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ISRCTN
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ISRCTN27508373
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled evaluation of the effectiveness of behavioural intervention in high risk gay men attending an sexually transmitted disease (STD) clinic
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Scientific title
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Acronym
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N/A
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Serial number at source
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RDC00058
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Study hypothesis
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Despite clear evidence that gay men are at increased risk of HIV infection, there has been little rigorous evaluation of the effectiveness of behavioural intervention in reducing sexual risk behaviour in the group. We propose a randomised control trial (RCT) to examine the effectiveness of group work in promoting safer sex in gay men who have high risk sexual lifestyles, since they are at a high risk of transmitting and acquiring the HIV infection. Building on experience in this department, the feasibility of various forms of group intervention will be investigated during a pilot survey of gay men attending an STD clinic. In the subsequent RCT, high risk gay men will be randomly assigned to either the intervention under evaluation, or to standard management as currently provided in the clinic.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Infection and infestations: Sexually transmitted diseases
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Participants - inclusion criteria
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All participants will be gay men attending an STD clinic. In order to recruit gay men at high risk of human immunodeficiency virus (HIV) infection, those who present with an acute STD or who indicate that they are having unprotected anal sex will be invited to enter the trial (except those in stable monogamous relationships where both partners repeatedly test negative). Estimated sample size will be around 145 men in each group of the study.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/05/1995
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Anticipated end date
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01/07/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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290
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Interventions
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One day 'safe' sex workshop vs standard management
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Primary outcome measure(s)
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Outcome measures will focus on the nature, as well as the number of sexual partnerships and the type of sexual practices within those relationships. STD rates will be a further outcome measure. Differences in outcome will be compared between intervention and control groups at 6 and 12 months after intervention.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive London (UK)
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Trial website
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Publications
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2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11408300
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Contact name
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Dr
Judith
Stephenson
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Address
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Department of Genitourinary Medicine
Public Health
University College London
The Mortimer Market Centre
Off Capper Street
Tottenham Court Road
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City/town
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London
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Zip/Postcode
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WC1 6AU
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Country
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United Kingdom
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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08/12/2008
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Date ISRCTN assigned
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23/01/2004
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