PrEP Impact Trial: A pragmatic health technology assessment of PrEP and implementation

Tenofovir containing regimens used as HIV Pre-exposure Prophylaxis (PrEP) have been proven to be highly effective at reducing the risk of HIV acquisition. The safety, efficacy and potential effectiveness of PrEP are well established, however several questions needed to be addressed prior to PrEP being commissioned on the NHS. The purpose of this trial is to address these outstanding questions, such as eligibility, uptake, duration of use and duration of eligibility (PrEP prevention care continuum), with a view to potentially implementing a PrEP programme in England. The trial will be non-interventional and a prospective open label health technology assessment. No procedures will be applied to participants above those recommended in national guidance (BASHH/BHIVA). 10,000 individuals will be recruited in participating Genitourinary Medicine (GUM) Clinics across England and in order to mitigate against future geographical inequity in PrEP provision as many high, medium and low throughput clinics as possible will be recruited to the trial. Identifying and engaging individuals in other populations than men who have sex with men (MSM) at high risk of HIV, including black Africans and transgender men and women, will be crucial to maximising the potential benefits of PrEP. The number of clinic attendees in such populations that will eligible for PrEP is currently unknown and will be monitored throughout the trial. Consented and enrolled participants will undergo assessments in accordance with establish practice based on clinical evidence. Once the assessments have been completed and eligibility has been confirmed, participants will be prescribed up to 3 months supply of PrEP. The participant will then be advised by clinic staff to return on a regular (i.e. quarterly) basis in line with established practice. Additional PrEP can then be dispensed at each visit, if the participant is still eligible. The trial will end 3 years after the first patient’s first visit (FPFV) and PrEP will not be available to participants via the trial after it has ended. The data arising from the trial will be analysed using epidemiological methods. The first objective of the trial measuring the PrEP prevention care continuum among GUM clinic attendees will be assessed by the proportion of GUM clinic attendees that meet PrEP eligibility criteria, the proportion that is prescribed PrEP per year and the duration of PrEP eligibility and PrEP-use among users. Additionally, we aim to measure change over time in bacterial STI and HIV diagnoses and incidence in those at high HIV risk by looking at STI diagnoses (gonorrhoea, chlamydia, syphilis and hepatitis C) and HIV diagnoses reported in the national surveillance dataset. The project timetable consists of set-up activities (protocol development, ethics, contracting and site feasibility) from Q2-Q3 2017 with a view to open sites to recruitment from Q3 2017 – Q2 2018. Recruitment at sites will be ongoing for 3 years following FPFV and is anticipated to conclude in Q3 2020. Close down activities (data retrieval and cleaning) are anticipated to end by Q4 2020 with analysis, write-up and dissemination occurring from Q1-Q3 2021.