Condition category
Infections and Infestations
Date applied
10/12/2007
Date assigned
06/02/2008
Last edited
09/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.derbyshirementalhealthservices.nhs.uk/

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21219504

Publication citations

  1. 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.

Additional files

Editorial Notes