Increasing tuberculosis case detection and reducing gender disparities through sputum submission instructions: a randomised controlled trial in Pakista
Completed
- Conditions
- TuberculosisInfections and Infestations
- Registration Number
- ISRCTN34123170
- Lead Sponsor
- ondon School of Hygiene and Tropical Medicine (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2600
Inclusion Criteria
New male and female tuberculosis (TB) suspects, who were referred by TB centre physicians for initial diagnostic sputum testing, were eligible to participate in the trial. According to the National Tuberculosis Control programme guidelines, the criteria for enrolment were:
1. History of a cough for >3 weeks and/or fever for 1 month
2. Blood in sputum
3. Night sweats
4. Weight loss
5. Loss of appetite
Exclusion Criteria
1. Age over 75 or below 14 years
2. History of TB diagnosis or treatment
3. Intake of oral steroids in the 3 months leading up to presentation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure was specimen smear-positivity.
- Secondary Outcome Measures
Name Time Method The secondary outcome, specimen quality, was determined by visual assessment of specimens and microscopic assessment of Ziehl-Neelsen (ZN) stained smears, using a modification of the rating system of Bartlett.<br>Specimens with a purulent/mucoid/blood-stained visual appearance and/or containing polymorphoneutrophils (PMNs) on microscopic inspection were designated ?sputum?.<br>Specimens with a clear/watery appearance containing squamous epithelial cells, but no PMNs were designated ?saliva?.