An analysis of baseline data from the PROUD study: an open-label randomised trial of pre-exposure prophylaxis

Abstract

BackgroundPre-exposure prophylaxis (PrEP) has proven biological efficacy to reduce the sexual acquisition of the human immunodeficiency virus (HIV). The PROUD study found that PrEP conferred higher protection than in placebo-controlled trials, reducing HIV incidence by 86 % in a population with seven-fold higher HIV incidence than expected. We present the baseline characteristics of the PROUD study population and place the findings in the context of national sexual health clinic data.MethodsThe PROUD study was designed to explore the real-world effectiveness of PrEP (tenofovir-emtricitabine) by randomising HIV-negative gay and other men who have sex with men (GMSM) to receive open-label PrEP immediately or after a deferral period of 12 months. At enrolment, participants self-completed two baseline questionnaires collecting information on demographics, sexual behaviour and lifestyle in the last 30 and 90 days. These data were compared to data from HIV-negative GMSM attending sexual health clinics in 2013, collated by Public Health England using the genitourinary medicine clinic activity database (GUMCAD).ResultsThe median age of participants was 35 (IQR: 29–43). Typically participants were white (81 %), educated at a university level (61 %) and in full-time employment (72 %). Of all participants, 217 (40 %) were born outside the UK. A sexually transmitted infection (STI) was reported to have been diagnosed in the previous 12 months in 330/515 (64 %) and 473/544 (87 %) participants reported ever having being diagnosed with an STI. At enrolment, 47/280 (17 %) participants were diagnosed with an STI. Participants reported a median (IQR) of 10 (5–20) partners in the last 90 days, a median (IQR) of 2 (1–5) were condomless sex acts where the participant was receptive and 2 (1–6) were condomless where the participant was insertive. Post-exposure prophylaxis had been prescribed to 184 (34 %) participants in the past 12 months. The number of STI diagnoses was high compared to those reported in GUMCAD attendees.ConclusionsThe PROUD study population are at substantially higher risk of acquiring HIV infection sexually than the overall population of GMSM attending sexual health clinics in England. These findings contribute to explaining the extraordinary HIV incidence rate during follow-up and demonstrate that, despite broad eligibility criteria, the population interested in PrEP was highly selective.Trial registrationCurrent Controlled TrialsISRCTN94465371. Date of registration: 28 February 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1286-4) contains supplementary material, which is available to authorized users.

Men who have sex with men more often chose daily than event‐driven use of pre‐exposure prophylaxis: baseline analysis of a demonstration study in Amsterdam

“…The proportion with a bacterial STI (19.0%) at PrEP initiation corresponded to other PrEP cohorts (15.9% to 28.8%) . However, the prevalence of HCV infection was higher in our study , indicating that STI testing strategies should include HCV among HIV‐negative MSM initiating PrEP.…”

A qualitative study exploring the social and environmental context of recently acquired HIV infection among men who have sex with men in South-East England

“…Evidence is emerging of high levels of engagement in these behaviours [11][12][13] with almost one in three HIV-positive MSM participating in a UK-based HIV clinic survey and 44% of HIV-negative MSM enrolled in the PROUD PrEP study reporting chemsex in the previous year. 12 14 However, the specific role of chemsex or social media and sexual networking in the acquisition of HIV or other STIs is less clear.…”

BHIVA/BASHH guidelines on the use of HIV pre–exposure prophylaxis (PrEP) 2018

“…Chemsex is frequently reported in MSM who are at risk of HIV . In the PROUD study, at baseline, drugs commonly associated with drug use in a sexual context (mephedrone, GHB/GBL and methamphetamine) were used by 231/525 (44%) participants in the previous 3 months . Strategies to identify those at risk and to provide support and interventions should form part of PrEP consultation .…”

“…Participants in the PROUD and IPERGAY studies reported high levels of recreational drug use and, in particular, drugs associated with chemsex . Chemsex is associated with high‐risk sexual practices, including group sex, high partner numbers and condomless anal sex.…”