Condition category
Mental and Behavioural Disorders
Date applied
12/08/2014
Date assigned
02/10/2014
Last edited
12/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The excessive drinking of alcohol, or binge drinking, is a major social and health issue in the UK. It can lead to having sex with a lot of different partners and is often the cause of unintended pregnancy. Binge drinking in young people is a key part of the UK's drinking culture and sexually transmitted diseases (STIs) are most often found in this age group. A study at a sexual health clinic in Portsmouth found that many people who came to the clinic with STIs were heavy drinkers, with 87% admitting to binge drinking with an average intake of alcohol of 20 units in a heavy night (the equivalent of 10 cans of beer or lager). Giving advice to people who have been identified to be drinking heavily could reduce the problem of binge drinking. An Australian study found a reduction in drinking when it was tried in a sexual health clinic. This study aims to find out if it is possible and effective to give advice to adults attending a sexual health clinic in the UK.

Who can participate?
People aged 16 and over attending the sexual health clinic for the first time.

What does the study involve?
Participants were screened for alcohol misuse and were asked if they were ready to take part in this study. They were randomly allocated to one of two groups: one received a brief intervention (BI), a short 5-minute discussion on alcohol as part of the clinic visit, and the other group received usual care (given an alcohol health-promoting leaflet during their appointment). All participants were followed up after 6 months to see if they benefitted.

What are the possible benefits and risks of participating?
Patients may benefit from reducing their alcohol usage and risky sexual behaviour.

Where is the study run from?
The study was run from the Portsmouth sexual health clinic, UK.

When is the study starting and how long is it expected to run for?
May 2011 to October 2012.

Who is funding the study?
National Institute for Health Research (NIHR), UK.

Who is the main contact?
Dr Harindra Veerakathy
veerakathy.harindra@solent.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Harindra Veerakathy

ORCID ID

Contact details

Genitourinary Medicine Department
Queen Alexandra Hospital
Southwick Road
Portsmouth
PO6 3LY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Assessing feasibility and acceptability of a BRief intervention for risky Alcohol consumption In Sexual Health clinic attendees: a randomised controlled trial

Acronym

BRAISH

Study hypothesis

To assess the feasibility and acceptability of screening attendees at a sexual health clinic (SHC) for alcohol misuse and delivering a brief intervention (BI) and to explore the effect on drinking and sexual behaviour.

Ethics approval

NRES Committee South Central - Southampton A, 01/12/2010, ref. 10/HO502/76

Study design

Individual randomised feasibility study to test screening, recruitment, baseline procedures, intervention process and follow-up

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Alcohol misuse
Sexual health problem

Intervention

Alcohol brief intervention plus leaflet vs leaflet (usual care)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Feasibility study, not powered on single outcome but included AUDIT score, alcohol units/week, binge drinking frequency, new sexual partner frequency, frequency of drunkenness and regretted sex

Timepoints: 6 weeks and 6 months after randomisation
Method: Questionnaire, self-reported measures of alcohol use and sexual risk behaviour

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2011

Overall trial end date

31/10/2012

Reason abandoned

Eligibility

Participant inclusion criteria

All attendees aged 16 and over, irrespective of their sexual orientation or gender, attending the clinic for the first episode of care were recruited. Both symptomatic and asymptomatic presentations were included

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Feasbility study, recruited n=215

Participant exclusion criteria

None

Recruitment start date

01/05/2011

Recruitment end date

31/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Alexandra Hospital
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Organisation

Portsmouth Hospitals NHS Trust (UK)

Sponsor details

Research and Development Department
1st Floor
Gloucester House
Queen Alexandra Hospital
Cosham
Portsmouth
PO63LY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.porthosp.nhs.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR RfPB PB-PG-1208-18156) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26259896

Publication citations

Additional files

Editorial Notes