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
| ISRCTN | ISRCTN38526137 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38526137 |
| Protocol serial number | 196AA |
| Sponsor | Derbyshire Mental Health Services NHS Trust (UK) |
| Funder | Gilead Sciences Ltd (UK) |
- Submission date
- 10/12/2007
- Registration date
- 06/02/2008
- Last edited
- 09/02/2012
- 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
Dr Ade Apoola
Scientific
Scientific
Genito-Urinary Medicine Clinic
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
| ade.apoola@derbyhospitals.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | Ethics approval received from the Leicestershire, Northamptonshire and Rutland Research Ethics Committee (REC) on the 16th January 2007 (ref: 06/Q2501/244). |
| Health condition(s) or problem(s) studied | Sexually transmitted infections/HIV |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
The number of individuals attending the Genito Urinary Medicine clinic for screening tests. |
| Key secondary outcome measure(s) |
1. The number of unvaccinated study participants receiving at least one dose of Hepatitis A and B vaccination |
| Completion date | 31/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 54 |
| Key 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. |
| Key exclusion criteria | All young people engaged with the young person's substance misue service who are deemed not competent to provide informed consent. |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 31/03/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Genito-Urinary Medicine Clinic
Derby
DE1 2QY
United Kingdom
DE1 2QY
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 | 01/01/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
