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 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 trial start date
14/03/2006
Overall trial end date
31/03/2007
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20798395
Publication citations
-
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.