Condition category
Infections and Infestations
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
30/05/2012
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

Prof Jonathan Ross

ORCID ID

Contact details

Department of GU Medicine
Whittall Street Clinic
Whittall Street
Birmingham
B4 6DH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0233179831

Study information

Scientific title

Acronym

Study hypothesis

The study will assess and compare the acceptability by patients of non-invasive screening for sexually transmitted infections with current procedures and standards of care. These will be asymptomatic low risk patients within a GUM clinic setting.

Ethics approval

Added 20/07/09: ethics approval granted by Solihull LREC date: 7th March 2006 REC ref: 05/Q2706/105.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infections and Infestations: Sexually transmitted diseases

Intervention

Patients will book in the normal way, then a nurse will approach with the patient information sheet. A sexual history will be taken. The standard group will be tested in the standard way, the non-invasive will have urine samples. A patient questionnaire will asses satisfaction at treatment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Acceptability of the non-invasive testing procedures as compared with the current standard of care.

Secondary outcome measures

Patient time spent in the clinic (consultation time and total visit time), detection of STI in both study and control group and consultation costs.

Overall trial start date

14/03/2006

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Asymptomatic heterosexual men
2. Asymptomatic hetrosexual women who have not had receptive anal intercourse within the last 3 years
3. Asymptomatic homosexual/ bisexual men who have not had receptive anal intercourse within the last 3 years

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

Added 20/07/09: trial aimed to recruit about 400 participants and managed 391.

Participant exclusion criteria

1. Contacts of an sexually transmitted infection (STI)
2. Pregnancy
3. Symptomatic patient

Recruitment start date

14/03/2006

Recruitment end date

31/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of GU Medicine
Birmingham
B4 6DH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 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

Hospital/treatment centre

Funder name

R&D for Birmingham and Solihull Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Heart of Birmingham Teaching Primary Care Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20798395

Publication citations

  1. Results

    Brown L, Patel S, Ives NJ, McDermott C, Ross JD, Is non-invasive testing for sexually transmitted infections an efficient and acceptable alternative for patients? A randomised controlled trial., Sex Transm Infect, 2010, 86, 7, 525-531, doi: 10.1136/sti.2009.039479.

Additional files

Editorial Notes