Sexual health and lifestyle advice: a clinical trial

ISRCTN ISRCTN99963322
DOI https://doi.org/10.1186/ISRCTN99963322
Secondary identifying numbers 09/9104
Submission date
12/07/2010
Registration date
29/07/2010
Last edited
18/06/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mike Crawford
Scientific

Centre for Mental Health
Claybrook Centre
37 Claybrook Road
London
W6 8LN
United Kingdom

Phone +44(0)20 7386 1233
Email m.crawford@imperial.ac.uk

Study information

Study designSingle-blind individually randomised parallel-arm controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use contact details to request a patient information sheet.
Scientific titleAlcohol misuse and sexual health: a randomised trial of brief intervention among people attending sexual health clinics
Study acronymSHEAR (Sexual Health & Excessive Alcohol: Randomised trial)
Study objectivesPrimary 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(s)The West London Research Ethics Committee, 24/05/2010, ref: 10/H0706/29
Health condition(s) or problem(s) studiedAlcohol misuse. Sexual health.
InterventionWe 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 typeOther
Primary outcome measureMean units of alcohol consumed per week measured at six months using the Form 90
Secondary outcome measures1. 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 study start date20/08/2010
Completion date31/05/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants320 patients (160 control, 160 treatment)
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment20/08/2010
Date of final enrolment31/05/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Centre for Mental Health
London
W6 8LN
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

Joint Research Office
G02 Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
England
United Kingdom

Phone +44(0)20 7594 1188
Email gary.roper@imperial.ac.uk
Website http://www3.imperial.ac.uk
ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Government

Department of Health (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 25/08/2012 Yes No
Results article results 01/05/2014 Yes No
Results article results 01/02/2015 Yes No