Contact information
Type
Scientific
Primary contact
Dr Ade Apoola
ORCID ID
Contact details
Genito-Urinary Medicine Clinic
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
ade.apoola@derbyhospitals.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
196AA
Study information
Scientific title
Acronym
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.
Ethics approval
Ethics approval received from the Leicestershire, Northamptonshire and Rutland Research Ethics Committee (REC) on the 16th January 2007 (ref: 06/Q2501/244).
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/04/2007
Overall trial end date
31/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
54
Participant exclusion criteria
All young people engaged with the young person's substance misue service who are deemed not competent to provide informed consent.
Recruitment start date
01/04/2007
Recruitment end date
31/03/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Genito-Urinary Medicine Clinic
Derby
DE1 2QY
United Kingdom
Sponsor information
Organisation
Derbyshire Mental Health Services NHS Trust (UK)
Sponsor details
Bramble House
Kingsway
Derby
DE22 3LZ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Gilead Sciences Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21219504
Publication citations
-
Results
Apoola A, Brunt L, A randomised controlled study of mouth swab testing versus same day blood tests for HIV infection in young people attending a community drug service., Drug Alcohol Rev, 2011, 30, 1, 101-103, doi: 10.1111/j.1465-3362.2010.00208.x.