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 |
| Protocol serial number | N0233179831 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | R&D for Birmingham and Solihull Consortium (UK), Heart of Birmingham Teaching Primary Care Trust (UK), NHS R&D Support Funding (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Acceptability of the non-invasive testing procedures as compared with the current standard of care. |
| Key secondary outcome measure(s) |
Patient time spent in the clinic (consultation time and total visit time), detection of STI in both study and control group and consultation costs. |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of GU Medicine
Birmingham
B4 6DH
United Kingdom
B4 6DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
