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

ISRCTN	ISRCTN34123170
DOI	https://doi.org/10.1186/ISRCTN34123170
Protocol serial number	N/A
Sponsor	London School of Hygiene and Tropical Medicine (UK)
Funder	Department for International Development (DFID) (UK) - Knowledge Programme on Tuberculosis

Submission date: 13/09/2005
Registration date: 03/11/2005
Last edited: 06/07/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Peter Godfrey-Faussett
Scientific

Keppel Street
London
WC1E 7HT
United Kingdom

Email	pgf@lshtm.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Giving women instructions on how to provide sputum samples will increase the yield of smear positive tuberculosis diagnoses in a chest clinic.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Tuberculosis
Intervention	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 officer to provide sputum submission instructions. The female health worker was not involved in recruitment or randomisation. The following points were explained in detail to patients: 1. The importance of submitting sputum rather than saliva, and a description of visual difference between the two 2. The technique that should be used to produce a good sputum specimen (take three deep breaths, followed by a deep cough to bring up sputum from your lungs) 3. The necessity of filling at least one-quarter of the container (5 ml), shown by pointing out the required level on a demonstration container 4. The importance of providing one spot specimen and returning the next day with another specimen which has been expectorated on awakening that morning Following instructions, which lasted between 2-3 min, patients in the intervention group were directed to the laboratory to obtain sputum submission containers. Control group: usual procedure
Intervention type	Other
Primary outcome measure(s)	The primary outcome measure was specimen smear-positivity.
Key secondary outcome measure(s)	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.
Completion date	01/09/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	2600
Key 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
Key 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
Date of first enrolment	01/07/2005
Date of final enrolment	01/09/2005

Locations

Countries of recruitment

United Kingdom
England
Pakistan

Study participating centre

Keppel Street

London
WC1E 7HT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	09/06/2007		Yes	No