Contact information
Type
Scientific
Primary contact
Dr Mike Crawford
ORCID ID
Contact details
Centre for Mental Health
Claybrook Centre
37 Claybrook Road
London
W6 8LN
United Kingdom
+44(0)20 7386 1233
m.crawford@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
09/9104
Study information
Scientific title
Alcohol misuse and sexual health: a randomised trial of brief intervention among people attending sexual health clinics
Acronym
SHEAR (Sexual Health & Excessive Alcohol: Randomised trial)
Study hypothesis
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
Ethics approval
The West London Research Ethics Committee, 24/05/2010, ref: 10/H0706/29
Study design
Single-blind individually randomised parallel-arm controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet.
Condition
Alcohol misuse. Sexual health.
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Mean units of alcohol consumed per week measured at six months using the Form 90
Secondary outcome measures
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
Overall trial start date
20/08/2010
Overall trial end date
31/05/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
320 patients (160 control, 160 treatment)
Participant exclusion criteria
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
Recruitment start date
20/08/2010
Recruitment end date
31/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Mental Health
London
W6 8LN
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
Joint Research Office
G02 Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
United Kingdom
+44(0)20 7594 1188
gary.roper@imperial.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Department of Health (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
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22920408
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24813652
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24936090
Publication citations
-
Protocol
Sanatinia R, Barrett B, Byford S, Dean M, Green J, Jones R, Leurent B, Lingford-Hughes A, Sweeting M, Touquet R, Tyrer P, Ward H, Crawford MJ, Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial., Trials, 2012, 13, 149, doi: 10.1186/1745-6215-13-149.
-
Results
Crawford MJ, Sanatinia R, Barrett B, Byford S, Dean M, Green J, Jones R, Leurent B, Lingford-Hughes A, Sweeting M, Touquet R, Tyrer P, Ward H, The clinical effectiveness and cost-effectiveness of brief intervention for excessive alcohol consumption among people attending sexual health clinics: a randomised controlled trial (SHEAR)., Health Technol Assess, 2014, 18, 30, 1-48, doi: 10.3310/hta18300.
-
Results
Crawford MJ, Sanatinia R, Barrett B, Byford S, Dean M, Green J, Jones R, Leurent B, Sweeting MJ, Touquet R, Greene L, Tyrer P, Ward H, Lingford-Hughes A, The clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people attending sexual health clinics: a randomised controlled trial., Sex Transm Infect, 2014, doi: 10.1136/sextrans-2014-051561.