Optimal hepatitis C treatment adherence patterns and sustained virologic response among people who inject drugs: The HERO study.

BACKGROUND & AIMS: Direct-acting antivirals (DAAs) are highly effective for treating HCV infection even among people who inject drugs (PWID). Yet, little is known about patients' adherence patterns and their association with sustained virologic response (SVR) rates. We aimed to summarize various adherence patterns and determine their associations with SVR. METHODS: Electronic blister packs were used to measure daily adherence to once-a-day sofosbuvir/velpatasvir during the 12-week treatment period among active PWIDs. Blister pack data were available for 496 participants who initiated DAAs for whom SVR status was known. Adherence was summarized in multiple patterns, such as total adherent days, consecutive missed days, and early discontinuations. Thresholds for adherence patterns associated with >90% SVR rates were also determined. RESULTS: The overall SVR rate was 92.7%, with a median adherence rate of 75%. All adherence patterns indicating greater adherence were significantly associated with achieving SVR. Participant groups with ≥50% (>42/84) adherent days or <26 consecutive missed days achieved an SVR rate of >90%. Greater total adherent days during 9-12 weeks and no early discontinuation were significantly associated with higher SVR rates only in those with <50% adherence. Participants with first month discontinuation and ≥2 weeks of treatment interruption had low SVR rates, 25% and 85%, respectively. However, greater adherent days were significantly associated with SVR (adjusted odds ratio 1.10; 95% CI 1.04-1.16; p <0.001) even among participants with ≥14 consecutive missed days. CONCLUSIONS: High SVR rates can be achieved in the PWID population despite suboptimal adherence. Encouraging patients to take as much medication as possible, with <2 weeks consecutive missed days and without early discontinuation, was found to be important for achieving SVR. IMPACT AND IMPLICATIONS: People who inject drugs can be cured of HCV in >90% of cases, even with relatively low adherence to direct-acting antivirals, but early discontinuations and long treatment interruptions can significantly reduce the likelihood of achieving cure. Clinicians should encourage people who inject drugs who are living with HCV to adhere daily to direct-acting antivirals as consistently as possible, but if any days are interrupted, to continue and complete treatment. These results from the HERO study are important for patients living with HCV, clinicians, experts writing clinical guidelines, and payers. CLINICAL TRIAL NUMBER: NCT02824640.

Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study.

BACKGROUND: Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold. METHODS: This study analyzed per-protocol data of participants with adherence data (N = 493) from the HERO (Hepatitis C Real Options) study. Self-reported and objective adherence to a 12-week DAA regimen were measured using visual analogue scales and electronic blister packs, respectively. The difference (Δ) between self-reported and objectively measured adherence was calculated. We used the Youden index based on receiver operating characteristic (ROC) curve analysis to identify an optimal threshold of overreporting for predicting lower SVR rates. Factors associated with the optimal threshold of overreporting were identified by comparing baseline characteristics between participants at/above versus those below the threshold. RESULTS: The self-reported, objective, and Δ adherence averages were 95.1% (SD = 8.9), 75.9% (SD = 16.3), and 19.2% (SD = 15.2), respectively. The ≥ 25% overreporting threshold was determined to be optimal. The SVR rate was lower for ≥ 25% vs. < 25% overreporting (86.7% vs. 95.8%, p <.001). The factors associated with ≥ 25% Δ adherence were unemployment; higher number of days and times/day of injecting drugs; higher proportion of positive urine drug screening for amphetamine, methamphetamine, and oxycodone, and negative urine screening for THC (tetrahydrocannabinol)/cannabis. CONCLUSIONS: Self-reported DAA adherence was significantly greater than objectively measured adherence among PWID by 19.2%. Having ≥ 25% overreported adherence was associated with optimal prediction of lower SVR rates. PWID with risk factors for high overreporting may need to be more intensively managed to promote actual adherence.

Available but inaccessible: patient experiences during the first 2 years of a primary care-based medical cannabis program at an academic medical center.

BACKGROUND: Medical cannabis use and public acceptance in the United States have increased over the past 25 years. However, access to medical cannabis remains limited, particularly for underserved populations. To understand how patients experience medical cannabis accessibility, we measured medical cannabis use and barriers to use after medical cannabis certification in an urban safety-net academic medical center. METHODS: We conducted a retrospective cohort study among patients seen in Montefiore's Medical Cannabis Program (MMCP) from 2017 to 2019. Patient demographic and clinical characteristics, as well purchase history of medical cannabis, were extracted from electronic medical records. We also administered a phone questionnaire to a subset of patients to assess usage patterns, effectiveness, and barriers to medical cannabis use. RESULTS: Among 562 patients who were newly certified for medical cannabis between 2017 and 2019, 45% purchased medical cannabis, while 55% did not. Patients who purchased medical cannabis were more likely to be white and have private insurance or Medicare. Unregulated cannabis use and current tobacco use were less common among those who purchased medical cannabis. In multivariable logistic regression analysis, unregulated cannabis use remained negatively associated with purchasing medical cannabis. Patients reported that affordability and dispensary accessibility were their main barriers to purchasing medical cannabis. CONCLUSION: Among patients certified for medical cannabis use, fewer than half purchased medical cannabis after certification. Improving access to medical cannabis is crucial for ensuring equitable access to regulated cannabis, and to reducing unregulated cannabis use.

Individual and Health System Factors for Uptake of Pre-exposure Prophylaxis Among Young Black and Latino Gay Men.

BACKGROUND: Young Black and Latino men who have sex with men (YBLMSM) have the highest rates of new HIV infections in the USA and use PrEP at lower rates than White MSM. OBJECTIVE: To explore YBLMSM's perspectives and experiences of PrEP use to identify factors enabling or impeding uptake. DESIGN: Qualitative study using semi-structured interviews conducted between August 2015 and April 2016. PARTICIPANTS: Black and Latino MSM, 18-20 years of age, who live, socialize, or work in the Bronx, and were fluent in English or Spanish. APPROACH: We used a thematic analysis to identify themes related to not taking PrEP and PrEP uptake. KEY RESULTS: Half the participants (n = 9) were currently using PrEP, a majority had Medicaid (n = 13), all reported having a PCP, all identified English as their primary language (n = 15), and all identified as gay. Salient themes included concerns over-side effects, stigma related to HIV and sexuality, mistrust of medical providers, provider's refusal to prescribe PrEP, and insurance and cost. CONCLUSIONS: Modifiable barriers for PrEP uptake and persistence were reported by most participants, with an emphasis on PrEP misinformation and the pervasiveness of intersectional stigma, providers' low awareness, and hesitant attitudes towards PrEP and barriers created by insurance companies. Supportive infrastructures for PrEP providers and patients are needed.

Addiction Consult Service and Inpatient Outcomes Among Patients with Alcohol Use Disorder.

BACKGROUND: Alcohol use disorder (AUD) is the most prevalent substance use disorder, but evidence-based medications to treat AUD (MAUD), including naltrexone and acamprosate, are substantially underutilized. Hospitalization provides an opportunity to start MAUD for patients who may not otherwise seek treatment. Addiction consultation services (ACSs) have been increasingly utilized to ensure appropriate treatment. There is little research examining the effect of an ACS on health outcomes among patients with AUD. OBJECTIVE: To determine the association between an ACS consultation and provision of MAUD during admission and MAUD at discharge among admissions with AUD. DESIGN: Retrospective study comparing admissions which received an ACS consult and propensity score-matched historical control admissions. Subjects A total of 215 admissions with a primary or secondary diagnosis of AUD who received an ACS consult and 215 matched historical control admissions. Intervention ACS consultation from a multidisciplinary team offering withdrawal management, substance use disorder treatment, patient-centered counseling, discharge planning, and linkage to outpatient care for patients with substance use disorders, including AUD. Main Measures Primary outcomes were initiation of new MAUD during admission and new MAUD at discharge. Secondary outcomes were patient-directed discharge, time to 7- and 30-day readmission, and time to 7- and 30-day post-discharge ER visit. Key Results Among 430 admissions with AUD, those that received an ACS consultation were significantly more likely to receive new inpatient MAUD (33.0% vs 0.9%; OR 52.5 [CI 12.6-218.6]) and significantly more likely to receive new MAUD at discharge (41.4% vs 1.9%; OR 37.3 [13.3-104.6]), compared with historical controls. ACS was not significantly associated with patient-directed discharge, time to readmission, or time to post-discharge ER visit. CONCLUSIONS: ACS was associated with a large increase in provision of new inpatient MAUD and new MAUD at discharge when compared to propensity-matched historical controls.

A Video-Observed Treatment Strategy to Improve Adherence to Treatment Among Persons Who Inject Drugs Infected With Hepatitis C Virus: Qualitative Study of Stakeholder Perceptions and Experiences.

BACKGROUND: Direct-acting antiviral medications have the potential to eliminate the hepatitis C virus (HCV) epidemic among people who inject drugs; yet, suboptimal adherence remains a barrier. Directly observed treatment (DOT), an effective strategy for optimizing adherence, has been frequently implemented in opioid treatment programs but less commonly in community health settings due to the heavy burden of daily visits. An alternative is video-observed therapy (VOT), which uses mobile health technology to monitor adherence. VOT has not been widely studied among people who inject drugs with HCV. OBJECTIVE: This qualitative study, part of a larger implementation evaluation, investigates stakeholder perceptions and experiences with VOT in Project HERO (Hepatitis C Real Outcomes), a multisite pragmatic trial testing treatment delivery models for people who inject drugs with HCV. Our goal was to understand the potential barriers and facilitators to the implementation of the VOT technology. METHODS: Qualitative interviews were conducted with 27 Project HERO study staff and 7 patients. Interviews focused on perceptions and experiences with the VOT app and barriers and facilitators to implementation. Team meeting minutes over the first 2 years of the project were transcribed. A coding system was developed and applied to the data. We summarized thematic data and compared participant perceptions to generate a close understanding of the data. RESULTS: Frequent barriers to VOT included mechanical failure, stolen or lost phones, and a steep learning curve for participants and study staff. In sites with older and less technically skilled participants, staff found it difficult to implement the VOT app. Research staff found that the routine monitoring of app use led to closer engagement with participants. This was both a benefit and a potential threat to the validity of this pragmatic trial. Patient participants reported mixed experiences. CONCLUSIONS: VOT may be a useful alternative to DOT for some patients, but it may not be feasible for all. Significant staff involvement may be required.

Dispensary Staff Perceptions About the Benefits, Risks, and Safety of Cannabis for Medical Purposes.

BACKGROUND: Therapeutic use of cannabis is common in the United States (up to 18.7% of Americans aged ≥12), and dispensaries in the US are proliferating rapidly. However, the efficacy profile of medical cannabis is unclear, and customers often rely on dispensary staff for purchasing decisions. The objective was to describe cannabis dispensary staff perceptions of medical cannabis benefits and risks, as well as its safety in high-risk populations. METHODS: Online Survey study conducted using Qualtrics from February 13, 2020 to October 2, 2020 with a national sample of dispensary staff who reportedinteracting with customers in a cannabis dispensary selling tetrahydrocannabinol-containing products. Participants were queried about benefits ("helpfulness") and risks ("worry") about cannabis for a variety of medical conditions, and safety in older adults and pregnant women on a five-point Likert scale. These results were then collapsed into three categories including "neutral" (3/5). "I don't know" (uncertainty) was a response option for helpfulness and safety. RESULTS: Participants (n = 434) were from 29 states and included patient-facing dispensary staff (40%); managers (32%); pharmacists (13%); and physicians, nurse practitioners, or physician assistants (5%). Over 80% of participants perceived cannabis as helpful for post-traumatic stress disorder (88.7%), epilepsy (85.3%) and cancer (83.4%). Generally, participants were not concerned about potential cannabis risks, including increased use of illicit drugs (76.3%), decreases in intelligence (74.4%), disrupted sleep (71.7%), and new/worsening health problems from medical cannabis use (70.7%). Cannabis was considered safe in older adults by 81.3% of participants, though there was much less consensus on safety in pregnancy. CONCLUSIONS: Cannabis dispensary staff generally view medical cannabis as beneficial and low-risk. However, improvements in dispensary staff training, an increased role for certifying clinicians, and interventions to reduce dispensary staff concerns (e.g., cost, judgment) may improve evidence-based staff recommendations to patients seeking medical cannabis.

HIV And HCV adherence and treatment outcomes among people who inject drugs receiving opioid agonist therapy.

Among people who inject drugs (PWID), 60% have HCV and 50-90% of HIV-infected PWID are co-infected with HCV. Data comparing adherence to direct-acting antiviral (DAA) therapy among HCV mono-infected and HIV/HCV co-infected PWID is limited. The impact of HCV treatment initiation on HIV antiretroviral therapy (ART) adherence is also poorly understood. We assessed DAA adherence in HCV mono-infected and HIV/HCV co-infected PWID and examined changes in ART adherence and HIV outcomes following HCV treatment. Study was conducted in three Medication for Opioid use Disorder (MOUD) programs in Bronx, New York. HCV treatment adherence was measured using electronic blister packs. 2-week DAA adherence rates were compared and controlled for study arm, psychiatric illness and alcohol intoxication within the past 30 days. ART adherence was measured using participant self-report and dichotomized to "excellent" or "other". ART adherence, CD4 count, and HIV viral load were identified six months prior to, during, and six months after HCV treatment. Statistical significance was assessed with mixed-effects regression linear or logistic models. Overall DAA adherence rates among HCV mono-infected and HIV/HCV co-infected PWID were 74% (95% CI=71-78%) and 76% (95%CI=70-83%), respectively (p=.55). There were no significant changes in ART adherence, CD4 counts, or HIV viral loads prior to, during, or after HCV treatment. This is the first study assessing the impact of DAA therapy on ART adherence and HIV treatment outcomes among PWID. It is one of the first to compare DAA adherence among HCV and HIV/HCV co-infected PWID. Our data demonstrate no significant difference in DAA adherence and no significant impact of HCV treatment on ART adherence or HIV outcomes.

The Impact of Coping With Stressful Events on Negative Affect and Cravings Among Smokers With Mood Disorders.

INTRODUCTION: Smokers with mental illness report elevated levels of stress and negative affect. Craving is often cited as a key precipitant of smoking. Coping with stress has been associated with reduced cravings among smokers attempting to quit. However, the effect of coping with stress on negative affect and craving among smokers with mental illness is not well understood. This study investigated whether coping with stress predicts lower subsequent craving, mediated by reduced negative affect, among socioeconomically disadvantaged smokers with mood disorders. AIMS AND METHODS: This study used ecologically momentary assessment (EMA) data from a randomized controlled trial involving smokers with mood disorders. The final sample included 39 participants. RESULTS: Traditional mediation path analyses showed that coping with stress predicts lower craving (p = .02) through its impact on negative affect (p < .001) for the contemporaneous model (ie, when craving was measured at the same report as coping). However, coping with stress did not have a prospective effect on craving (ie, when craving was measured at the next report, up to 12 hours later) (p = .11). CONCLUSIONS: The results suggest that coping with stress reduces craving through negative effect, but only for a limited timeframe. The findings could guide future research on the length of time that the effect of coping lasts and research on interventions to increase coping with stress among smokers with mental illness. IMPLICATIONS: This is the first study to use EMA to demonstrate that coping with stressful events effectively reduces craving through reducing negative affect among smokers with mood disorders. This finding suggests that individuals heavily burdened with stress and negative affect benefit from coping with stress. We utilized within-subject analyses of EMA data which allowed us to understand these effects within an individual near real time. Our sample is hard to reach and ethnoculturally diverse. Findings could guide intervention research on helping smokers with mental illness cope when experiencing stress.

Hepatitis C Virus Direct-Acting Antiviral Treatment Adherence Patterns and Sustained Viral Response Among People Who Inject Drugs Treated in Opioid Agonist Therapy Programs.

BACKGROUND: Adequate medication adherence is critical for achieving sustained viral response (SVR) of hepatitis C virus (HCV) among people who inject drugs (PWID). However, it is less known which patterns of direct-acting antiviral (DAA) treatment adherence are associated with SVR in this population or what factors are associated with each pattern. METHODS: The randomized 3-arm PREVAIL study used electronic blister packs to obtain daily time frame adherence data in opiate agonist therapy program settings. Exact logistic regressions were applied to test the associations between SVR and 6 types of treatment adherence patterns. RESULTS: Of the 113 participants treated with combination DAAs, 109 (96.5%) achieved SVR. SVR was significantly associated with all pattern parameters except for number of switches between adherent and missed days: total adherent daily doses (exact adjusted odds ratio [AOR] = 1.12; 95% confidence interval [CI] = 1.04-1.22), percent total doses (1.09; 1.03-1.16), days on treatment (1.16; 1.05-1.32), maximum consecutive adherent days (1.34; 1.06-2.04), and maximum consecutive nonadherent days (0.85; .74-.95 = 0.003). SVR was significantly associated with total adherent doses in the first 2 months of treatment, it was not in the last month. While alcohol intoxication was significantly associated with frequent switches, drug use was not associated with any adherence pattern. CONCLUSIONS: Consistent maintenance of adequate total dose adherence over the entire course of HCV treatment is important in achieving SVR among PWID. Additional integrative addiction and medical care may be warranted for treating PWID who experience alcohol intoxication.

Prevalence and Medication Treatment of Opioid Use Disorder Among Primary Care Patients with Hepatitis C and HIV.

BACKGROUND: Hepatitis C and HIV are associated with opioid use disorders (OUD) and injection drug use. Medications for OUD can prevent the spread of HCV and HIV. OBJECTIVE: To describe the prevalence of documented OUD, as well as receipt of office-based medication treatment, among primary care patients with HCV or HIV. DESIGN: Retrospective observational cohort study using electronic health record and insurance data. PARTICIPANTS: Adults ≥ 18 years with ≥ 2 visits to primary care during the study (2014-2016) at 6 healthcare systems across five states (CO, CA, OR, WA, and MN). MAIN MEASURES: The primary outcome was the diagnosis of OUD; the secondary outcome was OUD treatment with buprenorphine or oral/injectable naltrexone. Prevalence of OUD and OUD treatment was calculated across four groups: HCV only; HIV only; HCV and HIV; and neither HCV nor HIV. In addition, adjusted odds ratios (AOR) of OUD treatment associated with HCV and HIV (separately) were estimated, adjusting for age, gender, race/ethnicity, and site. KEY RESULTS: The sample included 1,368,604 persons, of whom 10,042 had HCV, 5821 HIV, and 422 both. The prevalence of diagnosed OUD varied across groups: 11.9% (95% CI: 11.3%, 12.5%) for those with HCV; 1.6% (1.3%, 2.0%) for those with HIV; 8.8% (6.2%, 11.9%) for those with both; and 0.92% (0.91%, 0.94%) among those with neither. Among those with diagnosed OUD, the prevalence of OUD medication treatment was 20.9%, 16.0%, 10.8%, and 22.3%, for those with HCV, HIV, both, and neither, respectively. HCV was not associated with OUD treatment (AOR = 1.03; 0.88, 1.21), whereas patients with HIV had a lower probability of OUD treatment (AOR = 0.43; 0.26, 0.72). CONCLUSIONS: Among patients receiving primary care, those diagnosed with HCV and HIV were more likely to have documented OUD than those without. Patients with HIV were less likely to have documented medication treatment for OUD.

Daily and near-daily cannabis use is associated with HIV viral load suppression in people living with HIV who use cocaine.

Disparities remain in HIV viral load (VL) suppression between people living with HIV (PLWH) who use cocaine and those who do not. It is not known how cannabis use affects VL suppression in PLWH who use cocaine. We evaluated the relationship between cannabis use and VL suppression among PLWH who use cocaine. We conducted a secondary data analysis of 119 baseline interviews from a randomized controlled trial in the Bronx, NY (6/2012 to 1/2017). Participants were adult PLWH prescribed antiretrovirals for ≥16 weeks, who endorsed imperfect antiretroviral adherence and used cocaine in the past 30-days. In bivariate and multivariable regression analyses, we examined how cannabis use, is associated with VL suppression among PLWH who use cocaine. Participants were a mean age of 50 years; most were male (64%) and non-Hispanic black (55%). Participants with VL suppression used cocaine less frequently than those with no VL suppression (p < 0.01); cannabis use was not significantly different. In regression analysis, compared with no use, daily/near-daily cannabis use was associated with VL suppression (aOR = 4.2, 95% CI: 1.1-16.6, p < 0.05). Less-frequent cannabis use was not associated with VL suppression. Further investigation is needed to understand how cannabis use impacts HIV outcomes among PLWH who use cocaine.

First-Year Trajectories of Medical Cannabis Use Among Adults Taking Opioids for Chronic Pain: An Observational Cohort Study.

OBJECTIVE: To describe first-year trajectories of medical cannabis use and identify characteristics associated with patterns of use in a cohort of adults using opioids for chronic pain. DESIGN: Latent class trajectory analysis of a prospective cohort study using data on the 14-day frequency of medical cannabis use. SETTING: A large academic medical center and four medical cannabis dispensaries in the New York City metropolitan area. SUBJECTS: Adults with chronic pain using opioids and newly certified for medical cannabis in New York between 2018 and 2020. METHODS: Using latent class trajectory analysis, we identified clusters of participants based on the 14-day frequency of medical cannabis use. We used logistic regression to determine factors associated with cluster membership, including sociodemographic characteristics, pain, substance use, and mental health symptoms. RESULTS: Among 99 participants, the mean age was 53 years; 62% were women, and 52% were White. We identified three clusters of medical cannabis use: infrequent use (n = 30, mean use = 1.5 days/14-day period), occasional use (n = 28, mean = 5.7 days/14-day period), and frequent use (n = 41, mean = 12.1 days/14-day period). Within clusters, use patterns did not vary significantly over 52 weeks. Differences were observed in two sociodemographic variables: Frequent (vs infrequent) use was associated with non-Hispanic White race/ethnicity (adjusted odds ratio 4.54, 95% confidence interval 1.49-14.29), while occasional (vs infrequent) use was associated with employment (adjusted odds ratio 13.84, 95% confidence interval 1.21-158.74). CONCLUSIONS: Three clusters of medical cannabis use patterns emerged and were stable over time. Results suggest that structural factors related to race/ethnicity and employment may be major drivers of medical cannabis use, even among adults certified for its use.

New normal: caring for hospitalised patients in the Bronx, New York, during COVID-19.

The Bronx, New York, is the poorest congressional district in the United States and has the highest COVID-19 infection rate in New York City. COVID-19 has led to major changes in our healthcare system, including heightened infection-control practices, novel staffing patterns and widespread social distancing. In this article, we describe how our experience with inpatient care has changed in the wake of COVID-19.

Impact of an Opt-In eConsult Program on Primary Care Demand for Specialty Visits: Stepped-Wedge Cluster Randomized Implementation Study.

BACKGROUND: eConsult programs have been instituted to increase access to specialty expertise. Opt-in choice eConsult programs maintain primary care physician (PCP) autonomy to decide whether to utilize eConsults versus traditional specialty referrals, but little is known about how this intervention may impact PCP eConsult adoption and traditional referral demand. OBJECTIVE: We assessed the feasibility of implementing an opt-in choice eConsult program and examined whether this intervention reduces demand for in-person visits for primary care patients requiring specialty expertise. DESIGN: Stepped-wedge, cluster randomized trial conducted from July 2018 to June 2019. PARTICIPANTS: Sixteen primary care practices in a large, urban academic health care system. INTERVENTION: Our intervention was an opt-in choice eConsult available in addition to traditional specialty referral; our implementation strategy included in-person training, audit and feedback, and incentive payments. MAIN MEASURES: Our implementation outcome measure was the eConsult rate: weekly proportion of eConsults per PCP visit at each site. Our intervention outcome measure was traditional referral rate: weekly proportion of referrals per PCP visit at each site. We also assessed PCP experiences with questionnaires. KEY RESULTS: Of 305,915 in-person PCP visits, there were 31,510 traditional referrals to specialties participating in the eConsult program, and 679 eConsults. All but one primary care site utilized the opt-in choice eConsult program, with a weekly rate of 0.05 eConsults per 100 PCP visits by the end of the study period. The weekly rate of traditional referrals was 11 per 100 PCP visits at the end of the study period; this represents a significant increase in traditional referral rate after implementation of eConsults. PCPs were generally satisfied with the eConsult program and valued prompt provider-to-provider communication. CONCLUSIONS: Implementation of an opt-in choice eConsult program resulted in widespread PCP adoption; however, this did not decrease the demand for traditional referrals. Future studies should evaluate different strategies to incentivize and increase eConsult utilization while maintaining PCP choice.

Intensive Models of Hepatitis C Care for People Who Inject Drugs Receiving Opioid Agonist Therapy: A Randomized Controlled Trial.

Background: Many people who inject drugs (PWID) are denied treatment for hepatitis C virus (HCV) infection, even if they are receiving opioid agonist therapy (OAT). Research suggests that HCV in PWID may be treated effectively, but optimal models of care for promoting adherence and sustained virologic response (SVR) have not been evaluated in the direct-acting antiviral (DAA) era. Objective: To determine whether directly observed therapy (DOT) and group treatment (GT) are more effective than self-administered individual treatment (SIT) in promoting adherence and achieving SVR among PWID receiving OAT. Design: Three-group, randomized controlled trial conducted from October 2013 to April 2017. (ClinicalTrials.gov: NCT01857245). Setting: Three OAT programs in Bronx, New York. Participants: Persons aged 18 years and older with genotype 1 HCV infection who were willing to receive HCV therapy on site in the OAT program. Of 190 persons screened, 158 were randomly assigned to a study group and 150 initiated treatment: DOT (n = 51), GT (n = 48), and SIT (n = 51). Intervention: 2 intensive interventions (DOT and GT) and 1 control condition (SIT). Measurements: Primary: adherence, measured by using electronic blister packs. Secondary: HCV treatment completion and SVR 12 weeks after treatment completion. Results: Mean age was 51 years; 65% of participants had positive results on urine drug testing during the 6 months before treatment, and 75% reported ever injecting drugs. Overall adherence, estimated from mixed-effects models using the daily timeframe, was 78% (95% CI, 75% to 81%) and was greater among participants randomly assigned to DOT (86% [CI, 80% to 92%]) than those assigned to SIT (75% [CI, 70% to 81%]; difference, 11% [CI, 5% to 18%]; Bonferroni-corrected P = 0.001). No significant difference in adherence was observed between participants randomly assigned to GT (80% [CI, 74% to 86%]) and those assigned to SIT (difference, 4.7% [CI, -2% to 11%]; Bonferroni-corrected P = 0.29). The HCV treatment completion rate was 97%, with no differences among groups (P = 0.53). Overall SVR was 94% (CI, 89% to 97%); the SVR rate was 98% in the DOT group, 94% in the GT group, and 90% in the SIT group (P = 0.152). Limitation: These findings may not be generalizable to PWID not enrolled in OAT programs. Conclusion: All models of onsite HCV care delivered to PWID in OAT programs resulted in high SVR, despite ongoing drug use. Directly observed therapy was associated with greater adherence than SIT. Primary Funding Source: National Institute on Drug Abuse and Gilead Sciences.

The Use of Online Posts to Identify Barriers to and Facilitators of HIV Pre-exposure Prophylaxis (PrEP) Among Men Who Have Sex with Men: A Comparison to a Systematic Review of the Peer-Reviewed Literature.

Pre-exposure prophylaxis (PrEP) remains an under-utilized HIV prevention tool among men who have sex with men (MSM). To more comprehensively elucidate barriers and facilitators to PrEP use among US MSM, we conducted a systematic review of peer-reviewed published articles and content analysis of online posts about PrEP. We searched peer-reviewed databases (Medline, Web of Science, Google Scholar) using MESH headings and keywords about PrEP and/or HIV prevention from 2005 to 2015. We included original studies among MSM in the US that reported on barriers, facilitators, or other factors related to PrEP use. We also searched online posts and associated comments (news articles, opinion pieces, blogs and other social media posts) in diverse venues (Facebook, Slate Outward, Huffington Post Gay Voices, Queerty, and My PrEP Experience blog) to identify posts about PrEP. We used content analysis to identify themes and compare potential differences between the peer-reviewed literature and online posts. We identified 25 peer-reviewed articles and 28 online posts meeting inclusion criteria. We identified 48 unique barriers and 46 facilitators to using PrEP. These 94 themes fit into six overarching categories: (1) access (n = 14), (2) attitudes/beliefs (n = 24), (3) attributes of PrEP (n = 13), (4) behaviors (n = 11), (5) sociodemographic characteristics (n = 8), and (6) social network (n = 6). In all categories, analysis of online posts resulted in identification of a greater number of unique themes. Thirty-eight themes were identified in the online posts that were not identified in the peer-reviewed literature. We identified barriers and facilitators to PrEP in online posts that were not identified in a systematic review of the peer-reviewed literature. By incorporating data both from a systematic review of peer-reviewed articles and from online posts, we have identified salient and novel information about barriers to and facilitators of PrEP use. Traditional research approaches may not comprehensively capture current factors important for designing and implementing PrEP related interventions.

Rationale, design, and methodology of a trial evaluating three models of care for HCV treatment among injection drug users on opioid agonist therapy.

BACKGROUND: People who inject drugs (PWID) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). Treatment of PWID is complex due to addiction, mental illness, poverty, homelessness, lack of positive social support, poor adherence-related skills, low motivation and knowledge, and poor access to and trust in the health care system. New direct-acting antiviral medications are available for HCV with high cure rates and few side effects. The life expectancy and economic benefits of new HCV treatments will not be realized unless we determine optimal models of care for the majority of HCV-infected patients. The purpose of this study is to evaluate the effectiveness of directly observed therapy and group treatment compared with self-administered individual treatment in a large, urban opioid agonist therapy clinic setting in the Bronx, New York. METHODS/DESIGN: In this randomized controlled trial 150 PWID with chronic HCV were recruited from opioid agonist treatment (OAT) clinics and randomized to one of three models of onsite HCV treatment in OAT: 1) modified directly observed therapy; 2) group treatment; or 3) control - self-administered individual treatment. Participants were age 18 or older, HCV genotype 1, English or Spanish speaking, treatment naïve (or treatment experienced after 12/3/14), willing to receive HCV treatment onsite, receiving methadone or buprenorphine at the medication window at least once per week, and able to provide informed consent. Outcomes of interest include adherence (as measured by self-report and electronic blister packs), HCV treatment completion, sustained virologic response, drug resistance, and cost-effectiveness. DISCUSSION: This paper describes the design and rationale of a randomized controlled trial comparing three models of care for HCV therapy delivered in an opioid agonist treatment program. Our trial will be critical to rigorously identify models of care that result in high adherence and cure rates. Use of blister pack technology will help us determine the role of adherence in successful cure of HCV. Moreover, the trial methodology outlined here can serve as a template for the development of future programs and studies among HCV-infected drug users receiving opioid agonist therapy, as well as the cost-effectiveness of such programs. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov ( NCT01857245 ). Trial registration was obtained prospectively on May 20th, 2013.

Cannabis Use is Associated with Lower Odds of Prescription Opioid Analgesic Use Among HIV-Infected Individuals with Chronic Pain.

BACKGROUND: Chronic pain is common in the United States and prescribed opioid analgesics use for noncancer pain has increased dramatically in the past two decades, possibly accounting for the current opioid addiction epidemic. Co-morbid drug use in those prescribed opioid analgesics is common, but there are few data on polysubstance use patterns. OBJECTIVE: We explored patterns of use of cigarette, alcohol, and illicit drugs in HIV-infected people with chronic pain who were prescribed opioid analgesics. METHODS: We conducted a secondary data analysis of screening interviews conducted as part of a parent randomized trial of financial incentives to improve HIV outcomes among drug users. In a convenience sample of people with HIV and chronic pain, we collected self-report data on demographic characteristics; pain; patterns of opioid analgesic use (both prescribed and illicit); cigarette, alcohol, and illicit drug use (including cannabis, heroin, and cocaine) within the past 30 days; and current treatment for drug use and HIV. RESULTS: Almost half of the sample of people with HIV and chronic pain reported current prescribed opioid analgesic use (N = 372, 47.1%). Illicit drug use was common (N = 505, 63.9%), and cannabis was the most commonly used illicit substance (N = 311, 39.4%). In multivariate analyses, only cannabis use was significantly associated with lower odds of prescribed opioid analgesic use (adjusted odds ratio = 0.57; 95% confidence interval: 0.38-0.87). Conclusions/Importance: Our data suggest that new medical cannabis legislation might reduce the need for opioid analgesics for pain management, which could help to address adverse events associated with opioid analgesic use.