The successful integration of HIV prevention programs that increase testing and offer early treatment for infected individuals is contributing to reductions in new HIV infections. By 2016, the 5,164 HIV diagnoses in gay and bisexual men living in England represented an 18% decline compared to the 6,286 diagnosis in 2015. Secure integration of pre-exposure prophylaxis (PrEP) will continue to reduce infections. HIV prevention programs need to address persistent barriers and doubts however, including limited access of PrEP in England.
There is still no cure or vaccine for preventing HIV. Public Health England (PHE) reports that by combining prevention strategies such as condom use, HIV testing, prompt treatment, and PrEP, HIV transmission could be eliminated. However, access to PrEP in England has been an ongoing debate for the last several years and improved access is dependent upon sustained efforts from National Health Service England (NHS). From 2012-2014 PHE funded the Pre-exposure Option for Reducing HIV in the UK: Immediate or Deferred (PROUD) Trial and enrolled 544 participants in an open-label randomized trial at 13 sexual health clinics throughout England. Participants were assigned to receive PrEP either at enrollment (immediate) or after deferral of 1 year (deferred). Among those who received PrEP at enrollment, there were 3 HIV infections versus 20 in the deferred group. This evidence supports the addition of PrEP to the standard of prevention care for men who have sex with men (MSM) at risk for HIV. Despite these results, promoting PrEP continues to be controversial and those most at risk remain unable to access this prevention intervention in England. Scotland remains the only country in the UK that offers PrEP provision through their NHS. Wales has just started their PrEPared Wales Project.
NHS England has argued that it cannot legally commission PrEP because the responsibility to arrange services that prevent the spread of HIV lies with local authorities. However, the High Court ruled that NHS England does have the legal power to commission PrEP. As a result, the HIV PrEP Impact Trial began as a new HIV Prevention Program within PHE and NHS England. Starting in October 2017, the 3-year trial aimed to enroll a maximum of 10,000 participants who are interested in accessing PrEP. Almost 200 level 3 GUM (genitourinary medicine) clinics are involved in the trial. The goal of the Impact Trial is to address outstanding questions on PrEP need in England. To be eligible for the trial, participants must be 16 years or older, are HIV negative, are considered to be at high risk of HIV and are willing to adhere to the PrEP regimen. The trial focuses on: cis or transgender MSM, transgender women who are HIV negative and report sex without condoms in the past 3 months, HIV negative partners of an HIV positive person when the positive partner is not known to be virally suppressed and sex without condoms is anticipated, and heterosexual people at high risk.
As of January 2018, more than 3,200 participants have enrolled across England, but they have been experiencing barriers enrolling new participants. Will Nutland a professor at the London School of Hygiene and Tropical Medicine and founder of PrEPster states that placing enrollment caps at each clinic is making it very difficult for eligible people to enroll and access PrEP. For example, one of the most visited sexual clinics in London, the 56 Dean Street clinic in Soho, filled its allocation of 1,700 spots in just weeks. Another popular clinic, the Colchester Sexual Health clinic in East England, also filled its allocation quickly. There are still many PrEP trial sites with available spots, but the remaining clinics are not evenly distributed geographically. The distribution of clinics poses an issue for MSM in the region, who may have to travel a far distance to one of the few remaining clinics. For example, there are not sites in or around Cambridge recruiting MSM and sites are not open yet outside Birmingham (see map for details).
Clinics maxing out their PrEP allocation was an anticipated potential issue with a trial that has cap numbers. The Impact Trial was intended to ask questions about how PrEP could be rolled out in England and ultimately its goal was to ensure that those who want to access PrEP for HIV prevention are able to do so. Nutland hopes that the trial doesn’t end early because he believes the NHS will stop distributing PrEP altogether. It is clear however that PrEP is an effective prevention tools and substantial evidence for why it must be given a long-term sustainable home on the NHS England.