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.

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.

"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.

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.

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.

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.

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 .

Medical provider stigma experienced by people who use drugs (MPS-PWUD): Development and validation of a scale among people who currently inject drugs in New York City.

BACKGROUND: Stigmatizing attitudes towards people who use drugs (PWUD) impact their access and retention in health care. Current measures of PWUD stigma in medical settings are limited. Therefore, we developed and validated theMedical Provider Stigma Experienced by PWUD (MPS-PWUD) scale. METHODS: As part of an ongoing clinical trial, we recruited HCV RNA positive people who inject drugs in New York City. Based on 164 participants, principal component analysis (PCA) was conducted on fifteen stigma items answered on a 5-point Likert scale. We evaluated internal consistency using Cronbach's alpha coefficient and assessed construct validity by comparing stigma levels with willingness to communicate health concerns with medical providers and likelihood to seek HCV treatment. RESULTS: PCA identified a 9-item scale with two components of stigmatization that explained 60.8 % of the total variance and overall high internal consistency (alpha = 0.90). Theenacted stigma (alpha = 0.90) consisted of 6 scale items related to the medical providers' stigmatizing actions or perceptions. The internalized stigma component (alpha = 0.84) included 3 scale items related to PWUD's shame or drug use disclosure. As hypothesized, higher levels of either stigma were associated with less likelihood to openly communicate with medical providers (p < 0.005). Participants with a higher level of enacted stigma were less likely to seek HCV treatment (p = 0.011). CONCLUSIONS: The validated MPS-PWUD scale could help healthcare providers, harm reduction services and researchers measure stigma experienced by PWUD in medical settings in efforts to minimize the impact of stigma on limiting access to and retention of care for PWUD.

A mixed-methods evaluation of the feasibility, acceptability, and preliminary efficacy of a mobile intervention for methadone maintenance clients.

Despite the recent explosion of behavioral health interventions delivered on mobile devices, little is known about factors that make such applications practical, engaging and useful to their target audience. This study reports on the feasibility, acceptability and preliminary efficacy of a prototype of a novel, interactive mobile psychosocial intervention to reduce problematic drug use among clients in methadone maintenance treatment (MMT). A mixed-methods pilot study with new MMT clients (n = 25) indicated that the mobile intervention approach was feasible, and that participants found the intervention highly acceptable and useful. On 100-point visual analog scale (VAS) items, participants reported high levels of liking the program (M = 75.6), and endorsed it as useful (M = 77.5), easy to use (M = 80.7), and containing a significant amount of new information (M = 74.8). When compared with 25 study participants who received standard MMT alone, pilot participants rated their treatment significantly higher in interestingness and usefulness, and were significantly more satisfied with their treatment. In qualitative interviews, participants reported using the mobile intervention in a range of settings, including during times of heightened risk for substance use, and finding it helpful in managing drug cravings. Additionally, pilot participants showed evidence of increased treatment retention and abstinence from illicit opioids (in terms of effect size) over a 3-month period relative to those in standard MMT, suggesting the application's potential to enhance treatment outcomes. These promising findings suggest that an evidence-based mobile therapeutic tool addressing substance use may appeal to drug treatment clients and have clinical utility as an adjunct to formal treatment.

Can persons with a history of multiple addiction treatment episodes benefit from technology delivered behavior therapy? A moderating role of treatment history at baseline.

A growing line of research has shown positive treatment outcomes from technology-based therapy for substance use disorders (SUDs). However, little is known about the effectiveness of technology-based SUD interventions for persons who already had numerous prior SUD treatments. We conducted a secondary analysis on a 12-month trial with patients (N=160) entering methadone maintenance treatment (MMT). Patients were randomly assigned to either standard MMT treatment or a model in which half of standard counseling sessions were replaced with a computer-based intervention, called Therapeutic Education System (standard+TES). Four treatment history factors at baseline, the number of lifetime SUD treatment episodes, detoxification episodes, and inpatient/outpatient treatment episodes were categorized into three levels based on their tertile points, and analyzed as moderators. Dependent variables were urine toxicology results for opioid and cocaine abstinence for 52-weeks. The standard+TES condition produced significantly better opioid abstinence than standard treatment for participants with 1) a moderate or high frequency of lifetime SUD treatment episodes, and 2) those with all three levels (low, moderate and high) of detoxification and inpatient/outpatient treatment episodes, ps<.01. The standard+TES condition enhanced cocaine abstinence compared to standard treatment among people with 1) a moderate or high frequency of lifetime SUD treatment episodes, 2) a high level of detoxification episodes, and 3) a moderate or high level of inpatient treatment history, ps<.01. We found that including technology-based behavioral therapy as part of treatment can be more effective than MMT alone, even among patients with a history of multiple addiction treatment episodes.

Predictors of outcome from computer-based treatment for substance use disorders: Results from a randomized clinical trial.

BACKGROUND: Although empirical evidence for the effectiveness of technology-mediated interventions for substance use disorders is rapidly growing, the role of baseline characteristics of patients in predicting treatment outcomes of a technology-based therapy is largely unknown. METHOD: Participants were randomly assigned to either standard methadone maintenance treatment or reduced standard treatment combined with the computer-based therapeutic education system (TES). An array of demographic and behavioral characteristics of participants (N=160) was measured at baseline. Opioid abstinence and treatment retention were measured weekly for a 52-week intervention period. Generalized linear model and Cox-regression were used to estimate the predictive roles of baseline characteristics in predicting treatment outcomes. RESULTS: We found significant predictors of opioid abstinence and treatment retention within and across conditions. Among 21 baseline characteristics of participants, employment status, anxiety, and ambivalent attitudes toward substance use predicted better opioid abstinence in the reduced-standard-plus-TES condition compared to standard treatment. Participants who had used cocaine/crack in the past 30 days at baseline showed lower dropout rates in standard treatment, whereas those who had not used exhibited lower dropout rates in the reduced-standard-plus-TES condition. CONCLUSIONS: This study is the first randomized controlled trial, evaluating over a 12-month period, how various aspects of participant characteristics impact outcomes for treatments that do or do not include technology-based therapy. Compared to standard alone treatment, including TES as part of the care was preferable for patients who were employed, highly anxious, and ambivalent about substance use and did not produce worse outcomes for any subgroups of participants.

Web-based behavioral treatment for substance use disorders as a partial replacement of standard methadone maintenance treatment.

This study is the first experimental trial to evaluate the effectiveness of a Web-based behavioral intervention when deployed in a model where it partially substituted for standard counseling in a community-based specialty addiction treatment program. New opioid-dependent intakes in methadone maintenance treatment (n=160) were randomly assigned for 12months to either: (1) standard treatment or (2) reduced standard treatment plus a Web-based psychosocial intervention, the Therapeutic Education System (TES). Results demonstrated that replacing a portion of standard treatment with TES resulted in significantly greater rates of objectively measured opioid abstinence (48% vs. 37% abstinence across all study weeks; F(1, 158)=5.90, p<.05 and 59% vs. 43% abstinence on weeks participants provided urine samples for testing; F(1, 158)=8.81, p<.01). This result was robust and was evident despite how opioid abstinence was operationally defined and evaluated. The potential implications for service delivery models within substance abuse treatment programs and other healthcare entities are discussed.

A Web-Based Behavior Therapy Program Influences the Association Between Cognitive Functioning and Retention and Abstinence in Clients Receiving Methadone Maintenance Treatment.

OBJECTIVE: Deficits in cognitive functioning have been well-documented in persons with substance use disorders. In addition, some evidence suggests that poorer cognitive functioning predicts poorer engagement in substance abuse treatment and worse treatment outcomes. TRIAL DESIGN: Non-blind, randomized clinical trial with parallel design. METHODS: Clients were recruited from a local methadone maintenance clinic within the first 30 days of treatment. All participants completed a comprehensive, computerized neuropsychological assessment (MicroCog) at the time they entered the clinical trial. Participants were randomized to receive 12 months of either standard methadone maintenance treatment, or methadone maintenance treatment with an integrated web-based intervention as part of treatment. The aims of the current study were to (1) characterize the cognitive functioning of clients entering methadone maintenance treatment; (2) evaluate the impact of cognitive functioning on the primary outcomes of treatment retention and opioid abstinence; and (3) determine whether cognitive functioning had a differential impact on these outcomes across treatment conditions. Randomization was non-blind and participants were stratified on past month cocaine use, prior history of methadone, LAAM or buprenorphine treatment, and counselor. RESULTS: Eighty participants were randomized to each condition (total n=160). Mean scores on MicroCog scales fell in the average and low average ranges and there were no differences in scores between treatment groups. Lower scores on General Cognitive Proficiency predicted longer study retention (χ2=5.03, p < .05), though this effect was quite small. Generalized linear modeling showed that scores on all MicroCog scales except for Spatial Processing significantly predicted opioid abstinence (defined as percent of total weeks and percent of tested weeks with continuous abstinence), with lower scores predicting smaller percentages of continuous weeks of abstinence. This pattern was not evident in regression analyses in which abstinence was defined as number of total weeks of abstinence. An interaction effect was observed, whereby lower cognitive scores predicted lower levels of abstinence for participants in standard methadone maintenance treatment, but not for those who received the web-based intervention as part of methadone maintenance treatment. CONCLUSIONS: Technology-based interventions may hold promise for minimizing the impact of poorer cognitive functioning on treatment outcomes.