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Introduction: Among people with an opioid use disorder in the United States, only 10% receive buprenorphine treatment. The Ryan Haight Act is a federal law that has regulated buprenorphine delivery, requiring an in-person examination between a patient and provider before initiating treatment. At the beginning of the COVID-19 pandemic, federal agencies waived in-person examination requirements for buprenorphine treatment initiation. We examined whether Ryan Haight Act waiver improved implementation of telehealth buprenorphine within syringe service programs (SSPs) - organizations that serve people with historically low access to treatment., Methods: We surveyed all known SSPs operating in the US in 2021 (N = 421) of which 77% responded (n = 325). We calculated the prevalence and accompanying 95% confidence intervals (CI) for implementation of telehealth buprenorphine inductions at SSPs in 2020. Multivariable logistic regression was used to assess differences in implementing telehealth buprenorphine inductions by organizational characteristics., Results: In 2020, the prevalence of implementing buprenorphine inductions via telehealth was 24% (95% CI:19-30%). Non-governmental SSPs had a higher odds of telehealth buprenorphine inductions (adjusted odds ratio (aOR)= 2.92; 95% CI:1.22-7.00; p = 0.016), compared to governmental SSPs. Furthermore, the larger the organization's annual budget, the higher the odds of telehealth buprenorphine implementation (aOR=2.00 per quartile (95% CI:1.33-2.99; p = 0.001). SSPs located in states with higher opioid overdose mortality rates did not have significantly higher likelihood of telehealth buprenorphine implementation., Conclusion: A substantial number of SSPs implemented telehealth buprenorphine after waiver of the Ryan Haight Act. Permanent adoption of this waiver will be critical and providing financial resources to SSPs is vital to support implementation of new innovations., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes., Methods: The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial (M 2 HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated., Discussion: The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings., Trial Registration: Clinicaltrials.gov NCT03981445 . Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201., (© 2022. The Author(s).)

CHOICES was an open-label, randomized, comparative effectiveness trial of office-based extended-release naltrexone versus treatment as usual in people with untreated opioid use disorder and HIV. This study explored facilitators to recruitment in Miami, a successful recruiting site in the national trial. The mixed-methods study included quantitative surveys of randomized participants, medical record abstraction, and qualitative interviews with study staff. Miami recruited 47 (40.5%) of 116 randomized participants in the six-site national trial. In-depth interviews of study staff (n = 6) revealed that Miami had a recruitment approach consisting of street level outreach and a close relationship with the local syringe services program (SSP). Partnership with a local SSP provided access to people living with HIV who inject drugs in Miami. SSPs' fundamental trust within the community of people who inject drugs can be leveraged in studies aiming to improve health outcomes in this underserved and high-priority population., (© 2021. National Council for Mental Wellbeing.)

Background: People who inject drugs (PWID) have been a marginalized and a stigmatized population since the beginning of the AIDS epidemic and have not experienced the same life-changing benefits of antiretroviral therapy as others. Tele-Harm Reduction (THR) is a telehealth-enhanced, harm reduction intervention, delivered within a trusted SSP venue. It aims to facilitate initiation of care and achieve rapid HIV viral suppression among PWID living with HIV., Methods: In this mixed-methods study, we employed the Practical, Robust, Implementation and Sustainability Model (PRISM) implementation science framework to identify multilevel barriers and facilitators to implementing the THR intervention. Focus groups (n = 2, 16 participants), stakeholder interviews (n = 7) and in-depth interviews were conducted with PWID living with HIV (n = 25). In addition, to assess feasibility and acceptability, we pilot tested the THR intervention and reported viral suppression at 6 months., Results: Focus groups and stakeholder interviews revealed system and organizational level barriers to implementation including requirements for identification and in person visits, waiting times, stigma, case management inexperience, multiple electronic health records, and billing. A potential facilitator was using telehealth for case management and initial provider visit. In the in depth interviews conducted with PWID living with HIV, participants expressed that the SSP creates a convenient, comfortable, confidential environment for delivering multiple, non-stigmatizing PWID-specific services. 35 PWID living with HIV were enrolled in the pilot study, 35 initiated antiretroviral therapy, and 25 (78.1%) were virally suppressed at six months., Conclusion: Rooted in harm reduction, the THR intervention shows promise in being an acceptable and feasible intervention that may facilitate engagement in HIV care and viral suppression among PWID., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: Combination strategies generate health benefits through improved health outcomes among people living with HIV (PLHIV) and prevention of new infections. We aimed to determine health benefits attributable to improved health among PLHIV versus HIV prevention for a set of combination strategies in six US cities., Design: A dynamic HIV transmission model., Methods: Using a model calibrated for Atlanta, Baltimore, Los Angeles, Miami, New York City (NYC) and Seattle, we assessed the health benefits of city-specific optimal combinations of evidence-based interventions implemented at publicly documented levels and at ideal (90% coverage) scale-up (2020-2030 implementation, 20-year study period). We calculated the proportion of health benefit gains (measured as quality-adjusted life-years) resulting from averted and delayed HIV infections; improved health outcomes among PLHIV; and improved health outcomes due to medication for opioid use disorder (MOUD)., Results: The HIV-specific proportion of total benefits ranged from 68.3% (95% credible interval: 55.3-80.0) in Seattle to 98.5% (97.5-99.3) in Miami, with the rest attributable to MOUD. The majority of HIV-specific health benefits in five of six cities were attributable HIV prevention, and ranged from 33.1% (26.1-41.1) in NYC to 83.1% (79.6-86.6) in Atlanta. Scaling up to ideal service levels resulted in three to seven-fold increases in additional health benefits, mostly from MOUD, with HIV-specific health gains primarily driven by HIV prevention., Conclusion: Optimal combination strategies generated a larger proportion of health benefits attributable to HIV prevention in five of six cities, underlining the substantial benefits of antiretroviral therapy engagement for the prevention of HIV transmission through viral suppression. Understanding to whom benefits accrue may be important in assessing the equity and impact of HIV investments., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The opioid epidemic has led to increases in injection drug use (IDU)-associated infectious diseases; however, little is known about how more recent increases in stimulant use have affected the incidence and outcomes of hospitalizations for infections among people who inject drugs (PWID)., Methods: All hospitalizations of PWID for IDU-associated infections in Florida were identified using administrative diagnostic codes and were grouped by substance used (opioids, stimulants, or both) and site of infection. We evaluated the association between substance used and the outcomes: patient-directed discharge (PDD, or "against medical advice") and in-hospital mortality., Results: There were 22 856 hospitalizations for infections among PWID. Opioid use was present in 73%, any stimulants in 43%, and stimulants-only in 27%. Skin and soft tissue infection was present in 50%, sepsis/bacteremia in 52%, osteomyelitis in 10%, and endocarditis in 10%. PWID using opioids/stimulants were youngest, most uninsured, and had the highest rates of endocarditis (16%) and hepatitis C (44%). Additionally, 25% of patients with opioid/stimulant use had PDD versus 12% for those using opioids-only. In adjusted models, opioid/stimulant use was associated with PDD compared to opioid-only use (aRR 1.28, 95% CI 1.17-1.40). Younger age and endocarditis were also associated with PDD. Compared to opioid-only use, stimulant-only use had higher risk of in-hospital mortality (aRR 1.26, 95% CI 1.03-1.46)., Conclusions: While opioid use contributed to most IDU-associated infections, many hospitalizations also involved stimulants. Increasing access to harm reduction interventions could help prevent these infections, while further research on the acute management of stimulant use disorder-associated infections is needed., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.)

Background: In the USA, Black and Hispanic or Latinx individuals continue to be disproportionately affected by HIV. Applying a distributional cost-effectiveness framework, we estimated the cost-effectiveness and epidemiological impact of two combination implementation approaches to identify the approach that best meets the dual objectives of improving population health and reducing racial or ethnic health disparities., Methods: We adapted a dynamic, compartmental HIV transmission model to characterise HIV micro-epidemics in six US cities: Atlanta, Baltimore, Los Angeles, Miami, New York, and Seattle. We considered combinations of 16 evidence-based interventions to diagnose, treat, and prevent HIV transmission according to previously documented levels of scale-up. We then identified optimal combination strategies for each city, with the distribution of each intervention implemented according to existing service levels (proportional services approach) and the racial or ethnic distribution of new diagnoses (between Black, Hispanic or Latinx, and White or other ethnicity individuals; equity approach). We estimated total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios of strategies implemented from 2020 to 2030 (health-care perspective; 20-year time horizon; 3% annual discount rate). We estimated three measures of health inequality (between-group variance, index of disparity, Theil index), incidence rate ratios, and rate differences for the selected strategies under each approach., Findings: In all cities, optimal combination strategies under the equity approach generated more QALYs than those with proportional services, ranging from a 3·1% increase (95% credible interval [CrI] 1·4-5·3) in New York to more than double (101·9% [75·4-134·6]) in Atlanta. Compared with proportional services, the equity approach delivered lower costs over 20 years in all cities except Los Angeles; cost reductions ranged from $22·9 million (95% CrI 5·3-55·7 million) in Seattle to $579·8 million (255·4-940·5 million) in Atlanta. The equity approach also reduced incidence disparities and health inequality measures in all cities except Los Angeles., Interpretation: Equity-focused HIV combination implementation strategies that reduce disparities for Black and Hispanic or Latinx individuals can significantly improve population health, reduce costs, and drive progress towards Ending the HIV Epidemic goals in the USA., Funding: National Institute on Drug Abuse., Competing Interests: Declaration of interests KA reports grants from the US National Institutes of Health (NIH), personal fees from The All of Us Research Program (NIH), personal fees from TrioHealth, and non-financial support from Cumming School of Medicine, University of Calgary, outside the submitted work. CNB reports grants from the National Institute on Drug Abuse, during the conduct of the study. EE reports personal fees from ViiV Healthcare, outside the submitted work. KAG reports personal fees from Simon Fraser University, during the conduct of the study. SHM reports personal fees from Gilead Sciences, outside the submitted work. MG reports research support from Hologic, outside the submitted work. SAS reports grants from NIH, outside the submitted work. HT reports grants from Gilead Sciences, outside the submitted work. BN reports grants from NIH, during the conduct of the study. All other authors declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

After the closure of pill mills and implementation of Florida's Prescription Drug Monitoring Program in 2010, high demand for opioids was met with counterfeit pills, heroin, and fentanyl. In response, medical students at the University of Miami Miller School of Medicine embarked on a journey to bring syringe services programs (SSPs) to Florida through an innovative grassroots approach. Working with the Florida Medical Association, students learned patient advocacy, legislation writing, and negotiation within a complex political climate. Advocacy over 4 legislative sessions (2013-2016) included committee testimony and legislative visit days, resulting in the authorization of a 5-year SSP pilot. The University of Miami's Infectious Disease Elimination Act (IDEA) SSP opened on December 1, 2016. Students identified an urgent need for expanded health care for program participants and founded a weekly free clinic at the SSP. Students who rotate through the clinic learn medicine and harm reduction through the lens of social justice, with exposure to people who use drugs, sex workers, individuals experiencing homelessness, and other vulnerable populations. The earliest success of the IDEA SSP was the distribution of over 2,000 boxes of nasal naloxone, which the authors believe positively contributed to a decrease in the number of opioid-related deaths in Miami-Dade County for the first time since 2013. The second was the early identification of a cluster of acute human immunodeficiency virus infections among program participants. Inspired by these successes, students from across the state joined University of Miami students and met with legislators in their home districts, wrote op-eds, participated in media interviews, and traveled to the State Capitol to advocate for decisive action to mitigate the opioid crisis. The 2019 legislature passed legislation authorizing SSPs statewide. In states late to adopt SSPs, medical schools have a unique opportunity to address the opioid crisis using this evidence-based approach., (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Association of American Medical Colleges.)

Background: Hepatitis C (HCV) is the most common infectious disease among people who inject drugs (PWID). Engaging PWID in harm reduction services, such as syringe service programs (SSPs), is critical to reduce HCV and HIV transmission. Additionally, testing for HIV and HCV among PWID is important to improve diagnosis and linkage to care. On March 1, 2018, Florida's only legal SSP implemented bundled opt-out HIV/HCV testing at enrollment. We aimed to examine the differences in HIV/HCV testing uptake before and after the implementation of the opt-out testing policy., Methods: Multivariable logistic regression was used to assess predictors of accepting HIV/HCV tests, controlling for opt-in and opt-out policy. Monthly estimates of the percent of participants accepting an HIV test, HCV test, or both were generated. Interrupted Time Series (ITS) analysis evaluated the immediate policy impact on level of uptake and trend in uptake over time for bundled HIV/HCV testing before and after the opt-out testing policy., Results: The total study period was 37 months between December 2016-January 2020 with 512 SSP participants 15 months prior and 547 SSP participants 22 months after implementation of bundled HIV/HCV opt-out testing. Significant predictors of accepting both HIV/HCV tests were cocaine injection (aOR = 2.36), self-reported HIV positive status (aOR = 0.39) and self-reported HCV positive status (aOR = 0.27). Based on the ITS results, there was a significant increase in uptake of HIV/HCV testing by 42.4% (95% CI: 26.2%-58.5%, p < 0.001) immediately after the policy change to opt-out testing., Conclusion: Bundled opt-out HIV/HCV testing substantially increased the percentage of SSP clients who received HIV and HCV rapid tests at enrollment into the program, and the effect remained stable across the 22 months post opt-out testing policy. Future investigation must assess PWID-level perspective of testing preferences and examine whether this testing approach improves HIV/HCV detection among PWID previously unaware of their status., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: Injection drug use (IDU) remains a significant public health problem. IDU has been associated closely with the opioid crisis; driving overdose, HIV, and Hepatitis C (HCV) infection nationwide. Syringe services programs (SSPs) remain pivotal evidence-based interventions to reduce harm and engage subgroups of people who inject drugs (PWID). This study aims to provide policy considerations from the IDEA SSP, the first legal SSP in the state of Florida., Methods: We performed a latent class analysis on patterns of substance use among participants (N = 982) newly enrolled in a syringe services program (SSP). Associations between classes of substance use and sociodemographic variables, risky injection and sex behaviors, HIV/HCV status and syringe coverage were analyzed using the R3STEP and BCH 3-step procedures in latent class regression., Results: We found a three-class solution: Heroin-Dominant class (73.9%), Methamphetamine-Dominant class (9.5%) and Heroin/Cocaine class (16.6%). Compared to Heroin-Dominant class, the Heroin/Cocaine class were more likely to report homelessness, sharing works, unprotected sex, public injection, and to be HCV positive. Compared to both Heroin-Dominant and Heroin/Cocaine classes, the Methamphetamine-Dominant class were more likely to be male, Hispanic, gay or bisexual orientation, HIV positive, to report unprotected sex and sex with PWID. In addition, the lowest and highest syringe coverage were among those in the Heroin/Cocaine and Methamphetamine-Dominant classes, respectively., Conclusion: Existing interventions among this population to mitigate infectious disease risk, such as SSPs, can be a used to engage differing PWID populations. However, multi-component, targeted preventive interventions and need-based syringe distribution policies are required to further reduce HIV and HCV risk among various PWID populations., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Prevention of HIV outbreaks among people who inject drugs remains a challenge to ending the HIV epidemic in the United States. The first legal syringe services program (SSP) in Florida implemented routine screening in 2018 leading to the identification of ten anonymous HIV seroconversions. The SSP collaborated with the Department of Health to conduct an epidemiologic investigation. All seven acute HIV seroconversions were linked to care (86% within 30 days) and achieved viral suppression (mean 70 days). Six of the seven individuals are epidemiologically and/or socially linked to at least two other seroconversions. Analysis of the HIV genotypes revealed that two individuals are connected molecularly at 0.5% genetic distance. We identified a risk network with complex transmission dynamics that could not be explained by epidemiological methods or molecular analyses alone. Providing wrap-around services through the SSP, including routine screening, intensive linkage and patient navigation, could be an effective model for achieving viral suppression for people who inject drugs.

Test and Rapid Response Treatment (TRRT) linkage programs have demonstrated improved HIV suppression rates. This paper describes the design and implementation of the Miami TRRT initiative and its clinical impact. Assisted by a dedicated care navigator, patients receiving a reactive HIV rapid test at the Florida Department of Health STD Clinic were offered same-day HIV care at the University of Miami/Jackson Memorial Medical Center Adult HIV Outpatient Clinic. Patient retention and labs were tracked for 12 months. Of the 2337 individuals tested, 46 had a reactive HIV test; 41 (89%) consented to participate. For the 36 patients in continued care for a year, 33 (91.7%) achieved virological suppression (< 200 copies/mL) within 70 days of their reactive HIV rapid test; at 12 months, 35 (97.2%) remained suppressed, and mean CD4 T cell counts increased from 452 ± 266 to 597 ± 322 cells/mm 3 . The Miami TRRT initiative demonstrated that immediate linkage to care is feasible and improves retention and suppression in a public/academic medical center in the U.S. South.

During apoptosis, DNA fragmentation is mainly mediated by the caspase-activated DFF40 nuclease. DFF40 exists as a heterodimeric complex with its inhibitor DFF45. Upon apoptosis induction, DFF45 is cleaved by caspases to allow DFF40 activation. Drep-3 is a recently identified regulator of the DFF40 system in Drosophila melanogaster. Here, Drep-3 was expressed with a C-terminal His tag in Escherichia coli and the protein was purified to homogeneity. Multi-angle light-scattering analysis showed that Drep-3 is a homotetramer in solution. Native and selenomethionine-substituted Drep-3 proteins were crystallized at 293 K and X-ray diffraction data were collected to 2.8 and 3.0 A resolution, respectively. The crystals belong to space group P2(1)2(1)2(1), with unit-cell parameters a = 56.9, b = 125.4, c = 168.7 A. The asymmetric unit is estimated to contain one homotetramer.