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
Secondary identifying numbers	196AA

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

Genito-Urinary Medicine Clinic
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Email	ade.apoola@derbyhospitals.nhs.uk

Study information

Study design	Single-centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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 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	The number of individuals attending the Genito Urinary Medicine clinic for screening tests.
Secondary outcome measures	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
Overall study start date	01/04/2007
Completion date	31/03/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	18 Years
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Genito-Urinary Medicine Clinic

Derby
DE1 2QY
United Kingdom

Sponsor information

Derbyshire Mental Health Services NHS Trust (UK)
Hospital/treatment centre

Bramble House
Kingsway
Derby
DE22 3LZ
England
United Kingdom

Website	http://www.derbyshirementalhealthservices.nhs.uk/
"ROR"	https://ror.org/02zfxwc21

Funders

Funder type

Industry

Gilead Sciences Ltd (UK)

No information available

Results and Publications

Intention to publish date
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?
Results article	results	01/01/2011		Yes	No