An intervention to reduce sexual risk after Post-Exposure Prophylaxis for HIV following Sexual Exposure (Project PEPSE)
| ISRCTN | ISRCTN00746242 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00746242 |
| Secondary identifying numbers | 11436 |
- Submission date
- 06/01/2012
- Registration date
- 06/01/2012
- Last edited
- 24/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Carrie Llewellyn
Scientific
Scientific
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 |
Study information
| Study design | Preventative, interventional randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 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(s) | National Research Ethics Service (NRES) Committee South East Coast, Surrey, 14 July 2011 ref: 11/LO/0718 |
| 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 |
| 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 study start date | 03/01/2012 |
| Overall study end date | 01/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | UK Sample Size: 250 |
| Total final enrolment | 175 |
| 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 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
- England
- United Kingdom
Study participating centre
Division of Public Health & Primary Care
Brighton
BN1 9PH
United Kingdom
BN1 9PH
United Kingdom
Sponsor information
Brighton & Sussex University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Clinical Investigation and Research Unit (CIRU)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
England
United Kingdom
| Phone | +44 (0)1273 696 955 |
|---|---|
| ciru.reception@bsuh.nhs.uk | |
| Website | http://www.bsuh.nhs.uk/ |
Funders
Funder type
Government
NIHR - Research for Patient Benefit (RfPB) (UK)
No information available
Results and Publications
| Intention to publish date | 26/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/03/2012 | Yes | No | |
| Results article | results | 23/05/2019 | 24/05/2019 | Yes | No |
Editorial Notes
24/05/2019: Publication reference and total final enrolment number added.
26/10/2018: An intention to publish date has been added.
