Achieving the "Ending the HIV Epidemic in the U.S." incidence reduction goals among at-risk populations in the South.

INTRODUCTION: Antiretroviral medication coverage remains sub-optimal in much of the United States, particularly the Sothern region, and Non-Hispanic Black or African American persons (NHB) continue to be disproportionately impacted by the HIV epidemic. The "Ending the HIV Epidemic in the U.S." (EHE) initiative seeks to reduce HIV incidence nationally by focusing resources towards the most highly impacted localities and populations. This study evaluates the impact of hypothetical improvements in ART and PrEP coverage to estimate the levels of coverage needed to achieve EHE goals in the South. METHODS: We developed a stochastic, agent-based network model of 500,000 individuals to simulate the HIV epidemic and hypothetical improvements in ART and PrEP coverage. RESULTS: New infections declined by 78.6% at 90%/40% ART/PrEP and 94.3% at 100%/50% ART/PrEP. Declines in annual incidence rates surpassed 75% by 2025 with 90%/40% ART/PrEP and 90% by 2030 with 100%/50% ART/PrEP coverage. Increased ART coverage among NHB MSM was associated with a linear decline in incidence among all MSM. Declines in incidence among Hispanic/Latino and White/Other MSM were similar regardless of which MSM race group increased their ART coverage, while the benefit to NHB MSM was greatest when their own ART coverage increased. The incidence rate among NHB women declined by over a third when either NHB heterosexual men or NHB MSM increased their ART use respectively. Increased use of PrEP was associated with a decline in incidence for the groups using PrEP. MSM experienced the largest absolute declines in incidence with increasing PrEP coverage, followed by NHB women. CONCLUSIONS: Our analysis indicates that it is possible to reach EHE goals. The largest reductions in HIV incidence can be achieved by increasing ART coverage among MSM and all race groups benefit regardless of differences in ART initiation by race. Improving ART coverage to > 90% should be prioritized with a particular emphasis on reaching NHB MSM. Such a focus will reduce the largest number of incident cases, reduce racial HIV incidence disparities among both MSM and women, and reduce racial health disparities among persons with HIV. NHB women should also be prioritized for PrEP outreach.

Perceived Interruptions to HIV Prevention and Treatment Services Associated With COVID-19 for Gay, Bisexual, and Other Men Who Have Sex With Men in 20 Countries.

BACKGROUND: The coronavirus pandemic has necessitated a range of population-based measures to stem the spread of infection. These measures may be associated with disruptions to other health services including for gay, bisexual, and other men who have sex with men (MSM) at risk for or living with HIV. Here, we assess the relationship between stringency of COVID-19 control measures and interruptions to HIV prevention and treatment services for MSM. SETTING: Data for this study were collected between April 16, 2020, and May 24, 2020, as part of a COVID-19 Disparities Survey implemented by the gay social networking app, Hornet. Pandemic control measures were quantified using the Oxford Government Response Tracker Stringency Index: each country received a score (0-100) based on the number and strictness of 9 indicators related to restrictions, closures, and travel bans. METHODS: We used a multilevel mixed-effects generalized linear model with Poisson distribution to assess the association between stringency of pandemic control measures and access to HIV services. RESULTS: A total of 10,654 MSM across 20 countries were included. Thirty-eight percent (3992/10,396) reported perceived interruptions to in-person testing, 55% (5178/9335) interruptions to HIV self-testing, 56% (5171/9173) interruptions to pre-exposure prophylaxis, and 10% (990/9542) interruptions to condom access. For every 10-point increase in stringency, there was a 3% reduction in the prevalence of perceived access to in-person testing (aPR: 0·97, 95% CI: [0·96 to 0·98]), a 6% reduction in access to self-testing (aPR: 0·94, 95% CI: [0·93 to 0·95]), and a 5% reduction in access to pre-exposure prophylaxis (aPR: 0·95, 95% CI: [0·95 to 0·97]). Among those living with HIV, 20% (218/1105) were unable to access their provider; 65% (820/1254) reported being unable to refill their treatment prescription remotely. CONCLUSIONS: More stringent responses were associated with decreased perceived access to services. These results support the need for increasing emphasis on innovative strategies in HIV-related diagnostic, prevention, and treatment services to minimize service interruptions during this and potential future waves of COVID-19 for gay men and other MSM at risk for HIV acquisition and transmission.

Persistence on oral pre-exposure prophylaxis (PrEP) among female sex workers in eThekwini, South Africa, 2016-2020.

BACKGROUND: Despite the established efficacy of PrEP to prevent HIV and the advantages of a user-controlled method, PrEP uptake and persistence by women in both trials and demonstration projects has been suboptimal. We utilized real-world data from an HIV service provider to describe persistence on oral PrEP among female sex workers (FSW) in eThekwini, South Africa. METHODS: We examined time from PrEP initiation to discontinuation among all FSW initiating PrEP at TB HIV Care in eThekwini between 2016-2020. We used a discrete time-to-event data setup and stacked cumulative incidence function plots, displaying the competing risks of 1) not returning for PrEP, 2) client discontinuation, and 3) provider discontinuation. We calculated hazard ratios using complementary log-log regression and sub-hazard ratios using competing risks regression. RESULTS: The number of initiations increased each year from 155 (9.3%, n = 155/1659) in 2016 to 1224 (27.5%, n = 1224/4446) in 2020. Persistence 1-month after initiation was 53% (95% CI: 51%-55%). Younger women were more likely to discontinue PrEP by not returning compared with those 25 years and older. Risk of discontinuation through non-return declined for those initiating in later years. Despite the COVID-19 pandemic, a greater number of initiations and sustained persistence were observed in 2020. CONCLUSIONS: Low levels of PrEP persistence were observed, consistent with data among underserved women elsewhere. Encouragingly, the proportion of women persisting increased over time, even as the number of women newly initiating PrEP and staff workload increased. Further research is needed to understand which implementation strategies the program may have enacted to facilitate these improvements and what further changes may be necessary.

Changes in Sexual Behavior, PrEP Adherence, and Access to Sexual Health Services Because of the COVID-19 Pandemic Among a Cohort of PrEP-Using MSM in the South.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has had unforeseen consequences on the delivery of HIV and sexually transmitted disease (STD) prevention services. However, little is known about how the pandemic has impacted pre-exposure prophylaxis (PrEP)-using men who have sex with men (MSM). METHODS: Data come from an online cohort of PrEP-using MSM in the Southern United States from October 2019 to July 2020. Participants were administered 10 surveys in total, including 1 ad hoc survey specifically on COVID-19. We conducted a cross-sectional analysis of this ad hoc survey (n = 56) and present changes in sexual behaviors and utilization of and access to sexual health services. Using linear mixed-effect regression models, we also analyzed data from the larger cohort and document how sexual behaviors and PrEP use varied longitudinally across several months. RESULTS: A fifth of participants discontinued or changed how often they take PrEP because of COVID-19. A quarter of the cohort documented challenges when attempting to access PrEP, HIV testing, or STD testing. For all sexual behaviors examined longitudinally-number of male sexual partners, anal sex acts, condomless anal sex, and oral sex (all measured in the past 2 weeks)-there was a decrease from February to April followed by an increase from April to June. DISCUSSION: Our findings suggest reduced access to and utilization of STD and HIV services coupled with a continuation of behaviors which confer STD/HIV risk. Ensuring appropriate delivery of STD/HIV prevention services during this pandemic is imperative.

The potential effect of COVID-19-related disruptions on HIV incidence and HIV-related mortality among men who have sex with men in the USA: a modelling study.

BACKGROUND: During the COVID-19 pandemic, men who have sex with men (MSM) in the USA have reported similar or fewer sexual partners and reduced HIV testing and care access compared with before the pandemic. Pre-exposure prophylaxis (PrEP) use has also declined. We aimed to quantify the potential effect of COVID-19 on HIV incidence and HIV-related mortality among US MSM. METHODS: We used a calibrated, deterministic, compartmental HIV transmission model for MSM in Baltimore (MD, USA) and available data on COVID-19-related disruptions to HIV services to predict effects of reductions in sexual partners (0%, 25%, 50%), condom use (5%), HIV testing (20%), viral suppression (10%), PrEP initiations (72%), PrEP adherence (9%), and antiretroviral therapy (ART) initiations (50%). In our main analysis, we modelled disruptions due to COVID-19 starting Jan 1, 2020, and lasting 6 months. We estimated the median change in cumulative new HIV infections and HIV-related deaths among MSM over 1 and 5 years, compared with a base case scenario without COVID-19-related disruptions. FINDINGS: A 25% reduction in sexual partners for 6 months among MSM in Baltimore, without HIV service changes, could reduce new HIV infections by median 12·2% (95% credible interval 11·7 to 12·8) over 1 year and median 3·0% (2·6 to 3·4) over 5 years. In the absence of changes in sexual behaviour, the 6-month estimated reductions in condom use, HIV testing, viral suppression, PrEP initiations, PrEP adherence, and ART initiations combined are predicted to increase new HIV infections by median 10·5% (5·8 to 16·5) over 1 year, and by median 3·5% (2·1 to 5·4) over 5 years. Disruptions to ART initiations and viral suppression are estimated to substantially increase HIV-related deaths (ART initiations by median 1·7% [0·8 to 3·2], viral suppression by median 9·5% [5·2 to 15·9]) over 1 year, with smaller proportional increases over 5 years. The other individual disruptions (to HIV testing, PrEP and condom use, PrEP initiation, and partner numbers) were estimated to have little effect on HIV-related deaths (<1% change over 1 or 5 years). A 25% reduction in sexual partnerships is estimated to offset the effect of the combined service disruptions on new HIV infections (change over 1 year: median -3·9% [-7·4 to 1·0]; over 5 years: median 0·0% [-0·9 to 1·4]), but not on HIV deaths (change over 1 year: 11·0% [6·2 to 17·7]; over 5 years: 2·6% [1·5 to 4·3]). INTERPRETATION: Maintaining access to ART and adherence support is of the utmost importance to maintain viral suppression and minimise excess HIV-related mortality due to COVID-19 restrictions in the USA, even if disruptions to services are accompanied by reductions in sexual partnerships. FUNDING: National Institutes of Health.

Brief Report: Changes in PrEP Use, Sexual Practice, and Use of Face Mask During Sex Among MSM During the Second Wave of COVID-19 in Melbourne, Australia.

BACKGROUND: A second wave of COVID-19 began in late June in Victoria, Australia. Stage 3 then Stage 4 restrictions were introduced in July-August. This study aimed to compare the use of pre-exposure prophylaxis (PrEP) and sexual practices among men who have sex with men taking PrEP between May-June (post-first lockdown) and July-August (second lockdown). METHODS: This was an online survey conducted among men who have sex with men who had their PrEP managed at the Melbourne Sexual Health Centre, Australia. A short message service with a link to the survey was sent to 503 PrEP clients who provided consent to receive a short message service from Melbourne Sexual Health Centre in August 2020. RESULTS: Of the 192 participants completed the survey, 153 (80%) did not change how they took PrEP. Of the 136 daily PrEP users, 111 (82%) continued to take daily PrEP, 3 (2%) switched to on-demand PrEP, and 22 (16%) stopped PrEP in July-August. Men generally reported that they had no partners or decreased sexual activities during second lockdown compared with post-first lockdown; the number of casual sex partners (43% decreased vs. 3% increased) and the number of kissing partners (36% decreased vs. 3% increased). Most men reported no chemsex (79%) or group sex (77%) in May-August. 10% (13/127) of men had ever worn face masks during sex in May-August. CONCLUSION: During the second wave of COVID-19 in Victoria, most men did not change the way they used PrEP but the majority had no risks or reduced sexual practices while one in 10 men wore a face mask during sex.

COVID-19 restrictions and changing sexual behaviours in HIV-negative MSM at high risk of HIV infection in London, UK.

OBJECTIVES: The COVID-19 pandemic and its related restrictions have affected attendance to and delivery of UK sexual healthcare services (SHS). We surveyed the impact on sexual behaviour of men having sex with men (MSM) to inform future SHS provision. METHODS: We conducted a cross-sectional, anonymous, web-based survey among HIV-negative MSM at high risk of HIV infection who attended 56 Dean Street, a sexual health and HIV clinic. The survey was conducted over a 7-day period in August 2020. Data on sociodemographic characteristics, sexual behaviour and related mental well-being experienced during lockdown (defined as 23 March-30 June 2020) were extracted. Categorical and non-categorical variables were compared according to HIV pre-exposure prophylaxis (PrEP) use. RESULTS: 814 MSM completed the questionnaire: 75% were PrEP users; 76% reported they have been sexually active, of which 76% reported sex outside their household. 75% reported fewer partners than prior to lockdown. Isolation/loneliness (48%) and anxiety/stress (27%) triggered sexual activity, and 73% had discussed COVID-19 transmission risks with their sexual partners. While 46% reported no change to emotions ordinarily experienced following sex, 20% reported guilt for breaching COVID-19 restrictions. 76% implemented one or more changes to their sexual behaviour, while 58% applied one or more steps to reduce COVID-19 transmission during sex. 36% accessed SHS and 30% reported difficulties in accessing testing/treatment. Of those who accessed SHS, 28% reported an STI diagnosis. PrEP users reported higher partner number, engagement in 'chemsex' and use of SHS than non-PrEP users. CONCLUSIONS: COVID-19 restrictions had a considerable impact on sexual behaviour and mental well-being in our survey respondents. High rates of sexual activity and STI diagnoses were reported during lockdown. Changes to SHS provision for MSM must respond to high rates of psychological and STI-related morbidity and the challenges faced by this population in accessing services.

How to Build the Plane While Flying: VTE/PE Thromboprophylaxis Clinical Guidelines for COVID-19 Patients.

Over the years, the practice of medicine has evolved from authority-based to experience-based to evidence-based with the introduction of the scientific process, clinical trials, and outcomes-based data analysis (Tebala GD. Int J Med Sci. 2018;15(12):1397-1405). The time required to perform the necessary randomized controlled trials, a systematic literature review, and meta-analysis of these trials to then create, accept, promulgate, and educate the practicing clinicians to use the evidence-based clinical guidelines is typically measured in years. When the severe acute respiratory syndrome novel coronavirus-2 (SARS-nCoV-2) pandemic commenced in Wuhan, China at the end of 2019, there were few available clinical guidelines to deploy, let alone adapt and adopt to treat the surge of coronavirus disease 2019 (COVID-19) patients. The aim of this study is to first explain how clinical guidelines, on which bedside clinicians have grown accustomed, can be created in the midst of a pandemic, with an evolving scientific understanding of the pathophysiology of the hypercoagulable state. The second is to adapt and adopt current venous thromboembolism diagnostic and treatment guidelines, while relying on the limited available observational reporting of COVID-19 patients to create a comprehensive clinical guideline to treat COVID-19 patients.

Increasing dosages of low-molecular-weight heparin in hospitalized patients with Covid-19.

We conducted an observational cohort study in adult patients consecutively admitted for the respiratory illness Covid-19 to our hub hospital from March 9 to April 7, 2020. The high observed rate of venous thromboembolism prompted us to increase the prophylactic doses of enoxaparin from 40 mg daily up to 1 mg/kg twice daily in patients admitted to intensive care units (ICU), 0.7 mg/kg twice daily in high-intensity of care wards and 1 mg/kg daily in low-intensity of care wards. Patients on high enoxaparin doses were compared to those who received prophylaxis with the standard dosage. Efficacy endpoints were mortality, clinical deterioration, and the occurrence of venous thromboembolism, safety endpoint was the occurrence of major bleeding. Of 278 patients with Covid-19, 127 received prophylaxis with high enoxaparin doses and 151 with standard dosage. At 21 days, the incidence rate of death and clinical deterioration were lower in patients on higher doses than in those on the standard dosage (hazard ratio 0.39, 95% confidence interval 0.23-0.62), and the incidence of venous thromboembolism was also lower (hazard ratio 0.52, 95% confidence interval 0.26-1.05). Major bleeding occurred in four of 127 patients (3.1%) on the high enoxaparin dosage. In conclusion, in the cohort of patients with Covid-19 treated with high enoxaparin dosages we observed a 60% reduction of mortality and clinical deterioration and a 50% reduction of venous thromboembolism compared to standard dosage prophylaxis. However, 3% of patients on high enoxaparin dosages had non-fatal major bleeding.

Substantial Decline in Use of HIV Preexposure Prophylaxis Following Introduction of COVID-19 Physical Distancing Restrictions in Australia: Results From a Prospective Observational Study of Gay and Bisexual Men.

BACKGROUND: In response to the novel coronavirus disease (COVID-19) pandemic, Australia introduced public health and physical distancing restrictions in late March 2020. We investigated the impact of these restrictions on HIV preexposure prophylaxis (PrEP) use among Australian gay and bisexual men (GBM). METHODS: Participants in an ongoing online cohort study previously reported PrEP use from 2014 to 2019. In April 2020, 847 HIV-negative and untested participants completed questionnaires assessing changes in PrEP use as a result of COVID-19 public health measures. Binary logistic multiple regression was used to estimate adjusted odds ratios (aOR) and 95% confidence intervals (95% CI) to compare changes in PrEP use behaviors. RESULTS: Among 847 men, mean age was 44.1 years (SD: 12.7). PrEP use rose from 4.9% in 2015 to 47.2% in 2020. Among those, 41.8% (n = 167) discontinued PrEP use during COVID-19 restrictions. Discontinuing PrEP during COVID-19 restrictions was independently associated with being less likely to have recently tested for HIV (aOR: 0.17; 95% CI: 0.09 to 0.34; P < 0.001) and less likely to report sex with casual partners (aOR: 0.28; 95% CI: 0.14 to 0.54; P < 0.001). CONCLUSIONS: By April 2020, following the introduction of COVID-19 restrictions, GBM dramatically reduced PrEP use, coinciding with a reduction in sexual activity. Longer-term impacts of COVID-19 restrictions on sexual behaviors among GBM need to be monitored because they may foreshadow fluctuations in prevention coverage and risk of HIV infection. Our findings indicate a potential need for clear, targeted information about resumption of PrEP and on-demand optimal dosing regimens in response to ongoing changes in restrictions.

Hydroxychloroquine for prophylaxis of COVID-19 physicians survey: Despite lack of evidence, many would take or give to dear ones, and despite the perceived necessity of an RCT, few would participate.

INTRODUCTION: There was no evidence concerning the prophylaxis with hydroxychloroquine, and only low-grade evidence regarding the use of hydroxychloroquine as a treatment for COVID-19 patients. We performed a survey among Romanian physicians in order to see how many of them would administer prophylactically hydroxychloroquine to themselves or to people close to them, and if they would participate to a randomized controlled trial. METHODS: Between March 30 and April 02, 2020, a 16-item questionnaire was shared in a Romanian Facebook group of 2645 physicians dedicated to COVID-19 information, asking to be completed by physicians who could be directly involved in the care of these patients. RESULTS: A total of 785 answers were collected. Nine physicians (1.1%) thought that there was clear evidence on prescribing hydroxychloroquine prophylaxis, 375 (48%) considered the evidence acceptable, 348 (44.3%) considered it weak, whereas 53 (6.8%) answered there was no evidence. 59 (7.5%) respondents were determined to take it (of which 31 = 4% already took), 192 (24.5%) were inclined to take, 271 (34.5%) were not decided yet. 175 (22.3%) of respondents declared they (would) give the treatment to their close ones, and this decision was associated with a higher age (P = 0.003), and the opinion that there was evidence (P < 0.001). When asked about the source of the treatment regimen, 286 (36.4%) indicated a scientific paper, while no scientific paper about the prophylaxis with hydroxychloroquine existed at that time. 718 (91.5%) considered a randomized clinical trial necessary (RCT), but only 333 (42.4%) answered they would enrol in such a trial. There was only a very weak correlation (Kendall's tau _b = 0.255, P < 0.001) between the belief that an RCT is necessary and the willingness to enrol in such an RCT. CONCLUSIONS: Despite the lack of evidence, many physicians considered the evidence as existing, and were ready to take or to give hydroxychloroquine prophylactically to family. They considered an RCT necessary, but they were not willing to participate.