Sexual health and lifestyle advice: a clinical trial

ISRCTN	ISRCTN99963322
DOI	https://doi.org/10.1186/ISRCTN99963322
Protocol serial number	09/9104
Sponsor	Imperial College London (UK)
Funder	Department of Health (UK)

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

Primary study design	Interventional
Study design	Single-blind individually randomised parallel-arm controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Alcohol misuse and sexual health: a randomised trial of brief intervention among people attending sexual health clinics
Study acronym	SHEAR (Sexual Health & Excessive Alcohol: Randomised trial)
Study objectives	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(s)	The West London Research Ethics Committee, 24/05/2010, ref: 10/H0706/29
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Mean units of alcohol consumed per week measured at six months using the Form 90
Key secondary outcome measure(s)	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
Completion date	31/05/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	320
Key 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
Key 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
Date of first enrolment	20/08/2010
Date of final enrolment	31/05/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Centre for Mental Health

London
W6 8LN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2014		Yes	No
Results article	results	01/02/2015		Yes	No
Protocol article	protocol	25/08/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes