Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077174487
Study information
Scientific title
Acronym
Study hypothesis
To find if giving female index patients diagnosed with chlamydia a home sampling kit for sexual contacts leads to more partners being identified and treated than giving out traditional contacts slips.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chlamydia
Intervention
200 female patients attending the Genito-Urinary clinic at the Derby Royal Infirmary with a diagnosis of genital chlamydia infection will be invited to participate in the study. Following informed consent, participants will be randomised to either the conventional partner notification arm using contact slips or the home sampling kit for partner notification arm.
Patients in the conventional arm of the study will be seen by a health advisor and details of contacts recorded. Contact slips will be given to the index patient to give to sexual contacts who then bring this into the clinic for testing using a traditional urethral swab and receive appropriate treatment. Sexual contacts will be invited to see the health advisor and have screening tests for other sexually transmitted infections when they come into the clinic.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The number of partners treated per index case
Secondary outcome measures
Not provided at time of registration
Overall trial start date
28/02/2006
Overall trial end date
31/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
200 female patients attending the Genito-Urinary clinic at the Derby Royal Infirmary during the study period with a diagnosis of genital chlamydia infection.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant exclusion criteria
1. Patients whose sexual contacts are not in Derbyshire or are untraceable
2. Sexual contacts under the age of 16
Recruitment start date
28/02/2006
Recruitment end date
31/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Derby Hospitals NHS Foundation Trust (UK) - NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19833688
Publication citations
-
Results
Apoola A, Beardsley J, Does the addition of a urine testing kit to use of contact slips increase the partner notification rates for genital chlamydial infection?, Int J STD AIDS, 2009, 20, 11, 775-777, doi: 10.1258/ijsa.2009.009196.