Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial.

Importance: Facilitated telemedicine may promote hepatitis C virus elimination by mitigating geographic and temporal barriers. Objective: To compare sustained virologic responses for hepatitis C virus among persons with opioid use disorder treated through facilitated telemedicine integrated into opioid treatment programs compared with off-site hepatitis specialist referral. Design, Setting, and Participants: Prospective, cluster randomized clinical trial using a stepped wedge design. Twelve programs throughout New York State included hepatitis C-infected participants (n = 602) enrolled between March 1, 2017, and February 29, 2020. Data were analyzed from December 1, 2022, through September 1, 2023. Intervention: Hepatitis C treatment with direct-acting antivirals through comanagement with a hepatitis specialist either through facilitated telemedicine integrated into opioid treatment programs (n = 290) or standard-of-care off-site referral (n = 312). Main Outcomes and Measures: The primary outcome was hepatitis C virus cure. Twelve programs began with off-site referral, and every 9 months, 4 randomly selected sites transitioned to facilitated telemedicine during 3 steps without participant crossover. Participants completed 2-year follow-up for reinfection assessment. Inclusion criteria required 6-month enrollment in opioid treatment and insurance coverage of hepatitis C medications. Generalized linear mixed-effects models were used to test for the intervention effect, adjusted for time, clustering, and effect modification in individual-based intention-to-treat analysis. Results: Among 602 participants, 369 were male (61.3%); 296 (49.2%) were American Indian or Alaska Native, Asian, Black or African American, multiracial, or other (ie, no race category was selected, with race data collected according to the 5 standard National Institutes of Health categories); and 306 (50.8%) were White. The mean (SD) age of the enrolled participants in the telemedicine group was 47.1 (13.1) years; that of the referral group was 48.9 (12.8) years. In telemedicine, 268 of 290 participants (92.4%) initiated treatment compared with 126 of 312 participants (40.4%) in referral. Intention-to-treat cure percentages were 90.3% (262 of 290) in telemedicine and 39.4% (123 of 312) in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9 (95% CI, 2.0-3.5; P < .001) with no effect modification. Observed cure percentages were 246 of 290 participants (84.8%) in telemedicine vs 106 of 312 participants (34.0%) in referral. Subgroup effects were not significant, including fibrosis stage, urban or rural participant residence location, or mental health (anxiety or depression) comorbid conditions. Illicit drug use decreased significantly (referral: 95% CI, 1.2-4.8; P = .001; telemedicine: 95% CI, 0.3-1.0; P < .001) among cured participants. Minimal reinfections (n = 13) occurred, with hepatitis C virus reinfection incidence of 2.5 per 100 person-years. Participants in both groups rated health care delivery satisfaction as high or very high. Conclusions and Relevance: Opioid treatment program-integrated facilitated telemedicine resulted in significantly higher hepatitis C virus cure rates compared with off-site referral, with high participant satisfaction. Illicit drug use declined significantly among cured participants with minimal reinfections. Trial Registration: ClinicalTrials.gov Identifier: NCT02933970.

Patient-centered HCV care via telemedicine for individuals on medication for opioid use disorder: Telemedicine for Evaluation, Adherence and Medication for Hepatitis C (TEAM-C).

BACKGROUND: Telemedicine has the potential to increase healthcare access especially for vulnerable populations. Telemedicine for Evaluation, Adherence, and Medication for Hepatitis C (TEAM-C) is comparing telemedicine access to specialty medical care to usual care for management of hepatitis C virus (HCV) infection among persons with opioid use disorder (PWOUD). PWOUD have the highest hepatitis C virus (HCV) prevalence and incidence, yet they infrequently receive HCV care. The study objectives are to compare access to specialty care via telemedicine to offsite specialty referral (usual care) on 1) treatment initiation, completion, and sustained virological response, 2) patient satisfaction with health care delivery, and 3) HCV reinfection after successful HCV cure. METHODS: TEAM-C is a multi-site, non-blinded, randomized pragmatic clinical trial conducted at 12 opioid treatment programs (OTP) throughout New York State that utilizes the stepped-wedge design. The unit of randomization is the OTP with a total sample size of 624 participants. HCV-infected PWOUD were treated via telemedicine or referral. Telemedicine encounters are conducted onsite in the OTP with co-administration of direct acting antivirals for HCV with medications for opioid use disorder. The primary outcome is undetectable HCV RNA obtained 12 weeks post-treatment cessation. We also follow participants for two years to assess for reinfection. CONCLUSIONS: The study utilizes a rigorous study design to evaluate the effectiveness and implementation of virtual treatment for HCV integrated into behavioral treatment. We demonstrate the feasibility, engagement principles and lessons learned from the initial prospective randomized trial of telemedicine targeted to a vulnerable population.

Toward precision prescribing for methadone: Determinants of methadone deposition.

BACKGROUND: Despite the World Health Organization listing methadone as an essential medication, effective dose selection is challenging, especially in racial and ethnic minority populations. Subtherapeutic doses can result in withdrawal symptoms while supratherapeutic doses can result in overdose and death. Although CYP3A4 was conventionally considered the principal methadone metabolizing enzyme, more recent data have identified CYP2B6 as the principal enzyme. CYP2B6 has ethnically-associated polymorphisms that affect the metabolic rate. Our objective was to investigate the effects of genetic and nongenetic factors on methadone metabolism. METHODS: We measured trough plasma methadone levels in 100 participants with opioid use disorder. We assessed methadone metabolism by calculating the metabolite ratio (major metabolite: 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine [EDDP] divided by methadone concentration). We assessed hepatic fibrosis and steatosis by transient elastography and CYP2B6 alleles, principally responsible for methadone metabolism. Mixed effects models modeled the data in 97 participants. RESULTS: Participants were largely male (58%), minority (61% African American) and non-Hispanic (68%). Forty percent were HCV mono-infected, 40% were uninfected, and 20% were HCV/HIV co-infected. Female sex had significant effects on (R)- and (S)-methadone metabolism (p = 0.016 and p = 0.044, respectively). CYP2B6 loss of function (LOF) alleles significantly affected (S)-methadone metabolism (p = 0.012). Body mass index (BMI) significantly affected (R)-methadone metabolism (p = 0.034). Methadone metabolism appeared to be lower in males, in individuals with LOF alleles, and elevated BMI. CONCLUSIONS: Genetic analysis, especially in minority populations, is essential to delivering individualized treatments. Although the principal methadone metabolizing enzyme remains controversial, our results suggest that sex, CYP2B6 genotype, and BMI should be incorporated into multivariate models to create methadone dosing algorithms. Methadone dosing algorithms should facilitate medication delivery, improve patient satisfaction, and diminish overdose potential.

Integrated, Co-located, Telemedicine-based Treatment Approaches for Hepatitis C Virus Management in Opioid Use Disorder Patients on Methadone.

BACKGROUND: Despite high hepatitis C virus (HCV) prevalence, opioid use disorder (OUD) patients on methadone rarely engage in HCV treatment. We investigated the effectiveness of HCV management via telemedicine in an opioid substitution therapy (OST) program. METHODS: OUD patients on methadone underwent biweekly telemedicine sessions between a hepatologist and physician assistant during the entire HCV treatment course. All pretreatment labs (HCV RNA, genotype, and noninvasive fibrosis assessments) were obtained onsite and direct-acting antivirals were coadministered with methadone using modified directly observed therapy. We used multiple correspondence analysis, least absolute shrinkage and selection operator, and logistic regression to identify variables associated with pursuit of HCV care. RESULTS: Sixty-two HCV RNA-positive patients (24% human immunodeficiency virus [HIV] infected, 61% male, 61% African American, 25.8% Hispanic) were evaluated. All patients were stabilized on methadone and all except 4 were HCV genotype 1 infected. Advanced fibrosis/cirrhosis was present in 34.5% of patients. Of the 45 treated patients, 42 (93.3%) achieved viral eradication. Of 17 evaluated patients who were not treated, 5 were discontinued from the drug treatment program or did not follow up after the evaluation, 2 had HIV adherence issues, and 10 had insurance authorization issues. Marriage and a mental health diagnosis other than depression were the strongest positive predictors of treatment pursuit, whereas being divorced, separated, or widowed was the strongest negative predictor. CONCLUSIONS: HCV management via telemedicine integrated into an OST program is a feasible model with excellent virologic effectiveness. Psychosocial and demographic variables can assist in identification of subgroups with a propensity or aversion to pursue HCV treatment.

Patient Reaction to Telemedicine for Clinical Management of Hepatitis C Virus Integrated into an Opioid Treatment Program.

Background and Introduction: Virtual integration of hepatitis C virus (HCV) infection management within the opioid treatment program (OTP) through telemedicine may overcome limited treatment uptake encountered when patients are referred offsite. To evaluate the diffusion of telemedicine within the OTP, we conducted a pilot study to assess acceptance of and satisfaction with telemedicine among 45 HCV-infected opioid use disorder (OUD) patients on methadone.Materials and Methods: We administered a modified 11-item telemedicine satisfaction questionnaire after the initial HCV telemedicine evaluation, when initiating HCV treatment, and 3 months post-HCV treatment completion. Among a patient subset, a semistructured interview further assessed issues of participant referral to the telemedicine program as well as convenience and confidentiality with the telemedicine encounters.Results: Patients demonstrated their acceptance of telemedicine-based encounters by referral of additional participants. They highlighted the convenience of on-site treatment with a liver specialist through recognition of the benefit of "one-stop shopping." They also expressed confidence in the privacy and confidentiality of telemedicine encounters.Discussion: In this pilot study, telemedicine appears to be well accepted as a modality for HCV management among OUD patients on methadone. Virtual integration of medical and behavioral therapy through telemedicine warrants further investigation for its use in this population.Conclusions: In this pilot study, we found that a largely racial minority population of substance users grew to accept telemedicine over time with diminished privacy and confidentiality concerns. Telemedicine was well accepted within the OTP community as reflected by participant referral to the program.

Hepatitis C virus core antigen: A potential alternative to HCV RNA testing among persons with substance use disorders.

BACKGROUND: The hepatitis C virus (HCV) core antigen (HCVcAg) may be an alternative diagnostic method to HCV RNA especially in populations such as substance users, the homeless or in resource-limited settings. AIMS: To evaluate performance of HCVcAg test in patients with opioid use disorder (OUD) on methadone in order to document its performance characteristics in the target population and to ensure that its specificity remains consistent across different populations. METHODS: HCVcAg levels from 109 methadone-maintained patients were compared to HCV RNA levels. RESULTS: Mean age was 53.8±7.8years, 59.6% were male, 68.8% African American, and 44% HCV-infected. HCVcAg was detectable in 47 of 48 HCV-infected, and undetectable in all HCV RNA negative patients. The HCVcAg assay had sensitivity of 97.9% and specificity of 100%. Correlation with HCV RNA levels was excellent (r=0.88, 95% CI 0.76; 0.95, p<0.01). CONCLUSION: HCVcAg has excellent performance for the diagnosis of HCV infection in patients with OUD on methadone.

Improvements in HCV-related Knowledge Among Substance Users on Opioid Agonist Therapy After an Educational Intervention.

OBJECTIVES: Lack of knowledge about hepatitis C virus (HCV) is a principal barrier to substance users' engagement into care for the infection. As a step toward their increased engagement into HCV care, the objective of this study was to deliver an HCV-related educational intervention to substance users on opioid agonist therapy and to assess the change in HCV-related knowledge after the intervention. METHODS: We designed a comprehensive and interactive hepatitis C-related educational intervention, composed of two 30 to 60-minute sessions conducted during 2 consecutive weeks. Patients' knowledge about hepatitis C was assessed immediately before and after the intervention using a 7-item questionnaire. RESULTS: A total of 110 patients completed both educational sessions. Patients' mean age was 54.7 ±â€Š7.8 years, 58.7% were men, 70.4% African American, and 30% were Hispanic. We observed a significant increase in HCV-related knowledge after completion of the educational intervention. Whereas 65.45% of patients answered 5 or more questions correctly before the intervention, 83.64% had 5 or more questions answered correctly on the posteducational quiz (P < 0.001). Male sex, ever receiving an HCV diagnostic test before the educational intervention, and a higher level of HCV knowledge on the preeducational quiz were found to be significantly associated with HCV-related knowledge after the educational intervention. CONCLUSIONS: Patients' knowledge about hepatitis C was found to be significantly improved after the educational intervention. Therefore, HCV-related education could be the first step toward effective enrollment of patients on opioid agonist therapy into hepatitis C care.

Smoking Behaviors and Attitudes Among Clients and Staff at New York Addiction Treatment Programs Following a Smoking Ban: Findings After 5 Years.

INTRODUCTION: Addiction treatment clients are more likely to die of tobacco-related diseases than of alcohol or illicit drug-related causes. We aimed to assess smoking behavior, and smoking-related attitudes and services, in New York addiction treatment programs before a statewide smoking ban in treatment facilities was implemented (2008), 1 year (2009) and 5 years after implementation (2013). METHODS: We conducted surveys at each time point with clients (N = 329, 341, and 353, respectively) and staff (N = 202, 203, and 166, respectively) from five residential and two methadone maintenance programs in New York State. At each data collection wave, questionnaires measured smoking behavior as well as smoking-related knowledge, attitudes, and experiences with tobacco cessation services as part of addiction treatment. RESULTS: Staff smoking prevalence decreased from 35.2% in 2008 to 21.8% in 2013 (P = .005) while client smoking prevalence over the same period was unchanged (68.1% vs. 66.0%, P = .564). Among clients who smoked, mean cigarettes per day decreased from 13.7 (SD = 8.38) to 10.2 (SD = 4.44; P < .001). There were significant time-by-treatment-type interactions for client tobacco-related attitudes and cessation services received; and for staff self-efficacy and cessation services provided. In residential programs, scores for most items decreased (became less positive) in 2009 followed by a partial rebound in 2013. Methadone program scores tended to rise (become more positive) throughout the study period. CONCLUSIONS: Staff and clients may respond differentially to tobacco-free policies depending on type of treatment program, and this finding may help to inform the implementation of tobacco-free policies in other statewide addiction treatment systems.

Evaluation of an electronic medical record system at an opioid agonist treatment program.

OBJECTIVES: The Addiction Research and Treatment Corporation evaluated the impact of an electronic medical record system. METHODS: A prospective pre- and postimplementation design was utilized that examined the domains of quality, productivity, satisfaction, risk management, and financial performance. RESULTS: There were highly statistically significant improvements in timely completion of Annual Medical and 30-Day, 90-Day, and Annual Multidiscipline assessments. There was no statistically significant change in obtaining hepatitis C viral load for hepatitis C antibody-positive patients. The prevalence of risk management events was too low to detect statistically meaningful changes. Patient satisfaction was unchanged pre- and postimplementation, although staff satisfaction trended upward postimplementation. Productivity significantly declined for counseling staff; there was a nonsignificant productivity decline for medical services staff and a nonsignificant productivity increase for case manager staff. Revenue per capita staff increased by 0.6%, while cost per patient visit increased by 5.7%. CONCLUSIONS: Despite less robust results than expected, had we not implemented the electronic system, recent changes in documentation and reimbursement for services would have paralyzed our agency.

The New York policy on smoking in addiction treatment: findings after 1 year.

OBJECTIVES: We assessed changes in smoking prevalence and other measures associated with the July 2008 New York Office of Alcoholism and Substance Abuse Services tobacco policy, which required that all publicly funded addiction treatment programs implement smoke-free grounds, have "no evidence" of smoking among staff, and make tobacco dependence treatment available for all clients. METHODS: In a random sample of 10 programs, staff and clients were surveyed before the policy and 1 year later. Measures included tobacco-related knowledge, attitudes, and practices used by counselors and received by clients. RESULTS: Client smoking decreased from 69.4% to 62.8% (P = .044). However, response to the policy differed by program type. Outpatient programs showed no significant changes on any of the staff and client survey measures. In methadone programs, staff use of tobacco-related practices increased (P < .01), client attitudes toward tobacco treatment grew more positive (P < .05), and clients received more tobacco-related services (P < .05). Residential clients were more likely to report having quit smoking after policy implementation (odds ratio = 4.7; 95% confidence interval = 1.53, 14.19), but they reported less favorable attitudes toward tobacco treatment (P < .001) and received fewer tobacco-related services from their program (P < .001) or their counselor (P < .001). CONCLUSIONS: If supported by additional research, the New York policy may offer a model that addiction treatment systems can use to address smoking in a population where it has been prevalent and intractable. Additional intervention or policy supports may be needed in residential programs, which face greater challenges to implementing tobacco-free grounds.

Hepatitis B virus and hepatitis C virus services offered by substance abuse treatment programs in the United States.

Although substance abuse treatment programs are important contact points for providing health services for hepatitis B virus (HBV) and hepatitis C virus (HCV) infections, availability of services in these programs has not been well characterized. This study evaluated the spectrum of HBV and HCV services offered by substance abuse treatment programs within the National Drug Abuse Treatment Clinical Trials Network. Our survey of substance abuse treatment program administrators covered availability of testing for HBV and HCV; hepatitis A virus (HAV) and HBV immunization; and HCV medical and nonmedical services. There were also questions covering clarity of guidelines for HBV and HCV testing and HAV and HBV immunization. Differences between methadone and nonmethadone programs were examined. Despite the importance of substance abuse in sustaining the hepatitis epidemics, few programs offer comprehensive HBV and HCV testing or HCV health care services. Interventions to improve access to hepatitis services for substance-abusing patients are needed.

Electronic medical record system at an opioid agonist treatment programme: study design, pre-implementation results and post-implementation trends.

RATIONALE: Electronic medical record (EMR) systems are commonly included in health care reform discussions. However, their embrace by the health care community has been slow. METHODS: At Addiction Research and Treatment Corporation, an outpatient opioid agonist treatment programme that also provides primary medical care, HIV medical care and case management, substance abuse counselling and vocational services, we studied the implementation of an EMR in the domains of quality, productivity, satisfaction, risk management and financial performance utilizing a prospective pre- and post-implementation study design. RESULTS: This report details the research approach, pre-implementation findings for all five domains, analysis of the pre-implementation findings and some preliminary post-implementation results in the domains of quality and risk management. For quality, there was a highly statistically significant improvement in timely performance of annual medical assessments (P < 0.001) and annual multidiscipline assessments (P < 0.0001). For risk management, the number of events was not sufficient to perform valid statistical analysis. CONCLUSIONS: The preliminary findings in the domain of quality are very promising. Should the findings in the other domains prove to be positive, then the impetus to implement EMR in similar health care facilities will be advanced.

Electronic health information system at an opioid treatment programme: roadblocks to implementation.

RATIONALE: Electronic health systems are commonly included in health care reform discussions. However, their embrace by the health care community has been slow. METHODS: At Addiction Research and Treatment Corporation, a methadone maintenance programme that also provides primary medical care, HIV medical care and case management, substance abuse counselling and vocational services, we describe our experience in implementing an electronic health information system that encompasses all of these areas. RESULTS: We describe the challenges and opportunities of this process in terms of change management, hierarchy of corporate objectives, process mastering, training issues, information technology governance, electronic security, and communication and collaboration. CONCLUSION: This description may provide practical insights to other institutions seeking to pursue this technology.

NIDA's Clinical Trials Network: an opportunity for HIV research in community substance abuse treatment programs.

BACKGROUND/OBJECTIVES: HIV continues to be a significant problem among substance users and their sexual partners in the United States. The National Drug Abuse Treatment Clinical Trials Network (CTN) offers a national platform for effectiveness trials of HIV interventions in community substance abuse treatment programs. This article presents the HIV activities of the CTN during its first 10 years. RESULTS: While emphasizing CTN HIV protocols, this article reviews the (1) HIV context for this work; (2) the collaborative process among providers, researchers, and National Institute on Drug Abuse CTN staff, on which CTN HIV work was based; (3) results of CTN HIV protocols and HIV secondary analyses in CTN non-HIV protocols; and (4) implications for future HIV intervention effectiveness research in community substance abuse treatment programs. CONCLUSION/SIGNIFICANCE: While the feasibility of engaging frontline providers in this research is highlighted, the limitations of small to medium effect sizes and weak adoption and sustainability in everyday practice are also discussed.

Barriers to providing health services for HIV/AIDS, hepatitis C virus infection and sexually transmitted infections in substance abuse treatment programs in the United States.

We sought to identify barriers to offering services for HIV/AIDS, hepatitis C virus, and sexually transmitted infections in substance abuse treatment programs. We surveyed treatment program administrators and clinicians within the National Drug Abuse Treatment Clinical Trials Network to evaluate the availability of medical and non-medical services for patients with or at risk for acquiring these infections. A substantial proportion of programs do not offer services (particularly medical services) for these infections. The most commonly cited barriers were funding, health insurance benefits, patient acceptance, and staff training. The findings highlight a missed opportunity to positively impact these infectious disease epidemics.