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Objectives: Anal cancer risk is elevated in MSM with HIV (MSMWH). Anal high-risk human papillomavirus (hr-HPV) infection is necessary but insufficient to develop high-grade squamous intraepithelial lesion (HSIL), the anal cancer precursor, suggesting additional factors. We sought to determine whether the microbiome of the anal canal is distinct by comparing it with the microbiome of stool. We also sought to determine whether changes in the anal microbiome are associated with HSIL among MSMWH., Design: Cross-sectional comparison of the microbiome of the anal canal with the microbiome of stool in MSMWH and cross-sectional comparison of the anal microbiome of MSMWH with anal HSIL with the anal microbiome of MSMWH without anal HSIL., Methods: Sterile swabs were used to sample the anus of MSMWH for microbiome and HPV testing, followed by high-resolution anoscopy. Stool samples were mailed from home. 16S sequencing was used for bacterial identification. Measures of alpha diversity, beta diversity, and differential abundance analysis were used to compare samples., Results: One hundred sixty-six anal samples and 103 matching stool samples were sequenced. Beta diversity showed clustering of stool and anal samples. Of hr-HPV-positive MSMWH, 31 had HSIL and 13 had no SIL. Comparison of the microbiome between these revealed 28 different species. The highest-fold enrichment among MSMWH/hr-HPV/HSIL included pro-inflammatory and carcinogenic Prevotella, Parasuterella, Hungatella, Sneathia, and Fusobacterium species. The anti-inflammatory Anaerostipes caccae showed the greatest reduction among MSMWH/hr-HPV/HSIL., Conclusion: The anal microbiome is distinct from stool. A pro-inflammatory and carcinogenic environment may be associated with anal HSIL., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: We assessed the association and concordance between self-reported oral pre-exposure prophylaxis (PrEP) intake in a diary app and intraerythrocytic drug metabolite concentrations., Design: AMPrEP was a prospective demonstration study providing daily and event-driven PrEP to MSM in Amsterdam, the Netherlands (2015-2020)., Methods: Participants could record their PrEP intake in a diary app. Dried blood spots (DBS) were taken at 6, 12, 24, and 48 months and analysed for tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) concentrations. We included TFV-DP measurements preceded by diary completion on at least 90% of days in the 6 weeks prior. We examined the association between self-reported PrEP intake (i.e. number of pills) and TFV-DP concentrations using tobit regression with a random intercept per participant. We also calculated concordance between categorized PrEP intake (i.e. <2, 2-3, 4-6 or 7 pills per week) and categorized TFV-DP concentrations (i.e. <350, 350-699,700-1249 or ≥1250 fmol/punch) using weighted Cohen's kappa. Last, we calculated concordance between self-reported recent PrEP intake (yes/no, in past 2 days) and quantifiability of FTC-TP (yes/no) using Cohen's kappa., Results: Seven hundred and fifty-nine DBS measurements from 282 MSM were included. Self-reported PrEP intake was strongly and positively associated with TFV-DP concentration ( β  = 0.77, 95% CI = 0.70-0.84, P  < 0.0001). Concordance between categorized PrEP intake and TFV-DP concentration was moderate ( κ  = 0.44, 95% CI = 0.39-0.50). Concordance between self-reported recent PrEP intake and FTC-TP quantifiability was perfect ( κ  = 0.83, 95% CI 0.76-0.90)., Conclusion: Self-reported PrEP intake in a diary app is strongly correlated with actual use, and therefore reliable for comparing PrEP adherence between groups. Still, suboptimal criterion validity according to clinically relevant categories warrants caution when assessing 6-week reported adherence for individuals., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate the effect of preexposure prophylaxis (PrEP) initiation on bacterial sexually transmitted infection (STI) occurrence (overall; chlamydia; gonorrhea; syphilis), in MSM., Design: Systematic review and meta-analysis., Methods: Systematic searches were performed in PubMed, Embase, and Scopus without language restrictions until 1 February 2023. We sought studies reporting data for the estimation of incidence rate ratios (IRR), prevalence ratios or cumulative incidence ratios (the latter in equal time periods before and after PrEP initiation) regarding bacterial STI occurrence. Separate analyses were performed overall for any STI, syphilis, chlamydia and gonorrhea (overall; rectal; urethral; pharyngeal for the two latter conditions); ratios greater than unity denoted increase in STI occurrence after PrEP initiation., Results: Twenty-three eligible studies with 11 776 participants (age range: 18-71 years) with a median follow-up of 12 months were included. Overall, PrEP initiation was associated with a significant increase in the occurrence of any STI (pooled effect size: 1.15, 95% confidence interval (CI): 1.04-1.26), any gonorrhea (pooled effect size: 1.17, 95% CI: 1.02-1.34), any chlamydia (pooled effect size: 1.31, 95% CI: 1.09-1.58) and rectal chlamydia (pooled effect size: 1.31, 95% CI: 1.05-1.64), whereas a borderline increase was found in urethral chlamydia (pooled effect size: 1.25, 95% CI: 0.99-1.60, P  = 0.064). Changes in pharyngeal chlamydia and site-specific gonorrhea occurrence did not reach statistical significance. Syphilis showed virtually no change after PrEP initiation (pooled effect size: 0.99, 95% CI: 0.72-1.37)., Conclusion: These results highlight the need for more comprehensive, accessible STI testing to tackle bacterial STI infections in PrEP users., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Coronavirus disease 2019 (COVID-19) and related disruptions led to a significant decline in HIV diagnoses in the United States in 2020. A previous analysis estimated 18% fewer diagnoses than expected among persons with HIV (PWH) acquiring infection in 2019 or earlier, suggesting that the decline in overall diagnoses cannot be attributed solely to decreased transmission. This analysis evaluates the progress made towards closing the 2020 diagnosis deficit in 2021., Methods: We apply previously developed methods analyzing 2021 diagnosis data from the National HIV Surveillance System to determine whether 2021 diagnosis levels of PWH infected pre-2020 are above or below the expected pre-COVID trends. Results are stratified by assigned sex at birth, transmission group, geographic region, and race/ethnicity., Results: In 2021, HIV diagnoses returned to pre-COVID levels among all PWH acquiring infection 2011-2019. Among Hispanic/Latino PWH and male individuals, diagnoses returned to pre-COVID levels. White PWH, MSM, and PWH living in the south and northeast showed higher-than-expected levels of diagnosis in 2021. For the remaining populations, there were fewer HIV diagnoses in 2021 than expected., Conclusion: Although overall diagnoses among persons acquiring HIV pre-2020 returned to pre-COVID levels, the diagnosis gap observed in 2020 remained unclosed at the end of 2021. Fewer than expected diagnoses among certain populations indicate that COVID-19-related disruptions to HIV diagnosis trends remained in 2021. Although some groups showed higher-than-expected levels of diagnoses, such increases were smaller than corresponding 2020 decreases. Expanded testing programs designed to close these gaps are essential., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: HIV molecular epidemiology (ME) is the analysis of sequence data together with individual-level clinical, demographic, and behavioral data to understand HIV epidemiology. The use of ME has raised concerns regarding identification of the putative source in direct transmission events. This could result in harm ranging from stigma to criminal prosecution in some jurisdictions. Here we assessed the risks of ME using simulated HIV genetic sequencing data., Methods: We simulated social networks of men-who-have-sex-with-men, calibrating the simulations to data from San Diego. We used these networks to simulate consensus and next-generation sequence (NGS) data to evaluate the risks of identifying direct transmissions using different HIV sequence lengths, and population sampling depths. To identify the source of transmissions, we calculated infector probability and used phyloscanner software for the analysis of consensus and NGS data, respectively., Results: Consensus sequence analyses showed that the risk of correctly inferring the source (direct transmission) within identified transmission pairs was very small and independent of sampling depth. Alternatively, NGS analyses showed that identification of the source of a transmission was very accurate, but only for 6.5% of inferred pairs. False positive transmissions were also observed, where one or more unobserved intermediaries were present when compared to the true network., Conclusion: Source attribution using consensus sequences rarely infers direct transmission pairs with high confidence but is still useful for population studies. In contrast, source attribution using NGS data was much more accurate in identifying direct transmission pairs, but for only a small percentage of transmission pairs analyzed., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Evaluating HIV preexposure prophylaxis (PrEP) use and HIV risk events concurrently remains challenging. We developed a single question method for measuring prevention-effective adherence with PrEP in self-report questionnaires. In a questionnaire completed by 409 gay and bisexual men, 46% reported condomless anal sex that was not covered by their own PrEP use, and this was more common among younger, lower-income participants. Refining this questionnaire item could improve measurement of prevention-effective adherence., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: We present findings from a large cohort of individuals treated during primary HIV infection (PHI) and examine the impact of time from HIV-1 acquisition to antiretroviral therapy (ART) initiation on clinical outcomes. We also examine the temporal changes in the demographics of individuals presenting with PHI to inform HIV-1 prevention strategies., Methods: Individuals who fulfilled the criteria of PHI and started ART within 3 months of confirmed HIV-1 diagnosis were enrolled between 2009 and 2020. Baseline demographics of those diagnosed between 2009 and 2015 (before preexposure prophylaxis (PrEP) and universal ART availability) and 2015-2020 (post-PrEP and universal ART availability) were compared. We examined the factors associated with immune recovery and time to viral suppression., Results: Two hundred four individuals enrolled, 144 from 2009 to 2015 and 90 from 2015 to 2020; median follow-up was 33 months. At PHI, the median age was 33 years; 4% were women, 39% were UK-born, and 84% were MSM. The proportion of UK-born individuals was 47% in 2009-2015, compared with 29% in 2015-2020. There was an association between earlier ART initiation after PHI diagnosis and increased immune recovery; each day that ART was delayed was associated with a lower likelihood of achieving a CD4 + cell count more than 900 cells/μl [hazard ratio 0.99 (95% confidence interval, 95% CI 0.98-0.99), P  = 0.02) and CD4/CD8 more than 1.0 (hazard ratio 0.98 (95% CI 0.97-0.99)., Conclusion: Early initiation of ART at PHI diagnosis is associated with enhanced immune recovery, providing further evidence to support immediate ART in the context of PHI. Non-UK-born MSM accounts for an increasing proportion of those with primary infection; UK HIV-1 prevention strategies should better target this group., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: HIV preexposure prophylaxis (PrEP) is highly effective at preventing HIV. We aimed to assess mental and physical health among long-term PrEP users in Australia's X-PLORE cohort., Methods: In early 2021, 1485 X-PLORE participants were emailed a survey covering demographics, sexual practices, ongoing PrEP use, physical and psychological diagnoses received since commencing PrEP, substance use, and impacts of the COVID-19 pandemic. Current anxiety and depression were assessed using GAD-7 and PHQ-9 questionnaires., Results: Of 476 participants (completion rate 32.1%), 99.8% were cis-gender men. Median PrEP use duration was 48 months (2002 person-years), with 81.7% currently using PrEP. PrEP-related toxicity was uncommon: 2.9% reported bone fractures, 1.3% low bone density, and 4.0% reported kidney problems, largely not necessitating PrEP cessation. Most (92.0%) rated their health as 'good' to 'excellent', and 22.6% reported improved health since starting PrEP, often because of improved mental health. Only 6.2% reported deterioration in health since starting PrEP, largely unrelated to PrEP. The most common diagnoses were hypertension (9.9%), depression (13.2%) and anxiety (14.9%); 17% had PHQ-9 scores indicating current moderate-to-severe depression, which was associated with unemployment [adjusted odds ratio (aOR) 3.90], regular cannabis use (aOR 2.49), and having ceased PrEP (aOR 2.13)., Conclusion: Among long-term PrEP users, of which over 80% were currently using PrEP, self-reported PrEP toxicity was uncommon. With almost one in five PrEP users categorized as having depression, and with higher risk among those having ceased PrEP, we recommend routine screening for depression and anxiety in PrEP users and corresponding follow-up of patients no longer attending for PrEP., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: Little is known about the impact that the COVID-19 pandemic had on risk of HIV acquisition in sub-Saharan Africa. We assessed the impact of COVID-19-related clinic closures on HIV incidence in a cohort of gay, bisexual, and other men who have sex with men (MSM) and transgender women in Kenya., Methods: MSM and transgender women enrolled in a prospective, multicentre cohort study were followed quarterly for HIV testing, behaviour assessments, and risk. We estimated the HIV incidence rate and its 95% credible intervals (CrI) among participants who were HIV-negative before COVID-19-related clinic closure, comparing incidence rate and risk factors associated with HIV acquisition before vs. after clinic reopening, using a Bayesian Poisson model with weakly informative priors., Results: A total of 690 (87%) participants returned for follow-up after clinic reopening (total person-years 664.3 during clinic closure and 1013.3 after clinic reopening). HIV incidence rate declined from 2.05/100 person-years (95% CrI = 1.22-3.26, n  = 14) during clinic closures to 0.96/100 person-years (95% CrI = 0.41-2.07, n  = 10) after clinic reopening (IRR = 0.47, 95% CrI = 0.20-1.01). The proportion of participants reporting hazardous alcohol use and several sexual risk behaviours was higher during clinic closures than after clinic reopening. In multivariable analysis adjusting for study site and participant characteristics, HIV incidence was lower after clinic reopening (IRR 0.57, 95% CrI = 0.23-1.33). Independent risk factors for HIV acquisition included receptive anal intercourse (IRR 1.94, 95% CrI = 0.88-4.80) and perceived risk of HIV (IRR 3.03, 95% CRI = 1.40-6.24)., Conclusion: HIV incidence during COVID-19-related clinic closures was moderately increased and reduced after COVID-19 restrictions were eased. Ensuring access to services for key populations is important during public health emergencies., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objectives: This study aims to estimate the incidence and persistence/clearance of anal human papilloma virus (HPV) infection and related factors among men with HIV in Taizhou, China., Design: A prospective cohort study., Methods: Men with HIV were recruited and followed up from 2016 to 2021. Questionnaire surveys were used to collect social-demographic and behavioral characteristics, and anal swabs were collected for HPV Genotyping., Results: A total of 675 men with HIV were recruited and followed up. After an average follow-up time of 1.75 years, HPV39 (3.8/100 person-years), HPV52 (3.6/100 person-years), HPV51 (3.1/100 person-years), HPV58 (2.5/100 person-years) and HPV16 (2.4 cases/100 person-years) in the high-risk types showed the highest incidence rate. In marriage with woman [adjusted hazard ratio (aHR) = 0.44, 95% confidence interval (CI) 0.20-0.99] showed an inverse association with HPV incidence, while bisexuality or undetermined sexual orientation (aHR = 2.62, 95% CI 1.08-6.36) showed a positive association. For those infected at baseline, the top three high-risk HPV with the lowest clearance density were HPV52 (32.2/100 person-years), HPV58 (38.1/100 person-years), and HPV16 (43.5/100 person-years). Daily consumption of 1-28 g alcohol (aHR = 0.62, 95% CI 0.41-0.95) showed an inverse association with HPV clearance, while illicit drug use (aHR = 3.24, 95% CI 1.59-6.59) showed a positive association., Conclusion: Anal HPV infection and clearance were both active in men with HIV in China. Marriage status and sexuality were associated with the incidence of HPV infection, while substance use including alcohol and illicit drug were associated with HPV clearance. More studies are needed to explore the risk factors of HPV persistence., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Retrospective, cohort analysis including people with four-class drug-resistant HIV. Bacterial sexually transmitted infections (STIs) had an incidence of 1.3/100-person-years-of-follow-up (PYFU) in men (3.5/100-PYFU in MSM) whereas no STIs were diagnosed in women. The occurrence of STIs in this fragile population might be related to the achievement of good HIV infection control; however, given the remaining risk of virological failure and possible transmission of a multidrug-resistant virus, STI prevention counselling and HIV viremia monitoring should be prioritized., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Preexposure prophylaxis (PrEP) significantly reduces HIV infection risk but is dependent on adherence. Available approaches to measuring adherence have limitations related to accuracy, cost, practicality, and timeliness. This study compared the performance of two methods implementable in clinics and research studies [interview and urine point of care (POC) assay] to the gold-standard for measuring recent and longer term adherence in dried blood spots (DBS)., Methods: Participants were recruited from RADAR, a cohort study of young MSM, or via online advertisements. At 3 monthly visits, an interviewer administered 7-day timeline follow-back (TLFB) questionnaire, DBS samples were tested for tenofovir-diphosphate (TFV-DP) to estimate average dosing over the prior month and emtricitabine-triphosphate (FTC-TP) to assess recent dosing (past 2-3 days), and a urine POC TFV test to qualitatively assess recent adherence (past 4 days)., Results: Eighty-three PrEP users contributed 163 observations. At visit 1, self-reported adherence was 86% (4+ doses in last 7 days), versus urine TFV (74%), DBS FTC-TP (76%), and DBS TFV-DP (69%). The objective measures of short-term adherence performed similarly well in predicting longer term adherence. In multivariable logistic regression analyses, the urine assay was a significant predictor of DBS TFV-DP (adjusted OR = 19.4, P  < 0.0001); self-report did not add significantly., Conclusion: The urine POC TFV assay had excellent predictive values for adherence and self-report did not add significantly to prediction. The POC assay provides results in several minutes to enable same-visit counseling, requires no specialized training, and is projected to be low-cost., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To estimate HIV incidence using successive cross-sectional surveys by creating retrospective nested cohorts among MSM, people who inject drugs (PWID), and heterosexually active persons (HET)., Design: Cohorts were created among participants who had at least one repeat observation across four surveillance cycles from National HIV Behavioral Surveillance in 20 US cities., Methods: Repeat participants were identified using a combination of date of birth, race/ethnicity, metropolitan statistical area, and gender. The analysis was limited to participants who tested negative for HIV at baseline and were assumed to be at risk between cycles. We calculated person-years at risk from the individual time between cycles and used the total number of seroconversions to estimate incidence and a Poisson distribution to approximate variance. Rate ratios were calculated using age, gender, race/ethnicity, and region., Results: From 2008 to 2019, successive surveys recaptured nested cohorts of 1747 MSM, 3708 PWID, and 1396 HET. We observed an incidence rate of 2.5 per 100 person-years [95% confidence interval (CI) 2.1-2.8) among MSM; 0.6 per 100 person-years (95% CI 0.5-0.7) among PWID; and 0.3 per 100 person-years (95% CI 0.1-0.4) among HET. HIV incidence was higher among younger MSM, black MSM (compared with white MSM), and PWID residing in the South and territories (compared with the Midwest)., Conclusion: These estimates are consistent with previously published incidence estimates from prospective cohort studies among these populations. Using repeat cross-sectional surveys to simulate a cohort, may serve as another strategy in estimating HIV incidence., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To assess Kaposi sarcoma (KS) by HIV-status in Sweden 1983-2017, with particular focus on extracutaneous KS., Design: Population-based study linking the Total Population Registry, the Swedish HIV Registry InfCareHIV, and the Swedish Cancer Registry., Methods: We included all Swedish residents, born in or outside Sweden between 1940 and 2000 ( n  = 8 587 829), assessing the annual incidence of KS, adjusted hazard ratios (adjHR), and odds ratios (adjOR) in the pre and postcombination antiretroviral therapy (ART) eras., Results: KS was found in 324 individuals of whom 202 (62%) were people with HIV (PWH). While the incidence of KS decreased in PWH, it remained higher compared to HIV-negative at end of follow-up (28 vs. 0.09 per 100 000 person-years, P  < 0.001). In the post-ART era, PWH still had an increased risk of both cutaneous [adjHR 616, 95% confidence interval (CI) 410-926] and extracutaneous KS (adjHR 2068, 95% CI 757-5654), compared to HIV-negative individuals, although there were no cases of extracutaneous disease among virally suppressed PWH. In the post-ART era, the relative risk for KS remained higher in men, particularly men who have sex with men, and viral suppression was associated with lower odds of KS (adjOR 0.05, 95% CI 0.03-0.09)., Conclusions: KS remained increased in PWH in the post-ART era, with a particularly high risk for extracutaneous disease compared to HIV-negative individuals. Notably, there were no cases of extracutaneous disease among virally suppressed PWH, suggesting a less aggressive disease in this population. Further studies on KS in virally suppressed PWH are warranted., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: Studies have shown varying trends in incidence of sexually transmitted infections (STIs) among individuals using HIV pre-exposure prophylaxis (PrEP). Characterization of individuals at increased risk for STIs may offer an opportunity for targeted STI screening., Design: Group-based trajectory modeling., Methods: We screened participants from the AMPrEP demonstration project (2015-2020) for urogenital, anal, and pharyngeal chlamydia and gonorrhea, and syphilis every 3 months and when needed. We identified trajectories of STI incidence within individuals over time and determinants of belonging to a trajectory group. We calculated cumulative proportions of STIs within STI trajectory groups., Results: Three hundred and sixty-six participants with baseline and at least one screening visit during follow-up were included (median follow-up time = 3.7 years [interquartile range, IQR = 3.5-3.7]). We identified three trajectories of STI incidence: participants with a mean of approximately 0.1 STIs per 3 months ('low overall', 52% of the population), participants with a mean 0.4 STI per 3 months ('medium overall', 43%), and participants with high and fluctuating (between 0.3 and 1 STIs per 3 months) STI incidence ('high and fluctuating', 5%). Participants in the 'low overall' trajectory were significantly older, and reported less chemsex and condomless anal sex with casual partners than participants in the other trajectories. Participants in the 'high and fluctuating' and 'medium overall' groups accounted for respectively 23 and 64% of all STIs observed during follow-up., Conclusions: STI incidence was concentrated in subpopulations of PrEP users who were younger, had more chemsex and condomless anal sex. Screening frequency for STIs could be reduced for subpopulations with low risk for incident STIs., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objectives: We aimed to examine the association of the country of birth and the other patients' characteristics with the prescription of two-drug regimens (2DRs) in virally suppressed people with HIV (PWH) in France., Design: Observational study conducted from the national Dat'AIDS prospectively collected database., Methods: We included all adults who were actively in care on 31 December 2020 in 26 French centers, with an HIV plasma viral load (pVL) <50 copies/ml for at least 6 months while on antiretroviral therapy (ART). Patients with chronic hepatitis B were excluded because they are not eligible to 2DRs. Univariate and multivariate logistic regressions were built to analyze relationships between patients' characteristics and receiving a 2DR., Results: We analyzed data from 28 395 PWH: 41.7% men who have sex with men, 31.7% women and 26.5% heterosexual men; 35% born abroad. Median age was 53 years [interquartile range (IQR) 44-60]; ART duration 14 years (8-23); duration of virological suppression 87 months (42-142). 2DRs (mainly dolutegravir/rilpivirine, 53.8%, or dolutegravir/lamivudine, 41.7%) were prescribed in 16.3% of the patients and were less common in the 'born abroad' group (18.9% versus 11.5%). The multivariate model showed that individuals born in France were more likely to receive a 2DR [adjusted odds ratio (aOR): 1.62 [1.50-1.74]], independently of other characteristics. Older PLWH and those with higher CD4 + T-cell counts were also more likely to receive a 2DR., Conclusion: Despite unrestricted access to ART in France, independently from HIV disease parameters, PWH born abroad were less likely to receive 2DRs as a maintenance regimen than those born in France. Qualitative data are needed to better understand physicians' prescribing practices., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: We aimed to describe factors associated with the choice of first antiretroviral therapy (ART) in persons with HIV (PWH) in France, included the country of birth, as well as the time to undetectable viral load and treatment discontinuation., Design: Observational study conducted from the national Dat'AIDS prospectively collected database., Methods: We included all adults who started their first ART between 01 January 2014 and 31 December 2020, with a pretherapeutic plasma viral load (pVL) at least 400 copies/ml. Univariable and multivariable logistic regressions were used to analyze PWH characteristics driving to an integrase strand transfer inhibitors (INSTI)-based first prescribed regimen. We also analyzed time to first line discontinuation, and to a first undetectable pVL, using Kaplan-Meier model., Results: We analyzed data from 9094 PWH: 45% MSM, 27% women and 27% heterosexual men; 48% born abroad; 4.7 and 2.8% with concomitant hepatitis B and tuberculosis, respectively. INSTIs were prescribed as first-line therapy in 50% of PWH, which increased over time. Native French PWH were more likely to receive an INSTI-based regimen than PWH born abroad [adjusted prevalence ratio 1.47, 95% confidence interval (CI) 1.33-1.60], as were high pVL at diagnosis, hepatitis B or concomitant tuberculosis. Time before discontinuation of the first ART and reaching a first undetectable pVL was not different according to the place of birth., Conclusion: Despite unrestricted access to INSTIs in France, independently from HIV disease parameters, PWH born abroad received INSTIs less frequently as a first regimen than those born in France. Qualitative data are needed to better understand physicians' prescribing practices., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Ablative electrocautery is effective treating anal high-grade squamous intraepithelial lesions (HSILs). However, persistence or recurrence of the HSIL despite ablative sessions is not uncommon. The aim of this study is to assess the feasibility of topical cidofovir as salvage therapy for the management of refractory HSIL., Design: A prospective uncontrolled unicenter study of men and transgender people who have sex with men with HIV who had a refractory intra-anal HSIL after ablative treatments and who received topical cidofovir (ointment at 1%, auto-applicated, three times a week, a total of 8 weeks) as salvage therapy. Effectiveness was evaluated on-treatment defining response as resolution or regression to low-grade lesion of HSIL in the biopsy posttreatment. Tolerance and recurrences were recorded., Results: From 2017 to 2022, 23 patients with refractory intra-anal HSIL (78.3% persistent lesions, 39% affecting > 50% of circumference, and a median of six previous ablative sessions) were treated with topical cidofovir. A response was observed in 16 of 23 patients [69.5% (95% confidence interval (95% CI) 50.8-88.4)]. Local tolerance was reported as regular or bad in 13 patients (52.2%), requiring modification of the treatment in eight patients (three early discontinuation and five dose reduction). Non-serious side effects were reported. After a median follow-up of 30.3 months, two of the 16 patients with a response developed recurrent HSIL [recurrence rate, 25.4% at 12 months (95% CI, 0-35)]., Conclusion: Topical cidofovir could be a good option in the management of anal HSIL due to its good effectiveness, low recurrence rate, and acceptable tolerance even in difficult-to-treat lesions., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To investigate the molecular epidemiology of HIV-1 in Heilongjiang, China, and try to spot signs of new circulating recombinant form (CRF) in this region., Design: A molecular epidemiological study was conducted in Heilongjiang, China during 2011-2020., Methods: Plasma samples were collected from three HIV-1-positive patients (two MSM and one man lacking risk factor information). The near full-length genome sequences (NFLGs) of a novel CRF were then obtained and subjected to phylogenetic analysis using Mega 7.0.26. Recombination analysis was performed by the jumping profile Hidden Markov Model (jpHMM). Finally, the origin time of this novel CRF was inferred using the Bayesian phylogenetic analysis in Beast v1.10.4., Results: The three NFLGs formed a distinct monophyletic cluster in the neighbor-joining (NJ) tree. Recombination analysis revealed that the recombinant genome was composed of five segments derived from CRF01&#95;AE, subtypes B, and C, but further confirmed to be a second-generation recombinant form of CRF01&#95;AE/CRF07&#95;BC by a comparison of genome maps and subregion phylogenetic analysis and, therefore, designated as CRF136&#95;0107. With Bayesian phylogenetic analysis, CRF136&#95;0107 was estimated to originate around 2010-2011., Conclusion: A novel HIV-1 CRF01&#95;AE/CRF07&#95;BC second-generation CRF called CRF136&#95;0107 was identified among MSM in Heilongjiang, a northeast province of China., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: This study examines the association between social support and cognitive function among midlife and older MSM living with or without HIV., Design: We analyzed longitudinal data from participants enrolled from October 2016 to March 2019 in the Patterns of Healthy Aging Study, a substudy of the Multicenter AIDS Cohort Study., Methods: We conducted a cross-sectional analysis to estimate the association between social support and three measures of cognitive function [Trail Making Test (TMT) Part A, TMT Part B to A ratio, and Symbol Digit Modalities Tasks (SDMT)]. We also used linear mixed-effects models to estimate the association between baseline social support and cognitive function across four subsequent time points. We evaluated a multiplicative interaction term between baseline social support and time, in order to determine whether cognitive trajectories over time vary by baseline social support., Results: Social support was associated with lower TMT Part A scores at baseline and over the subsequent 2 years, indicating better psychomotor ability. Social support was associated with higher SDMT scores at baseline and across 2 years, indicating better information processing. We observed no association between social support and TMT B to A ratio at baseline or across 2 years, indicating no effect on set-shifting ability. Longitudinal cognition outcome trajectories did not vary by the level of baseline social support., Conclusion: Social support and cognitive function were associated in this sample over a short time period. Further research should explore causal relationships over the lifespan., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Since 2015, we prescribed dolutegravir (DTG)-based two drug regimens (DTG-2DR) for 620 people [total cohort 3133 (19.8%)]., Method: Clinic database search 1 January 15 to 31 October 21. Demographic, tolerability and HIV related data analysed., Results: In total, 620 people identified; 561 had complete data. 446 male (79.5%); median age 54 years (interquartile range 46, 59). 343 (61.1%) MSM. Nine people who initiated naïvely achieved viral suppression (100%). 546/552 (99.0%) switched or continued and were suppressed at data censor. 460/552 (83.3%) received DTG-lamivudine (DTG/3TC), 74/552 (13.4%) received DTG-rilpivirine (DTG/RPV) and 18/552 (3.3%) received DTG-emtricitabine (DTG/FTC). 70 (12.5%) switched off DTG-2DR (55 DTG/3TC, 13 DTG/RPV, two DTG/FTC) due to side-effects. 41 episodes of blip (1 off >50 copies/ml) occurred in 30 people (5.3%). 11/41 on DTG-RPV [ n  = 7 multi-tablet regimen (MTR), n  = 4 single tablet regimen (STR)]. 27/41 DTG-3TC, 3/41 DTG/FTC ( n  = 26 MTR, n  = 4 STR). Six people (1.1%) failed (confirmed viral load >200 copies/ml or persistent low level viraemia) ( n  = 4 DTG-3TC STR, n  = 1 DTG-3TC MTR, n  = 1 DTG-RPV MTR). Four failures due to low level viraemia, one due to non-adherence and one due to high viral load. Resistance tests performed for 5/6 - mutations detected only in latter person with high viral load failure (on DTG-3TC MTR) who developed triple class resistance., Conclusion: Majority of experience is in DTG/3TC stable switch. Minority of patients developed side-effects. Low number of virological failures, one developed integrase inhibitor resistance. Viral failure associated with MTR, commensurate with trial data showing no failure with resistance if DTG/3TC STR used. Overall DTG-2DR demonstrates high efficacy in real-world setting., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Crowdsourcing, which taps into the wisdom of crowds, has been successful in generating strategies to enhance HIV self-testing (HIVST) uptake. We determined the cost-effectiveness of a crowdsourced intervention (one-off or annual) compared with a control scenario (no crowdsourcing) among MSM living in China., Design: Economic evaluation., Methods: We used data from our cluster randomized controlled trial of MSM (NCT02796963). We used a micro-costing approach to measure direct health costs ($USD2017) from a health provider perspective. Using outputs from a dynamic transmission model over a 20-year time horizon, we estimated the incremental cost-effectiveness ratios using cost per disability-adjusted life years (DALYs) averted with 3% discounting. An intervention was considered highly cost-effective if it was less than one gross domestic product (GDP, $8823) per DALY averted., Results: Across all cities, the crowdsourced intervention was highly cost-effective compared with the control scenario (incremental cost-effectiveness ratios ranged from $2263 to 6152 per DALY averted for annual crowdsourcing; $171 to 204 per DALY averted for one-off crowdsourcing). The one-off intervention was cost-saving in Guangzhou and Qingdao. Sensitivity analyses confirmed the robustness of the findings; specifically, changes in discounting, costs of the crowdsourced intervention, costs of HIV testing and cost of antiretroviral therapy did not alter our conclusions., Conclusion: Scaling up a one-off or annual crowdsourced HIV prevention intervention in four cities in China was very likely to be cost-effective. Further research is warranted to evaluate the feasibility of scaling up crowdsourced HIV prevention interventions in other settings and populations., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Although HIV infection in the Russian Federation was historically concentrated among marginalized populations (people who inject drugs, sex workers, MSM, and the prison population), recent evidence suggests that it has become a more generalized epidemic. The objective of our research was to explore how these trends in HIV prevalence and HIV-related mortality compare across Russia., Methods: We calculated HIV-associated mortality for both male and female individuals in each region (oblast) of the Russian Federation using data from the Russian Fertility and Mortality Database (RusFMD). Using current data on HIV prevalence, we computed the correlation between HIV prevalence and HIV-associated mortality. We also used oblast-level data to examine the associations between HIV prevalence and the risk factors most commonly associated with HIV infection., Results: Over the past 20 years, the Russian Federation has experienced a rapid increase in HIV-associated mortality in both male and female individuals. Our findings revealed significant heterogeneity, with higher rates of HIV-associated mortality reported in oblasts in the Siberian and Ural Federal Districts. There is a strong correlation (0.8) between HIV-associated mortality and virus prevalence. These findings confirm that there are regional disparities in access and adherence to antiretroviral therapy (ART), as indicated by the low correlation (-0.4) between virus prevalence and access to ART coverage. The results from our modeling analysis revealed that, in addition to the factors most commonly associated with this disease (e.g. intravenous drug use), knowledge about sexual transmission of HIV in the general population has a broad impact on its prevalence at the oblast level., Conclusion: Interventions that reduce HIV prevalence, for example, opioid substitution therapy and needle-sharing programs for people who inject drugs, as well as the increased availability of educational and preventive programs may halt the spread of HIV across the Russian Federation. Similarly, increased access to treatment could help in reducing HIV-related mortality., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objectives: After identifying and recruiting men who have sex with men living with HIV and virally unsuppressed, this study attempted to enhance treatment and care via case management to increase the proportion who achieved viral suppression., Design: Participants were randomized into one of two study arms: standard of care (SOC) or enhanced case management (CM) intervention. Participants were followed for 12 months with quarterly study assessments, with blood collected for CD4+ cell count testing, HIV viral load testing (primary prespecified outcome), and plasma storage., Methods: Participants identified via respondent-driven sampling and direct recruitment and were invited to participate in the randomized controlled trial. The CM intervention provided a wide range of support services including, health education, clinical care coordination, medication adherence support, and social service assistance. The month-12 assessment included questions about healthcare utilization, stigma, substance use, and mental health., Results: Among the 144 participants virally unsuppressed at baseline, most had had a previous positive HIV test result; were Black, non-Hispanic, gay and bisexual men, aged 22-50. Among the 128 participants at the last study visit, 68 were virally suppressed, with no statistically significant difference between the CM and SOC arms (viral suppression 42% and 53%, respectively; adjusted odds ratio = 0.62 [P = 0.15; 95% confidence interval: 0.32, 1.2])., Conclusions: Reaching targets of at least 90% sustained viral suppression among all people with HIV will likely require more than an individual-level CM approach that addresses barriers to optimal care and treatment at multiple levels., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Timely identification of acute or early HIV infection (AEHI) is important to help prevent onward transmission, and understanding the number of secondary infections resulting from individuals with AEHI is key to planning HIV prevention services and case finding., Design: We performed a phylogenetic investigation of a dense sample of individuals with AEHI who took part in the Netherlands Cohort Study on Acute HIV infection (NOVA) in the Netherlands during 2015-2021., Methods: Transmission clusters were identified using phylogenetic analyses based on HIV pol sequences. The Tamura-Nei model was used to estimate genetic distance. A number of 1000 bootstraps was used to check the reliability of clustering using maximum likelihood. A cluster was defined as having a bootstrap value of at least 95% and a genetic distance of at most 1.5%. Sensitivity analyses using different values for the bootstrap and genetic distance were performed to study the reproducibility of the clustering., Results: Of the 156 participants included in NOVA between July 2015 and April 2021, 134 individuals for whom baseline characteristics and genotypic resistance data at baseline were available could be included. We identified 10 clusters, but the majority of persons (111/134) were not part of a cluster, suggesting mainly independent transmission events., Conclusion: Mainly independent transmission events among a study population consisting predominantly of MSM in a low-incidence high-resource setting is likely the result of active AEHI case finding and direct start of treatment, and the roll-out over recent years of preventive measures such as preexposure prophylaxis., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objectives: To analyze phylogenetic relations and assess the role of cross-border clusters in the spread of HIV-1 subtype B across the Balkans, given the general trends of new HIV diagnoses in seven Balkan countries., Design: Retrospective phylogenetic and trend analysis., Methods: In-depth phylogenetic, phylodynamic and phylogeographic analysis performed on 2415 HIV-1 subtype B sequences from 1999 to 2019 using maximal likelihood and Bayesian methods. The joinpoint regression analysis of new HIV diagnoses by country and modes of transmission using 2004-2019 ECDC data., Results: Ninety-three HIV-1 Subtype B transmission clusters (68% of studied sequences) were detected of which four cross-border clusters (11% of studied sequences). Phylodynamic analysis showed activity of cross-border clusters up until the mid-2000s, with a subsequent stationary growth phase. Phylogeography analyses revealed reciprocal spread patterns between Serbia, Slovenia and Montenegro and several introductions to Romania from these countries and Croatia. The joinpoint analysis revealed a reduction in new HIV diagnoses in Romania, Greece and Slovenia, whereas an increase in Serbia, Bulgaria, Croatia and Montenegro, predominantly among MSM., Conclusion: Differing trends of new HIV diagnoses in the Balkans mirror differences in preventive policies implemented in participating countries. Regional spread of HIV within the countries of former Yugoslavia has continued to play an important role even after country break-up, whereas the spread of subtype B through multiple introductions to Romania suggested the changing pattern of travel and migration linked to European integration of Balkan countries in the early 2000s., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To estimate trends in the proportion of sexually active U.S. adults with HIV (PWH) reporting an HIV-discordant sexual partner taking preexposure prophylaxis (PrEP) and proportion of partners taking PrEP., Design: The Medical Monitoring Project is a complex sample survey of U.S. adults with diagnosed HIV., Methods: We used annual cross-sectional data collected during June 2015-May 2020 to estimate the annual percentage change (EAPC), overall and by selected characteristics, in reported partner PrEP use among PWH with HIV-discordant partners (N = 8707) and reported PrEP use among these partners (N = 15 844)., Results: The proportion of PWH reporting PrEP use by one or more HIV-discordant sex partner rose 19.5% annually (11.3 to 24.4%). The prevalence rose from 6.0 to 17.4% (EAPC, 25.8%) among Black PWH, 10.1 to 26.0% (EAPC, 19.5%) among Hispanic/Latino PWH, and 20.8 to 34.6% (EAPC, 16.3%) among White PWH. Among MSM with HIV, the prevalence increased from 9.6 to 32.6% (EAPC, 28.2%) among Black MSM, 16.6 to 36.0% (EAPC, 15.6%) among Hispanic/Latino MSM, and 24.9 to 44.1% (EAPC, 17.9%) among White MSM. Among HIV-discordant sex partners, the proportion reported to be taking PrEP increased 21.1% annually (7.8 to 18.8%). Reported PrEP use rose from 4.9 to 14.2% (EAPC, 29.9%) among Black partners, 6.5 to 16.8% (EAPC, 20.3%) among Hispanic/Latino partners, and 12.7 to 26.1% (EAPC, 17.0%) among White partners., Conclusions: One in five HIV-discordant sexual partners of PWH was reported to be taking PrEP. PrEP use rose among all examined populations, although the increases did not eliminate disparities in PrEP use., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The rectal mucosa is a critical site of HIV vulnerability. We sought to identify transcriptomic features of rectal mucosal tissue prior to exposure associated with support or restriction of HIV replication., Design: Rectal tissue from HIV-negative cis gender men ( n  = 57) underwent concurrent RNAseq transcriptomic analyses (two biopsies/participant) and challenge with HIV in the ex-vivo explant model of infection (three biopsies challenged/participant) as part of a larger cohort study to understand the rectal mucosal immune environment among MSM., Methods: P24 was quantified in the explant supernatants over a culture period of 18 days via ELISA. Participant median p24 log area under the curve was correlated with bulk transcriptomic data (Illumina HiSeq3000) to identify associations between gene expression and p24 production. Significant differentially expressed genes (DEGs) were identified via DESeq2 analysis and analyzed with Reactome to identify pathways of interest., Results: In total, 183 DEG (181 upregulated, two downregulated) were associated with higher p24 accumulation in the ex-vivo challenge model, including T-cell activation, B-cell function, and chemokine DEG. Reactome analysis of the upregulated genes identified 'Adaptive Immune System', 'Cytokine Signaling in Immune System', and 'Innate Immune System' as significantly upregulated pathways., Conclusion: For the first time, we identified rectal tissue transcriptomic signatures associated with increased p24 production utilizing an ex-vivo model. Our findings are highly relevant to HIV transmission and the early establishment of HIV reservoirs in humans, and future studies should examine the identified pathways as targets for new or improved biomedical prevention or treatment interventions., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate if community-level HIV PrEP coverage is correlated with individual sexual behaviors., Design: We used demographic, behavioral, and sexual network data from ARTnet, a 2017-2019 study of United States MSM., Methods: Multivariable regression models with a Bayesian modeling framework were used to estimate associations between area-level PrEP coverage and seven sexual behavior outcomes [number of total, main, and casual male partners (network degree); count of one-time partnerships; consistent condom use in one-time partnerships; and frequency of casual partnership anal sex (total and condomless)], controlling for individual PrEP use., Results: PrEP coverage ranged from 10.3% (Philadelphia) to 38.9% (San Francisco). Total degree was highest in Miami (1.35) and lowest in Denver (0.78), while the count of one-time partners was highest in San Francisco (11.7/year) and lowest in Detroit (1.5/year). Adjusting for individual PrEP use and demographics, community PrEP coverage correlated with total degree [adjusted incidence rate ratio (aIRR) = 1.73; 95% credible interval (CrI), 0.92-3.44], casual degree (aIRR = 2.05; 95% CrI, 0.90-5.07), and count of one-time partnerships (aIRR = 1.90; 95% CrI, 0.46-8.54). Without adjustment for individual PrEP use, these associations strengthened. There were weaker or no associations with consistent condom use in one-time partnerships (aIRR = 1.68; 95% CrI, 0.86-3.35), main degree (aIRR = 1.21; 95% CrI, 0.48-3.20), and frequency of casual partnership condomless anal sex (aIRR = 0.23; 95% CrI, 0.01-3.60)., Conclusion: Most correlations between community PrEP coverage and sexual behavior were explained by individual PrEP use. However, some residual associations remained after controlling for individual PrEP use, suggesting that PrEP coverage may partially drive community-level differences in sexual behaviors., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Non-governmental organizations (NGOs) in Ukraine have provided HIV testing, treatment, and condom distribution for MSM. HIV prevalence among MSM in Ukraine is 5.6%. We estimated the impact and cost-effectiveness of MSM-targeted NGO activities in Ukraine., Design: A mathematical model of HIV transmission among MSM was calibrated to data from Ukraine (2011-2018)., Methods: The model, designed before the 2022 Russian invasion of Ukraine, evaluated the impact of 2018 status quo coverage levels of 28% of MSM being NGO clients over 2016-2020 and 2021-2030 compared with no NGO activities over these time periods. Impact was measured in HIV incidence and infections averted. We compared the costs and disability adjusted life years (DALYs) for the status quo and a counterfactual scenario (no NGOs 2016-2020, but with NGOs thereafter) until 2030 to estimate the mean incremental cost-effectiveness ratio (cost per DALY averted)., Results: Without NGO activity over 2016-2020, the HIV incidence in 2021 would have been 44% (95% credibility interval: 36-59%) higher than with status quo levels of NGO activity, with 25% (21-30%) more incident infections occurring over 2016-2020. Continuing with status quo NGO coverage levels will decrease HIV incidence by 41% over 2021-2030, whereas it will increase by 79% (60-120%) with no NGOs over this period and 37% (30-51%) more HIV infections will occur. Compared with if NGO activities had ceased over 2016-2020 (but continued thereafter), the status quo scenario averts 14 918 DALYs over 2016-2030 with a mean incremental cost-effectiveness ratio of US$600.15 per DALY averted., Conclusion: MSM-targeted NGOs in Ukraine have prevented considerable HIV infections and are highly cost-effective compared with a willingness-to-pay threshold of 50% of Ukraine's 2018 GDP (US$1548)., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: HIV-infected men who have sex with men (MSM) are at high risk to develop human papilloma virus (HPV)-related oropharyngeal cancer. The aim of our study was to assess the usefulness of a pilot oral dysplasia screening program and its correlation with an anal dysplasia screening program., Methods: This was a prospective study with HIV-infected MSM. Oral and anal screenings were performed based on HPV determination, liquid cytology, direct and microscopy oral examinations, high-resolution anoscopy and biopsies, if necessary., Results: A total of 103 patients were included. The mean age of the patients was 44.6 years, 55.3% were smokers, and 57.3% had a history of previous anal high-grade squamous intraepithelial lesions (HSILs). The prevalence of oral HPV infections was 14% (9% HPV-high risk), the prevalence of abnormal cytology was 25.2%, and in 4.8% of the patients, oral examinations showed suspicious HSILs. Oral microscopy did not detect additional lesions that visual inspection. Five oral biopsies were performed and the results were normal. No risk factors for oral HPV infections were identified. The prevalence of anal HPV infections was 88.3% (76.7% HPV-high risk), 52.9% of the patients had altered cytology, and in 45.6% anoscopy showed changes suggestive of HSILs. Seventy-two anal biopsies were performed, detecting 25 cases of HSILs (24.3%).A poor correlation was observed between oral and anal HPV infections (κ = 0.037)., Conclusions: The prevalence of oral HPV infections, abnormal cytology and lesions in HIV-infected MSM was low, and their correlation with anal HPV-related lesions was slight. These results confirm the current barriers to oral dysplasia screening techniques., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: High rates of sexually transmitted infections (STIs) have been reported among pre-exposure prophylaxis (PrEP) users. We wished to assess the incidence and risk factors for recurrent STIs., Design: The ANRS IPERGAY trial was a prospective study investigating PrEP among MSM and transgender women in outpatient clinics in France and Canada. In all, 429 participants were enrolled, offered up to 4 years of PrEP and screened for bacterial STIs (syphilis, chlamydia and gonorrhea) at baseline and every 6 months., Methods: STIs incidence was calculated yearly. Cox proportional hazards model regression was used to explore associations between participants characteristics at baseline and recurrent STI during follow-up., Results: Over a median follow-up of 23 months, bacterial STI incidence was 75, 33, 13, 32 and 30 per 100 person-years for all STIs, rectal STIs, syphilis, gonorrhea and chlamydia, respectively. STI incidence significantly increased from the first year to the fourth year of the study (55 vs. 90 per 100 person-years, P  < 0.001). During the study period, 167 participants (39%) presented with more than one bacterial STIs which accounted for 86% of all STIs. Baseline risk factors associated with recurrent STIs in a multivariate analysis were an STI at baseline [hazards ratio: 1.48 (95% confidence interval (CI): 1.06-2.07), P  = 0.02], more than eight sexual partners in prior 2 months [hazards ratio: 1.72 (95% CI: 1.21-2.43), P  = 0.002] and the use of gamma-hydroxybutyrate [hazards ratio: 1.66 (95% CI: 1.16-2.38), P  = 0.005]., Conclusion: STI incidence was high and increased over time. Most STIs were concentrated in a high-risk group that should be targeted for future interventions., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To describe hepatitis C virus (HCV)-viremia prevalence and barriers to direct-acting antiviral (DAA) treatment during unrestricted access to DAA in a nationwide cohort of people with HIV (PWH)., Design: Retrospective analysis of prospectively collected data., Methods: We calculated yearly HCV-viremia prevalence as proportion of HCV RNA-positive individuals ever HCV-tested. We then included HCV-viremic individuals with ≥1 visit during the era of universal DAA-access (database lock = December 31, 2018). Based on their last visit, individuals were grouped as DAA-treated or -untreated. Variables associated with lack of DAA-treatment were assessed using targeted maximum likelihood estimation. In November 2020, physicians of DAA-untreated individuals completed a questionnaire on barriers to DAA-uptake and onward HCV-transmission risk., Results: Among 25 196 PWH, HCV-viremia decreased from 4% to 5% between 2000 and 2014 to 0.6% in 2019. Being DAA-untreated was associated with HIV-transmission route other than men who have sex with men, older age, infrequent follow-up, severe alcohol use, detectable HIV-RNA, HCV-genotype 3, and larger hospital size. With universal DAA-access, 72 of 979 HCV-viremic individuals remained DAA-untreated at their last visit. Of these, 39 were no longer in care, 27 remained DAA-untreated in care, and six initiated DAA since database lock. Most common physician-reported barriers to DAA-uptake were patient refusal (20/72, 28%) and infrequent visit attendance (19/72, 26%). Only one DAA-untreated individual in care was engaging in activities associated with onward HCV-transmission., Conclusions: Prevalence of HCV-viremic PWH is low in the Netherlands, coinciding with widespread DAA-uptake. Barriers to DAA-uptake appear mostly patient-related, while HCV-transmission seems unlikely from the few DAA-untreated in care., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Unintentional drug poisoning and overdose deaths in New York City (NYC) increased 175% between 2010 and 2017, partly due to the transition from noninjectable opioids to heroin injection. This transition has led to concern of a resurgent HIV epidemic among persons who inject drugs (PWID) in NYC. Thus, we sought to characterize HIV transmission dynamics in PWID., Design: Genetic network analysis of HIV-1 public health surveillance data., Methods: We analyzed HIV diagnoses reported to public health surveillance to determine the trajectory of the HIV epidemic among PWID in NYC, from 1985 through 2019. Genetic distance-based clustering was performed using HIV-TRACE to reconstruct transmission patterns among PWID., Results: The majority of the genetic links to PWID diagnosed in the 1980s and 1990s are to other PWID. However, since 2011, there has been a continued decline in new diagnoses among PWID, and genetic links between PWID have become increasingly rare, although links to noninjecting MSM and other people reporting sexual transmission risk have become increasingly common. However, we also find evidence suggestive of a resurgence of genetic links among PWID in 2018-2019. PWID who reported male-male sexual contact were not preferentially genetically linked to PWID over the surveillance period, emphasizing their distinct risk profile from other PWID., Conclusion: These trends suggest a transition from parenteral to sexual transmission among PWID in NYC, suggesting that harm reduction, syringe exchange programs, and legalization of over-the-counter syringe sales in pharmacies have mitigated HIV risk by facilitating well tolerated injection among new PWID., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To assess differences in anal cancer incidence between racial/ethnic groups among a clinical cohort of men with HIV who have sex with men., Design: Clinical cohort study., Methods: We studied men who have sex with men (MSM) in the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) who initiated antiretroviral therapy (ART) under HIV care in CNICS. We compared anal cancer incidence between Black and non-Black men and calculated hazard ratios controlling for demographic characteristics (age, CNICS site, year of ART initiation), HIV disease indicators (nadir CD4+, peak HIV RNA), and co-infection/behavioral factors including hepatitis B virus (HBV), hepatitis C virus (HCV), tobacco smoking and alcohol abuse., Results: We studied 7473 MSM with HIV who contributed 41 810 person-years of follow-up after initiating ART between 1996 and 2014 in CNICS. Forty-one individuals had an incident diagnosis of anal cancer under observation. Crude rates of anal cancer were 204 versus 61 per 100 000 person-years among Black versus non-Black MSM. The weighted hazard ratio for anal cancer in Black MSM (adjusting for demographics, HIV disease factors, and co-infection/behavioral factors) was 2.37 (95% confidence interval: 1.17, 4.82) compared to non-Black MSM., Conclusions: In this large multicenter cohort, Black MSM were at significantly increased risk for anal cancer compared to non-Black MSM. Further detailed studies evaluating factors impacting anal cancer incidence and outcomes in Black men with HIV are necessary. Inclusion of more diverse study cohorts may elucidate modifiable factors associated with increased anal cancer risk experienced by Black MSM., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: 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., Methods: 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., Results: 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., Discussion: 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., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objectives: The aim of this study was to evaluate whether infection occurred pre or postmigration and the associated diagnosis delay in migrants diagnosed with HIV in the UK., Design: We analyzed a cohort of individuals diagnosed with HIV in the UK in 2014-2016 born in Africa or elsewhere in Europe. Inclusion criteria were arrival within 15 years before diagnosis, availability of HIV pol sequence, and viral subtype shared by at least 10 individuals., Methods: We examined phylogenies for evidence of infection after entry into the UK and incorporated this information into a Bayesian analysis of timing of infection using biomarkers of CD4+ cell count, avidity assays, proportion of ambiguous nucleotides in viral sequences, and last negative test dates where available., Results: One thousand, two hundred and fifty-six individuals were included. The final model indicated that HIV was acquired postmigration for most MSM born in Europe (posterior expectation 65%, 95% credibility interval 64-67%) or Africa (65%, 62-69%), whereas a minority (20-30%) of men and women with heterosexual transmission acquired HIV postmigration. Estimated diagnosis delays were lower for MSM than for those with heterosexual transmission, and were lower for those with postmigration infection across all subgroups. For MSM acquiring HIV postmigration, the estimated mean time to diagnosis was less than one year, but for those who acquired HIV premigration, the mean time from infection to diagnosis was more than five years for all subgroups., Conclusion: Acquisition of HIV postmigration is common, particularly among MSM, calling for prevention efforts aimed at migrant communities. Delays in diagnosis reinforce the need for targeted testing initiatives., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The aim of this study was to investigate introductions and spread of different HIV-1 subtypes in the Netherlands., Design: We identified distinct HIV-1 transmission chains in the Netherlands within the global epidemic context through viral phylogenetic analysis of partial HIV-1 polymerase sequences from individuals enrolled in the ATHENA national HIV cohort of all persons in care since 1996, and publicly available international background sequences., Methods: Viral lineages circulating in the Netherlands were identified through maximum parsimony phylogeographic analysis. The proportion of HIV-1 infections acquired in-country among heterosexuals and MSM was estimated from phylogenetically observed, national transmission chains using a branching process model that accounts for incomplete sampling., Results: As of 1 January 2019, 2589 (24%) of 10 971 (41%) HIV-1 sequenced individuals in ATHENA had non-B subtypes (A1, C, D, F, G) or circulating recombinant forms (CRF01AE, CRF02AG, CRF06-cpx). The 1588 heterosexuals were in 1224, and 536 MSM in 270 phylogenetically observed transmission chains. After adjustments for incomplete sampling, most heterosexual (75%) and MSM (76%) transmission chains were estimated to include only the individual introducing the virus (size = 1). Onward transmission occurred mostly in chains size 2-5 amongst heterosexuals (62%) and in chains size at least 10 amongst MSM (64%). Considering some chains originated in-country from other risk-groups, 40% (95% confidence interval: 36-44) of non-B-infected heterosexuals and 62% (95% confidence interval: 49-73) of MSM-acquired infection in-country., Conclusion: Although most HIV-1 non-B introductions showed no or very little onward transmission, a considerable proportion of non-B infections amongst both heterosexuals and MSM in the Netherlands have been acquired in-country., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: To investigate HIV-related and age-related differences in hip bone structure in men and women., Design: Cross sectional study of bone structure and HIV serostatus., Methods: We used Quantitative Computed Tomography (QCT) data from the Multicenter AIDS Cohort Study (MACS) and Women's Interagency HIV Study (WIHS) to examine cortical thickness (CT) and cortical (CBMD), trabecular (TBMD), and integral (IBMD) bone mineral density across anatomic quadrants of the femoral neck in older adult MSM and women with (PWH) and without (PWOH) HIV infection. The percentage difference (%diff) in the means for CT and BMD overall and by quadrant between PWH and PWOH were estimated., Results: Among 322 MSM (median age 60 years) with bone measures, distributions were similar between HIV serostatus groups with %diff in the quadrant means ranging from -7 to -1% for CT and from -1 to 4% for BMD, and overall lower hip cortical thickness than expected. In contrast, in 113 women (median age 51 years), PWH had lower CT, IBMD and TBMD consistently across all quadrants, with differences ranging from -10 to -20% for CT, -6 to -11% for IBMD and -3 to -6% for TBMD. Estimates reached statistical significance in superoanterior quadrant for CT and IBMD and inferoposterior for CT., Conclusion: Among women, PWH appear to have a thinner cortex and less dense integral bone compared with PWOH, particularly in the superior quadrants whereas MSM overall had a thinner than expected hip cortex., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: HIV co-infection among persons diagnosed with gonorrhea is not well characterized. Trends in HIV prevalence among persons diagnosed with gonorrhea may have significant implications for HIV prevention interventions, especially for MSM. MSM are increasingly and disproportionately represented among incident gonorrhea cases reported in a multistate sentinel surveillance network. Using data from this network, we estimated HIV prevalence among MSM by self-report and explored trends in co-infection by key demographics., Design: Observational study using enhanced surveillance data., Methods: Six geographically diverse jurisdictions in the STD Surveillance Network (SSuN) 2010-2019 randomly sampled laboratory-confirmed gonorrhea cases. Enhanced investigations on sampled cases included patient interviews eliciting demographic, behavioral and HIV testing history. These data were weighted to adjust for study design and nonresponse to estimate trends in HIV prevalence., Results: Of 653 522 reported cases, 28 979 were sampled and investigated. The proportion of cases reporting living with diagnosed HIV at the time of their gonorrhea diagnosis increased 61% across the study period from 6.6% in 2010 to 10.8% in 2019. The observed increase in HIV prevalence is concurrent with an increase in the proportion of gonorrhea cases attributable to MSM. HIV prevalence among MSM decreased in two jurisdictions and increasing trends were observed among non-Hispanic Black and Hispanic MSM. HIV prevalence decreased among non-Hispanic white MSM, MSM under 20 and those 40 years of age or older., Conclusion: Diagnosis with gonorrhea, especially among MSM, should be a sentinel event triggering screening for HIV, referral to high-impact HIV prevention interventions or to HIV primary care., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To study the conditions under which preexposure prophylaxis (PrEP) coverage can eliminate HIV among MSM in the Paris region., Design: Mathematical modeling., Methods: We propose an innovative approach, combining a transmission model with a game-theoretic model, for decision-making about PrEP use. Individuals at high risk of HIV infection decide to use PrEP, depending on their perceived risk of infection and the relative cost of using PrEP versus antiretroviral treatment (ART), which includes monetary and/or nonmonetary aspects, such as price and access model of PrEP, consequences of being infected and lifelong ART., Results: If individuals assessed correctly their infection risk, and the cost of using PrEP were sufficiently low, then the PrEP rollout could lead to elimination. Specifically, assuming 86% PrEP effectiveness, as observed in two clinical trials, a minimum PrEP coverage of 55% [95% confidence interval (CI) 43-64%] among high-risk MSM would achieve elimination in the Paris region. A complete condom drop by MSM using PrEP slightly increases the minimum PrEP coverage required for elimination, by ∼1%, whereas underestimation of their own HIV infection risk would require PrEP programs reduce the cost of using PrEP by a factor ∼2 to achieve elimination., Conclusion: Elimination conditions are not yet met in the Paris region, where at most 47% of high-risk MSM were using PrEP as of mid-2019. Further lowering the cost of PrEP and promoting a fair perception of HIV risk are required and should be maintained in the long-run, to maintain elimination status., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To assess the time from HIV diagnosis to ART initiation and the effect of rapid ART initiation (i.e. within 7 days of HIV diagnosis) on attrition and virologic and immunologic responses among MSM in Burkina Faso, Côte d'Ivoire, Mali, and Togo., Design: Prospective cohort study between 2015 and 2019., Methods: MSM aged 18 years or older newly diagnosed with HIV infection were eligible to participate. ART was proposed to participants upon HIV diagnosis, irrespective of clinical stage and CD4+ cell count, and was initiated as soon as possible, with no specific time frame. Determinants of rapid ART initiation and its effect on treatment outcomes were assessed using multivariate analyses., Results: Of 350 MSM, 335 (95.7%) initiated ART after a median time of 5 days. Of the latter, 216 (64.5%) had rapid ART initiation. The 335 participants were followed up for a median time of 24.1 months. One hundred and eleven (33.1%) were not retained in care. Rapid ART initiation was less likely in participants with a CD4+ cell count at least 200 cells/μl [adjusted odds ratio (aOR) 0.37, 95% confidence interval (CI) 0.15-0.88]. It improved viral load suppression (aOR 6.96, 95% CI 1.98-24.46) but had no effect on attrition (aOR 0.87, 95% CI 0.57-1.33) or CD4+ cell count increase (adjusted coefficient 28.23, 95% CI -17.00 to 73.45)., Conclusion: These results in MSM in West Africa support the WHO recommendation for rapid ART initiation. Clinics need to develop context-specific strategies for rapid ART initiation and for retaining MSM in HIV care.ClinicalTrials.gov, number NCT02626286., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Despite the risks of immunosuppression, recommendations regarding screening for HIV infection prior to initiation of biologic therapies targeting common rheumatologic disorders, including inflammatory bowel disease (IBD) and inflammatory arthritides, are limited. Few cases of patients started on biologics while living with undiagnosed HIV infection have been reported., Methods: We report three cases of patients initiated on biologics in the absence of recent or concurrent HIV screening who developed refractory disease or unanticipated complications and were later found to have undiagnosed chronic HIV infection., Results: In Case 1, a 53-year-old MSM with negative HIV testing 2 years prior presented with presumed rheumatoid arthritis. He did not respond to methotrexate, so adalimumab was started. HIV testing to evaluate persistent symptoms was positive 9 months later; CD4+ T-cell count was 800 cells/μl. Antiretroviral therapy (ART) resulted in resolution of symptoms, which were attributed to HIV-associated arthropathy. In Case 2, a 55-year-old woman with injection drug use in remission and no prior HIV testing presented with hidradenitis suppurativa. She started infliximab and methotrexate therapy with good response. After she developed weight loss and lymphopenia, an HIV test was positive; CD4+ T-cell count was 334 cells/μl. Biologic hidradenitis suppurativa therapy was discontinued, with subsequent poor hidradenitis suppurativa control. In Case 3, a 32-year-old MSM with no prior HIV testing presented with presumed IBD; infliximab and steroids were started. Symptoms progressed despite IBD-directed therapy, and he was diagnosed with extensive Kaposi sarcoma with visceral and cutaneous involvement, likely exacerbated by immunosuppression. HIV testing was positive; CD4+ T-cell count was 250 cells/μl. Kaposi sarcoma initially worsened due to ART-associated immune reconstitution inflammatory syndrome. He is now improving with systemic chemotherapy and ART. HIV-associated Kaposi sarcoma is presumed to be the underlying diagnosis., Conclusion: All three patients had elevated risk for HIV infection, and two had final diagnoses attributed to chronic HIV infection, not warranting therapeutic immunosuppression. Screening for HIV infection prior to initiation of biologic therapy should be incorporated into clinical practice guidelines., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Anal cancer precursor lesions high-grade anal intraepithelial neoplasia (HGAIN) are highly prevalent among HIV+ MSM. Treatment of HGAIN is frustrated by high recurrence rates. We investigated the efficacy of the quadrivalent human papillomavirus (qHPV) vaccine as posttreatment adjuvant in preventing HGAIN recurrence in HIV+ MSM., Design: Randomized, double-blind, placebo-controlled, multicentre trial., Setting: Three HIV outpatient clinics in Amsterdam, the Netherlands., Subjects: HIV+ MSM with CD4+ cell count more than 350 cells/μl, biopsy-proven intra-anal HGAIN successfully treated in the past year, and lesions still in remission at enrolment, as assessed by high-resolution anoscopy (HRA)., Intervention: Participants were randomized to three doses of qHPV (Gardasil-4, MSD) or placebo with vaccinations at 0, 2, and 6 months. HRA was repeated at 6, 12, and 18 months., Main Outcome Measure: The primary outcome was cumulative, biopsy-proven HGAIN recurrence rate at 18 months, evaluated in an intention-to-treat (ITT) (received all vaccinations) and per-protocol analysis (all vaccinations and complete follow-up)., Results: We randomized 126 participants of which 64 (50.8%) received qHPV and 62 (49.2%) placebo. All participants received three vaccinations, and in both groups for two participants follow-up was incomplete. We found no difference (P = 0.38) in cumulative HGAIN recurrence rates between the qHPV (44/64, 68.8%) and placebo group (38/62, 61.3%) in the ITT analysis [absolute risk reduction -7.5 (95% confidence interval (CI) -24.1 to 9.2)]. This was similar in the per-protocol analysis., Conclusion: Despite adequate serological responses to qHPV vaccination, short-term recurrence of HGAIN was not prevented. These findings do not support qHPV vaccination as a treatment adjuvant to prevent HGAIN recurrence in HIV+ MSM., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: Improving adherence to preexposure prophylaxis (PrEP) by providing automated feedback on self-reported PrEP use via a mobile application (app)., Design: Randomized clinical trial among MSM participating in the Amsterdam PrEP demonstration project (AMPrEP)., Methods: Eligible participants were randomized 1 : 1 to the control or intervention app. Both allowed daily reporting of sexual behaviour and medication intake; the intervention app also provided visual feedback. Dried blood spots collected at 12 and 24 months yielded intracellular tenofovir diphosphate concentrations (TFV-DP). We assessed proportions of participants with poor (TFV-DP <700 fmol/punch; primary outcome), good (TFV-DP ≥700 fmol/punch) and excellent (TFV-DP ≥1250 fmol/punch; secondary outcome) adherence at both time-points, and the association with the control or intervention app., Results: We randomized 229 participants, 118 to the intervention and 111 to the control arm. The primary, per-protocol, analysis included 83 participants per arm. In total, 22/166 (13%) of participants adhered poorly, 144/166 (87%) good and 66/166 (40%) excellently. App feedback did not result in a lower proportion of participants with poor adherence [control: 9 of 83 (11%); intervention: 13 of 83 (16%); P = 0.36]. App feedback did result in a larger proportion of participants with excellent adherence [control: 26/83 (31%); intervention: 40/83 (48%); P = 0.026]., Conclusion: In this highly adherent population, app feedback did not improve the proportion of participants with poor adherence to PrEP.Clinical Trial Number Netherlands Trial Register: NL5413., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: To examine the association between HIV laws, perceived community stigma, and behaviors and to compare differences between and within Black and White men who have sex with men (MSM)., Design/methods: National HIV Behavioral Surveillance conducted interviews and HIV testing with MSM in 23 U.S. cities in 2017 using venue-based sampling methods. We used weighted cross-sectional data to compare MSM living in states with versus without HIV laws using Rao-Scott chi-square tests. We modeled the association between stigma and state HIV laws within racial groups to obtain adjusted prevalence ratios (aPR) and 95% confidence intervals (CIs)., Results: Among 7392 MSM, 56% lived in a state with HIV laws. In law states, Black MSM were more likely than White MSM to report their community would discriminate against persons with HIV (PWH) (59 versus 34%), not support the rights of PWH (20 versus 9%), not be friends with PWH (19 versus 10%), believe PWH 'got what they deserved' (27 versus 16%), and be intolerant of MSM (14 versus 5%). Adjusted for confounders, Black MSM in HIV law states were more likely to think their community would discriminate against PWH (aPR, 1.14; 95% CI, 1.02-1.29; P = 0.02) and be intolerant toward MSM (aPR, 2.02; 95% CI, 1.43-2.86; P < 0.001) than Black MSM in states without such laws., Conclusions: HIV laws were related to higher stigma, but only for Black MSM. Future research regarding HIV-related laws should account for racial/ethnic disparities. Modernizing laws can delegitimize stigma and promote focusing on effective HIV prevention strategies., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: To assess the cost-effectiveness of a preexposure prophylaxis (PrEP) programme offering a choice of daily and event-driven PrEP for men who have sex with men (MSM) in the Netherlands., Methods: We used an agent-based transmission model and an economic model to simulate a programme offering only daily PrEP and a programme offering daily and event-driven PrEP. Use of PrEP medication and preference for daily versus event-driven PrEP were estimated from the Amsterdam PrEP Demonstration Project (AMPrEP). We calculated costs, quality-adjusted life-years (QALY), and incremental cost-effectiveness ratios (ICER), over 2018-2027. An ICER less than €20 000 per QALY gained was considered cost-effective., Results: Using AMPrEP data, we estimated that 27% of PrEP users chose event-driven PrEP with a median of 12 pills per month; daily PrEP users used a median of 30 pills per month. With PrEP, 3740 HIV infections were averted and 1482 QALYs were gained over 2018-2027, compared to the scenario without PrEP. The probability of the PrEP programme being cost-effective (compared to not having a PrEP programme) increased from 91% with daily PrEP to 94% with a choice of daily and event-driven PrEP. The probability of being cost-saving increased from 42% with only daily PrEP to 48% with choice of daily and event-driven PrEP., Conclusions: A daily PrEP programme for MSM would be cost-effective. Providing a choice of daily and event-driven PrEP can result in savings and is more likely to be cost-effective and cost-saving, compared to a programme offering only daily PrEP., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)