The HIV National PrEP IMPACT Trial - The London Agreement

  • By Valerie Solomon

In December 2016, the NHS announced that funding would be available for a national Pre-Exposure Prophylaxis (PrEP) Trial offering 10,000 places across the country. In February 2019, the NHS made a decision to expand the trial to offer an additional 16,000 places. This briefing contains details of the agreement reached in London which will enable the additional places to be managed effectively.

Background

There are more than 38,600 people in London living with HIV (39 per cent of the national total). HIV largely affects certain groups, such gay, bisexual and other men who have sex with men, aged between 15 and 59 years. In recent years, there has been a decline in new diagnoses of HIV, representing a 22 per cent fall from 2016.

PrEP IMPACT Trial and Trial Expansion
The national PrEP Trial began enrolment in October 2017 and is expected to end in September 2020. The purpose of the trial is to assess how to distribute the drug on a large scale and ensure that eligibility and the uptake of PrEP is offered to those most in need. To date 7,500 places has been taken up in London, with patients accessing the drug via genitourinary medicine (GUM) clinics.

In March 2019, the NHS reported its intention to extend the trial places to over 26,000 nationally, an increase of 13,00 additional places. London Councils welcomed the announcement of a further expansion of the trial and reiterated its support to work with partners to tackle HIV. However, due to the increased numbers of places, discussions took place with the national PrEP Oversight Board, sexual health commissioners and the PrEP trial team to discuss how to effectively manage the additional places successfully, as well as raise concerns with government about the financial impact on boroughs. The London Sexual Health Programme agreed to develop a collective response on behalf of London.

In April 2019 London announced that it had agreed to accept around 4,500 additional places, or 60 per cent, as part of the expansion plans. London will effectively be accepting 12, 174 places in total. This agreement to provide an additional 60 per cent is expected to ensure a sufficient number of places are available and clinics in London are able to reopen places with continuity across the coming months.

An issue of concern expressed by London authorities is the shortfall in funding for the participating clinics, particularly affecting those boroughs with a high prevalence of HIV. The PrEP drugs are funded by the NHS, but the costs associated with appointments by trial participants is unfunded and has to be met by local authorities. Participants are required to visit a GUM clinic four times a year for the duration of the trial. On conservative estimates this shortfall in funding for the 60 per cent increase in places would mean £2.6 million in extra trial costs in 2019/20. The financial impact varies across London, reflecting the differences in the level of need. This unresolved issue continues to remain a concern and London Councils is committed to continue lobbying for the shortfall in funding to be met by central government.

London commissioners and local authorities will be implementing new measures to reduce the financial impact of the trial on existing services and to adapt the method to reflect current practice in the London Sexual Health Programme. These include:

• Proactive monitoring with the trial team including the of uptake of places, with a quarterly review on progress and impact on London clinics and authorities.
• Further work to understand the impact of the trial on clinic capacity (including equity analyses on access to GUM clinic services). This will be done in selected localities, which will inform the future implementation of a national PrEP Programme.
• Working in partnership with PHE and the PrEP Impact trial team to ensure that the uptake of PrEP trial continues to include a broad range of populations at high risk, including women, minorities, young MSM and those from disadvantaged backgrounds.
• Work towards implementing the online service which is expected to become available for trial participants from the summer. Not all participants will choose to use the online service, and some may not be eligible, e.g. they have symptoms, but we expect uptake to increase through 2019/20. However, use of the online service could help bring the cost to boroughs down by an estimated £200,000 - 440,000 in 2019/20.

The trial expansion is a complex and evolving picture, there are no immediate plans to reallocate any places earmarked for London sites, but this may be reviewed after six months, when the position regarding the uptake of the extra trial places and service patterns is clearer.
There is also a commitment for the programme and trial team to meet regularly, initially at least monthly, to review the uptake of places, and will complete a more in-depth stocktake after the first three months, and again at six months.

Commentary

London Councils will continue with the discussions that are underway to explore how additional funding could be provided to help offset the capital’s additional trial costs. This includes adjusting the trial protocol so that participants could be offered regular HIV and STI testing through London’s Sexual Health London online service rather than the requirement to test in clinic every time. These proposals are intended to facilitate the release of further places in the longer term.

It is important that London continues to work together collectively to support the trial and to ensure open access services is planned and delivered in a sustainable way. There is collective support across authorities for online HIV and STI testing to be introduced as an option for trial participants, which will both help reduce pressure on services and manage costs, assisting with the release of additional trial places.

The trial website will be updated to show the recruitment status of each London GUM clinic as additional places start to be released 

 

Valerie Solomon, Policy and Project Manager