spontaneous sputum specimen for testing. The collected sputum specimen will be tested for Mycobacterium tuberculosis using a fully automated polymerase chain reaction (PCR) (Xpert MTB/RIF, Cepheid Inc). Those who test positive will be referred to the TB treatment program for further management. We will conduct a public information campaign within the selected intervention clusters to enhance participation in the screening process. This will include meeting with community leaders, announcements broadcast over loudspeakers in the village and distributing information flyers to households.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The primary unit of randomisation is the cluster. All clusters (sub-communes) within the Province of Ca Mau, Vietnam, are eligible for selection. Within each cluster all persons aged 15 years and over who are capable of giving informed consent are eligible.
Exclusion criteria
Unable to give informed consent
Outcome results
None listed