|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
13 January 2015 |
|
Main ID: |
ISRCTN38526137 |
|
Date of registration:
|
06/02/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
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:
|
|
|
Date of first enrolment:
|
01/04/2007 |
|
Target sample size:
|
54 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN38526137 |
|
Study type:
|
Interventional |
|
Study design:
|
Single-centre randomised controlled trial (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Ade
Apoola |
|
Address:
|
Genito-Urinary Medicine Clinic
Derbyshire Royal Infirmary
London Road
DE1 2QY
Derby
United Kingdom |
|
Telephone:
|
|
|
Email:
|
ade.apoola@derbyhospitals.nhs.uk |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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.
Exclusion criteria: All young people engaged with the young person's substance misue service who are deemed not competent to provide informed consent.
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Sexually transmitted infections/HIV
Infections and Infestations
Sexually transmitted infections
|
|
Intervention(s)
|
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(s)
|
|
The number of individuals attending the Genito Urinary Medicine clinic for screening tests.
|
|
Secondary Outcome(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
|
|
Source(s) of Monetary Support
|
|
Gilead Sciences Ltd (UK)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|