Condition category
Urological and Genital Diseases
Date applied
12/07/2010
Date assigned
29/07/2010
Last edited
18/06/2014
Prospective/Retrospective
Prospectively 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 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 measures

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

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

http://www3.imperial.ac.uk

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes