Condition category
Infections and Infestations
Date applied
06/01/2012
Date assigned
06/01/2012
Last edited
14/09/2012
Prospective/Retrospective
Retrospectively 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 Carrie Llewellyn

ORCID ID

Contact details

Division of Public Health & Primary Care
Brighton & Sussex University Hospitals NHS Trust
Village Way
Falmer
Brighton
BN1 9PH
United Kingdom
c.d.llewellyn@bsms.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11436

Study information

Scientific title

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)

Acronym

PEPSE

Study hypothesis

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.

Ethics approval

National Research Ethics Service (NRES) Committee South East Coast, Surrey, 14 July 2011 ref: 11/LO/0718

Study design

Preventative, interventional randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Infectious diseases and microbiology

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The proportion of risky sexual practices measured at 3, 6 and 12 months after the end of treatment

Secondary outcome measures

No secondary outcome measures

Overall trial start date

03/01/2012

Overall trial end date

01/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

UK Sample Size: 250

Participant exclusion criteria

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.

Recruitment start date

03/01/2012

Recruitment end date

01/04/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Public Health & Primary Care
Brighton
BN1 9PH
United Kingdom

Sponsor information

Organisation

Brighton & Sussex University Hospitals NHS Trust (UK)

Sponsor details

Clinical Investigation and Research Unit (CIRU)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
+44 (0)1273 696 955

Sponsor type

Hospital/treatment centre

Website

http://www.bsuh.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR - Research for Patient Benefit (RfPB) (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

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22440090

Publication citations

  1. Protocol

    Llewellyn C, Abraham C, Miners A, Smith H, Pollard A, Benn P, Fisher M, 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): a protocol., BMC Infect. Dis., 2012, 12, 70, doi: 10.1186/1471-2334-12-70.

Additional files

Editorial Notes