Objectives Pre-exposure prophylaxis (PrEP) is not commissioned within National Health Service (NHS) England. Individuals can access it privately online or by enrolment into a clinical trial. We established a list of individuals not enrolled in trials, awaiting PrEP. In response to the observation that patients awaiting PrEP trials were being referred with newly diagnosed HIV, we aimed to measure attendance, incident HIV, STI acquisition and missed opportunities for prevention.
Methods The search was conducted for patients on the list from November 2017 to November 2019. We examined the electronic clinical records of those on the list and extracted demographic information, STI and HIV diagnoses. In addition, for those diagnosed with HIV, we reviewed risk factors including chemsex and prior postexposure prophylaxis.
Results There were 1073 patients on list, and 520 (48.6%) were still awaiting recruitment in a PrEP trial. Eight (0.75%) had an enrolment appointment booked while 200 (18.64%) had been contacted and deemed ineligible according to PrEP trial criteria. 45 (32.15%) had not responded to contact. We identified 15 new HIV infections in patients awaiting PrEP. Of these, 9/15 (60.00%) did not meet eligibility criteria at point of contact, though had been eligible at first referral.
Conclusion It is unacceptable that 15 patients acquired HIV while waiting. The individual lifetime cost of treating HIV is estimated at £360 800(1). This equals £5 412 000 for these 15 infections notwithstanding the psychological and physical burden. We advocate the immediate role out of universal PrEP for those who need it on the NHS. While this decision is delayed, harm is coming to those waiting. Wider provision of PrEP may encourage increased attendance, but must consider additional resources to accommodate added visits. We are relieved that at the point of final submission (21 March 2020) NHS England have recently announced funding of PrEP for eligible patients from, further details are pending.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Pre-exposure prophylaxis (PrEP) is not funded within the National Health Service (NHS) in England. Individuals can access it privately online or by enrolment into clinical trials. Our genitourinary medicine and HIV service runs across five sites in a metropolitan city in North-West England. Since PrEP trials started recruiting from our research department, many service users requested access to it. To register this interest, the service established a list of individuals eligible at the point of contact, not already enrolled in trials, awaiting PrEP from November 2017 to the present day who were identified during routine clinical visits or who contacted the clinic independently.
Our designated research team work through the list sequentially and once at the top of the list patients are contacted for trial recruitment via a phone call and subsequent text message.
In response to the observation that patients awaiting PrEP trial recruitment were being referred with newly diagnosed HIV, we aimed to measure attendance, incident HIV, STI acquisition and missed opportunities for prevention in patients on PrEP trial waiting lists.
The list, held on an excel spreadsheet and maintained by the research team, was set up from November 2017 and eligible individuals were continuously added. It is a dynamic list and once individuals are recruited into a clinical PrEP trial, they were removed. If the attempt to contact the individual was unsuccessful or they were ineligible at the time of contact, they remained on the list. The search was conducted for patients remaining on the list from the time they were added to the date of analysis in November 2019.
We examined the electronic clinical records of those individuals on the PrEP waiting list and extracted demographic patient information, STI and HIV diagnoses.
In addition, for those diagnosed with HIV, we reviewed risk factors including chemsex and prior postexposure prophylaxis (PEP).
A descriptive statistical analysis was undertaken.
We identified 1073 patients on list, of whom 520 (48.6%) were still awaiting recruitment in a clinical PrEP trial. Of the remaining patients, only 8 (0.75%) had an enrolment appointment booked while 200 (18.64%) had been contacted and deemed ineligible, 345 (32.15%) had not responded to contact. Table 1 summarises the demographics and diagnoses identified.
We identified 15 new HIV infections in patients while awaiting PrEP after excluding nine patients with HIV diagnosed at the time of PrEP trial referral.
Risk factors: Chemsex was reported in 6/15 (40.00%) including a mixture of crystal meth, gamma hydroxybutyrate/gamma butyrolactone (GHB/GBL) and mephedrone (4/6 (66.67%) injected, 1/6 (16.67%) shared needles). Of these, 4 (66.67%) were referred to a chemsex clinic but only 1 (25.00%) attended. Prior PEP use was documented in five individuals. All 15 had received safer sex advice on multiple occasions. While all 15 had been made aware of online PrEP availability, only 2 (13.33%) individuals reported accessing it.
We found that 1/15 (6.67%) had not yet been contacted for recruitment at diagnosis and 5/15 (33.33%) had not responded to contact for recruitment. In those who had been successfully contacted, 9/15 (60.00%) did not meet eligibility at that time, though they had been eligible at first referral. Information outlining ineligibility at the point of contact was not recorded. Anecdotally, this was due to change in circumstances, for example, no unprotected anal intercourse (UPAI) in the past 3 months or denied they were likely to have unprotected sex (excluding oral sex) in the next 3 months, or their HIV positive partner had become undetectable and they were in a monogamous relationship.
All 24 patients diagnosed with HIV are engaged in care. Twenty-three have HIV viral load <200 copies/mL and one remains detectable having stopped treatment.
It is unacceptable that 15 patients acquired HIV awaiting PrEP. To our knowledge, we are the only service to have analysed data of this type. This is an underestimate for a number of reasons. First, individuals could have been diagnosed HIV positive at another clinic, via home-testing or voluntary sector testing without links to our service. A proportion of these patients may have subsequently become HIV positive and are still unaware of their infection. Second, when trial places were filled and ahead of the expansion of trial numbers, many clinicians stopped referring individuals to the waiting list but directed them to online resources. Finally, any individuals diagnosed at enrolment to a clinical trial were excluded from analysis.
Nine patients were deemed ineligible for PrEP at the point of recruitment, having been eligible at referral, demonstrating fluctuations in sexual risk taking. Enrolment criteria of PrEP trials suggesting ineligibility without UPAI within 3 months (or confirm a likelihood that they will in the next 3 months) are inappropriate and ignore the unpredictability of sexual intercourse, variation in behaviour and other prior risk-factors. BHIVA/BASHH guidance recommends offering PrEP if there has been (and ongoing) UPAI in the previous 6 months.1 PrEP trial recruitment also offers ‘other high-risk activity’ as an eligibility criterion; however, involvement of patients in chemsex and recent STI acquisition can also fluctuate depending on periods of changing sexual activity and it is often a difficult judgement call when waiting lists are oversubscribed compared with available places.
Five out of the nine ‘ineligible’ patients used chemsex while on the waiting list (including injecting and sharing needles). One PrEP trial outlines a ‘participant population’ category “HIV negative persons who: are considered to be at similar high risk of HIV acquisition as those with a serodiscordant partner who is not known to be virally suppressed’ 2. Arguably some individuals diagnosed in our service could fall into this latter category, for example, with use of chemsex, but it is open to interpretation. Furthermore, sexual health services are often stretched to breaking point.3 It is beyond the scope of those managing waiting lists to establish this detail for every potential participant at screening. If PrEP was prescribed routinely the clinician could make a real time assessment and prescribe PrEP at the point of identified need.
PrEP is freely available in other European countries, such as France.4 It is extraordinary that a drug has remained in a clinical trial years after European approval. The cost of generic PrEP is low5 relative to the cost of caring for someone infected with HIV for life which is currently estimated at £360 800.6 This equals £5 412 000 for these 15 infections notwithstanding psychological and physical burdens. If PrEP had been funded more widely, these infections could have been preventable. Reassuringly, all 24 patients diagnosed with HIV are engaged in care and those on treatment are undetectable. Their attendance to access PrEP may have expedited their diagnosis.
All patients diagnosed with HIV were repeatedly given safer sex advice and directed towards online resources, yet only two accessed it. The reasons behind this are unknown and likely multifactorial including financial constraints; however, patients are made aware of PrEP hardship funds if suitable. A recent survey of PrEP users found that those accessing PrEP online compared with those enrolled into the PrEP trials were significantly less likely to have had an HIV test in the past 3 months: 71% vs 86%, respectively (and 58% vs 79% for those who had tested three or more times in the past year).7
In response to our findings, we have made several changes. First, we inform individuals that people are acquiring HIV on the waiting list and urgently direct them to online resources. We are introducing 3-monthly texts to recommend screening and prospectively refer to voluntary sector initiatives for high-risk individuals. We are developing novel models of care using online protocols to streamline follow-up aiming to reduce pressure on clinics. We are reviewing our PrEP trial recruitment procedures, considering additional risk factors, for example, ‘recently’ injecting chems when contacting patients for enrolment. This adds additional burden and risks a trial place being given to one individual at the expense of another with higher risk of HIV acquisition.
Enrolment into a clinical trial is necessarily more onerous than prescribing medication as routine practice and is limited to clinicians who are specifically trained in ‘Good Clinical Practice’,8 and for nurses, requires extra training on consent We are relieved that at the point of final submission (21 March 2020), NHS England have recently announced funding of PrEP for eligible patients; further details are pending. Previous increases in the number of funded places as part of the PrEP IMPACT trial have not come with added resources for enrolment and follow-up.9
Our findings support the immediate role out of universal PrEP for those who need it on the NHS. The wider provision of PrEP may encourage increased attendance but must consider additional resources to accommodate added visits.
Handling editor Jason J Ong
Contributors This paper was conceived by SJ, CW and OM. All authors contributed to data collection. SJ wrote the first draft of the article, with further contributions from CS, SYT, CW and OM. MR conducted the data searches and SJ conducted the descriptive analysis. All authors provided intellectual content, reviewed successive drafts and approved the final version of the article.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.