Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Carrie Llewellyn


Contact details

Division of Public Health & Primary Care
Brighton & Sussex University Hospitals NHS Trust
Village Way
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


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)



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.

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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Infectious diseases and microbiology


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



Not Applicable

Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants

UK Sample Size: 250

Total final enrolment


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Division of Public Health & Primary Care
United Kingdom

Sponsor information


Brighton & Sussex University Hospitals NHS Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre



Funder type


Funder name

NIHR - Research for Patient Benefit (RfPB) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

1. 2012 protocol in:
2. 2019 results in: (added 24/05/2019)

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

24/05/2019: Publication reference and total final enrolment number added. 26/10/2018: An intention to publish date has been added.