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Multicenter Study
. 2023 Dec;10(12):e790-e806.
doi: 10.1016/S2352-3018(23)00256-4.

HIV pre-exposure prophylaxis and its implementation in the PrEP Impact Trial in England: a pragmatic health technology assessment

Ann K Sullivan  1 , John Saunders  2 , Monica Desai  3 , Andrea Cartier  4 , Holly D Mitchell  3 , Sajjida Jaffer  4 , Dana Ogaz  3 , Chiara Chiavenna  3 , Andre Charlett  3 , Victor Diamente  4 , Rainer Golombek  4 , Kaveh Manavi  5 , Cecilia Priestley  6 , Laura J Waters  7 , Ana Milinkovic  4 , Alan McOwan  4 , Claudia Estcourt  8 , Caroline A Sabin  9 , Alison Rodger  10 , Deborah Gold  11 , Brian G Gazzard  4 , Sheena McCormack  12 , O Noel Gill  3 ; Impact Study Group
Affiliations
Multicenter Study

HIV pre-exposure prophylaxis and its implementation in the PrEP Impact Trial in England: a pragmatic health technology assessment

Ann K Sullivan et al. Lancet HIV. 2023 Dec.

Abstract

Background: HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV acquisition. To enable routine commissioning of PrEP in England, we aimed to establish population need, duration of need, PrEP uptake, and duration of use in attendees of sexual health services (SHS) in England.

Methods: The Impact Trial was a prospective, open-label, single-arm, multicentre trial conducted at 157 SHS across England between Oct 13, 2017, and July 12, 2020. Clinicians assessed HIV-negative attendees for their risk of HIV acquisition to identify those who were eligible to participate and receive either daily or event-based oral PrEP (tenofovir disoproxil maleate with emtricitabine), as appropriate. Eligible participants were aged 16 years or older, considered HIV-negative on the day of enrolment, and willing to adhere to the trial procedures. Non-trial attendees are mutually exclusive of trial participants and included SHS attendees who were not recruited to the Impact Trial at any point. They include HIV-negative individuals aged 16 years or older who attended a participating SHS at least once after recruitment at that SHS had begun and before Feb 29, 2020. The main outcomes assessed were PrEP need, uptake, and use, and HIV and sexually transmitted infection (STI) incidence. Data are presented up to Feb 29, 2020, before the introduction of COVID-19 control measures. The study is registered with ClinicalTrials.gov, NCT03253757.

Findings: In this analysis, we include 21 356 of 24 268 participants enrolled before Feb 29, 2020. 20 403 participants (95·5%) were men who have sex with men (MSM). Uptake of PrEP among SHS attendees clinically assessed and coded as eligible was 21 292 (57·1%) of 37 289. 18 400 trial participants had at least one post-enrolment visit and a median of 361 days of follow-up (IQR 143-638); 14 039 (75·9%) of these had enough PrEP prescribed to provide protection for 75% of their follow-up time. Among MSM, HIV incidence was 0·13 (95% CI 0·08-0·19) per 100 person-years in trial participants (27 seroconversions) and 0·95 (95% CI 0·88-1·03) per 100 person-years in non-trial attendees (587 seroconversions; proportionate reduction of 86·8%, 95% CI 80·2-91·6). 18 607 bacterial STIs were recorded (incidence 68·1 per 100 person-years in trial participants who were MSM). 4343 (24·4%) MSM participants were diagnosed with two or more STIs, accounting for 14 800 (79·5%) of all 18 607 diagnoses.

Interpretation: PrEP need was higher than initially estimated by an expert stakeholder group. The high proportion of follow-up time protected by PrEP suggests that the need for protection persisted throughout trial participation for most participants. HIV incidence among MSM trial participants was low. The large unmet need for PrEP suggests that greater provision is required to maximise the potential of a national programme. The high incidence of bacterial STIs among participants, concentrated within a subgroup of PrEP users, presents an opportunity for tailored STI control measures.

Funding: NHS England.

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Conflict of interest statement

Declaration of interests The salaries of AKS, JS, BGG, ACh, ACa, SJ, VD, RG, CC, DO, HDM, and ONG were partly funded through the trial by National Health Service (NHS) England and managed by the National Institute for Health Research (NIHR; NIHR17/47/01). MD received payment directly from trial funding (NIHR17/47/01). CE reports payment for travel expenses to attend research meetings (reimbursed), being a trustee of the British Association of Sexual Health & HIV (BASHH), and chairing the Trial Steering Committee. SMcC was supported by a Medical Research Council grant (MC_UU_00004/03), and received payment to institution from the trial (NIHR17/47/01) and institutional grants from NIHR, EU (Horizon 2020), and EDCTP 2, as well as participating on the data safety and monitoring board of the Magee Women's Research Institute. AR reports receiving a speaker fee from Gilead Sciences in February, 2020. CAS reports payment or honoraria for preparation of educational materials for Gilead Sciences, ViiV Healthcare, and Janssen-Cilag, as well as being a member of an Advisory Board for ViiV Healthcare and Janssen-Cilag. LJW reports payment or honoraria for speaking or advisory fees from Gilead, ViiV, Janssen, MSD, and Theratech. DG reports support from the Elton John AIDS Foundation and MAC AIDS Fund. AM, KM, CP, and AMcO declare no competing interests.

Figures

Figure 1
Figure 1. Participant flow chart
PrEP=pre-exposure prophylaxis. SHS=sexual health services.
Figure 2
Figure 2. HIV incidence in MSM
MSM=men who have sex with men.
See this image and copyright information in PMC

Comment in

References

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