A randomised controlled trial to assess the efficacy and acceptability of non-invasive testing sexually transmitted infections in asymptomatic patients within a GUM setting

ISRCTN ISRCTN13804526
DOI https://doi.org/10.1186/ISRCTN13804526
Secondary identifying numbers N0233179831
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
30/05/2012
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

Prof Jonathan Ross
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesThe 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(s)Added 20/07/09: ethics approval granted by Solihull LREC date: 7th March 2006 REC ref: 05/Q2706/105.
Health condition(s) or problem(s) studiedInfections and Infestations: Sexually transmitted diseases
InterventionPatients 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 typeOther
Primary outcome measureAcceptability of the non-invasive testing procedures as compared with the current standard of care.
Secondary outcome measuresPatient time spent in the clinic (consultation time and total visit time), detection of STI in both study and control group and consultation costs.
Overall study start date14/03/2006
Completion date31/03/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participantsAdded 20/07/09: trial aimed to recruit about 400 participants and managed 391.
Key inclusion criteria1. 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
Key exclusion criteria1. Contacts of an sexually transmitted infection (STI)
2. Pregnancy
3. Symptomatic patient
Date of first enrolment14/03/2006
Date of final enrolment31/03/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of GU Medicine
Birmingham
B4 6DH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

R&D for Birmingham and Solihull Consortium (UK)

No information available

Heart of Birmingham Teaching Primary Care Trust (UK)

No information available

NHS R&D Support Funding (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2010 Yes No