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ISRCTN
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ISRCTN00746242
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DOI
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10.1186/ISRCTN00746242
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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An intervention to reduce sexual risk after Post-Exposure Prophylaxis for HIV following Sexual Exposure (Project PEPSE)
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Scientific title
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Multicentre RCT and economic evaluation of a psychological intervention together with a leaflet to reduce risk behaviour amongst men who have sex with men (MSM) prescribed post-exposure prophylaxis for HIV following sexual exposure (PEPSE)
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Acronym
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PEPSE
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Serial number at source
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11436
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Study hypothesis
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Men who have sex with men (MSM) are most affected by HIV in the UK and they are increasingly likely to engage in risky sexual behaviour. One to one behavioural interventions, such as motivational interviewing (MI) have been recommended to reduce HIV in high risk groups by National Institute for Health and Clinical Excellence (NICE) in the UK, as part of current STI/HIV service provision. MSM who receive a preventative regimen of HIV treatment after potential sexual exposure to HIV (PEPSE) are at particularly high risk of later acquiring HIV and therefore could greatly benefit from targeted risk reduction interventions, so as to reduce the likelihood of further risk behaviour, subsequent infection and costs to the National Helath Service (NHS) in the UK.
Aims:
1. Examine whether MI is effective in reducing risky sexual behaviour in MSM prescribed PEPSE compared to ‘usual treatment’.
2. Examine whether motivational interviewing increases adherence to PEPSE and whether the intervention could represent ‘value for money’ to the NHS.
HIV is a condition affecting both length and quality of life, even with highly effective treatments. Therefore, a relatively low-cost intervention for MSM that is effective in reducing the likelihood of risky sexual behaviour and further HIV infections will not only directly benefit recipients, but also the wider MSM community and the NHS as a whole.
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Lay summary
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Not provided at time of registration
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Ethics approval
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National Research Ethics Service (NRES) Committee South East Coast, Surrey, 14 July 2011 ref: 11/LO/0718
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Study design
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Preventative, interventional randomised trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Infectious diseases and microbiology
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Participants - inclusion criteria
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1. Men who have sex with men (MSM)
2. Minimum age =16 years
3. A prescription for PEP after sexual exposure
4. Attending a Genito-Urinary Medicine (GUM) clinic
5. Willing and able to give written, informed consent
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Participants - exclusion criteria
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The following groups of patients will be excluded: those that do not consider themselves to be MSM, patients under the age of 16 years, people who have received previous psychological support from a clinical psychologist in relation to their sexual risk taking; people with learning difficulties; people unable to read study materials; people with no means of communication acceptable to the patient; people who are seeking PEP after sexual assault.
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Anticipated start date
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03/01/2012
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Anticipated end date
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01/04/2013
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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UK Sample Size: 250
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Interventions
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RCT conducted in Brighton and London is proposed. Participants will be MSM who have been prescribed PEP after sexual exposure.
Those randomised to receive the intervention will receive two telephone administered sessions of motivational interviewing (MI) augmented by information and skills training. Each telephone session will be a maximum of 30 minutes long. The second session will contain similar content to the first but will reiterate and build on the risk reduction motivation from session 1. In the case of drop-out between the 2 intervention sessions, a dose-response can then be assessed. The interventionist will initially assess individual risk behaviours and any informational, motivational or skill deficits which have contributed to maintenance of participants.
This group will be compared to a ‘treatment as usual’ control group. Individuals will be followed up for one year to determine whether the intervention has long term effects on sexual behaviour. ‘Value for money’ will be estimated by conducting an economic evaluation, where the costs and health outcomes of the interventions are compared.
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Primary outcome measure(s)
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The proportion of risky sexual practices measured at 3, 6 and 12 months after the end of treatment
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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NIHR - Research for Patient Benefit (RfPB) (UK)
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Trial website
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Publications
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1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22440090
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Contact name
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Dr
Carrie
Llewellyn
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Address
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Division of Public Health & Primary Care
Brighton & Sussex University Hospitals NHS Trust
Village Way
Falmer
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City/town
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Brighton
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Zip/Postcode
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BN1 9PH
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Country
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United Kingdom
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Email
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c.d.llewellyn@bsms.ac.uk
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Sponsor
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Brighton & Sussex University Hospitals NHS Trust (UK)
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Address
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Clinical Investigation and Research Unit (CIRU)
Royal Sussex County Hospital
Eastern Road
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City/town
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Brighton
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Zip/Postcode
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BN2 5BE
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Country
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United Kingdom
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Tel
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+44 (0)1273 696 955
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Email
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Sponsor website:
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http://www.bsuh.nhs.uk/
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Date applied
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06/01/2012
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Last edited
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14/09/2012
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Date ISRCTN assigned
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06/01/2012
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