"Treated like a Human Being": perspectives of people who inject drugs attending low-threshold HCV treatment at a syringe service program in New York City.

BACKGROUND: Hepatitis C virus (HCV) treatment can effectively cure HCV among people who inject drugs (PWID). Perspectives of PWID treated in innovative models can reveal program features that address barriers to treatment, and guide implementation of similar models. METHODS: We interviewed 29 participants in the intervention arm of a randomized trial. The trial enrolled PWID with HCV in New York City from 2017 to 2020 and tested the effectiveness of a low-threshold HCV treatment model at a syringe services program. Participants were purposively sampled and interviewed in English or Spanish. The interview guide focused on prior experiences with HCV testing and treatment, and experiences during the trial. Interviews were inductively coded and analyzed using thematic analysis. RESULTS: Before enrollment, participants reported being tested for HCV in settings such as prison, drug treatment, and emergency rooms. Treatment was delayed because of not being seen as urgent by providers. Participants reported low self-efficacy, competing priorities, and systemic barriers to treatment such as insurance, waiting lists, and criminal-legal interactions. Stigma was a major factor. Treatment during the trial was facilitated through respect from staff, which overcame stigma. The flexible care model (allowing walk-ins and missed appointments) helped mitigate logistical barriers. The willingness of the staff to address social determinants of health was highly valued. CONCLUSION: Our findings highlight the need for low-threshold programs with nonjudgmental behavior from program staff, and flexibility to adapt to participants' needs. Social determinants of health remain a significant barrier, but programs' efforts to address these factors can engender trust and facilitate treatment. Trial registration NCT03214679.

Hepatitis C testing and treatment uptake among young people who use opioids in New York City: A cross-sectional study.

Young people who use drugs have a rising hepatitis C (HCV) incidence in the United States, but they may face barriers to testing and treatment adoption due to stigma. We conducted a cross-sectional study of New York City residents aged 18-29 years who reported non-medical prescription opioid and/or heroin use in the past 30 days. Participants were recruited from the community between 2014-2016 via respondent-driven sampling. Participants completed an in-person structured survey that included questions about HCV testing and treatment and received HCV antibody testing. There were 539 respondents: 353 people who inject drugs (PWID) and 186 non-PWID. For PWID, median age was 25 years, 65% were male and 73% non-Hispanic White. For non-PWID, median age was 23 years, 73% were male and 39% non-Hispanic White. 20% of PWID and 54% of non-PWID had never been tested for HCV (P < .001). Years since first injection (aOR 1.16, CI: 1.02-1.32, P = .02) and history of substance use treatment (aOR 3.17, CI: 1.53-6.61, P = .02) were associated with prior testing among PWID. The seroprevalence of HCV among PWID was 25%, adjusted for sampling weights. Of the 75 who were aware of their HCV-positive status, 53% had received HCV-related medical care, and 28% had initiated treatment. HCV prevalence among young PWID is high, and many have never been tested. Injection experience and treatment engagement is associated with testing. Interventions to increase testing earlier in injection careers, and to improve linkage to HCV treatment, will be critical for young PWID.

Web-based cognitive behavior therapy for chronic pain patients with aberrant drug-related behavior: How did it work and for whom?

This study explored mediating pathways, moderating factors, and moderated mediation effects of a web-based, cognitive behavioral therapy (CBT) intervention for chronic pain patients with aberrant drug-related behavior (ADRB). In a 2-arm RCT, patients with chronic pain who screened positive for ADRB received treatment-as-usual (TAU, n = 55) or TAU plus a 12-week, web-based CBT intervention (n = 55). Assessments were conducted at weeks 4, 8, and 12, and at 1- and 3-months post intervention. Web-CBT significantly reduced pain catastrophizing, which, in turn, reduced pain interference and pain severity via a pathway of pain catastrophizing. Web-CBT also significantly reduced ADRB both directly and indirectly by reducing pain catastrophizing. For pain interference and pain severity, web-CBT was more effective than TAU for younger patients (≤ age 50). For pain severity, web-CBT was more effective for both younger patients (≤ age 50), and those with a lifetime substance use disorder. Findings suggest that web-CBT's positive impact on pain outcomes and ADRB are mediated by its effect on pain catastrophizing, and its treatment effects may be most robust for younger patients and those with histories of substance dependence.

The impact of COVID-19 on people who inject drugs in New York City: increased risk and decreased access to services.

BACKGROUND: While people who inject drugs (PWID) are vulnerable to the adverse outcomes of events like COVID-19, little is known regarding the impact of the current pandemic on PWID. We examine how COVID-19 has affected PWID in New York City across four domains: substance use, risk behaviors, mental health, and service utilization. METHODS: As part of a randomized trial to improve access to HCV treatment for PWID, we recruited 165 participants. Eligibility criteria included detectable HCV RNA and recent drug injection. The present cross-sectional analysis is based on a subsample of 106 participants. We compared responses between two separate samples: 60 participants interviewed prior to the pandemic (pre-COVID-19 sample) and 46 participants interviewed during the pandemic (COVID-19 sample). We also assessed differences by study group [accessible care (AC) and usual care (UC)]. RESULTS: Compared to the pre-COVID-19 sample, those interviewed during COVID-19 reported higher levels of mental health issues, syringe reuse, and alcohol consumption and greater reductions in syringe-service programs and buprenorphine utilization. In the analysis conducted by study group, the UC group reported significantly higher injection risk behaviors and lower access to buprenorphine treatment during COVID-19, while during the same period, the AC group reported lower levels of substance use and injection risk behaviors. CONCLUSION: The current study provides insight on how COVID-19 has negatively affected PWID. Placing dispensing machines of harm-reduction supplies in communities where PWID live and increasing secondary exchange, mobile services, and mail delivery of supplies may help maintain access to lifesaving supplies during big events, such as COVID-19. Trial registration ClinicalTrials.gov NCT03214679. Registered July 11 2017. https://clinicaltrials.gov/ct2/show/NCT03214679 .

Online Medication Assisted Treatment Education for Court Professionals: Need, Opportunities and Challenges.

INTRODUCTION: Although medication-assisted treatment (MAT) effectively treats opioid use disorders (OUD), MAT access is restricted in criminal justice (CJ) settings. Previous studies have documented that stigma and limited knowledge about MAT are prevalent among CJ court personnel. We describe development and pilot testing of an eLearning intervention to improve MAT knowledge and increase MAT referrals in Ohio courts. Methods: Building upon a nationwide survey conducted in 2011 of drug courts and informed by MAT opinions from judges who supervised OUD clients, we developed two eLearning MAT modules. Judges completed a brief online MAT knowledge-attitude scale (K-A) before, after, and at 3 months. Judges were asked about MAT referrals pretest and 3 months later. Results: Sixty-three judges expressed interest in the study, 25 completed the pretest and viewed the modules, 11 completed a 3 month posttest. At pretest, K-A scores were significantly (p<.05) lower for agonist medications than for extended-release naltrexone (XR-NTX; Vivitrol). K-A scores improved at posttest for agonist medications (p<.05) but declined to pretest levels three months later. Three months after the pretest, buprenorphine referrals increased from 2.6% to 9.7% (p<.05). There was no significant difference on K-A scores for agonist medication between the Ohio sample (at pretest) and the 2011 sample. Conclusion: Although there is some indication that eLearning may have strengthened knowledge gains and increased buprenorphine referrals, a more robust eLearning intervention will likely be required to increase court personnel participation and sustain eLearning knowledge gains. Recruiting and sustaining judges' participation in the study represented a significant study limitation.

Prescription opioid injection among young people who inject drugs in New York City: a mixed-methods description and associations with hepatitis C virus infection and overdose.

AIM: Evidence is emerging that prescription opioid (PO) injection is associated with increased health risks. This mixed-methods study compares the mechanics of PO and heroin injection and examines the demographic and drug-related correlates of lifetime PO injection in a sample of young people who inject drugs (PWID) in New York City (NYC). METHODS: Qualitative analysis of 46 semi-structured interviews with young adult opioid users ages 18-32. Interview segments describing PO injection were analyzed for common themes. Quantitative analysis of structured interviews with 539 young adult opioid users ages 18-29 recruited via respondent-driven sampling (RDS). Analyses are based on the subsample of 353 participants (65%) who reported having ever injected drugs. All variables were assessed via self-report, except hepatitis C virus status, which was established via rapid antibody testing. RESULTS: Participants described injecting POs and reported that preparing abuse-deterrent pills for injection is especially cumbersome, requiring extended manipulation and large amounts of water. Injecting POs, in contrast to injecting heroin, requires repeated injections per injection episode. Among RDS-recruited participants, the majority of injectors reported injecting POs, sporadically (33%) or regularly (26%), but often infrequently (≤ 7 days/month). In separate multivariable analyses controlling for syringe- and cooker-sharing, ever injecting POs was a significant predictor of testing HCV antibody-positive (AOR = 2.97) and lifetime experience of non-fatal overdose (AOR = 2.51). Ever injecting POs was independently associated with lifetime homelessness (AOR = 2.93) and having grown up in a middle-income ($51,000-100,000/year vs. ≤ $50,000/year; AOR = 1.86) or a high-income household (> $100,000/year vs. ≤ $50,000/year; AOR = 2.54). CONCLUSIONS: Even in an urban environment like NYC with widespread heroin access, most young PWID have injected POs, although less frequently than heroin. PO injection involves practices that are known to increase risk for blood-borne viral infection (e.g., repeated injections) and predicted testing HCV-positive, as well as overdose. PO injection may also serve as a marker for a subgroup of PWID at elevated risk for multiple drug use-related comorbidities. Programs that provide prevention services to PWID need to tailor harm reduction measures and messaging to the specific practices and harms associated with the injection of POs.

Web-Based Cognitive Behavior Therapy for Chronic Pain Patients with Aberrant Drug-Related Behavior: Outcomes from a Randomized Controlled Trial.

Objective: There is high unmet need for effective behavioral treatments for chronic pain patients at risk for or with demonstrated histories of opioid misuse. Despite growing evidence supporting technology-based delivery of self-management interventions for chronic pain, very few such programs target co-occurring chronic pain and aberrant drug-related behavior. This randomized controlled trial evaluated the effectiveness of a novel, web-based self-management intervention, grounded in cognitive behavior therapy, for chronic pain patients with aberrant drug-related behavior. Methods: Opioid-treated chronic pain patients at a specialty pain practice who screened positive for aberrant drug-related behavior (N = 110) were randomized to receive treatment as usual plus the web-based program or treatment as usual alone. The primary outcomes of pain severity, pain interference, and aberrant drug-related behavior, and the secondary outcomes of pain catastrophizing and pain-related emergency department visits, were assessed during the 12-week intervention and at one and three months postintervention. Results: Patients assigned to use the web-based program reported significantly greater reductions in aberrant drug-related behavior, pain catastrophizing, and pain-related emergency department visits-but not pain severity or pain interference-relative to those assigned to treatment as usual. The positive outcomes were observed during the 12-week intervention and for three months postintervention. Conclusions: A web-based self-management program, when delivered in conjunction with standard specialty pain treatment, was effective in reducing chronic pain patients' aberrant drug-related behavior, pain catastrophizing, and emergency department visits for pain. Technology-based self-management tools may be a promising therapeutic approach for the vulnerable group of chronic pain patients who have problems managing their opioid medication.

Racial/Ethnic Differences in Prevalence Trends for Heroin use and Non-Medical use of Prescription Opioids Among Entrants to Opioid Treatment Programs, 2005-2016.

Recent data suggest an increase in use of heroin and non-medical use of prescription opioids (POs) in the United States, but it is unclear if these trends are consistent across racial/ethnic groups. In a nationwide prevalence study, 69,140 patients newly admitted to an opioid treatment program (OTP) completed a brief self-administered survey of past month heroin use and PO misuse from January 2005 through September 2016. We calculated heroin use and PO misuse prevalence rates, and prevalence rate ratios of Black and Latino OTP entrants compared to White entrants over time. Initially, Black and Latino respondents reported much higher prevalence of heroin use and much lower prevalence of PO misuse than White respondents. Heroin use increased among White respondents, while it decreased among Black respondents, resulting in rates that were no longer significantly different. PO misuse prevalence decreased among White respondents while it increased among Black respondents, but remained significantly higher among White respondents. Heroin use decreased and PO misuse increased among Latino respondents during the late 2000s, but these trends largely reversed in more recent years. Among OTP entrants, racially/ethnically disparate rates of heroin use, and to a lesser extent, of PO misuse have become more similar over time. These trends were stronger when analysis was restricted to OTP entrants who either had no previous OTP history or were younger. To understand potential impacts of interventions to deter PO misuse and to maximize the effectiveness of OTPs it is important to consider potential changes in opioid use across racial/ethnic groups.

Prevalence and associated risk factors of hepatitis C antibody and RNA among people who inject drugs in Puerto Rico.

INTRODUCTION: As a public health crisis, hepatitis C viral infection (HCV) is highly prevalent among people who inject drugs (PWID). We aimed to assess factors associated with HCV antibody (Ab) and HCV ribonucleic acid (RNA) positivity among PWID in Puerto Rico. METHODS: The study recruited a total of 150 persons in rural and peri-urban community settings through the respondent-driven sampling method and administered a structured questionnaire. We conducted HIV and HCV testing using dried blood spots (DBS). We examined correlates of HCV infection with sociodemographics, drug use patterns, and injection practices using regression in bivariate and multivariable analysis. RESULTS: Of the 150 participants, 89 % were male; 11 % were female; 72 % identified as mixed race; and the median duration of drug injection was 17.8 years. The mean age was 43.1 years, with 64 % of the population being from 23 to 45 years old. Among study participants (n = 150), the prevalence of HCV Ab was 73 %, and HCV RNA was 53 %. Factors significantly associated with HCV Ab and RNA included older age, increasing years of injection, incarceration, injecting other people, and identifying as Black. The belief that syringe air blowing reduces HCV transmission was also independently associated with HCV Ab positivity. CONCLUSIONS: Our findings regarding risk factors associated with HCV infection show the need to enhance prevention and control strategies for reducing transmission among PWID. Direct-acting antiviral treatment, sustained access to harm reduction, and culturally tailored services will be required to substantially reduce rates of HCV. Community-based treatment models and treatment in correctional settings are needed.

Heterogeneity of provider preferences for HIV Care Coordination Program features: latent class analysis of a discrete choice experiment.

The PROMISE study assessed revisions designed to facilitate implementation of an HIV care coordination program (CCP) addressing gaps in care and treatment engagement among people living with HIV in New York City (NYC). Through latent class analysis (LCA) of a discrete choice experiment (DCE), we explored heterogeneity of provider preferences regarding CCP features. From January-March 2020, 152 NYC CCP providers completed a DCE with 3-4 levels on each of 4 program attributes: 1) Help with Adherence to Antiretroviral Therapy (ART), 2) Help with Primary Care Appointments, 3) Help with Issues Other than Primary Care, and 4) Where Program Visits Happen. We used LCA to assess patterns of preference, and choice simulation to estimate providers' endorsement of hypothetical CCPs. LCA identified three subgroups. The two larger subgroups (n = 133) endorsed more intensive individual program features, including directly observed therapy, home visits, and appointment reminders with accompaniment of clients to their appointments. The smallest subgroup (n = 19) endorsed medication reminders only, appointment reminders without accompaniment, and meeting at the program location rather than clients' homes. Choice simulation analysis affirmed the highest degree of endorsement (62%) for hypothetical programs combining the intensive features described above. Results indicated providers' preference for intensive program features and also reinforced the need for flexible service delivery options. Provider perspectives on service delivery approaches can inform program adjustments for successful long-term implementation, which in turn can improve patient outcomes.

Client preferences for HIV Care Coordination Program features in New York City: latent class analysis of a discrete choice experiment.

INTRODUCTION: The PROMISE study, launched in 2018, evaluates the implementation of revisions to the HIV Care Coordination Program (CCP) designed to minimize persistent disparities in HIV outcomes among high-need persons living with HIV in New York City. We conducted a discrete choice experiment (DCE) assessing the preferences of CCP clients to inform improvements to the program's design. METHODS: Clients chose between two hypothetical CCP options that varied across four program attributes: help with antiretroviral therapy (ART) adherence (directly observed therapy [DOT] vs. remind via phone/text vs. adherence assessment), help with primary care appointments (remind and accompany vs. remind and transport vs. remind only), help with issues other than primary care (coverage and benefits vs. housing and food vs. mental health vs. specialty medical care) and visit location (meet at home vs. via phone/video vs. program visit 30 or 60 minutes away). The latent class analysis identified different preference patterns. A choice simulation was performed to model client preferences for hypothetical CCPs as a whole. RESULTS: One hundred and eighty-one CCP clients from six sites implementing the revised CCP completed the DCE January 2020-March 2021. Most clients had stable housing (68.5%), reported no problem substance use in the last 3 months (72.4%) and achieved viral suppression (78.5) with only 26.5% receiving DOT within a CCP. 77.3% of responses were obtained before the COVID-19 pandemic. Preferences clustered into three groups. Visit location and ART adherence support were the most important attributes. Group 1 (40%) endorsed telehealth for visit location; telehealth for ART adherence support; and help with securing housing/food; Group 2 (37%) endorsed telehealth for visit location; telehealth for ART adherence support; and staff reminding/arranging appointment transportation; Group 3 (23%) endorsed staff meeting clients at program location and staff working with clients for medication adherence. In the choice simulation, Basic and Medium hypothetical CCPs were endorsed more than Intensive CCPs. CONCLUSIONS: This DCE revealed a strong preference for telehealth and a relatively low preference for intensive services, such as DOT and home visits; preferences were heterogeneous. The findings support differentiated care and remote service delivery options in the NYC CCP, and can inform improvements to CCP design.

Removal of Free Liquid Layer from Liquid-Infused Catheters Reduces Silicone Loss into the Environment while Maintaining Adhesion Resistance.

Silicone urinary catheters infused with silicone liquid offer an effective alternative to antibiotic coatings, reducing microbial adhesion while decreasing bladder colonization and systemic dissemination. However, loss of free silicone liquid from the surface into the host system is undesirable. To reduce the potential for liquid loss, free silicone liquid was removed from the surface of liquid-infused catheters by either removing excess liquid from fully infused samples or by partial infusion. The effect on bacterial and host protein adhesion was then assessed. Removing the free liquid from fully infused samples resulted in a ~64% decrease in liquid loss into the environment compared to controls, with no significant increase in deposition of the host protein fibrinogen or the adhesion of the common uropathogen Enterococcus faecalis. Partially infusing samples decreased liquid loss as total liquid content decreased, with samples infused to 70-80% of their maximum capacity showing a ~85% reduction in liquid loss compared to fully infused controls. Furthermore, samples above 70% infusion showed no significant increase in fibrinogen or E. faecalis adhesion. Together, the results suggest that eliminating free liquid layer, mechanically or through partial infusion, can reduce liquid loss from liquid-infused catheters while preserving functionality.

Hepatitis C virus care cascade among people who inject drugs in puerto rico: Minimal HCV treatment and substantial barriers to HCV care.

Background: People who inject drugs (PWID) in Puerto Rico are disproportionately affected by the hepatitis C virus (HCV) epidemic. However, there is a scarcity of data on the HCV care cascade among PWID in Puerto Rico. This study aims to describe the HCV cascade of care among PWID in Puerto Rico, identify gaps, and explore barriers to HCV care. Methods: Participants were recruited using respondent-driven sampling and tested for both HCV antibodies (Ab) and RNA (ribonucleic acid) using rapid testing and dried blood spot samples (DBS). The cascade of care was estimated based on the DBS HCV Ab and RNA results, as well as self-reported data on HCV screening, linkage to care, treatment uptake and sustained virologic response collected through a questionnaire. The cascade was constructed sequentially, with each step using the number of people from the preceding step as the base denominator. The survey also assessed participants' perceived barriers to HCV care. Results: Out of 150 participants, 126 (84%) had previously been HCV screened, 87% (109/126) were HCV Ab positive, 72% (79/109) were RNA positive,48% (38/79) were linked to care, 32% (12/38) initiated treatment, 58% (7/12) finished treatment, and 71% (5/7) achieved SVR. Barriers to HCV care included concerns about drug abstinence requirements, access to transportation, stigma in healthcare settings, and lack of knowledge about HCV treatment sites. Conclusion: This study provides insights into the HCV cascade of care among PWID in Puerto Rico for the first time and highlights limited diagnosis, treatment uptake, and barriers to care.

Why Young Women Who Use Opioids Are at Risk for Rape: The Impact of Social Vulnerabilities and Sexually Coercive Drug Using Contexts.

This study tests a theoretically informed model to understand why women who use opioids (WWUO) are at risk of rape while using drugs. Structured interviews were conducted with 168 WWUO. Three domains were hypothesized to increase risk: the sexually coercive context of drug use, women's social vulnerability, and drug use severity. Logistic regression examined the odds of being raped by domain. One-third of WWUO had been raped while using drugs. The sexually coercive context and social vulnerability domains significantly increased women's odds of being raped. Prevention efforts should target social and contextual factors.

Baseline Physical Activity Behaviors and Relationships with Fitness in the Army Training at High Intensity Study.

United States Army soldiers must meet physical fitness test standards. Criticisms of the Army Physical Fitness Test (APFT) include limited testing of only aerobic and muscular endurance activity domains; yet, it is unclear what levels of aerobic and muscle strengthening activity may help predict performance in aspects of the new Army Combat Fitness Test (ACFT). This study explored relationships between baseline self-reported aerobic and muscle strengthening activities and APFT- and ACFT-related performance. Baseline participant data (N = 123) were from a cluster-randomized clinical trial that recruited active-duty military personnel (mean age 33.7 ± 5.7 years, 72.4% White, 87.0% college-educated, 81.5% Officers). An online survey was used for self-report of socio-demographic characteristics and weekly aerobic and muscle-strengthening physical activity behaviors. Participants also completed the APFT (2 min push-ups, 2 min sit-ups, 2-mile run) and ACFT-related measures (1-repetition maximum deadlift, pull-up repetitions or timed flexed arm hang, horizontal jump, and dummy drag). Bivariate logistic regression found greater aerobic and muscle-strengthening activity predicted better APFT performance, while better ACFT-related performance was predicted by greater muscle-strengthening activity. Although our data are mostly from mid-career officers, command policies should emphasize the new Holistic Health and Fitness initiative that encourages regular aerobic and muscle-strengthening physical activity for soldiers.

Provider preferences for delivery of HIV care coordination services: results from a discrete choice experiment.

INTRODUCTION: The PROMISE study was launched in 2018 to assess and document the implementation of changes to an existing HIV Care Coordination Programme (CCP) designed to address persistent disparities in care and treatment engagement among persons with HIV in New York City. We evaluated provider endorsement of features of the CCP to understand drivers of engagement with the programme. METHODS: We used a discrete choice experiment to measure provider endorsement of four CCP attributes, including: (1) how CCP helps with medication adherence, (2) how CCP helps with primary care appointments, (3) how CCP helps with issues other than primary care and (4) where CCP visits take place (visit location). Each attribute had three to four levels. Our primary outcomes were relative importance and part-worth utilities, measures of preference for the levels of the four CCP program attributes, estimated using a hierarchical-Bayesian multinomial logit model. All non-medical providers in the core CCP positions of patient navigator, care coordinator and programme director or other administrator from each of the 25 revised CCP-implementing agencies were eligible to participate. RESULTS: We received responses from 152 providers, 68% of whom identified as women, 49% identified as Latino/a, 34% identified as Black and 60% were 30-49 years old. Visit location (28.6%, 95% confidence interval [CI] 27.0-30.3%) had the highest relative importance, followed by how staff help with ART adherence (24.3%, 95% CI 22.4-26.1%), how staff help with issues other than primary care (24.2%, 95% CI 22.7-25.7%) and how staff help with primary care appointments (22.9%, 95% CI 21.7-24.1%). Within each of the above attributes, respectively, the levels with the highest part-worth utilities were home visits 60 minutes from the program or agency (utility 19.9, 95% CI 10.7-29.0), directly observed therapy (utility 26.1, 95% CI 19.1-33.1), help with non-HIV specialty medical care (utility 26.5, 95% CI 21.5-31.6) and reminding clients about and accompanying them to primary care appointments (utility 20.8, 95% CI 15.6-26.0). CONCLUSIONS: Ongoing CCP refinements should account for how best to support and evaluate the intensive CCP components endorsed by providers in this study.

Inhibiting host-protein deposition on urinary catheters reduces associated urinary tract infections.

Microbial adhesion to medical devices is common for hospital-acquired infections, particularly for urinary catheters. If not properly treated these infections cause complications and exacerbate antimicrobial resistance. Catheter use elicits bladder inflammation, releasing host serum proteins, including fibrinogen (Fg), into the bladder, which deposit on the urinary catheter. Enterococcus faecalis uses Fg as a scaffold to bind and persist in the bladder despite antibiotic treatments. Inhibition of Fg-pathogen interaction significantly reduces infection. Here, we show deposited Fg is advantageous for uropathogens E. faecalis, Escherichia coli, Pseudomonas aeruginosa, K. pneumoniae, A. baumannii, and C. albicans, suggesting that targeting catheter protein deposition may reduce colonization creating an effective intervention for catheter-associated urinary tract infections (CAUTIs). In a mouse model of CAUTI, host-protein deposition was reduced, using liquid-infused silicone catheters, resulting in decreased colonization on catheters, in bladders, and dissemination in vivo. Furthermore, proteomics revealed a significant decrease in deposition of host-secreted proteins on liquid-infused catheter surfaces. Our findings suggest targeting microbial-binding scaffolds may be an effective antibiotic-sparing intervention for use against CAUTIs and other medical device infections.

Accessible Hepatitis C Care for People Who Inject Drugs: A Randomized Clinical Trial.

Importance: To achieve hepatitis C elimination, treatment programs need to engage, treat, and cure people who inject drugs. Objective: To compare a low-threshold, nonstigmatizing hepatitis C treatment program that was colocated at a syringe service program (accessible care) with facilitated referral to local clinicians through a patient navigation program (usual care). Design, Setting, and Participants: This single-site randomized clinical trial was conducted at the Lower East Side Harm Reduction Center, a syringe service program in New York, New York, and included 167 participants who were hepatitis C virus RNA-positive and had injected drugs during the prior 90 days. Participants enrolled between July 2017 and March 2020. Data were analyzed after all patients completed 1 year of follow-up (after March 2021). Interventions: Participants were randomized 1:1 to the accessible care or usual care arm. Main Outcomes and Measures: The primary end point was achieving sustained virologic response within 12 months of enrollment. Results: Among the 572 participants screened, 167 (mean [SD] age, 42.0 [10.6] years; 128 (77.6%) male, 36 (21.8%) female, and 1 (0.6) transgender individuals; 8 (4.8%) Black, 97 (58.5%) Hispanic, and 53 (32.1%) White individuals) met eligibility criteria and were enrolled, with 2 excluded postrandomization (n = 165). Baseline characteristics were similar between the 2 arms. In the intention-to-treat analysis, 55 of 82 participants (67.1%) in the accessible care arm and 19 of 83 participants (22.9%) in the usual care arm achieved a sustained virologic response (P < .001). Loss to follow-up (12.2% [accessible care] and 16.9% [usual care]; P = .51) was similar in the 2 arms. Of the participants who received therapy, 55 of 64 (85.9%) and 19 of 22 (86.3%) achieved a sustained virologic response in the accessible care and usual care arms, respectively (P = .96). Significantly more participants in the accessible care arm achieved all steps in the care cascade, with the greatest attrition in the usual care arm seen in referral to hepatitis C virus clinician and attending clinical visit. Conclusions and Relevance: In this randomized clinical trial, among people who inject drugs with hepatitis C infection, significantly higher rates of cure were achieved using the accessible care model that focused on low-threshold, colocated, destigmatized, and flexible hepatitis C care compared with facilitated referral. To achieve hepatitis C elimination, expansion of treatment programs that are specifically geared toward engaging people who inject drugs is paramount. Trial Registration: ClinicalTrials.gov Identifier: NCT03214679.

Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial.

Background: Young people who inject drugs (PWID) have high hepatitis C virus (HCV) incidence and low treatment initiation rates. Novel, simplified care models need to be developed to engage, treat, and cure hard-to-reach patient populations, such as young PWID. We present final data from the randomized pilot clinical trial "HCV-Seek Test and Rapid Treatment" for curing HCV in young PWID. Methods: Participants were recruited from the community and eligible if they were 18-29 years of age, HCV antibody-positive, treatment naive, and had injected drugs in the past 30 days. Participants were randomized 1:1 to "Rapid Treatment or Usual Care". Participants randomized to Rapid Treatment received same-day medical evaluation, confirmatory and baseline laboratory testing, and a 7-day starter pack of sofosbuvir/velpatasvir at a syringe service program (SSP). Participants in "Usual Care" received same-day HCV confirmatory testing at the SSP and, if positive, facilitated referral to local providers. The primary endpoint was sustained virologic response at 12 weeks (SVR12) in HCV ribonucleic acid (RNA)+ participant. Results: Forty-seven HCV antibody-positive participants were enrolled, and 25 participants had confirmed HCV and were included in the modified intention to treat analysis, with 9 of 14 (64%) of the Rapid Treatment arm and 1 of 11 (9.1%) of the Usual Care arm achieving a confirmed SVR12 (P = .01). Conclusions: Among young HCV RNA+ PWID, significantly higher rates of cure were achieved using the Rapid Treatment model compared with facilitated referral. Providing easy access to HCV treatment for young PWID in low-threshold settings and initiating HCV treatment quickly appears to be a promising strategy for treating this hard-to-reach population.

Cost of providing co-located hepatitis C treatment at a syringe service program exceeds potential reimbursement: Results from a clinical trial.

Background: Co-located hepatitis C treatment at syringe service programs (SSP) is an emerging model of care for people who inject drugs (PWID). Implementation of these models can be informed by understanding the program costs. Methods: We conducted an economic evaluation of a hepatitis C treatment intervention at an SSP in New York City implemented as one arm of a randomized trial from 2017 to 2021. Start-up and operating costs were determined from the treatment program's perspective using micro-costing and were compared to potential Medicaid reimbursement. We applied nationally representative unit costs and wage rates. Results are reported in 2020 USD. Results: The treatment program was staffed by one physician and one care coordinator. Participants were offered hepatitis C clinical evaluation and treatment, a 45-min reinfection prevention education session, and additional care coordination as needed. The trial enrolled 84 PWID with hepatitis C in the intervention arm; 64 initiated treatment and 55 achieved sustained virological response. Start-up costs including training and equipment totaled $4677. Overhead costs including rent, utilities and software totaled $2229 per month. Clinical and care coordination totaled $4867 per participant, of which $3722 was care coordination. The total cost excluding startup was $6035 per enrolled participant and $7921 per treated participant; estimated potential reimbursement was $628 per enrolled participant. Conclusion: Our results provide insight to US-based SSPs seeking to provide co-located hepatitis C care and highlight the intensive care coordination services provided. Successful implementation likely requires funding sources beyond health insurers or substantial changes to insurance reimbursement for care coordination.