Condition category
Infections and Infestations
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
11/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ade Apoola

ORCID ID

Contact details

Derby Hospitals NHS Foundation Trust
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19833688

Publication citations

  1. 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.

Additional files

Editorial Notes