HIV Risk and Interest in Preexposure Prophylaxis in Justice-Involved Persons.

Preexposure prophylaxis (PrEP) is underused in persons who use drugs and justice-involved persons. In an ongoing randomized controlled trial in 4 US locations comparing patient navigation versus mobile health unit on time to initiation of HIV medication or PrEP for justice-involved persons who use stimulants or opioids and who are at risk for or living with HIV, we assessed HIV risk factors, perceived HIV risk, and interest in PrEP. Participants without HIV (n = 195) were 77% men, 65% White, 23% Black, and 26% Hispanic; 73% reported a recent history of condomless sex, mainly with partners of unknown HIV status. Of 34% (67/195) reporting injection drug use, 43% reported sharing equipment. Despite risk factors, many persons reported their risk for acquiring HIV as low (47%) or no (43%) risk, although 51/93 (55%) with PrEP indications reported interest in PrEP. Justice-involved persons who use drugs underestimated their HIV risk and might benefit from increased PrEP education efforts.

Reducing Nighttime Interruptions and Improving Sleep for Hospitalized Patients by Restructuring Nighttime Clinical Workflow.

BACKGROUND: Nighttime sleep disruptions negatively impact the experience of hospitalized patients. OBJECTIVE: To determine the impact of adopting a sleep-promoting nighttime clinical workflow for hospitalized patients on nocturnal disruptions and sleep. DESIGN: Survey-based pre- and post-intervention cross-sectional study using convenience samples. PARTICIPANTS: Hospitalized veterans on a 23-bed general medical ward at a tertiary Veterans Administration Hospital. INTERVENTIONS: Baseline sleep surveys (N=149) identified two major sources of interruptions: blood pressure checks at 4 am for telemetry patients and subcutaneous (SQ) heparin injections between 4:30 and 6 am for venous thromboembolism prophylaxis. Clinical workflow was restructured to eliminate these disruptions: moving 4 am blood pressure checks to 6 am and providing daily SQ enoxaparin at 9 am as an alternative to Q 8-h SQ heparin, which had prompted an injection between 4:30 and 6 am. The impact of these changes was assessed in a second round of surveys (N=99). MAIN MEASURES: Frequency and sources for nighttime sleep disruptions; percentage of patients reporting longer time to fall asleep, more interruptions, and worse sleep quality (vs. home) before and after restructuring nighttime clinical workflow. KEY RESULTS: After restructuring nighttime clinical workflow, medication administration as a source of nighttime disruption decreased from 40% (59/149) to 4% (4/99) (p<0.001). Blood pressure checks as a source of disruption decreased from 56% (84/149) to 42% (42/99) (p=0.033). Fewer patients reported taking longer to fall asleep in the hospital vs. home (39% pre-intervention vs. 25% post-intervention, p=0.021). Similarly, fewer patients experienced waking up more frequently in the hospital vs. home (46% pre-intervention vs. 32% post-intervention, p=0.036). Fewer patients reported sleeping worse in the hospital (44% pre-intervention vs. 39% post-intervention), though this trend was not statistically significant (p=0.54). CONCLUSIONS: Nighttime disruptions in hospitalized patients frequently interfere with sleep. Restructuring of the clinical workflow significantly reduced disruptions and improved sleep.

Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons.

BACKGROUND: Persons involved in the justice system are at high risk for HIV and drug overdose upon release to the community. This manuscript describes a randomized controlled trial of two evidence-based linkage interventions for provision of HIV prevention and treatment and substance use disorder (SUD) services in four high risk communities to assess which is more effective at addressing these needs upon reentry to the community from the justice system. METHODS: This is a 5-year hybrid type 1 effectiveness-implementation randomized controlled trial that compares two models (Patient Navigation [PN] or Mobile Health Unit [MHU] service delivery) of linking justice-involved individuals to the continuum of community-based HIV and SUD prevention and treatment service cascades of care. A total of 864 justice-involved individuals in four US communities with pre-arrest histories of opioid and/or stimulant use who are living with or at-risk of HIV will be randomized to receive either: (a) PN, wherein patient navigators will link study participants to community-based service providers; or (b) services delivered via an MHU, wherein study participants will be provided integrated HIV prevention/ treatment services and SUD services. The six-month post-release intervention will focus on access to pre-exposure prophylaxis (PrEP) for those without HIV and antiretroviral treatment (ART) for people living with HIV (PLH). Secondary outcomes will examine the continuum of PrEP and HIV care, including: HIV viral load, PrEP/ ART adherence; HIV risk behaviors; HCV testing and linkage to treatment; and sexually transmitted infection incidence and treatment. Additionally, opioid and other substance use disorder diagnoses, prescription, receipt, and retention on medication for opioid use disorder; opioid and stimulant use; and overdose will also be assessed. Primary implementation outcomes include feasibility, acceptability, sustainability, and costs required to implement and sustain the approaches as well as to scale-up in additional communities. DISCUSSION: Results from this project will help inform future methods of delivery of prevention, testing, and treatment of HIV, HCV, substance use disorders (particularly for opioids and stimulants), and sexually transmitted infections for justice-involved individuals in the community. TRIAL REGISTRATION: Clincialtrials.gov NCT05286879 March 18, 2022.

Gender differences among persons entering medication treatment for opioid use disorder in the community.

BACKGROUND AND OBJECTIVES: We evaluated gender differences among persons initiating medications for opioid use disorder (MOUD). METHODS: Analyses of baseline assessments for a study evaluating the impact of MOUD on outcomes included: demographics, DSM-5 diagnoses, depression severity, quality of life (QoL), and medication history (N = 125). RESULTS: When compared to men, women had a greater prevalence of generalized anxiety and posttraumatic stress disorders; and worse psychological QoL. Women were less likely to be prescribed psychiatric medications. DISCUSSION AND CONCLUSIONS: Women may benefit from tailored multidisciplinary programs with MOUD. SCIENTIFIC SIGNIFICANCE: This study identified that women with OUD seeking MOUD in the community had greater sedative hypnotic nonprescribed medication use and psychiatric comorbidity than men, all of which can contribute to poorer retention on MOUD and higher risk of morbidity and mortality. Thus, concurrent psychiatric disorder screening and treatment integrated with MOUD may improve retention on MOUD, opioid relapse and overdose for women.

Gender differences among criminal justice-involved persons living with HIV interested in extended-release naltrexone treatment.

Background: Previous research has shown gender differences with respect to entry into medication treatment of substance use disorders (SUDs), yet few have examined gender differences among participants consented to be treated with extended-release naltrexone (XR-NTX). Understanding gender differences is critical to developing interventions to overcome barriers to initiation of and retention on medication treatment for SUDs. Methods: Data from two double-blind placebo-controlled trials of XR-NTX among persons with HIV and alcohol or opioid use disorders leaving the criminal justice system (CJS) were analyzed for gender differences among clinical characteristics, mental health, drug use severity, and other domains. The study that recruited persons with alcohol use disorder (AUD) was conducted from September 2010-February 2016 at two sites in Connecticut (CT), and the opioid use disorder (OUD) study was conducted from September 2010-March 2016 at three sites in CT and one site in Massachusetts. Results: Baseline data were analyzed from 193 participants consented to be randomized to XR-NTX or placebo; 40 women and 153 men. Women were younger, had worse mental health severity, and were more likely to be diagnosed with cocaine use disorder. There were no statistical differences between men and women in the prescription of antiretroviral therapy (ART) or ART adherence. Conclusions: Women had greater mental health severity and a higher prevalence of cocaine use as compared to men, both of which are known to be barriers to engagement and retention on medication treatment for alcohol and opioid use disorders. For women with CJS involvement and living with HIV and SUDs, understanding factors that may affect initiation and retention on medication treatment of SUDs are necessary to improve treatment outcomes in women.

A Literature Review Examining Primary Outcomes of Medication Treatment Studies for Opioid Use Disorder: What Outcome Should Be Used to Measure Opioid Treatment Success?

BACKGROUND AND OBJECTIVES: Medications for opioid use disorder (MOUD) reduce opioid use and overdose; however, MOUD clinical trials have used varying primary outcomes to document treatment success. We conducted a literature review to assess and critically examine the methodologies used in MOUD treatment studies. METHODS: Published studies in English that examined MOUD (buprenorphine, methadone, or extended-release naltrexone) were included (N = 20). The methods and frequencies of measuring primary opioid outcomes, including urine drug tests (UDTs) and self-report of opioid use were compared among studies. RESULTS: A total of 20 studies fit the inclusion criteria. Each study assessed opioid use; only 12 had opioid use as a primary outcome. Other primary outcomes included retention in treatment (N = 6), and two had other primary outcomes (death and opioid withdrawal symptoms). Opioid use was assessed through both self-report and UDTs in 15 studies. Two studies did not use UDTs. Differences were found in the methods used for how opioid use, retention in treatment, self-report of opioid use, and UDTs were measured. DISCUSSION AND CONCLUSIONS: The different primary outcomes used and operational definitions in each study make comparisons between studies difficult. The use of both self-report and UDTs for opioid use has several advantages, and if possible, researchers should use both measures. SCIENTIFIC SIGNIFICANCE: This is the first review critically examining outcome measures from MOUD treatment studies. Creating a standard for opioid treatment outcomes in MOUD studies will allow for generalizable results that can inform both researchers and clinicians to better care for those with OUD. (Am J Addict 2020;00:00-00).

A culture of future planning: perceptions of sexual risk among educated young adults.

In this study we examined how social processes, specifically the acquisition of postsecondary education and capital, shaped perceptions of sexual risk and impacted sexual practices and sexual health among young adults. Using qualitative research methods we collected and analyzed data among students attending a 4-year university in the northeastern region of the United States over a 1-year period. By analyzing participants' narratives, we found that the reproduction of shared norms and values encouraged educated young adults to focus on educational and professional success, pressing many of them to be concerned about preventing pregnancy rather than preventing disease transmission, and increasing their risk for sexually transmitted infections, including HIV/AIDS. Sexual-health educators need to address how social processes shape sexual practices, encourage educated young adults to challenge unequal gender expectations, and consider how sexually transmitted infections might also interfere with life plans.

Missed Opportunities for Preexposure Prophylaxis Initiation in Hospitalized Persons With Opioid Use Disorder and Infectious Diseases.

Hospitalizations are increasing among persons who use opioids, secondary to overdose and infections. Our study identified acute hospitalization as a reachable moment for engaging people who use drugs in increased screening and education about human immunodeficiency virus risk and prevention (preexposure prophylaxis).

Inpatient Low-dose Transitions From Full Agonist Opioids Including Methadone Onto Long-acting Depot Buprenorphine: Case Series From a Multicenter Clinical Trial.

OBJECTIVES: Persons with opioid use disorder (OUD) suffer disproportionately from morbidity and mortality related to serious addiction-related infections requiring hospitalization. Long-acting buprenorphine (LAB) is an underused medication for OUD that may facilitate linkage to care and treatment retention when administered before hospital discharge. Transition onto buprenorphine in the inpatient setting is often complicated by pain, active infection management, potential surgical interventions, and risk of opioid withdrawal in transition from full agonists to a partial agonist. METHODS: The COMMIT Trial is a randomized controlled trial evaluating LAB administered by infectious disease physicians and hospitalists compared with treatment as usual for persons with OUD hospitalized with infections. We report a case series of participants on full agonist opioids including methadone who were transitioned to sublingual buprenorphine using low-dose ( microdosing ) strategies followed by LAB injection. RESULTS: Seven participants with current opioid use disorder and life-threatening infections, all with significant concurrent pain and many requiring surgical intervention, underwent low-dose transitions starting at buccal buprenorphine doses ranging from 225 µg to 300 µg 3 times a day on the first day. All were well tolerated with average time to LAB injection of 7.5 days (range, 5-10 days). CONCLUSIONS: Inpatient low-dose buprenorphine transition from full agonist opioids including methadone onto LAB is feasible even in those with complex hospitalizations for concurrent infections and/or surgery. This strategy facilitates dosing of LAB before hospital discharge when risk of opioid relapse and overdose are significant.

Fostemsavir for the treatment of HIV.

Introduction: For those with heavily treatment experienced (HTE) HIV-1 and virologic failure, therapeutic options are limited. A variety of barriers such as drug resistance, side effects, past intolerance, and administration inability contribute to the need for novel drug classes in this population.Areas Covered: Herein, we review the pharmacology, clinical efficacy, and safety profile of fostemsavir, a first in its class attachment inhibitor recently FDA approved for use.Expert Opinion: Fostemsavir is a well-tolerated oral medication with relatively few drug-drug interactions. Clinical trial data demonstrates virologic and notable immunologic response in conjunction with optimal background therapy in HTE persons living with HIV. Fostemsavir exhibits no cross-resistance with other ARV classes and thus is an important advancement for patients harboring drug-resistant HIV. Further study will be needed to determine outstanding clinical questions such as the role of drug resistance testing and fostemsavir use outside of the HTE population.

Linking criminal justice-involved individuals to HIV, Hepatitis C, and opioid use disorder prevention and treatment services upon release to the community: Progress, gaps, and future directions.

Improving HIV and Hepatitis C Virus (HCV) management among people involved in the criminal justice (CJ) system who use drugs, in particular those with opioid use disorder (OUD), requires effective approaches to screening, linkage, and adherence to integrated prevention and treatment services across correctional and community agencies and providers. This manuscript reviews the literature to explore gaps in HIV, Hepatitis C, and OUD prevention, treatment, and delivery cascades of care for persons involved in the CJ system. Specifically, we compare two models of linkage to prevention and treatment services: Peer/Patient Navigation (PN) wherein the PN links CJ-involved individuals to community-based infectious disease (ID) and substance use prevention and treatment services, and Mobile Health Units (MHU) wherein individuals are linked to a MHU within their community that provides integrated ID and substance use prevention and treatment services. The most notable finding is a gap in the literature, with few to no comparisons of models linking individuals recently released from the CJ system to integrated HIV, Hepatitis C, and OUD prevention and treatment and other harm reduction services. Further, few published studies address the geographical distinctions that affect service implementation and their effects on these substance use, ID and harm reduction care cascades. This manuscript makes specific recommendations to fill this gap through a detailed evaluation of PN and MHU linkage models to co-located and integrated HIV, Hepatitis C, and OUD prevention and treatment services across different communities within the U.S.

Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder.

BACKGROUND: Hospitalization with co-occurring opioid use disorder (OUD) and infections presents a critical time to intervene to improve outcomes for these intertwined epidemics that are typically managed separately. A surge in life-threatening infectious diseases associated with injection drug use, including bacterial and fungal infections, HIV, and HCV accounts for substantial healthcare utilization, morbidity, and mortality. Infectious Disease (ID) specialists manage severe infections that require hospitalization and are a logical resource to engage patients in medication treatment for OUD (MOUD). An injectable long-acting monthly formulation of buprenorphine (LAB) has a potential advantage for initiating MOUD within hospital settings and bridging to treatment after discharge. METHODS: A randomized multi-site trial tests a new model of care (ID/LAB) in which OUD and infections are managed by ID specialists and hospitalists using LAB coupled with referrals to community resources for long-term MOUD. A sample of 200 adults admitted to three U.S. hospitals for OUD and infections are randomly assigned 1:1 to ID/LAB or treatment as usual (TAU). The primary outcome measure is the proportion of patients enrolled in effective MOUD at 12 weeks after randomization. Secondary outcomes include relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose. RESULTS: We describe the design, procedures, statistical analysis, and early implementation issues of this randomized trial. CONCLUSIONS: Study findings will provide insight into the feasibility and effectiveness of integrated treatment of OUD and serious infections and have the potential to reduce morbidity and mortality in this vulnerable population.

A Call to Action to Combat the Opioid Epidemic Among Women.

: Acknowledging the needs and challenges of women with opioid use disorder is an essential step to reduce the opioid epidemic in the United States. Efforts that can help women include increasing psychosocial services to address trauma, increasing access to medication treatment for opioid use disorder, reducing barriers and stigma that impede access to and retention on treatment, and addressing structural and policy barriers. This commentary discusses the reasons why women-focused treatment for opioid use disorder is necessary and makes specific recommendations for interventions, treatment, services, and policies that can reduce barriers to care and improve treatment and retention among women.

Stethoscope hygiene: Using cultures and real-time feedback with bioluminescence-based adenosine triphosphate technology to change behavior.

BACKGROUND: Stethoscope hygiene is rarely done despite guideline recommendations. We wanted to determine whether demonstrating what is growing on the stethoscopes of providers via culture or bioluminescence technology alters perceptions and improves compliance. METHODS: Providers were given the opportunity to (1) culture their stethoscopes before and after disinfection with alcohol pads, alcohol-based hand rub, or hydrogen peroxide disinfectant wipes and (2) swab stethoscopes for bioluminescence-based adenosine triphosphate testing before and after disinfection. Outcomes were observed for hand and stethoscope hygiene rates and before and after intervention survey responses. The bacteria that were isolated, colony-forming units (CFU), and bioluminescence scores were tracked. RESULTS: A total of 1,245 observed hand hygiene opportunities showed that compliance improved from 72.5%-82.3% (P < .001). In addition, 590 observed patient-provider encounters revealed no significant change in stethoscope hygiene rates of 10% initially and 5% afterward (P = .08), although self-reported rates trended from 56%- 67% postintervention (P = .06). Perceptions regarding stethoscope hygiene importance improved (8.5/10 to 9.3/10; P = .04). Disinfection with alcohol pads, alcohol-based hand rub, and hydrogen peroxide disinfectant wipes were equivalent in CFU reduction (P = .21). CONCLUSIONS: Showing providers what is growing on their stethoscopes via cultures and bioluminescence technology before and after disinfection improved "buy in" regarding stethoscope hygiene importance. Both methods were rated as having an equal impact, however, objective observations failed to show improvement.

Reduced Sexual Risk Behaviors Among Persons With HIV After Release From the Criminal Justice System.

BACKGROUND: HIV prevalence is 3 times greater for those in the criminal justice system than the general population, with an assumed increase in sexual risk behaviors (SRBs) postrelease. HIV viral suppression impacts HIV transmission; however, studies of SRBs among persons with HIV leaving the criminal justice system are limited, and no studies have examined viral suppression in relation to SRBs in persons leaving the criminal justice system. METHODS: Data were examined from 2 double-blind placebo-controlled trials of extended-release naltrexone among persons with HIV and alcohol use or opioid use disorder. Participants self-reported sexual activity, including number of sexual partners, sex type, and condom use. HIV viral suppression was evaluated prerelease and at 6 months. RESULTS: Thirty days before incarceration, 60% reported having sex compared with 41% and 46%, respectively, at months 1 and 6 postrelease. The number of sex partners and sexual intercourse events decreased from pre-incarceration to months 1 and 6 postrelease. Condom use increased but was not statistically significant. Of the 11 (9.7%) who reported having sex without a condom 1 month postrelease, only 2 did not have viral suppression (VS; HIV VL <200 copies/mL), whereas the 7 (6.5%) who reported SRBs at 6 months all had VS. CONCLUSIONS: After release, SRBs decreased, and among those who reported SRBs, most were virally suppressed, and thus risk of transmitting HIV was low.