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 |
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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
Scientific
Department of GU Medicine
Whittall Street Clinic
Whittall Street
Birmingham
B4 6DH
United Kingdom
Study information
Study design | Randomised controlled trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of GU Medicine
Birmingham
B4 6DH
United Kingdom
B4 6DH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/12/2010 | Yes | No |