HIV Infection: Clinical Trials

(asked on 29th June 2017) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, with reference to Public Health England's announcement of 20 June 2017 on the HIV PrEP Impact trial in England, when the frequently asked questions document referred to in the announcement will be published.


Answered by
Steve Brine Portrait
Steve Brine
This question was answered on 4th July 2017

The HIV pre-exposure prophylaxis (PrEP) Impact trial will seek to engage as many of the approximately 230 genitourinary medicine clinics in England as possible. All clinics will be offered the opportunity to participate, regardless of where they are situated. In keeping with the open access nature of sexual health services, patients will be able to attend any clinic in England that is participating in the trial and therefore have their trial eligibility assessed regardless of where they live.

NHS England and Public Health England have stated that the trial will begin by the summer of 2017, available to view here:

https://www.gov.uk/government/news/update-on-prep-impact-trial-in-england

The final timescale will be considered at the July meeting of the PrEP Programme Oversight Board (POB) when updated information on the likely timeline of availability of trial drug at trial sites will be provided. Several bids to supply the trial drug were received on the June 29 deadline. If the trial timeline needs to change, new information will be provided in the Stakeholder Update due to be issued after the July 14 PrEP POB.

The Frequently Asked Questions will be published following review at the July meeting of the PrEP POB.

The PrEP Impact trial application was submitted to the Research Ethics Committee (REC) at the end of June. The committee will issue a final ethical opinion within 60 days. The current expectation is that approval will be obtained in time for the drug becoming available. The REC approval timeline is independent of the trial drug procurement process.

Before a trial site can begin to recruit patients, they must provide confirmation of capacity and capability to the Trial co-ordination centre and the timescales for this can vary across localities. This process includes negotiating and finalising local trial contracts and having site staff undergo trial-specific training provided by the Trial co-ordination centre (St Stephen’s Clinical Research). This process will occur in parallel to obtaining national ethics approval and the trial drug procurement activities. Some sites may be in a position to begin trial participant recruitment as soon as the trial drug becomes available.

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