Background Lateral flow device (LFD) viral antigen immunoassays have been developed around the world as diagnostic tests for SARS-CoV-2 infection. They have been proposed to deliver an infrastructure-light, cost-economical solution giving results within half an hour. Methods LFDs were initially reviewed by a Department of Health and Social Care team, part of the UK government, from which 64 were selected for further evaluation from 1st August to 15th December 2020. Standardised laboratory evaluations, and for those that met the published criteria, field testing in the Falcon-C19 research study and UK pilots were performed (UK COVID-19 testing centres, hospital, schools, armed forces). Findings 4/64 LFDs so far have desirable performance characteristics (orient Gene, Deepblue, Abbott and Innova SARS-CoV-2 Antigen Rapid Qualitative Test). All these LFDs have a viral antigen detection of >90% at 100,000 RNA copies/ml. 8951 Innova LFD tests were performed with a kit failure rate of 5.6% (502/8951, 95% CI: 5.1–6.1), false positive rate of 0.32% (22/6954, 95% CI: 0.20–0.48). Viral antigen detection/sensitivity across the sampling cohort when performed by laboratory scientists was 78.8% (156/198, 95% CI 72.4–84.3). Interpretation Our results suggest LFDs have promising performance characteristics for mass population testing and can be used to identify infectious positive individuals. The Innova LFD shows good viral antigen detection/sensitivity with excellent specificity, although kit failure rates and the impact of training are potential issues. These results support the expanded evaluation of LFDs, and assessment of greater access to testing on COVID-19 transmission. Funding Department of Health and Social Care. University of Oxford. Public Health England Porton Down, Manchester University NHS Foundation Trust, National Institute of Health Research.

Background Human immunodeficiency virus pre-exposure prophylaxis (PrEP) clinical guidelines recommend men who have sex with men (MSM) PrEP users be screened biannually for syphilis and gonorrhea/chlamydia at all anatomic sites. We sought to determine the proportion screened and positive by STI and anatomic site at PrEP initiation and PrEP-care visits and patient-level characteristics associated with screening among MSM PrEP users in Baltimore City, Maryland. Methods Medical records among MSM initiating PrEP between 30 September 2015 and 31 March 2018 were abstracted. STI screening (syphilis and gonorrhea/chlamydia at all anatomic sites) and positivity at PrEP visits ≤12 months following initiation were calculated. Poisson regression with cluster robust SEs was used to assess associations with STI screening. Results Among 290 MSM initiating PrEP, 43.1% (n = 125) were screened per guidelines at PrEP initiation; 79.3% (230), 69.3% (201), 55.9% (162), and 69.3% (201) were screened for syphilis, urogenital, rectal, and oropharyngeal gonorrhea/chlamydia, respectively. Positivity among those screened was syphilis, 7.8% (n = 18/230); gonorrhea, 5.0% urogenital (10/201), 11.1% rectal (18/162), and 7.5% oropharyngeal (15/201); chlamydia, 5.0% urogenital (10/201), 11.7% rectal (19/162), and 1.5% oropharyngeal (3/201). Reported anal and oral sex (vs neither) was independently associated with STI screening (aPR, 2.11; 1.05–4.27) at PrEP initiation. At biannual PrEP-care visits, STI screening was lower and syphilis and rectal gonorrhea/chlamydia positivity was higher. Conclusions Observed STI screening levels and disease burden suggest the effectiveness of STI screening in PrEP care for STI prevention may be limited. Our results suggest providers may be offering screening based on sexual practices; clarification of STI screening guidelines for PrEP users is needed.

Background: HIV pre-exposure prophylaxis (PrEP) retention, defined as quarterly clinical evaluation, is critical to reducing HIV incidence. Our objectives were to determine: (1) visit- and individual-level PrEP retention patterns; (2) and individual-level characteristics associated with low-level PrEP retention 12 months after initiation among PrEP users in Baltimore City, Maryland. Methods: Information was abstracted from medical records among individuals initiating PrEP between October 1, 2015 and February 28, 2018. Visit-level PrEP retention was defined as evidence of PrEP use, documented PrEP prescription, or current PrEP use at each quarterly follow-up visit. Low-level PrEP retention was defined as <3/4 quarters with documented PrEP use. Multilevel mixed effects Poisson regression was used to determine characteristics associated with low-level PrEP retention. Results: Among 412 individuals initiating PrEP and followed for 12 months, the majority was: cis-gender male (83.7%, n = 345), non-Hispanic Black (56.3%, n = 232) and gay, bisexual, or other man who has sex with men (74.0%, n = 305). By quarterly visits, PrEP retention was: 3-month: 69.4% (n = 286); 6-month: 51.9% (n = 214); 9-month: 44.5% (n = 183); and 12-month: 41.1% (n = 169). Three-fifths (58.5%, n = 241) had low-level PrEP retention. Cis-gender females (vs. cis-gender males) (adjusted relative risk: 1.36, 95% confidence interval: 1.04 to 1.77) were more likely to have low-level PrEP retention. Conclusions: Our observed PrEP retention rates are lower than what may be needed to reduce HIV incidence. Future research should examine individual- and clinic-level barriers and facilitators to PrEP retention programs by key population to inform interventions for PrEP retention.

Background: Reducing HIV incidence requires addressing persistent racial/ethnic disparities in HIV burden. Our goal was to evaluate preexposure prophylaxis (PrEP) delivery, overall and relative to community need, among 7 clinical sites participating in a health department-led demonstration project to increase PrEP in Baltimore city, MD.Methods: PrEP care continuum stages (screened, indicated, referred, linked, evaluated, prescribed) were examined among HIV-negative individuals receiving services at participating sites between September 30, 2015 and September 29, 2019. Community need was defined using information on new HIV diagnoses (2016)(2017)(2018). Differences in care continuum progression by demographics/priority population and comparison of demographic compositions between care continuum stages and new HIV diagnoses were examined using modified Poisson regression and x 2 tests, respectively.Results: Among 25,886 PrEP-screened individuals, the majority were non-Hispanic (NH) black (81.1%, n = 20,998), cisgender male (61.1%, n = 15,825), and heterosexual (86.7%, n = 22,452). Overall, 31.1% (n = 8063) were PrEP-indicated; among whom, 56.8% (n = 4578), 15.6% (n = 1250), 10.8% (n = 868), and 9.0% (n = 722) were PrEP-referred, linked, evaluated, and prescribed, respectively. Among 2870 men who have sex with men (MSM), 18.7% (n = 538) were PrEP-prescribed. Across all groups, the highest attrition was between PrEP-referred and PrEP-linked. NHblack race (vs. NH-white) was independently associated with lower likelihood of PrEP prescription (aPR, 0.89; 95% confidence interval, 0.81 to 0.98 controlling for age/gender). Relative to the demographic composition of new HIV diagnoses, fewer NH-blacks (80.2% vs. 54.3%) and more NH-whites (10.7% vs. 30.3%) and MSM were PrEP prescribed (55.2% vs. 74.5%).Conclusions: This project showed promise delivering PrEP referrals and prescriptions overall and to MSM. Substantial improvement is needed to improve linkage overall and to decrease disparities in PrEP prescriptions among NH-blacks. Future work should focus on addressing service gaps that hinder PrEP utilization.

Background Chronic hepatitis C infection (HCV) is common in injecting drug users and is a major cause of liver disease. Antiviral treatment can 'cure' HCV, but is frequently associated with side effects and requires regular monitoring. Non-attendance at hospital appointments is frequent. To try and improve attendance and increase the number of current and previous injecting drug users treated we developed three outreach clinics. Objective To review the outcome of patients referred to the outreach clinics. Methods Retrospective service review of three clinics at drug treatment centres in Newcastle and Northumberland. Data was collected on attendance rates, patient demographics, treatment rates and outcomes. Results 141 referrals were received across the three sites with an overall attendance rate of 75% (106 patients, 79% men and median age 36), which compared favourably with that at our hospital (50%). All patients were on methadone/subutex. 45% were infected with Genotype 1 HCV. 10% were cirrhotic. To date, 30% have started treatment and 21% are waiting to start or are still in workup. 13% elected to delay treatment due to early stage disease and 11% were not ready for treatment on psychological or social grounds. Only 12% failed to attend follow up after initial assessment. To date, 24 patients have completed full courses of treatment with sustained viral response in 13 patients. Results are awaited for seven patients. Conclusions The development of outreach clinics for HCV in drug treatment centres can substantially improve clinic attendance and increase access to treatment in this marginalised group.