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Increasing tuberculosis case detection and reducing gender disparities through sputum submission instructions: a randomised controlled trial in Pakistan

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN34123170
Enrollment
2600
Registered
2005-11-03
Start date
2005-07-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis Infections and Infestations Tuberculosis

Interventions

Patients in the intervention arm were referred to a designated room at the TB centre where they received guidance from a female health worker who was trained by the researcher and a senior TB control

Sponsors

London School of Hygiene and Tropical Medicine (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary outcome measure was specimen smear-positivity.

Secondary

MeasureTime frame
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. Specimens with a purulent/mucoid/blood-stained visual appearance and/or containing polymorphoneutrophils (PMNs) on microscopic inspection were designated ?sputum?. Specimens with a clear/watery appearance containing squamous epithelial cells, but no PMNs were designated ?saliva?.

Countries

Pakistan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026