| Source of record | UK Trials |
| ISRCTN | ISRCTN38526137 |
| Date ISRCTN assigned | 06/02/2008 |
| Local reference number(s) | 196AA |
| Public title | A randomised controlled study of mouth swab testing versus same-day blood tests for human immunodeficiency virus (HIV) infection in young people attending a young person's community drug service |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Sexually transmitted infections/HIV |
| Study hypothesis | The objective is to determine if providing an oral swab test in the community for blood borne virus testing leads to an increase in subsequent attendance for sexually transmitted infection screening at the Genito Urinary Medicine (GUM) clinic compared to making appointments for young people to attend the clinic for same day HIV testing and sexually transmitted infections (STI) screening. |
| Design/methodology | Single-centre randomised controlled trial |
| Research ethics review | Ethics approval received from the Leicestershire, Northamptonshire and Rutland Research Ethics Committee (REC) on the 16th January 2007 (ref: 06/Q2501/244). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | All young people (under 18 years, male and female) engaged with the young person's substance misuse service deemed competent to provide informed consent. |
| Participants - exclusion criteria | All young people engaged with the young person's substance misue service who are deemed not competent to provide informed consent. |
| Patient information material |
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| Anticipated start date | 01/04/2007 |
| Anticipated end date | 31/03/2008 |
| Status of trial | Completed |
| Target number of participants | 54 |
| Interventions | Control group:
Participants will have a discussion about HIV; they will then be offered an appointment at the GUM clinic. If they agree to an appointment they will be referred to the same-day HIV testing service carried out at the GUM clinic. Here they will be offered blood tests for syphilis, HIV, Hepatitis B and C as per clinic protocol and offered screening tests for genital infections (chlamydia, gonorrhoea and trichomonas). This is the approach which is currently used at the community drug service.
Study group:
Participants will have a pre-test discussion about HIV; they will then be offered an oral swab test for HIV, Hepatitis B and Hepatitis C. The swab tests are sent to the lab for processing with results available in 48 hours. Participants will also be offered an appointment at the Genito Urinary Medicine Clinic for screening tests for genital infections. Negative mouth swab results will result in advice and support regarding sexual health and harm minimisation regarding substance misuse. Positive mouth swab results will result in fast-track referral to the GUM clinic. |
| Primary outcome measure(s) | The number of individuals attending the Genito Urinary Medicine clinic for screening tests. |
| Secondary outcome measure(s) | 1. The number of unvaccinated study participants receiving at least one dose of Hepatitis A and B vaccination
2. The number of unvaccinated study participants receiving 3 doses of the rapid Hepatitis A and B vaccination
3. The number of participants receiving results within a week of testing |
| Sources of funding | Gilead Sciences Ltd (UK) |
| Sponsor name | Derbyshire Mental Health Services NHS Trust (UK) |
| Sponsor details | Bramble House
Kingsway
Derby
United Kingdom
DE22 3LZ |
| Sponsor website | http://www.derbyshirementalhealthservices.nhs.uk/ |
| Contact name | Dr Ade Apoola |
| Contact details | Genito-Urinary Medicine Clinic
Derbyshire Royal Infirmary
London Road
Derby
United Kingdom
DE1 2QY |
| Contact email | ade.apoola@derbyhospitals.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN38526137 |
| Date last extracted from ISRCTN register | 17/04/2008 |
