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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Jonathan Ross
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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(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) studied	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
Primary outcome measure	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 study start date	14/03/2006
Completion date	31/03/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	Added 20/07/09: trial aimed to recruit about 400 participants and managed 391.
Key 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
Key exclusion criteria	1. Contacts of an sexually transmitted infection (STI) 2. Pregnancy 3. Symptomatic patient
Date of first enrolment	14/03/2006
Date of final enrolment	31/03/2007

Department of GU Medicine

Birmingham
B4 6DH
United Kingdom

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

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

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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