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ISRCTN
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ISRCTN99963322
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ClinicalTrials.gov identifier
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Public title
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Sexual health and lifestyle advice: A clinical trial
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Scientific title
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Alcohol misuse and sexual health: a randomised trial of brief intervention among people attending sexual health clinics
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Acronym
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SHEAR (Sexual Health & Excessive Alcohol: Randomised trial)
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Serial number at source
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09/9104
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Study hypothesis
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Primary hypothesis:
Brief intervention among those attending sexual health clinics and drinking excessively reduces mean weekly alcohol consumption measured six months later.
Secondary hypotheses:
1. Brief intervention among those attending sexual health clinics and drinking excessively reduces the likelihood of regretted, unplanned and unprotected sexual intercourse
2. Brief intervention among those attending sexual health clinics and drinking excessively is more cost-effective than control treatment
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Lay summary
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Ethics approval
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The West London Research Ethics Committee approved on the 24th of May 2010 (ref: 10/H0706/29)
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Study design
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Single blind individually randomised parallel arm 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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Alcohol misuse. Sexual health.
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Participants - inclusion criteria
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1. Aged 18 years or above
2. Drinking excessively according to the Modified-Single Alcohol Screening Question (M-SASQ)
3. Willing to provide written informed consent to take part in the study
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Participants - exclusion criteria
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1. Unable to communicate in English sufficiently to complete baseline questionnaires (While a significant minority of people attending these clinics will speak English as a second language we anticipate that only a very small proportion will be excluded on the basis of the ability to complete baseline questionnaires [less than 5%])
2. No address or contact telephone number available
3. Participant believes they may not be contactable in six months time
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Anticipated start date
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20/08/2010
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Anticipated end date
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31/05/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use contact details to request a patient information sheet.
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Target number of participants
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320 patients (160 control, 160 treatment)
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Interventions
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We will test the effects of a brief intervention delivered by the treating clinician. The intervention consists of;
1. Brief assessment of current alcohol consumption
2. Feedback on level of alcohol use and its potential to effect health
3. Written information on alcohol and health in the form of a leaflet recommended by the Department of Health: 'How much is too much'
4. An appointment with an Alcohol Nurse Specialist (ANS) based in the same clinic
The intervention delivered by the Alcohol Nurse Specialist will be based on recommendations by the Department of Health, will last up to 30 minutes and use the 'FRAMES' approach (Feedback, Responsibility, Advice, Menu of options, Empathy, Self-Efficacy). For any participant who is drinking at a harmful or dependent level the Alcohol Nurse Specialist will have the option of referring the patient for further help e.g. individual alcohol counselling, detoxification services etc. In the event that the participant is unable to attend an appointment that day they will be offered an appointment on a later date of their choosing.
Control treatment
Those randomised to control treatment will be offered a copy of leaflet 'Five Choices to Help You Stay Healthy' which provides general information on preventative health including alcohol use, diet, exercise, cigarette smoking and details of how to obtain further information about health and lifestyle.
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Primary outcome measure(s)
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Mean units of alcohol consumed per week measured at six months using the Form 90
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Secondary outcome measure(s)
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1. Proportion of participants with harmful/ hazardous drinking measured using the Alcohol Use Disorders Identification Test (short form) (AUDIT-C)
2. Sexual behaviour measured using key variables that have been validated in other studies to record the number and type of sexual partners in the previous six months, and incidence of unprotected, regretted or forced sex
3. Health related quality of life, using the five item EQ-5D
4. Resource use during the previous six months using the Adult Service Use Schedule
5. Contacts with the sexual health service in the six months following randomisation will be checked using the clinics electronic database
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Sources of funding
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Department of Health (UK)
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Trial website
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Publications
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Contact name
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Dr
Mike
Crawford
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Address
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Centre for Mental Health
Claybrook Centre
37 Claybrook Road
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City/town
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London
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Zip/Postcode
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W6 8LN
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Country
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United Kingdom
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Tel
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+44(0)20 7386 1233
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Fax
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+44(0)20 7386 1216
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Email
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m.crawford@imperial.ac.uk
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Sponsor
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Imperial College London (UK)
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Address
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Joint Research Office
G02 Sir Alexander Fleming Building
South Kensington Campus
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City/town
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London
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Zip/Postcode
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SW7 2AZ
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Country
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United Kingdom
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Tel
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+44(0)20 7594 1188
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Fax
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+44(0)20 7954 1792
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Email
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gary.roper@imperial.ac.uk
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Sponsor website:
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http://www3.imperial.ac.uk
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Date applied
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12/07/2010
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Last edited
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29/07/2010
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Date ISRCTN assigned
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29/07/2010
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