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

Sullivan, Ann K; Saunders, John; Desai, Monica; Cartier, Andrea; Mitchell, Holly D; Jaffer, Sajjida; Ogaz, Dana; Chiavenna, Chiara; Charlett, Andre; Diamente, Victor; Golombek, Rainer; Manavi, Kaveh; Priestley, Cecilia; Waters, Laura J; Milinkovic, Ana; McOwan, Alan; Estcourt, Claudia; Sabin, Caroline A; Rodger, Alison; Gold, Deborah; Gazzard, Brian G; McCormack, Sheena; Gill, O Noel

doi:10.1016/s2352-3018(23)00256-4

Cited by 14 publications

(3 citation statements)

References 23 publications

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“…This finding is in line with other studies with less follow-up time [8,28]. The stable, high STI rates are comparable to those in contemporaneous studies ranging from 75 to 98 per 100PY [34,[37][38][39], although differences in methods could explain some of the variation between estimates. Post-exposure prophylaxis using doxycycline can effectively prevent bacterial STIs [40], and could, in the future, be considered for specific PrEP users.…”

Section: Plos Medicinesupporting

confidence: 89%

Sexual behaviour and incidence of sexually transmitted infections among men who have sex with men (MSM) using daily and event-driven pre-exposure prophylaxis (PrEP): Four-year follow-up of the Amsterdam PrEP (AMPrEP) demonstration project cohort

van den Elshout,

Wijstma,

Boyd

et al. 2024

PLoS Med

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Background An increasing number of countries are currently implementing or scaling-up HIV pre-exposure prophylaxis (PrEP) care. With the introduction of PrEP, there was apprehension that condom use would decline and sexually transmitted infections (STIs) would increase. To inform sexual health counselling and STI screening programmes, we aimed to study sexual behaviour and STI incidence among men who have sex with men (MSM) and transgender women who use long-term daily or event-driven PrEP. Methods and findings The Amsterdam PrEP demonstration project (AMPrEP) was a prospective, closed cohort study, providing oral daily PrEP and event-driven PrEP to MSM and transgender women from 2015 to 2020. Participants could choose their PrEP regimen and could switch at each three-monthly visit. STI testing occurred at and, upon request, in-between 3-monthly study visits. We assessed changes in numbers of sex partners and condomless anal sex (CAS) acts with casual partners over time using negative binomial regression, adjusted for age. We assessed HIV incidence and changes in incidence rates (IRs) of any STI (i.e., chlamydia, gonorrhoea, or infectious syphilis) and individual STIs over time using Poisson regression, adjusted for age and testing frequency. A total of 367 participants (365 MSM) commenced PrEP and were followed for a median 3.9 years (interquartile range [IQR] = 3.4–4.0). Median age was 40 years (IQR = 32–48), 315 participants (85.8%) self-declared ethnicity as white and 280 (76.3%) had a university or university of applied sciences degree. Overall median number of sex partners (past 3 months) was 13 (IQR = 6–26) and decreased per additional year on PrEP (adjusted rate ratio [aRR] = 0.86/year, 95% confidence interval [CI] = 0.83–0.88). Overall median number of CAS acts with casual partners (past 3 months) was 10 (IQR = 3–20.5) and also decreased (aRR = 0.92/year, 95% CI = 0.88–0.97). We diagnosed any STI in 1,092 consultations during 1,258 person years, resulting in an IR of 87/100 person years (95% CI = 82–92). IRs of any STI did not increase over time for daily PrEP or event-driven PrEP users. Two daily PrEP users, and no event-driven PrEP users, were diagnosed with HIV during their first year on PrEP. Study limitations include censoring follow-up due to COVID-19 measures and an underrepresentation of younger, non-white, practically educated, and transgender individuals. Conclusions In this prospective cohort with a comparatively long follow-up period of 4 years, we observed very low HIV incidence and decreases in the numbers of casual sex partners and CAS acts over time. Although the STI incidence was high, it did not increase over time. Trial registration The study was registered at the Netherlands Trial Register (NL5413) https://www.onderzoekmetmensen.nl/en/trial/22706

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Section: Plos Medicinesupporting

confidence: 89%

Sexual behaviour and incidence of sexually transmitted infections among men who have sex with men (MSM) using daily and event-driven pre-exposure prophylaxis (PrEP): Four-year follow-up of the Amsterdam PrEP (AMPrEP) demonstration project cohort

van den Elshout,

Wijstma,

Boyd

et al. 2024

PLoS Med

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“…3 4 Although overall the incidence and prevalence of STIs is high in people requesting and taking PrEP, there is significant heterogeneity among PrEP clients. 5 A global systematic review and meta-analysis found that 24% of individuals initiating PrEP were diagnosed with any of three curable STIs (ie, syphilis, chlamydia and/or gonorrhoea) and pooled STI incidence remained high during PrEP follow-up visits. 6 Similarly, high STI baseline prevalence was found among young African women (age 18-25) from three PrEP cohorts, with 29% of them diagnosed with chlamydia and 11% for gonorrhoea.…”

Section: Original Researchmentioning

confidence: 99%

Missed opportunities for guidance on sexually transmitted infection services: a global review of national HIV PrEP guidance

Spielman,

Mello,

Schaefer

et al. 2024

Sex Transm Infect

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ObjectivesPeople who use or would benefit from pre-exposure prophylaxis (PrEP) for HIV infection are disproportionately affected by sexually transmitted infections (STIs). Integrating STI services when offering PrEP fosters synergies and efficiencies in response to HIV/STI and promotes people-centred care. Including guidance on STI interventions for people on PrEP may facilitate implementation and uptake. We conducted a global review of national PrEP guidance documents and analysed the inclusion of recommendations for the provision of STI services by country level of income.MethodsWe searched national PrEP guidance documents published by WHO Member States through the WHO, the Joint United Nations Programme on HIV/AIDS (UNAIDS) databases, thePrEPWatchrepository and Google. Information on a range of STI-related interventions was extracted from documents available by October 2023.ResultsOf the 113 national PrEP guidance documents retrieved, STIs were mentioned in 77% (90/117). Viral hepatitis B testing and vaccination were recommended by most high-income countries (HICs) and low-income and middle-income countries (LMICs). Recommendation for syphilis testing was prominent in HICs (91%) and moderately noted in LMICs (68%). Gonorrhoea and chlamydia testing was recommended frequently in HICs (88%) and 42% in LMICs. However, the review noted that, to a much lesser extent, specific type of testing for these pathogens was mentioned. Recommendation for quarterly STI testing for syphilis, gonorrhoea and chlamydia was ubiquitous, while the need to offer STI partner services was rarely mentioned.ConclusionsPrEP services offer an opportunity for improved and expanded STI services, increasing person-centred care and addressing STI epidemics alongside HIV. Our review highlights the strengths and gaps in incorporating critical STI interventions into national PrEP normative guidance. Addressing these gaps through a stepwise approach and increasing targeted testing and partner services can help improve quality of care and support an effective response to HIV and other STIs.

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“…The announcement came as the landmark PrEP Impact Trial reported that HIV pre-exposure prophylaxis is highly effective at preventing HIV acquisition, leading to suggestions that it should be used more widely 2…”

Section: Prep Is Highly Effectivementioning

confidence: 99%

Opt-out HIV testing programme in England will be expanded to high prevalence areas

Mahase

2023

BMJ

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

Cited by 14 publications

References 23 publications

Sexual behaviour and incidence of sexually transmitted infections among men who have sex with men (MSM) using daily and event-driven pre-exposure prophylaxis (PrEP): Four-year follow-up of the Amsterdam PrEP (AMPrEP) demonstration project cohort

Sexual behaviour and incidence of sexually transmitted infections among men who have sex with men (MSM) using daily and event-driven pre-exposure prophylaxis (PrEP): Four-year follow-up of the Amsterdam PrEP (AMPrEP) demonstration project cohort

Missed opportunities for guidance on sexually transmitted infection services: a global review of national HIV PrEP guidance

Opt-out HIV testing programme in England will be expanded to high prevalence areas

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