None listed
Conditions
Brief summary
This is a cluster-randomised controlled trial for screening household contacts of tuberculosis patients in 8 Provinces in Vietnam. It is an effectiveness and cost-effectiveness study. We will screen household contacts from districts in the intervention group regularly over a two year follow-up period and determine the case detection rate of tuberculosis disease in the screening and control groups.
Interventions
Household contacts in the intervention group will receive basic education about tuberculosis and a two year programme of systematic screening and follow-up for active tuberculosis disease. These household contacts will be screened using clinical assessment and plain chest Xrays at the time of enrolment and periodically over the next 2 years. Contacts with symptoms or signs suspicious of active tuberculosis will submit sputum samples for smear and culture.
Sponsors
National Health and Medical Research Council, Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion for index patients: - smear positive (stain positive for acid fast bacilli on at least one sputum smear) - aged 15 years or older Inclusion for household contacts - members of the household of index patients during the previous 2 months (including contact with the index patient for a minimum of 8 hours in total) - no age limit
Exclusion criteria
Exclusion for index patients: - primary residence outside of the geographical region of the study (due to difficulty with follow-up) - index patient has no household contacts - severe difficulty with communication Exclusion for household contacts: - not living in same household as the index patient - already taking treatment for tuberculosis at the time of recruitment - unwilling to participate in follow-up over 2 years of the study
Outcome results
None listed