A pragmatic health technology assessment of PrEP and implementation
ABOUT THE PrEP IMPACT TRIAL
We know from previous studies that PrEP can effectively reduce the risk of HIV infection. Several countries have implemented PrEP programmes to provide the drug to individuals at high risk of HIV. To plan a PrEP programme in England, NHS England and Local Authorities need to know how many people need PrEP, how many will want to take it and for how long. In order to find this out, we are conducting this research. This study does not involve a placebo, so everyone who is enrolled in the trial will have access to PrEP.
The PrEP Impact trial will answer three important questions:
1. How many people attending sexual health clinics need PrEP?
2. How many of these start PrEP?
3. How long do they need PrEP for?
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26,000 people will be recruited to the trial over three years. HIV negative people attending sexual health clinics in England will have their risk of acquiring HIV checked by the clinic staff. If the clinic staff consider an individual meet the eligibility criteria for the trial and a are consider to be at high risk, they will offered PrEP . We will measure how many attendees at sexual health clinics meet eligibility criteria for PrEP, how many of these take up the offer of PrEP and how long they use PrEP for.
There won’t be any additional tests other than those already recommended routinely for the safe delivery of PrEP, including tests for STIs, hepatitis, HIV and monitoring of kidney function. Information about attendances and test results will be collected through the existing information system that sexual health clinics currently use to report to Public Health England.
For further information about what is involved in taking part in the trial please read the current version of the participant information sheet.
If you choose to participate you will need to read this information thoroughly. The clinic staff at your local participating clinic will guide you through the process of confirming that you would like to participate.
If you have any questions, please get in touch with your local participating clinic
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This trial has been approved by the London-Hampstead Research Ethics Committee.