The role of Home packs of HIV PEPSE in High Risk Individuals
Research type
Research Study
Full title
The role of Home packs of HIV Post-Exposure Prophylaxis for sexual exposure (PEPSE) to improve the speed and appropriate uptake of PEPSE in high risk individuals
IRAS ID
172634
Contact name
Julie Fox
Contact email
Sponsor organisation
Guy's & St. Thomas' NHS Foundation Trust
Eudract number
2013-004809-24
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
Research Summary
The study is looking at a new way to reduce the risk of catching HIV. Post-exposure Prophylaxis for sexual exposure (PEPSE) is where a month of HIV drugs can be given to reduce the chance of getting HIV, after a risk. To improve its use we want to see whether providing a 5-day course of PEPSE for people to keep at home (HOME PEPSE) will lead to it being taken much quicker than having to get it from sexual health clinics or A&E. The HOME PEPSE packs contain HIV tablets that are used in routine HIV care. However the type of HIV drugs are slightly different to those currently used in PEPSE and we hope that they will have fewer side effects. HOME PEP consists of Truvada and Maraviroc.
140 gay men who are at high risk of getting HIV will be randomised to one of two groups. Group A will receive HOME PEPSE immediately and group B will receive HOME PEPSE after 48 weeks on the study.
Summary of Results
139 participants were randomised: 69 (HOME PEPSE) and 70 (control). Average age 30 years, 75% white, 55% UK born and 72% university educated. 33 in HOME PEPSE arm and 15 in control arm took PEPSE were included in the main analysis. There was one HIV seroconversion (infection) - this individual had repeatedly been advised to start PrEP (pre-exposure prophylaxis) due to his ongoing high risk sexual behaviour. There were 58 cases bacterial STI (sexually transmitted infection) during the study with no difference between the groups. The most reported reason for taking PEPSE was receptive anal sex with a man of unknown HIV status (81% cases).
The Median time from sex to first dose of PEPSE was 7.6 hours for the HOME PEPSE arm and 28.5 hours for the control for ARM B (p < 0.01). 6 people in arm A and 2 in arm B accessed PEPSE more than once in 48 weeks. 22/26 people who started HOME PEPSE kept it at home, 1/26 kept in a bag, 3/26 other. 2/66 (3%) reported giving their HOME PEPSE to other people to use.
HOME PEPSE was safe and well tolerated. The commonest side effects were headache and fatigue.There was no change in the number of anal sex acts without a condom over time or in the number of bacterial STI between the groups.
Conclusion
1. HOME PEPSE was taken appropriately by men who have sex with men
2. HOME PEPSE reduced time from sex to first dose of PEPSE by 20 hours, with no impact on safety
3. For MSM not wanting to take PrEP, or those with sexual practices in which they cannot predict sex, HOME PEPSE may be a valuable HIV prevention tool
4. Clinical guidelines should consider this as a prevention optionREC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0548
Date of REC Opinion
5 Jun 2015
REC opinion
Further Information Favourable Opinion