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Background:The scale of the 2022 global mpox (formerly known as monkeypox) outbreak has been unprecedented. In less than 6 months, non-endemic countries have reported more than 67 000 cases of a disease that had previously been rare outside of Africa. Mortality has been reported as rare but hospital admission has been relatively common. We aimed to describe the clinical and laboratory characteristics and outcomes of individuals admitted to hospital with mpox and associated complications, including tecovirimat recipients. Methods:In this cohort study, we undertook retrospective review of electronic clinical records and pathology data for all individuals admitted between May 6, and Aug 3, 2022, to 16 hospitals from the Specialist and High Consequence Infectious Diseases Network for Monkeypox. The hospitals were located in ten cities in England and Northern Ireland. Inclusion criteria were clinical signs consistent with mpox and MPXV DNA detected from at least one clinical sample by PCR testing. Patients admitted solely for isolation purposes were excluded from the study. Key outcomes included admission indication, complications (including pain, secondary infection, and mortality) and use of antibiotic and anti-viral treatments. Routine biochemistry, haematology, microbiology, and virology data were also collected. Outcomes were assessed in all patients with available data. Findings:156 individuals were admitted to hospital with complicated mpox during the study period. 153 (98%) were male and three (2%) were female, with a median age of 35 years (IQR 30–44). Gender data were collected from electronic patient records, which encompassed full formal review of clincian notes. The prespecified options for data collection for gender were male, female, trans, non-binary, or unknown. 105 (71%) of 148 participants with available ethnicity data were of White ethnicity and 47 (30%) of 155 were living with HIV with a median CD4 count of 510 cells per mm3(IQR 349–828). Rectal or perianal pain (including proctitis) was the most common indication for hospital admission (44 [28%] of 156). Severe pain was reported in 89 (57%) of 156, and secondary bacterial infection in 82 (58%) of 142 individuals with available data. Median admission duration was 5 days (IQR 2–9). Ten individuals required surgery and two cases of encephalitis were reported. 38 (24%) of the 156 individuals received tecovirimat with early cessation in four cases (two owing to hepatic transaminitis, one to rapid treatment response, and one to patient choice). No deaths occurred during the study period. Interpretation:Although life-threatening mpox appears rare in hospitalised populations during the current outbreak, severe mpox and associated complications can occur in immunocompetent individuals. Analgesia and management of superimposed bacterial infection are priorities for patients admitted to hospital.

Outbreaks of bacterial enteric pathogens (BEPs) in men who have sex with men (MSM) associated with antimicrobial resistance are a public health concern. We investigated the prevalence and risk factors of BEPs in MSM to inform infection control.We conducted a cross-sectional study at a London sexual health clinic between 20/12/2017 and 06/02/2018. Residual rectal swabs from MSM attending for sexually transmitted infection (STI) testing were anonymously tested for a range of BEPs using real-time PCR. A sub-set of samples were tested for the mphA gene (a marker of azithromycin resistance). Results were linked to electronic health records.BEPs were detected in 207 of 2116 participants, giving an overall prevalence of 9.8% (95% CI 8.5%-11.1%) ranging from 0.8% (0.4%-1.2%) for Shigella to 4.9% (4.0%-5.9%) for Enteroaggregative E. coli. MSM with BEPs were more likely to have a history of bacterial STIs (p = 0.010), to report more sexual partners (p0.001), and among HIV-negative MSM, to report current HIV pre-exposure prophylaxis use (p0.001). Gastrointestinal symptoms were rare (1.7%) and not associated with BEPs. 41.3% of MSM with BEPs and 14.1% of those without BEPs carried mphA (p0.001). Among the former, this was associated with a history of bacterial STIs (51.5% vs 31.1%, p = 0.003).One in ten MSM had a BEP detected and most did not report symptoms. MphA carriage was common, particularly among those with BEPs. Bacterial STI treatment might contribute to selection of resistant gut organisms, emphasising the need for better antimicrobial stewardship.

We describe 2 cases of infectious proctitis secondary to human monkeypox in patients presenting with rectal pain. These cases highlight the importance of multidisciplinary management of monkeypox and in expanding case definitions and enabling clinical recognition in patients presenting without skin rash.

In January 2021, 56 Dean Street, a London sexual health clinic, changed clinic policy so that all those attending for post-exposure prophylaxis (PEP) were offered quick-start opt-out pre-exposure prophylaxis (PrEP) following completion of the 28-day PEP course. We assessed the uptake of this quick-start PrEP in service users attending for PEP.We undertook a case note review of those who received PEP during the 2-week period from 17 February to 1 March 2021, assessing the data and comparing them to those from the same period in 2020 (15 February-28 February 2020) before quick-start opt-out PrEP was introduced.The number of service users receiving PEP was 82 in 2020 and 42 in 2021, of which an unmet PrEP need was demonstrated in 81.7% (67/82) in 2020 and 78.6% (33/42) in 2021 (p = 0.8106). Of those with an unmet need, a higher proportion (97.0% [32/33]) were offered PrEP in 2021 following the introduction of opt-out PrEP compared with the 85.1% (57/67) in 2020 (p = 0.0953). Of those eligible for PrEP who were offered it during their PEP consultation, 53.1% (17/32) in 2021 were dispensed PrEP compared with 17.5% (10/57) in 2020 (p = 0.0007).Since the introduction of quick-start opt-out PrEP, uptake in eligible candidates increased from 17.5% to 53.1%. This suggests that this strategy was acceptable to service users.

IntroductionHIV-1 pre-exposure prophylaxis (PrEP) has been available in England since March 2020 on the National Health Service using generic emtricitabine and tenofovir disoproxil. 56 Dean Street (56DS) provided PrEP through (1) additional private care from September 2015, estimated to be providing 11% of England’s PrEP in 2019; and (2) the IMPACT trial, as well as monitoring those self-sourcing PrEP. Providing PrEP at scale through a nurse-led service required a safety net for complex individuals. 56DS introduced a consultant-led PrEP outpatient service, the PrEP review clinic, in January 2018 and we report the outcomes of this service.MethodsWe present a retrospective case note review of the PrEP review clinic with descriptive outcomes from 26 January 2018 to 20 December 2019. Reason for referral, demographics, PrEP management and PrEP discontinuations were recorded.Results13 980 unique users accessed PrEP from 56DS during the two year evaluation period. 220 individuals were seen in the PrEP review clinic. Majority of patients were referred for renal issues (114 of 220, 51.8%), followed by side effects (59 of 220, 26.8%) and comorbidities (38 of 220, 17.2%). Of those with renal issues, 89 (out of 114, 78.1%) users were referred for an abnormal estimated glomerular filtration rate (eGFR). 35 (out of 114, 30.7%) PrEP users had an eGFR between 45 and 59 mL/min/1.73 m2, of whom 2 (5.7%) discontinued PrEP. Majority of users were advised to stop supplements±switch to event-based dosing (24 of 35, 68.6%). Ten PrEP users were referred with an eGFR between 30 and 44 mL/min/1.73 m2; 4 (40%) stopped or did not start PrEP and 6 (60%) were asked to stop supplements±switch to event-based dosing.DiscussionA small proportion of PrEP users have complex PrEP issues. Methods to manage renal dysfunction with PrEP included stopping supplements and switching to event-based dosing. Those with side effects were managed with an array of options, with only modest effectiveness. Other PrEP options are needed to support those with toxicities or intolerances.

Preexposure prophylaxis (PrEP) is contributing to achieve a reduction in HIV diagnoses in men having sex with men (MSM). Albeit infrequent, HIV infections in the context of recent PrEP exposure represent a clinical challenge.Data on recent PrEP use and possible reasons leading to HIV infection were analysed in individuals newly diagnosed with HIV at 56 Dean Street clinic in 2016-2020. Demographics, immune-virological parameters, genotypic resistance test results and treatment management in this group were compared with those not reporting recent PrEP exposure using Mann-Whitney U test and Fisher's exact test.Fifty-two of 1030 (5%) individuals reported recent PrEP exposure at HIV diagnosis; 98% were MSM, median age 34 years (interquartile range [IQR] 28-42), 65% of white ethnicity, 65% non-UK-born. 35% reported PrEP intake the day before testing HIV positive, 46% reported sub-optimal PrEP adherence since their last negative HIV test result. Thirty-three of 52 (63%) were self-sourcing PrEP and 9/52 (17%) reported issues with its supply. Recent PrEP use was associated to lower HIV viral load and higher CD4+ cell count at baseline than in counterparts non-recently exposed to PrEP (P 0.01). M184V mutation was harboured more commonly in the recent PrEP use group (30% vs. 1%, P 0.01). The proportion of individuals recently exposed to PrEP among those diagnosed with HIV rose sharply, reaching 21% in the first semester of 2020. Viral suppression was achieved by all patients intensified from PrEP to antiretroviral treatment (ART) who remained in care at week 24.Rapid PrEP intensification to ART allowed to achieve high rates of HIV viral suppression despite significant rates of M184V mutation harboured in those newly diagnosed with HIV and reporting recent PrEP exposure.

Mpox has disproportionately affected people with HIV (PWH) since its global spread and preliminary data suggest a higher burden of complications and worse outcomes in this group. Little is known on the impact generated by managing mpox in sexual health clinic and HIV outpatients’ services and how PWH are affected by complications.

Digital media has a global reach that includes increasingly marginalised and vulnerable communities. Engaging, empowering media paired with key health messaging can provide education in more effective ways, build trust and bring communities together. An HIV testing and study recruitment film was co-created with a multidisciplinary team of HIV/sexual health physicians, medical and social science researchers from Bali, Jakarta and London, as well as members of the community and commercial film and media creatives. This short film provides a novel and innovative approach to recruit to a social science study and encourage HIV testing among men who have sex with men in Indonesia. This study aims to inform a digital HIV risk reduction tool for a community affected by increasing marginalisation and a fast-growing HIV epidemic.

Summary Background In DISCOVER, a multinational, randomised controlled trial, emtricitabine and tenofovir alafenamide compared with emtricitabine and tenofovir disoproxil fumarate showed non-inferior efficacy for HIV prevention and improved bone mineral density and renal safety biomarkers at week 48. We report outcomes analysed after all participants had completed 96 weeks of follow-up. Methods This study is an ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial done at 94 community, public health, and hospital-associated clinics located in Europe and North America. Adult cisgender men and transgender women who have sex with men, both with a high risk of acquiring HIV as determined by self-reported sexual behaviour or recent sexually transmitted infections, were randomly assigned (1:1) to receive either emtricitabine and tenofovir alafenamide (200/25 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir alafenamide group), or emtricitabine and tenofovir disoproxil fumarate (200/300 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir disoproxil fumarate group). The primary efficacy outcome was incident HIV infection. Incidence of HIV-1 infection per 100 person-years was assessed when the last participant had completed 96 weeks of follow-up. This trial is registered with ClinicalTrials.gov , number NCT02842086 . Findings Between Sept 13, 2016, and June 30, 2017, 5387 participants were randomly assigned to receive emtricitabine and tenofovir alafenamide (n=2694) or emtricitabine and tenofovir disoproxil fumarate (n=2693), contributing 10 081 person-years of follow-up. At 96 weeks of follow-up, there were eight HIV infections in participants who had received emtricitabine and tenofovir alafenamide (0·16 infections per 100 person-years [95% CI 0·07–0·31]) and 15 in participants who had received emtricitabine and tenofovir disoproxil fumarate (0·30 infections per 100 person-years [0·17–0·49]). Emtricitabine and tenofovir alafenamide maintained its non-inferiority to emtricitabine and tenofovir disoproxil fumarate for HIV prevention (IRR 0·54 [95% CI 0·23–1·26]). Approximately 78–82% of participants reported taking study medication more than 95% of the time across all study visits. Rates of sexually transmitted infections remained high and similar across groups (21 cases per 100 person-years for rectal gonorrhoea and 28 cases per 100 person-years for rectal chlamydia). Emtricitabine and tenofovir alafenamide continued to show superiority over emtricitabine and tenofovir disoproxil fumarate in all but one of the six prespecified bone mineral density and renal biomarkers. There was more weight gain among participants who had received emtricitabine and tenofovir alafenamide (median weight gain 1·7 kg vs 0·5 kg, p Interpretation Emtricitabine and tenofovir alafenamide is safe and effective for longer-term pre-exposure prophylaxis in cisgender men and transgender women who have sex with men. Funding Gilead Sciences.

BackgroundPrimary syphilis is characterised by the appearance of an ulcerated lesion (chancre) on the anogenital or oral mucosa from which Treponema pallidum DNA may be detectable by PCR. Serological tests for syphilis may be non-reactive in early infection, even after the appearance of a chancre. We reviewed the use of a multiplex-PCR (M-PCR) test to determine the added value of T. pallidum DNA detection in the management of individuals presenting with mucocutaneous ulceration at a sexual health service in central London.MethodsWe performed a cross-sectional analysis of all individuals with detectable T. pallidum DNA from September 2019 to April 2020. Electronic patient records were reviewed and concomitant results for treponemal serology and/or rapid plasma reagin (RPR) extracted, along with demographic data, history of syphilis and indices of sexual behaviour including number of sexual partners contacted. Any subsequent treponemal serology and RPR results were also reviewed.ResultsM-PCR swab specimens were performed in 450 individuals, of whom 63 (14%) had detectable T. pallidum DNA; 60 of 63 (95%) were gay or bisexual men and 11 of 63 (17%) were living with HIV. A history of treated syphilis was present in 17 of 63 (27%). Same-day treponemal serology/RPR testing was performed in 58 of 63 (92%) patients. Of the 58 who had same-day syphilis serology/RPR, 9 (16%) had their syphilis infection confirmed by treponemal DNA PCR alone. A total of 165 partners were traced as contacts of infection, of whom 25 (15%) were contacts of individuals diagnosed by M-PCR testing alone.ConclusionIn individuals with T. pallidum PCR-positive lesions, around one in six in our cohort were negative on standard diagnostic serological tests for syphilis. Treponemal DNA testing is an important addition to serological assays in individuals with mucocutaneous ulceration who are at risk of recent syphilis infection and facilitates early diagnosis and contact tracing.

ObjectivesThe COVID-19 pandemic and its related restrictions have affected attendance to and delivery of UK sexual healthcare services (SHS). We surveyed the impact on sexual behaviour of men having sex with men (MSM) to inform future SHS provision.MethodsWe conducted a cross-sectional, anonymous, web-based survey among HIV-negative MSM at high risk of HIV infection who attended 56 Dean Street, a sexual health and HIV clinic. The survey was conducted over a 7-day period in August 2020. Data on sociodemographic characteristics, sexual behaviour and related mental well-being experienced during lockdown (defined as 23 March–30 June 2020) were extracted. Categorical and non-categorical variables were compared according to HIV pre-exposure prophylaxis (PrEP) use.Results814 MSM completed the questionnaire: 75% were PrEP users; 76% reported they have been sexually active, of which 76% reported sex outside their household. 75% reported fewer partners than prior to lockdown. Isolation/loneliness (48%) and anxiety/stress (27%) triggered sexual activity, and 73% had discussed COVID-19 transmission risks with their sexual partners. While 46% reported no change to emotions ordinarily experienced following sex, 20% reported guilt for breaching COVID-19 restrictions. 76% implemented one or more changes to their sexual behaviour, while 58% applied one or more steps to reduce COVID-19 transmission during sex. 36% accessed SHS and 30% reported difficulties in accessing testing/treatment. Of those who accessed SHS, 28% reported an STI diagnosis. PrEP users reported higher partner number, engagement in ‘chemsex’ and use of SHS than non-PrEP users.ConclusionsCOVID-19 restrictions had a considerable impact on sexual behaviour and mental well-being in our survey respondents. High rates of sexual activity and STI diagnoses were reported during lockdown. Changes to SHS provision for MSM must respond to high rates of psychological and STI-related morbidity and the challenges faced by this population in accessing services.

A fourth-generation HIV test is conventionally performed at baseline for individuals given HIV post-exposure prophylaxis (PEP). However, early HIV infection may be missed by fourth-generation tests especially in settings of high HIV incidence, meaning that recently infected individuals are potentially at risk of transmitting HIV. In 2013, HIV incidence in PEP recipients at the 56 Dean Street clinic was 7.6 per 100 person-years. We therefore wished to see if using a point-of-care PCR HIV test in such individuals would shorten the testing window period and pick up early infections that would be undiagnosed by conventional tests. We compared HIV detection in PEP recipients using the Cepheid GeneXpert® HIV-1 Qual viral load (Qual VL) assay with the standard HIV tests used in our clinical service. Between March 2017 and August 2018, a Qual VL assay was performed in addition to standard baseline HIV tests in consented PEP recipients. Of 494 consented PEP recipients, 476 had valid Qual VL assay results. Of these, 474 (99.6%) had a negative Qual VL result and were also negative on standard baseline HIV tests. Two (0.4%) tested positive for HIV on Qual VL. One of these patients was also HIV-positive on all baseline HIV tests. The other had discordant baseline point-of-care HIV test results. Although no additional HIV infections were diagnosed in PEP recipients using Qual VL, in one individual, it provided confirmation of new HIV infection more quickly than the standard HIV testing pathway.

Introduction: Chemsex in a European context is the use of any of the following drugs to facilitate sex: crystal methamphetamine, mephedrone and gamma-hydroxybutyrate (GHB)/gamma-butyrolactone (GBL) and, to a lesser extent, cocaine and ketamine. This study describes the prevalence of self-reported recreational drug use and chemsex in HIV-positive men who have sex with men (MSM) accessing HIV services in four countries. It also examines the problematic impacts and harms of chemsex and access to chemsex-related services. Methods: This is a cross-sectional multi-centre questionnaire study of HIV-positive MSM accessing nine HIV services in the UK, Spain, Greece and Italy. Results: In all, 1589 HIV-positive MSM attending HIV services in four countries completed the questionnaire. The median age of participants was 38 years (interquartile range: 32���46 years) and 1525 (96.0%) were taking antiretroviral therapy (ART). In the previous 12 months, 709 (44.6%) had used recreational drugs, 382 (24.0%) reported chemsex and 104 (6.5%) reported injection of chemsex-associated drugs (���slamsex���). Of the 382 engaging in chemsex, 155 (40.6%) reported unwanted side effects as a result of chemsex and 81 (21.2%) as a result of withdrawal from chemsex. The reported negative impacts from chemsex were on work (25.1%, 96), friends/family (24.3%, 93) and relationships (28.3%, 108). Fifty-seven (14.9%) accessed chemsex-related services in the past year, 38 of whom (67%) felt the service met their needs. Discussion: A quarter of participants self-reported chemsex in the past 12 months. There were high rates of harms from chemsex across all countries, including negative impacts on work, friends/family and relationships. Although a minority of those engaging in chemsex accessed support, most found this useful.

The 56 Dean Street combination prevention model, a strong engagement with the LGBTQI community and flexible services adapted to users' changing needs led to an 80% drop in HIV diagnoses in gay, bisexual and other men who have sex with men (GBMSM) from 2015 to 2017. We describe the service changes at 56 Dean Street since 2012 which resulted in an increase in the frequency of HIV testing, the introduction of pre-exposure prophylaxis, earlier HIV diagnosis and a shorter time to viral suppression in those living with HIV. This model could be adapted to deliver similar results in those settings of high HIV prevalence among GBMSM and where access to technological innovation in healthcare and engagement with the community can be achieved.

Background: In DISCOVER, a multinational randomized controlled trial, emtricitabine and tenofovir alafenamide compared with emtricitabine and tenofovir disoproxil fumarate demonstrated noninferior efficacy for HIV prevention and improved bone mineral density and renal safety biomarkers at week 48. Here, we report outcomes analysed after all participants had completed 96 weeks of follow up. Methods: Adult cisgender men and transgender women who have sex with men with a high risk of acquiring HIV were randomly assigned (1:1) to either of two study arms. This trial is registered with ClinicalTrials.gov, NCT02842086. Findings: 5,387 participants were randomly assigned to receive emtricitabine and tenofovir alafenamide (n=2,694) or emtricitabine and tenofovir disoproxil fumarate (n=2,693), contributing 10,081 person-years (PY) of follow-up. There were eight HIV infections in emtricitabine and tenofovir alafenamide users (0·16 infections/100 PY [95% CI 0·07–0·31]), and 15 in emtricitabine and tenofovir disoproxil fumarate users (0·30 infections/100 PY [0·17–0·49]). Emtricitabine and tenofovir alafenamide was noninferior to emtricitabine and tenofovir disoproxil fumarate for HIV prevention, as the upper limit of the 95% CI of the infection rate ratio (IRR) was less than the prespecified noninferiority margin of 1·62 (IRR 0·54 [95% CI 0·23–1·26]). Approximately 78% to 82% of participants reported taking study medication more than 95% of the time across all study visits. Rates of sexually transmitted infections remained high and similar across arms (21 per 100 PYs for rectal gonorrhea and 28 per 100 PY for rectal chlamydia). Emtricitabine and tenofovir alafenamide continued to demonstrate superiority over emtricitabine and tenofovir disoproxil fumarate in all six prespecified bone mineral density and renal biomarkers. There was more weight gain among emtricitabine and tenofovir alafenamide users (median weight gain 1·7 kg vs. 0·5 kg, p

ObjectivesPenicillin-based antibiotic treatment for syphilis infection with CNS involvement (early neurosyphilis) is not always a suitable treatment option. We compared outcomes of patients diagnosed with early neurosyphilis and treated with doxycycline or procaine G penicillin.MethodsSerological and clinical outcomes were analysed in patients diagnosed with early neurosyphilis between January 2015 and October 2019 at 56 Dean Street, a combined sexual health and HIV service based in London, UK. Acute onset of CNS, ocular and/or otic symptomatology and a documented seroconverting syphilis serology or a >4-fold increase in rapid plasma reagin (‘RPR)’ test titre within the previous 12 months were criteria used to define a case. Mann–Whitney U-test and χ2 tests were used to test distributions between baseline characteristics and outcomes according to treatment administered.ResultsEighty-seven patients were included: median age = 35 years (IQR = 31–45), 98% MSM, 79% white ethnicity, 53% HIV-1 positive and 40% previously diagnosed with syphilis at any stage. They were treated exclusively with either intramuscular (IM) procaine G penicillin (71%) or oral doxycycline (18%). Patients received doxycycline treatment over a penicillin-based regimen due to IM treatment declined (31%), inability to attend for IM injections (31%) or penicillin allergy (19%). Serological response was achieved by all patients; 91% reported full symptom resolution at 30 days from end of treatment. Similar rates of clinical and serological response and seroreversion were observed in the groups treated with procaine G penicillin versus doxycycline.ConclusionsThe clinical and serological outcomes seen with penicillin-based versus doxycycline treatments were similar. A randomized controlled trial is needed to establish the effectiveness of doxycycline in the treatment of early neurosyphilis.

The role of condomless anal intercourse (CAI) as a driver for the epidemic of hepatitis C in MSM is still debated. Timely access to direct-acting antivirals (DAA) could represent an essential strategy to tackle this. Case notes of MSM diagnosed with acute hepatitis C (AHC) between July 2016 and June 2017 in a sexual health clinic in London were included. Behavioural data on sexual practices and STI monitoring in the 6 months prior to AHC diagnosis were collected. DAA routes of access and timing from AHC diagnosis to start of treatment were analysed. A total of 60 individuals were enrolled (median age 39 years, IQR = 33-46, 62% HIV co-infected, 72% genotype 1a). CAI was reported by 97%, drug use prior to or during sex by 73%; 46% was diagnosed with a rectal STI and 29% with syphilis. About 37% did not report any HCV risk factors other than condomless anal sex. About 36% had a new rectal STI in the 6 months following AHC. About 82% accessed DAA treatment and median time from AHC to DAA start was 278 days for those following the NHS standard of care route, 132 days for those accessing DAA via participation in trials and 114 for those who had self-sourced DAA online (P

It is unclear how the COVID-19 pandemic has affected sexual behaviour and the transmission of STIs. Reports suggest a decline in STIs during the first COVID-19 lockdown attributed variously to fewer sexual encounters1 and decreased testing or case reporting.2 However, in some settings, diagnoses of symptomatic STIs appeared to remain unchanged.3 Neisseria gonorrhoeae (NG) infection of the male urethra causes symptoms in >90% of individuals but is mostly asymptomatic at other sites. As symptoms usually present within 5 days of exposure and unpleasant enough to seek assistance, urethral NG is a potential marker of recent sexual behaviour.4 First-line NG treatment is a single-dose ceftriaxone injection administered at medical services, whereas other STIs are standardly treated using oral antibiotics which can be sent by post or purchased online. On 23 March 2020, following instructions to avoid unnecessary travel and non-essential contact with others, the UK government introduced measures to reduce the transmission of SARS-CoV-2 including home isolation and social distancing, although individuals could travel for medical care. From 13 May 2020, England’s lockdown gradually eased. In 2018, 56 Dean Street (56DS), a sexual health clinic part of Chelsea and Westminster Hospital, …

Objectives The National Health Service in England (NHS England) does not provide pre-exposure prophylaxis (PrEP) against HIV, forcing people to purchase generic versions on the internet. However, there are concerns about the authenticity of medicines purchased online. We established an innovative service offering plasma tenofovir (TFV) and emcitrabine (FTC) therapeutic drug monitoring for people buying generic PrEP online, to ensure that drug concentrations in vivo were consistent with those of propriety brands and previously published data. Methods TFV/FTC concentrations were measured by ultra-performance liquid chromatography ultraviolet detection. Evaluation of renal function and testing for HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) were also carried out, at baseline and every 3-6 months, with risk reduction advice. Results A total of 293 individuals presented having purchased PrEP on the internet: 85% were white, 84% were taking daily PrEP, and 16% were event-driven. Most were on generic TFV disoproxil fumarate (TDF)/FTC from Cipla Ltd. Median (range) TFV and FTC plasma concentrations were 104 (21-597) ng/mL and 140 (17-1876) ng/mL, respectively. All concentrations were above our established plasma TFV and FTC targets, based on previously published data. Renal function was normal in all evaluable individuals and no new cases of HIV, HBV or HCV infection were seen. Conclusions In a population at high risk of HIV acquisition, who cannot yet access PrEP on the NHS, concentrations of TFV and FTC in generic formulations purchased over the internet were similar to (or slightly higher than) those measured in phase I studies with the original formulation from Gilead (Truvada™), which has demonstrated high levels of protection against HIV infection in previous PrEP clinical trials.

The 2016 RAD-AID Conference analyzed the accelerated global activity in the radiology community that is transforming medical imaging into an effective spearhead of health care capacity building in low- and middle-income countries. Global health efforts historically emphasized disaster response, crisis zones, and infectious disease outbreaks. However, the projected doubling of cancer and cardiovascular deaths in developing countries in the next 15 years and the need for higher technology screening and diagnostic technologies in low-resource regions, as articulated by the United Nations' new Sustainable Development Goals of 2016, is heightening the role of radiology in global health. Academic US-based radiology programs with RAD-AID chapters achieved a threefold increase in global health project offerings for trainees in the past 5 years. RAD-AID's nonprofit radiology volunteer corps continue to grow by more than 40% yearly, with a volunteer base of 5,750 radiology professionals, serving in 23 countries, donating close to 20,000 pro bono hours globally in 2016. As a high-technology specialty interfacing with nearly all medical and surgical disciplines, radiology underpins vital health technology infrastructure, such as digital imaging archives, electronic medical records, and advanced diagnosis and treatment, essential for long-term future health care capacity in underserved areas of the world.

Objectives Rapid antiretroviral therapy (ART) initiation is recommended in early HIV infection (EHI), even in the absence of baseline viral resistance test result. We analysed time to viral suppression according to ART regimen started in a cohort of patients diagnosed with EHI. Methods Clinical records of individuals consecutively diagnosed with EHI between July 2016-June 2018 were reviewed. The distribution of clinical, virological and immunological factors was compared in treatment groups using the Mann-Whitney U-test. Results 262 individuals (97% MSM) were diagnosed with EHI. 58% of patients agreed to start ART within 14 days of diagnosis. Tenofovir-based combinations were prescribed to all patients. DRV/b was the most commonly prescribed third agent (78%), when genotypic resistance testing was not available at time of ART choice. Switching to INSTI was encouraged once VRT became available and 27% switched from DRV/b to INSTI (mainly RAL) within 28 days from ART start. Those receiving INSTI were more likely to have a baseline viral load exceeding 1 million HIV-1 RNA copies/mL compared with those starting with DRV/b. Rapid start with INSTI regimens resulted in quicker viral suppression than when DRV/b was chosen in EHI, even when that was subsequently switched to INSTI. Retention in care following rapid ART start was achieved by all patients at 24 weeks. Conclusions Starting an INSTI-based ART combination was associated with quicker viral suppression than when a protease inhibitor-based combination was chosen. No differences in the achievement of viral suppression or in retention in care were observed.

Background Increasing rates of sexually transmissible enteric infections (STEIs) in men who have sex with men (MSM), often associated with antimicrobial resistance, are a growing public health concern. There is a need to better understand the characteristics and burden of STEIs to improve control measures. Methods We conducted a cross-sectional study at a large London sexual health clinic (SHC) from December 2017 to February 2018. Residual rectal swabs collected from consecutive MSM attending for routine chlamydia/gonorrhoea testing (80% from asymptomatic screening), were anonymously tested for Shigella, Campylobacter, Salmonella and Escherichia coli by PCR. We generated STEI prevalence estimates and explored factors associated with STEIs using linked socio-demographic, behavioural and clinical data from electronic health records. Results Of 2,138 specimens tested, overall STEI prevalence was 9.9% (95% CI: 8.6%-11.2%), ranging from 0.7% (95% CI: 0.4%-1.2%) for Shigella to 5.0% (95% CI: 4.1%-6.0%) for enteroaggregative E. coli. Salmonella was not detected. MSM with an STEI-positive specimen were more likely to be co-infected with gonorrhoea (23.7% vs 16.2%, p=0.006), to have a previous bacterial STI diagnosis (past year) (48.3% vs 37.4%, p Conclusion Nearly one in ten MSM attending a London SHC had a rectal STEI detected. The association with higher-risk sexual behaviour and STIs strengthens the evidence that these pathogens are sexually transmitted. STEIs might be widely underdiagnosed in MSM and sub-clinical infection may support sustained transmission, suggesting the need for well-considered clinical and public health responses. Disclosure No significant relationships.

People living with HIV in England, as well as non-UK born and individuals without residency, can access free HIV care at any service in England. We investigated reasons for transfer of care to three London HIV units by asking all patients transferring to fill in a questionnaire exploring reasons for leaving their previous centre and reasons for choosing the new service. A total of 111 patients completed the questionnaire. The majority of patients transferred from abroad to London HIV units, compared to within the UK. The main reason for leaving their current service was location, which was also the main reason for choosing the service they transferred to. The results of this audit can be used to improve all services to ensure any concerns patients may have are eliminated and provide healthcare tailored to patients’ needs.

Objectives HIV pre-exposure prophylaxis (PrEP) is becoming a pivotal strategy for HIV prevention. Understanding the impact of risk factors for HIV transmission to identify those at highest risk would favour the implementation of PrEP, currently limited by costs. In this service evaluation, we estimated the incidence of bacterial STIs in men who have sex with men (MSM) diagnosed with early syphilis attending a London sexual health clinic according to their HIV status. In addition, we estimated the incidence of HIV infection in HIV-negative MSM, following a diagnosis of early syphilis. Methods We undertook a retrospective case note review of all MSM patients diagnosed with early syphilis between January and June 2014. A number of sexual health screens and diagnoses of chlamydia, gonorrhoea and HIV were prospectively analysed following the syphilis diagnosis. Results 206 MSM were diagnosed with early syphilis. 110 (53%) were HIV-negative at baseline, 96 (47%) were HIV-positive. Only age (37 vs 32 years, p=0.0005) was significantly different according to HIV status of MSM at baseline. In HIV-negative versus HIV-positive MSM, incidence of rectal chlamydia infection at follow-up was 27 cases vs 50/100 person-years of follow-up (PYFU) (p=0.0039), 33 vs 66/100 PYFU (p=0.0044) for rectal gonorrhoea and 10 vs 26/100 PYFU (p=0.0044) for syphilis reinfection, respectively. Total follow-up for 110 HIV-negative MSM was 144 person-years. HIV incidence was 8.3/100 PYFU (CI 4.2 to 14). Conclusions A diagnosis of early syphilis carries a high risk of consequent HIV seroconversion and should warrant prioritised access to prevention measures such as PrEP and regular STI screening to prevent HIV transmission.

Background/aims There are limited outcome data for men who have sex with men (MSM) who have received HIV postexposure prophylaxis (PEP). The objective of this service evaluation was to determine HIV incidence and repeat PEP use among MSM PEP recipients in London, UK. Methods Retrospective electronic case-note review of all MSM who were prescribed PEP between January and April 2013 at a central London sexual health service. Results 530 MSM received PEP between 1 January and 30 June 2013. Of these, 449 had more than 30 days subsequent follow-up at our service. Median age was 31 years. PEP indication was unprotected anal intercourse, 98% (receptive 88% and insertive 10%) and other, 2%. Up to 1 November 2015, total follow-up was 756 person-years. 183 users received repeat PEP. The total number of repeat PEP courses was 442. 57 MSM newly acquired HIV: the HIV incidence was 7.6 per 100 person-years. Conclusions PEP was associated with a high risk of subsequent HIV seroconversion in this cohort; this group may be appropriate candidates for pre-exposure prophylaxis.

Background Rapid Point-Of-Care Tests for Chlamydia trachomatis (CT) may reduce onward transmission and reproductive sexual health (RSH) sequelae by reducing turnaround times between diagnosis and treatment. The io® single module system (Atlas Genetics Ltd.) runs clinical samples through a nucleic acid amplification test (NAAT)-based CT cartridge, delivering results in 30 min. Methods Prospective diagnostic accuracy study of the io® CT-assay in four UK Genito-Urinary Medicine (GUM)/RSH clinics on additional-to-routine self-collected vulvovaginal swabs. Samples were tested “fresh” within 10 days of collection, or “frozen” at − 80 °C for later testing. Participant characteristics were collected to assess risk factors associated with CT infection. Results CT prevalence was 7.2% (51/709) overall. Sensitivity, specificity, positive and negative predictive values of the io® CT assay were, respectively, 96.1% (95% Confidence Interval (CI): 86.5–99.5), 97.7% (95%CI: 96.3–98.7), 76.6% (95%CI: 64.3–86.2) and 99.7% (95%CI: 98.9–100). The only risk factor associated with CT infection was being a sexual contact of an individual with CT. Conclusions The io® CT-assay is a 30-min, fully automated, high-performing NAAT currently CE-marked for CT diagnosis in women, making it a highly promising diagnostic to enable specific treatment, initiation of partner notification and appropriately intensive health promotion at the point of care., Highlights • The io® CT assay's sensitivity is comparable to that of laboratory-based assays commonly used for Chlamydia detection. • The specificity as shown is this study is at the lower end of the range reported for laboratory-based assays. • The resulting positive predictive value, in this population, indicates that a targeted testing approach may be optimal. Until now, there have been no ≤ 30-min point-of-care test (POCT) nucleic acid amplification tests (NAATs) on the market for detecting Chlamydia trachomatis (CT), despite cost-effectiveness analyses demonstrating they may improve Genito-Urinary Medicine (GUM)/Reproductive and Sexual Health (RSH) clinical care pathway efficiencies and patient outcomes. Our evaluation of the 30-min Atlas Genetics io® CT NAAT POCT, on vaginal swabs from women attending four GUM/RSH clinics in England, shows that the test's sensitivity (accurately detecting CT-positive infections) is similar to that of laboratory-based NAATs, and its specificity (accurately detecting CT-negative infections) is at the lower end of the laboratory-based NAAT range.

BackgroundRapid Point-Of-Care Tests (POCTs) forChlamydia trachomatis(CT) may reduce onward transmission and reproductive sexual health (RSH) sequelae by reducing turnaround times between diagnosis and treatment. The io®single module system (Atlas Genetics Ltd) runs clinical samples through a microfluidic CT cartridge, delivering results in 30 minutes. We evaluated its performance on female genital samples in four UK Genito-Urinary Medicine (GUM)/RSH clinics.MethodsProspective diagnostic accuracy study, using BD ProbeTec CT/GC assay as the routine clinic nucleic acid amplification test (NAAT) as the initial comparator test, and the QIAgen Artus CT assay to resolve discrepancies. In these instances, the reference standard was defined as the resolved result when two out of three assay results concurred. Female participants aged ≥16 provided additional-to-routine self-collected vulvovaginal swabs. Samples were tested fresh with the io®CT assay within 7 days of collection, or were frozen at −80°C for later testing. Participant clinical, demographic and behavioural characteristics were collected to assess risk factors associated with CT infection.ResultsOf 785 participants recruited, final analyses were conducted on 709 (90.3%). CT prevalence was 7.2% (51/709) overall. Sensitivity, specificity, positive and negative predictive values of the io®CT assay were, respectively, 96.1% (95% Confidence Interval (CI): 86.5-99.5), 97.7% (95%CI: 96.3-98.7), 76.6% (95%CI: 64.3-86.2) and 99.7% (95%CI: 98.9-100). There was no significant difference in performance measures between fresh and frozen samples, or between symptomatic and asymptomatic participants (p>0.05). The only risk factor associated with CT infection was being a sexual contact of an individual with CT.ConclusionsThe io®CT-assay is the only 30-minute, fully automated, high-performing NAAT currently CE-marked for CT diagnosis in women, making it a highly promising diagnostic to enable specific treatment, initiation of partner notification and appropriately intensive health promotion at the point of care. Future research is required to evaluate acceptability by clinicians and patients in GUM/RSH clinics, impact on clinical pathways and patient management, and cost-effectiveness.

In England, pre-exposure prophylaxis (PrEP) will shortly be available through the NHS-funded PrEP trial which hopes to address the number of men-who-have-sex-with-men (MSM) who will take up PrEP.1 56 Dean Street, and several other sexual health services, are already monitoring those sourcing generic tenofovir/emtricitabine as PrEP. In March 2017, we introduced an additional question in the sexual history for all MSM attending Dean Street Express …

BACKGROUND: Russian adults have extraordinarily high rates of premature death. Retrospective enquiries to the families of about 50,000 deceased Russians had found excess vodka use among those dying from external causes (accident, suicide, violence) and eight particular disease groupings. We now seek prospective evidence of these associations. METHODS: In three Russian cities (Barnaul, Byisk, and Tomsk), we interviewed 200,000 adults during 1999-2008 (with 12,000 re-interviewed some years later) and followed them until 2010 for cause-specific mortality. In 151,000 with no previous disease and some follow-up at ages 35-74 years, Poisson regression (adjusted for age at risk, amount smoked, education, and city) was used to calculate the relative risks associating vodka consumption with mortality. We have combined these relative risks with age-specific death rates to get 20-year absolute risks. FINDINGS: Among 57,361 male smokers with no previous disease, the estimated 20-year risks of death at ages 35-54 years were 16% (95% CI 15-17) for those who reported consuming less than a bottle of vodka per week at baseline, 20% (18-22) for those consuming 1-2·9 bottles per week, and 35% (31-39) for those consuming three or more bottles per week; trend p

Introduction: Dolutegravir is the first second-generation integrase inhibitor approved for the treatment of naive as well as experienced HIV-infected individuals. Areas covered: Data from pharmacokinetics, efficacy, safety, tolerability and resistance are reviewed from in vitro studies, Phase II and III clinical trials published in PubMed (Dolutegravir; S/GSK1349572) or presented in international meetings. Expert opinion: Data from studies and clinical trials indicate that dolutegravir is safe, well tolerated and highly efficacious in the treatment of both antiretroviral-naive and treatment-experienced patients and appears to have a higher genetic barrier to resistance than first-generation integrase inhibitors.

This study investigates the association of avascular necrosis (AVN) in human immunodeficiency virus (HIV)-positive individuals with possible risk factors, including antiretroviral therapy. Clinic records of all AVN cases diagnosed up to July 2009 in HIV-positive patients attending North Middlesex Hospital, London, UK were retrospectively reviewed. For each case, one control was randomly selected, matched for gender, age, nadir CD4 count and date of HIV diagnosis. Of 15 symptomatic AVN cases identified, eight were in women. Univariate analysis demonstrated significant associations between AVN and a history of systemic steroid use ( p = 0.004) and cumulative exposure to protease inhibitor ( p = 0.03). Physicians should be aware of the risk of AVN with steroid use, the importance of early diagnosis and avoidance of other risk factors in order to prevent further joint involvement if possible.

Most large, prospective studies of the effects of diabetes on mortality have focused on high-income countries where patients have access to reasonably good medical care and can receive treatments to establish and maintain good glycemic control. In those countries, diabetes less than doubles the rate of death from any cause. Few large, prospective studies have been conducted in middle-income countries where obesity and diabetes have become common and glycemic control may be poor.From 1998 through 2004, we recruited approximately 50,000 men and 100,000 women 35 years of age or older into a prospective study in Mexico City, Mexico. We recorded the presence or absence of previously diagnosed diabetes, obtained and stored blood samples, and tracked 12-year disease-specific deaths through January 1, 2014. We accepted diabetes as the underlying cause of death only for deaths that were due to acute diabetic crises. We estimated rate ratios for death among participants who had diabetes at recruitment versus those who did not have diabetes at recruitment; data from participants who had chronic diseases other than diabetes were excluded from the main analysis.At the time of recruitment, obesity was common and the prevalence of diabetes rose steeply with age (3% at 35 to 39 years of age and20% by 60 years of age). Participants who had diabetes had poor glycemic control (mean [±SD] glycated hemoglobin level, 9.0±2.4%), and the rates of use of other vasoprotective medications were low (e.g., 30% of participants with diabetes were receiving antihypertensive medication at recruitment and 1% were receiving lipid-lowering medication). Previously diagnosed diabetes was associated with rate ratios for death from any cause of 5.4 (95% confidence interval [CI], 5.0 to 6.0) at 35 to 59 years of age, 3.1 (95% CI, 2.9 to 3.3) at 60 to 74 years of age, and 1.9 (95% CI, 1.8 to 2.1) at 75 to 84 years of age. Between 35 and 74 years of age, the excess mortality associated with previously diagnosed diabetes accounted for one third of all deaths; the largest absolute excess risks of death were from renal disease (rate ratio, 20.1; 95% CI, 17.2 to 23.4), cardiac disease (rate ratio, 3.7; 95% CI, 3.2 to 4.2), infection (rate ratio, 4.7; 95% CI, 4.0 to 5.5), acute diabetic crises (8% of all deaths among participants who had previously diagnosed diabetes), and other vascular disease (mainly stroke). Little association was observed between diabetes and mortality from cirrhosis, cancer, or chronic obstructive pulmonary disease.In this study in Mexico, a middle-income country with high levels of obesity, diabetes was common, glycemic control was poor, and diabetes was associated with a far worse prognosis than that seen in high-income countries; it accounted for at least one third of all deaths between 35 and 74 years of age. (Funded by the Wellcome Trust and others.).

There are concerns that those taking HIV pre-exposure prophylaxis (PrEP) may increase their frequency of condomless sexual intercourse and, hence, their risk of acquiring STIs other than HIV. To date, PrEP is not available in England on the National Health Service (NHS). In September 2015, at 56 Dean Street, we opened a weekly PrEP clinic which offers single tablet Truvada (tenofovir/emtricitabine) at cost price, and in February 2016, we initiated PrEP monitoring in the general sexual …

Background Domain-specific physical activities may have different correlates and health effects, but few large studies have examined these questions, especially their separate associations with adiposity. Methods We analysed cross-sectional data of 466 605 adults without any prior chronic diseases, enrolled during 2004–8, from 10 diverse localities across China. Physical activity level in each of 4 domains (occupation, commuting, household, and active-recreation), calculated as metabolic equivalent (MET)-hr/day, was related to social-demographic factors and measures of adiposity (body mass index [BMI], waist circumference [WC], and bio-impedance derived percentage body fat), using multivariable linear and logistic regression models. Results The overall mean age was 50.8 years. The mean total physical activity was 21.7 MET-hr/day, mainly from occupation (62%) and household chores (26%), but little from active-recreation (4%), with women having a much higher household activity than men. Older participants had a lower level of occupational activity but a higher level of household and active-recreational activity, particularly after retirement. There was no linear association of occupational activity with adiposity, but working women tended to have a lower adiposity (e.g. 1.0 cm WC) than non-working women. In men, there was an inverse and apparently linear association between adiposity and levels of both commuting-related and household activities, with 3 MET-hr/day associated with -0.11 and -0.13 kg/m2 BMI, -0.42 and -0.62 cm WC, and -0.28 and -0.33 percentage points of body fat, respectively. In women, only household activity showed a linear, but weaker, association with adiposity. A higher adiposity was observed among men and women with higher levels of active-recreational activity. Conclusions In Chinese adults, physical activity mainly involves occupation and housework, with little from active-recreational activity. Domain-specific physical activities varied by socio-demographic factors and had different associations with adiposity. Electronic supplementary material The online version of this article (doi:10.1186/1471-2458-14-826) contains supplementary material, which is available to authorized users.

The Mexico City Prospective Study (Estudio Mexicano deCohorte Para Enfermedades Cro´nicas en una Poblacio´nMetropolitana) is a blood-based cohort study involvingfollow-up of 150000 adults (50000 men and 100000women) who were aged at least 35 years when recruited in1998–2004. The study resulted from discussions in the early1990s about how best to measure the changing health effects oftobacco in Mexico. These discussions evolved into a plan toestablish a prospective cohort study that could investigate notonly the health effects of tobacco but also those of blood lipidsand various other risk factors. Ideally, such a study should bebig enough to assess the effects of risk factors not only overallbut also in specific circumstances (e.g. at particular ages andseparately in each sex) and at different levels of other riskfactors (to examine possible causal interactions). In Mexico,there have been substantial decreases in overall mortality frominfectious diseases over the past few decades, leaving thechronic diseases of middle age as the main causes of prematuredeath.

OBJECTIVES: Mean blood pressure varies moderately with outdoor air temperature in many western populations. Substantial uncertainty exists, however, about the strength of the relationship in other populations and its relevance to age, adiposity, medical treatment, climate and housing conditions. METHODS: To investigate the relationship of blood pressure with season and outdoor temperature, we analysed cross-sectional data from the China Kadoorie Biobank study of 506,673 adults aged 30-79 years recruited from 10 diverse urban and rural regions in China. Analyses related mean blood pressure - overall and in various subgroups - to mean local outdoor temperature. RESULTS: The mean difference in SBP between summer (June-August) and winter (December-February) was 10 mmHg overall, and was more extreme, on average, in rural than in urban areas (12 vs. 8 mmHg; P for interaction