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To achieve WHO targets for the elimination of hepatitis C virus (HCV) as a public threat, an increased uptake of HCV treatment among people who inject drugs (PWID) is urgently needed. Optimal HCV co-located treatment models for PWID have not yet been identified. We aimed to compare two patient-centred models of HCV care in PWID with active drug use.We did a pragmatic randomised controlled trial at eight US cities in eight opioid treatment programmes and 15 community health centres. PWID actively injecting within 90 days of study entry were randomly assigned (1:1) to either patient navigation or modified directly observed therapy (mDOT) using computer-generated variable block sizes of 2-6 stratified by city, clinical settings, and cirrhosis status. The randomisation code was concealed, in a centralised REDCap database platform, from all investigators and research staff except for an authorised data manager at the data coordinating centre. All participants received a fixed-dose combination tablet (sofosbuvir 400 mg plus velpatasvir 100 mg) orally once daily for 12 weeks. The primary outcome was sustained virological response (SVR; determined by chart review between 70 days and 365 days after end of treatment and if unavailable, by study blood draws), and secondary outcomes were treatment initiation, adherence (measured by electronic blister packs), and treatment completion. Analyses were conducted within the modified intention-to-treat (mITT; all who initiated treatment), intention-to-treat (all who were randomised), and per-protocol populations. This trial is registered with ClinicalTrials.gov, NCT02824640.Between Sept 15, 2016, and Aug 14, 2018, 1891 individuals were screened and 1136 were excluded (213 declined to participate and 923 did not meet the eligibility criteria). We randomly assigned 755 participants to patient navigation (n=379) or mDOT (n=376). In the mITT sample of participants who were randomised and initiated treatment (n=623), 226 (74% [95% CI 69-79]) of 306 participants in the mDOT group and 236 (76% [69-79]) of 317 in the patient navigation group had an SVR, with no significant difference between the groups (adjusted odds ratio [AOR] 0·97 [95% CI 0·66-1·42]; p=0·35). In the ITT sample (n=755), 226 (60% [95% CI 55-65]) of 376 participants in the mDOT group and 236 (62% [57-67]) of 379 in the patient navigation group had an SVR (AOR 0·92 [0·68-1·25]; p=0·61) and in the per-protocol sample (n=501), 226 (91% [87-94]) of 248 participants in the mDOT group and 235 (93% [89-96]) of 253 in the patient navigation group had an SVR (AOR 0·79 [0·41-1·55]; p=0·44). 306 (81%) of 376 participants in the mDOT group and 317 (84%) of 379 participants in the patient navigation group initiated treatment (AOR 0·86 [0·58-1·26]; p=0·44) and, among those, 251 (82%) participants in the mDOT group and 264 (83%) participants in the patient navigation group completed treatment (AOR 0·90 [0·58-1·39]; p=0·63). Mean daily adherence was higher in the mDOT group (78% [95% CI 75-81]) versus the patient navigation group (73% [70-77]), with a difference of 4·7% ([1·9-7·4]; p=0·0010). 421 serious adverse events were reported (217 in the mDOT group and 204 in the patient navigation group), with the most common being hospital admission (176 in the mDOT group vs 161 in the patient navigation group).In this trial of active PWID, both models resulted in high SVR. Although adherence was significantly higher in the mDOT group versus the patient navigation group, there was no significant difference in SVR between the groups. Increases in adherence and treatment completion were associated with an increased likelihood of SVR. These results suggest that active PWID can reach high SVRs in diverse settings with either mDOT or patient navigation support.Patient-Centered Outcomes Research Institute, Gilead Sciences, Quest Diagnostics, Monogram Biosciences, and OraSure Technologies.

Background: Antiretroviral therapy (ART) non-adherence and methamphetamine use are associated with higher HIV drug resistance prevalence. How they affect drug resistance mutations accumulation is less studied. Objective: We assessed factors associated with drug resistance mutations accumulation. Methods: We evaluated HIV chronically-infected patients from a clinic-based research cohort on first-line ART regimens with genotype results within 30 days of baseline. Methamphetamine use and ART adherence were self-reported at each study visit. High ART adherence was defined as 0-5% missed doses in the last 30 days. Results: One-hundred twenty-five patients contributed 496 study visits. At baseline, 81% of patients reported high ART adherence; 90% reported no methamphetamine use in the prior 4 months, 8% used monthly or less and 2% used daily or weekly. Methamphetamine users and non-users had similarly high ART adherence (p=0.93). Adjusted incidence rate ratio (aIRR) of drug resistance mutations accumulation was 2.04 (95% CI 0.64, 6.46) for daily/weekly users and 1.71 (95% CI 0.66, 4.42) for patients with monthly or less users, compared to non-users. aIRR was 0.71 (95% CI 0.44, 1.15) with >5-10% missed ART doses and 1.21 (95% CI 0.80, 1.83) with >10% missed doses compared to 0-5% missed doses. Conclusions: We found no strong evidence for the effect of methamphetamine use and ART adherence on drug resistance mutations accumulation. Research cohort patients may have been more engaged in care and treatment adherent than non-cohort patients. Our findings suggest methamphetamine use might not lead to treatment failure among HIV patients who are otherwise engaged in care.

BACKGROUND: A safe and effective vaccine to prevent chronic hepatitis C virus (HCV) infection is a critical component of efforts to eliminate the disease. METHODS: In this phase 1–2 randomized, double-blind, placebo-controlled trial, we evaluated a recombinant chimpanzee adenovirus 3 vector priming vaccination followed by a recombinant modified vaccinia Ankara boost; both vaccines encode HCV nonstructural proteins. Adults who were considered to be at risk for HCV infection on the basis of a history of recent injection drug use were randomly assigned (in a 1:1 ratio) to receive vaccine or placebo on days 0 and 56. Vaccine-related serious adverse events, severe local or systemic adverse events, and laboratory adverse events were the primary safety end points. The primary efficacy end point was chronic HCV infection, defined as persistent viremia for 6 months. RESULTS: A total of 548 participants underwent randomization, with 274 assigned to each group. There was no significant difference in the incidence of chronic HCV infection between the groups. In the per-protocol population, chronic HCV infection developed in 14 participants in each group (hazard ratio [vaccine vs. placebo], 1.53; 95% confidence interval [CI], 0.66 to 3.55; vaccine efficacy, −53%; 95% CI, −255 to 34). In the modified intention-to-treat population, chronic HCV infection developed in 19 participants in the vaccine group and 17 in placebo group (hazard ratio, 1.66; 95% CI, 0.79 to 3.50; vaccine efficacy, −66%; 95% CI, −250 to 21). The geometric mean peak HCV RNA level after infection differed between the vaccine group and the placebo group (152.51×10(3) IU per milliliter and 1804.93×10(3) IU per milliliter, respectively). T-cell responses to HCV were detected in 78% of the participants in the vaccine group. The percentages of participants with serious adverse events were similar in the two groups. CONCLUSIONS: In this trial, the HCV vaccine regimen did not cause serious adverse events, produced HCV-specific T-cell responses, and lowered the peak HCV RNA level, but it did not prevent chronic HCV infection. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT01436357.)

Across the USA, morbidity and mortality from substance use are rising as reflected by increases in acute care hospitalisations for substance use complications and substance-related deaths. Patients with substance use disorders (SUD) have long and costly hospitalisations and higher readmission rates compared to those without SUD. Hospitalisation presents an opportunity to diagnose and treat individuals with SUD and connect them to ongoing care. However, SUD care often remains unaddressed by hospital providers due to lack of a systems approach and addiction medicine knowledge, and is compounded by stigma. We present a blueprint to launching an interprofessional inpatient addiction care team embedded in the hospital medicine division of an urban, safety-net integrated health system. We describe key factors for successful implementation including: (1) demonstrating the scope and impact of SUD in our health system via a needs assessment; (2) aligning improvement areas with health system leadership priorities; (3) involving executive leadership to create goal and initiative alignment; and (4) obtaining seed funding for a pilot programme from our Medicaid health plan partner. We also present challenges and lessons learnt.

The Association for Multidisciplinary Education and Research in Substance Use and Addiction (AMERSA) acknowledges that racism profoundly affects persons who use alcohol and other drugs. Racism's deadly effects compounded with other social determinants of health result in a cascade of negative impacts. The AMERSA Board of Directors (BOD) proposes an initial set of strategies to promote diversity, equity, and inclusion using a framework that speaks to four key AMERSA experiences: engagement, education, mentorship, and leadership. Through these strategies, AMERSA commits to promoting equity and inclusion to dismantle the individual, institutional, and structural racism that has permeated the United States for centuries. Abstracts of paper and poster presentations are also provided (Supplemental Material).

BACKGROUND. Associations between fentanyl use and initiation and retention on medications for opioid use disorder (MOUD) are poorly understood. METHODS. Data were from a multisite clinical trial comparing extended-release naltrexone (XRNTX) with treatment as usual (TAU; buprenorphine or methadone) to achieve HIV viral suppression among people with OUD and uncontrolled HIV disease. The exposure of interest was fentanyl use, as measured by urine drug screening. Outcomes were time to MOUD initiation, defined as date of first injection of XR-NTX, buprenorphine prescription, or methadone administration; MOUD persistence, the total number of injections, prescriptions, or administrations received over 24 weeks; and MOUD retention, having an injection, prescription, or administration during weeks 20 to 24. RESULTS. Participants (N = 111) averaged 47 years old and 62% were male. Just over half (57%) were Black and 13% were Hispanic. Sixty-four percent of participants tested positive for fentanyl at baseline. Participants with baseline fentanyl positivity were 11 times less likely to initiate XR-NTX than those negative for fentanyl (aHR = 0.09, 95% CI 0.03 to 0.24, p < .001), but there was no evidence that fentanyl use impacted the likelihood of TAU initiation (aHR = 1.50, 0.67 to 3.36, p = .323). Baseline fentanyl use was not associated with persistence or retention on any MOUD. CONCLUSIONS. Fentanyl use was a substantial barrier to XR-NTX initiation for the treatment of OUD in persons with uncontrolled HIV infection. There was no evidence that fentanyl use impacted partial/full agonist initiation and, once initiated, retention on any MOUD.

Pain has always been an important part of human immunodeficiency virus (HIV) disease and its experience for patients. In this guideline, we review the types of chronic pain commonly seen among persons living with HIV (PLWH) and review the limited evidence base for treatment of chronic noncancer pain in this population. We also review the management of chronic pain in special populations of PLWH, including persons with substance use and mental health disorders. Finally, a general review of possible pharmacokinetic interactions is included to assist the HIV clinician in the treatment of chronic pain in this population. It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. The Infectious Diseases Society of American considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient’s individual circumstances.

Pain has always been an important part of human immunodeficiency virus (HIV) disease and its experience for patients. In this guideline, we review the types of chronic pain commonly seen among persons living with HIV (PLWH) and review the limited evidence base for treatment of chronic noncancer pain in this population. We also review the management of chronic pain in special populations of PLWH, including persons with substance use and mental health disorders. Finally, a general review of possible pharmacokinetic interactions is included to assist the HIV clinician in the treatment of chronic pain in this population.It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. The Infectious Diseases Society of American considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances.

Clinical practice guidelines recommend that clinicians implement the 5As (Ask, Advise, Assess, Assist, and Arrange) for smoking cessation at every clinical encounter. We sought to examine the prevalence of patient- and clinician-reported 5As in two primary care and one HIV care clinics in San Francisco, California between August 2013 and March 2014 (n = 462 patients and n = 61 clinicians). We used multivariable logistic regression analysis to identify factors associated with receipt of the 5As, adjusting for patient demographics, patient insurance, clinic site, patient tobacco use, and patient comorbidities. The patient-reported prevalence of 5As receipt was as follows: Ask, 49.9%; Advise, 47.2%; Assess, 40.6%; any Assist, 44.9%; and Arrange, 22.4%. In multivariable analysis, receipt of Advise, Assess, and Assist were associated with older patient age. Whereas patients with HIV had a lower odds of reporting being advised (AOR 0.5, 95% CI 0.3–0.8) or assessed for readiness to quit (AOR 0.6, 95% CI 0.4–0.9), patients with pulmonary diseases had higher odds of reporting being assisted (AOR 1.6, 95% 1.0–2.6) than patients without these diagnoses. Although the majority of clinicians reported asking (91.8%), advising (91.8%), and assessing (93.4%) tobacco use ‘most of the time’ or ‘always’ during a clinical encounter, fewer reported assisting (65.7%) or arranging (19.7%) follow-up. Only half of patients reported being screened for tobacco use and fewer reported receipt of the other 5As, with significant disparities in receipt of the 5As among patients with HIV. Our findings confirm the need for interventions to increase clinician-delivered cessation treatment in primary and HIV care., Highlights • Clinical practice guidelines recommend the use of 5As for smoking cessation. • Patient reports of Assist and Arrange were low in primary care and HIV care. • There were significant disparities in the receipt of 5As among patients with HIV. • Digital interventions could facilitate clinician-delivered 5As for patients.

© 2017 Society for the Study of Addiction Background and aims: HIV-infected people with substance use disorders are least likely to benefit from advances in HIV treatment. Integration of extended-release naltrexone (XR-NTX) into HIV clinics may increase engagement in the HIV care continuum by decreasing substance use. We aimed to compare (1) XR-NTX treatment initiation, (2) retention and (3) safety of XR-NTX versus treatment as usual (TAU) for treating opioid use disorder (OUD) and/or alcohol use disorder (AUD) in HIV clinics. Design: Non-blinded randomized trial of XR-NTX versus pharmacotherapy TAU. Setting: HIV primary care clinics in Vancouver, BC, Canada and Chicago, IL, USA. Participants: Fifty-one HIV-infected patients seeking treatment for OUD (n = 16), AUD (n = 27) or both OUD and AUD (n = 8). Measurements: Primary outcomes were XR-NTX initiation (receipt of first injection within 4 weeks of randomization) and retention at 16 weeks. Secondary outcomes generated point estimates for change in substance use, HIV viral suppression [HIV RNA polymerase chain reaction (pcr)

BACKGROUND: Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) - results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (< 80%), failure to achieve SVR, DAA resistance, and HCV reinfection. METHODS: The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT. CONCLUSIONS: This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.

Introduction Although evidence-based, the 5A’s (Ask, Advise, Assess, Assist, and Arrange) for smoking cessation are often incompletely delivered by primary care providers. This study examines whether a computer tablet 5A’s intervention improves primary care provider adherence to the 5A’s. Study design Cluster RCT. Setting/participants All primary care providers in three urban, adult primary care clinics were randomized for participation. Any English- or Spanish-speaking patient with a primary care appointment who had smoked >100 lifetime cigarettes and at least one cigarette in the past week was eligible. Intervention A cluster RCT comparing computer-facilitated 5A’s with usual care assessed effects on provider adherence to each of the 5A’s as determined by patient report. Intervention subjects used a computer tablet to complete the 5A’s immediately before a primary care appointment. A tailored, patient handout and a structured, clinician guide were generated. Data were collected in 2014–2015 and analyzed in 2016–2017. Main outcome measures Provider adherence to the 5A’s. Results Providers (N=221) saw 961 patients (n=412 intervention, n=549 control) for a total of n=1,340 encounters with n=1,011 completed post-visit interviews (75.4% completion). Intervention providers had significantly higher odds of completing Assess (AOR=1.32, 95% CI=1.02, 1.73) and Assist (AOR=1.45, 95% CI=1.08, 1.94). When looking at first study visits only, intervention providers had higher odds for Arrange (AOR=1.72, 95% CI=1.23, 2.40) and all 5A’s (AOR=2.04, 95% CI=1.35, 3.07) but study visit did not influence receipt of the other 5A’s. Conclusions A computer-facilitated 5A’s delivery model was effective in improving the fidelity of provider-delivered 5A’s to diverse primary care patients. This relatively low-cost, time-saving intervention has great potential for smoking cessation and other health behaviors. Future studies should identify ways to promote and sustain technology implementation. Trial registration This study is registered at www.clinicaltrials.gov NCT02046408.

We measured HIV incidence rate, trend and risk factors in 564 HIV-negative young people (

Background The American Academy of Pediatrics Committee on Substance Use recommends screening, brief intervention, and referral to treatment (SBIRT) at every adolescent preventive and all appropriate urgent visits. We designed an SBIRT curriculum as part of the adolescent block of a pediatric residency that combined online modules with an in-person workshop, faculty feedback on resident interactions with patients, and resident self-reflection on their motivational interviewing (MI) skills. Methods To evaluate the curriculum, we measured resident satisfaction and self-reported confidence in using SBIRT and MI with teens using a retrospective pre/post questionnaire. We used qualitative analysis to evaluate the written comments from faculty observations of patient-trainee interactions and comments from resident self-reflection(s) on patient interactions. Results Thirty-two residents completed the curriculum. Residents reported high satisfaction with the training. Comparing retrospective pre/post scores on the survey of resident self-reported confidence, measures increased significantly in all domains, including for both alcohol and other drug use. Regarding self-reported MI, skillfulness also increased significantly. Analysis of specific faculty feedback to residents revealed subthemes such as normalizing confidentiality and focusing more on the patient's perspectives on substance use. Resident reflections on their own abilities with SBIRT/MI focused on using the ruler tool and on adapting the MI style of shared decision-making. Conclusions A curriculum that combines online training, small-group practice, clinical observations, and self-reflection is valued by residents and can increase resident self-reported confidence in using SBIRT and MI in adolescent encounters. Future studies should examine to what extent confidence predicts performance using standardized measures of MI skillfulness in patient encounters.

Objectives. To determine the association between multiple drug use and nonfatal overdose among young people (younger than 30 years) who inject drugs. Methods. We completed a longitudinal study of 173 injection drug users younger than 30 years living in San Francisco, California, between April 2012 and February 2014. Results. The odds of nonfatal overdose increased significantly as heroin and benzodiazepine pill-taking days increased and when alcohol consumption exceeded 10 drinks per day compared with 0 drinks per day. Conclusions. Heroin, benzodiazepine, and alcohol use were independently associated with nonfatal overdose over time among young people who inject drugs. Efforts to address multiple central nervous system depressant use remain an important component of a comprehensive approach to overdose, particularly among young people.

An editorial is presented which addresses the authors' views about the lack of a Hepatitis C virus (HCV) preventive vaccine, and it mentions opioid abuse epidemics and another article which appears in the same issue of the journal and deals with an increase in the number of reported acute cases of HCV in the U.S. The Treatment Episode Data Set-Admissions (TEDS) system and substance use treatments are examined, as well as syringe service programs, pharmacotherapies, and HCV treatment.

Background While brief intervention (BI) for risky alcohol use generally yields positive effects among those identified by screening, effect sizes are small and there is unexplained heterogeneity in outcome. The heterogeneity may be related to differences in intervention style and content, including elements of motivational interviewing (MI). To date, it has been difficult to interpret the role of MI in BI and these gaps in knowledge interfere with efforts to train, disseminate and implement BI that retains and maximizes efficacy. This study sought to develop BI protocols with varying doses of MI and test their differentiability. Differentiable BI protocols could allow for future studies that prospectively evaluate the role MI plays in affecting BI outcome. Methods We developed three intervention protocols: brief advice, standard BI (NIAAA Clinician’s Guide), and MI-enhanced BI and administered them to 45 primary care patients who reported exceeding recommended drinking limits. We then rated the BI sessions for fidelity to the assigned protocol as well as MI consistency based on Motivational Interviewing Treatment Integrity (MITI) scale scores. The differentiability of BI protocols was determined by calculating fidelity to assigned protocols and comparing MITI scores using pairwise, Tukey-adjusted comparisons of least squares mean scores. Results High rates of fidelity to each protocol were achieved. The three BI protocols were also highly differentiable based on MITI scores. Conclusions The three interventions can be used in future trials to prospectively examine the role MI has in determining BI outcome. Trial registration clinicaltrials.gov NCT02978027, retrospectively registered 11/28/16 Electronic supplementary material The online version of this article (10.1186/s13722-017-0102-0) contains supplementary material, which is available to authorized users.

BackgroundElectronic cigarette (e-cigarette) use is rising in both the general and clinical populations. Little is known about e-cigarette use in primary care, where physicians report discussing e-cigarette use with patients.ObjectiveIdentify how and why smokers in primary care use e-cigarettes.DesignCross-sectional secondary data analysis from a randomized controlled trial of a tablet intervention to deliver the 5As for smoking cessation in primary care.ParticipantsCurrent smokers aged 18 and older in three primary care clinics in San Francisco, CA (N=788).Main measuresPatients reported sociodemographics, cigarette smoking habits, quitting readiness, and ever and current use of e-cigarettes. We also asked reasons they have used or would use e-cigarettes. ICD-9 codes from the medical record determined comorbidities.Key resultsFifty-two percent (n=408) of patients reported ever using an e-cigarette, and 20% (n=154) reported past-30-day use. Ever e-cigarette use was associated with younger age and negatively associated with being seen at practices at a public safety-net hospital compared to a practice at University-affiliated hospital. The most common reason for having used e-cigarettes among ever e-cigarette users, and for interest in future use of e-cigarettes among never e-cigarette users, was to cut down cigarette use. The mean number of days of e-cigarette use in the past 30 increased with duration of e-cigarette use. Most current e-cigarette users did not know the nicotine content of their e-cigarettes.ConclusionsOver half of smokers in primary care have ever used e-cigarettes, and one-fifth are currently using them. Most reported using e-cigarettes to cut down or quit cigarettes. Primary care providers should be prepared to discuss e-cigarettes with patients. Screening for e-cigarette use may help identify and treat patients interested in changing their cigarette smoking habits.

BackgroundPersons living with HIV and unhealthy substance use are often less engaged in HIV care, have higher morbidity and mortality and are at increased risk of transmitting HIV to uninfected partners. We developed a quality-improvement tracking system at an urban methadone clinic to monitor patients along the HIV care continuum and identify patients needing intervention.ObjectiveTo evaluate patient outcomes along the HIV Care Continuum at an urban methadone clinic and explore the relationship of HIV primary care site and patient demographic characteristics with retention in HIV treatment and viral suppression.MethodsWe reviewed electronic medical record data from 2015 for all methadone clinic patients with known HIV disease, including age, gender, race, HIV care sites, HIV care visit dates and HIV viral load. Patients received either HIV primary care at the methadone clinic, an HIV specialty clinic located in the adjacent building, or a community clinic. Retention was defined as an HIV primary care visit in both halves of the year. Viral suppression was defined as an HIV viral load

Background The development of a safe and effective vaccine to prevent chronic hepatitis C virus (HCV) infection is a critical component of elimination efforts, providing the rationale for the first HCV vaccine efficacy trial. Methods In a randomized, multicenter, double-blind, placebo-controlled efficacy trial (NCT01436357), we evaluated a recombinant chimpanzee adenovirus 3 vector vaccine prime followed by a recombinant modified vaccinia Ankara boost, both encoding nonstructural proteins of HCV. HCV-uninfected adults 18–45 years old at-risk for HCV infection due to injection drug use were randomized to receive the prime-boost regimen or placebo at Days 0 and 56. Trial participants were monitored for vaccine reactogenicity, adverse events, and HCV viremia. Vaccine safety, immunogenicity, and efficacy against progression to chronic HCV infection were assessed. Results A total of 455 subjects received the prime-boost regimen or two doses of placebo, with 202 and 199 in the respective groups included in the according-to-protocol efficacy cohort. Overall incidence of infection was 14.1 infections per 100 person-years. There were no differences in development of chronic infection between vaccine and placebo arms, with 14 chronically infected subjects in each group. Specifically, the vaccine efficacy in preventing chronic infection was −0.53 (95% confidence interval [CI], −2.5 to 0.34). Of vaccinated subjects, 78% generated T-cell responses to ≥1 vaccine-encoded HCV antigens. The vaccine was generally safe and well tolerated with no serious vaccine-related adverse events. There were more solicited reports of adverse events after either injection in the vaccine group (81%) than in the placebo group (59%), with the difference mainly due to injection-site reactions. Serious adverse events and deaths occurred with similar frequencies in the two groups. Conclusion A randomized, placebo controlled, Phase I/II trial of a prime-boost vaccine to prevent chronic HCV infection was completed in an at-risk population, demonstrating the feasibility of conducting rigorous vaccine research in people who inject drugs. The regimen elicited robust immune responses without evident safety concerns, but did not provide protection against chronic HCV infection. Disclosures Ventzislav Vassilev, PhD, GlaxoSmithKlein Vaccines (Employee), Lan Lin, MD, GlaxoSmithKlein Vaccines (Employee), Alfredo Nicosia, PhD, ReiThera (Employee, Shareholder), Antonella Folgori, PhD, ReiThera (Employee), ReiThera (Employee, Shareholder. Other Authors: No reported disclosures.

Objective Alcohol abuse occurs frequently in those with human immunodeficiency virus (HIV) infection. Alcohol has been linked to poor response to HIV treatment and more rapid progression of HIV. One possible contributor to such observations is drug interactions between alcohol and antiretroviral (ARV) medications. This study examined drug interactions between antiretroviral therapies (ARTs) containing either efavirenz or ritonavir with alcohol. Methods Human immunodeficiency virus-infected individuals not currently receiving ARTs participated in a randomized, double-blind, placebo-controlled study in which alcohol (or placebo) was administered and followed by blood sampling for pharmacokinetics, subjective, cardiovascular, and neuropsychological responses obtained at predetermined times. Antiretroviral therapy was then initiated and alcohol (or placebo) sessions were repeated after at least 2 weeks of observed ART. Results Blood alcohol concentrations (BAC) were lower after ART in a pattern consistent with decreased bioavailability. No effect of alcohol on ritonavir or efavirenz pharmacokinetics was observed. A pharmacodynamic interaction between alcohol and efavirenz was observed as evidenced by no change in intoxication or drowsiness before and after efavirenz ART despite lower BAC. Conclusions These results show the effectiveness of implementing ART and its role in diminution of BAC, which could be associated with decreased risk of physiological toxicities related to alcohol consumption relative to those with untreated HIV infection. A potential pharmacodynamic interaction between alcohol and efavirenz was observed as demonstrated by a lack of decline in ratings of intoxication and drowsiness despite decreased BAC. Alcohol consumption did not alter the pharmacokinetics of ritonavir or efavirenz.

Electronic health record (EHR) implementation may affect patient-clinician communication for diverse safety-net populations. We conducted a cross-sectional survey of English-, Spanish-, and Cantonese-speaking patients in a public hospital clinic with a basic EHR. We examined multivariate associations of patient race/ethnicity, language, and education with perceptions of primary-care provider (PCP) computer use. Among 399 respondents, 25% had less than a high school education, 22% preferred Spanish, and 17% Cantonese. Asian (AOR 3.1), non-English-speakers (AOR 3.6) were more likely to report that PCPs used the computer half or more of the visit. Asians were more likely to report that computers helped PCPs remember patient concerns (AOR 5.6). Non-English-speakers had lower odds of reporting that PCPs listened less carefully to them because of computers (AOR 0.3). Patients at risk for communication barriers may perceive advantages of PCP computer use. Safety-net clinics should consider EHR impact on communication disparities.

Background Pharmacotherapy, such as oral naltrexone, has proven effective in treating alcohol use disorder, although medication adherence has presented challenges. Although a formulation of extended-release naltrexone for intramuscular injection has been developed to counter daily adherence issues, injection-site reactions can occur within days of depot injection. Case: The authors report a case of an individual with alcohol use disorder who had a previously undescribed delayed injection-site reaction that occurred 11 days after injection. Subsequent challenge with the medication resulted in recurrence of the reaction. Discussion: Although extended-release naltrexone is generally well tolerated, injection-site reactions can complicate treatment and can appear more than 10 days after medication administration.

A major barrier to actualizing the public health impact potential of screening, brief intervention, and referral to treatment (SBIRT) is the suboptimal development and implementation of evidence-based training curricula for healthcare providers. As part of a federal grant to develop and implement SBIRT training in medical residency programs, the authors assessed 95 internal medicine residents before they received SBIRT training to identify self-reported characteristics and behaviors that would inform curriculum development. Residents confidence in their SBIRT skills significantly predicted SBIRT practice. Lack of experience dealing with alcohol or drug problems and discomfort in dealing with these issues were significantly associated with low confidence. To target these barriers, the authors revised their SBIRT curriculum to increase residents confidence in their skills and developed an innovative SBIRT Proficiency Checklist and Feedback Protocol for skills practice observations. Qualitative feedback suggests that, despite the discomfort residents experience in being observed, a proficiency checklist and feedback protocol appear to boost learner confidence. © 2012 Taylor & Francis Group, LLC.

This study examined associations between mortality and demographic and risk characteristics among young injection drug users in San Francisco, California, and compared the mortality rate with that of the population. A total of 644 young (

Treatment for acute hepatitis C virus (HCV) infection has significantly better outcomes than treatment for chronic infection. The short window of the acute period poses challenges for young injection drug users (IDU), who are at highest risk of HCV infection, to demonstrate treatment candidacy. We recruited patients with acute HCV from a prospective cohort study to examine clinical and behavioral issues related to treatment candidacy. We report on outcomes and how nursing case management affected candidacy. All five acutely-infected participants reported daily drug use at baseline. All established primary care and decreased their drug use. None received treatment for their acute infection; one was treated within 12 months of infection. Establishing treatment candidacy for young IDU in the acute phase involves various health domains. An acute infection's short period poses many challenges to establishing candidacy, but it is a window of opportunity to engage young IDU in health care.

Background: Buprenorphine/naloxone allows the integration of opioid dependence and HIV treatment. Methods: We conducted a prospective study in HIV-infected opioid-dependent patients to investigate the impact of buprenorphine/ naloxone treatment on drug use. Self-report and chart review assessments were conducted every 3 months (quarters 1-4) for 1 year. Outcomes were buprenorphine/naloxone treatment retention, drug use, and addiction treatment processes. Results: Among 303 patients enrolled between July 2005 and December 2007, retention in buprenorphine/naloxone treatment was 74%, 67%, 59%, and 49% during Quarters 1, 2, 3, and 4, respectively. Past 30-day illicit opioid use decreased from 84% of patients at baseline to 42% in retained patients over the year. Patients were 52% less likely to use illicit opioids for each quarter in treatment (Odds ratio = 0.66; 95% CI: 0.61 to 0.72). Buprenorphine/naloxone doses and office visits approximated guidelines published by the United States Department of Health and Human Services. Urine toxicology monitoring was less frequent than recommended. Conclusions: Buprenorphine/naloxone provided in HIV treatment settings can decrease opioid use. Strategies are needed to improve retention and address ongoing drug use in this treatment population.

Background: Opioid-dependent HIV-infected patients are less likely to receive HIV quality of care indicators (QIs) compared with nondependent patients. Buprenorphine/naloxone maintenance therapy (bup/nx) could affect the quality of HIV care for opioid-dependent patients. Methods: We abstracted 16 QIs from medical records at nine HIV clinics 12 months before and after initiation of bup/nx versus other treatment for opioid dependence. Summary quality scores (number of QIs received/number eligible × 100) were calculated. We compared change in QIs and summary quality scores in patients receiving bup/nx versus other participants. Results: One hundred ninety-four of 268 participants (72%) received bup/nx and 74 (28%) received other treatment. Mean summary quality scores increased over 12 months for participants receiving bup/nx (45.6% to 51.6%, P < 0.001) but not other treatment (48.6% to 47.8%, P = 0.788). Bup/nx participants experienced improvements in six of 16 HIV QIs versus three of 16 QIs in other participants. Improvements were mostly in preventive and monitoring care domains. In multivariable analysis, bup/nx was associated with improved summary quality score (β 8.55; 95% confidence interval, 2.06-15.0). Conclusions: In this observational cohort study, HIV-infected patients with opioid dependence received approximately half of HIV QIs at baseline. Buprenorphine treatment was associated with improvement in HIV QIs at 12 months. Integration of bup/nx into HIV clinics may increase receipt of high-quality HIV care. Further research is required to assess the effect of improved quality of HIV care on clinical outcomes.

Being able to recruit high-risk volunteers who are also willing to consider future participation in vaccine trials are critical features of vaccine preparedness studies. We described data from two cohorts of injection- and non-injection drug users in Barcelona, Spain [Red Cross centre] and in San Francisco, USA, [UFO-VAX study] at high risk of HIV/HCV infection to assess behaviour risk exposure and willingness to participate in future preventive HIV vaccine trials. We successfully identified drug-using populations that would be eligible for future HIV vaccine efficacy trials, based on reported levels of risk during screening and high levels of willingness to participate. In both groups, Red Cross and UFO-VAX respectively, HCV infection was highly prevalent at baseline (41% and 34%), HIV baseline seroprevalence was 4.2% and 1.5%, and high levels of willingness were seen (83% and 78%).

Clinician-delivered prevention interventions offer an opportunity to integrate risk-reduction counseling as a routine part of medical care. The HIV Intervention for Providers study, a randomized controlled trial, developed and tested a medical provider HIV prevention training intervention in 4 northern California HIV care clinics. Providers were assigned to either the intervention or control condition (usual care). The intervention arm received a 4-hour training on assessing sexual risk behavior with HIV-positive patients and delivering risk-reduction-oriented prevention messages to patients who reported risk behaviors with HIV-uninfected or unknown-status partners. To compare the efficacy of the intervention versus control on transmission risk behavior, 386 patients of the randomized providers were enrolled. Over six-months of follow-up, patients whose providers were assigned the intervention reported a relative increase in provider-patient discussions of safer sex (OR = 1.49; 95% CI = 1.06 to 2.09), assessment of sexual activity (OR = 1.60; 95% CI = 1.05 to 2.45), and a significant decrease in the number of sexual partners (OR = 0.49, 95% CI = 0.26 to 0.92). These findings show that a brief intervention to train HIV providers to identify risk and provide a prevention message results in increased prevention conversations and significantly reduced the mean number of sexual partners reported by HIV-positive patients.

Trials to evaluate the efficacy of preventive HCV vaccines will need participation from high risk HCV seronegative injection drug users (IDUs). To guide trial planning, we assessed willingness of young IDU in San Francisco to participate in HCV vaccine efficacy trials and evaluate knowledge of vaccine trial concepts: placebo, randomization and blinding. During 2006 and 2007, a total of 67 participants completed the survey. A substantial proportion (88%) would definitely (44%) or probably (44%) be willing to participate in a randomized trial, but knowledge of vaccine trial concepts was low. Reported willingness to participate in an HCV vaccine trial decreased with increasing trial duration, with 67% of participants surveyed willing to participate in a trial of one year duration compared to 43% of participants willing to participate in a trial of 4 years duration. Willingness to enroll in HCV vaccine trials was higher in young IDU than reported by most at-risk populations in HIV vaccine trials. Educational strategies will be needed to ensure understanding of key concepts prior to implementing HCV vaccine trials.

Aims Young injection drug users (IDU) are at high risk for hepatitis C virus (HCV). We sought to determine whether perceiving one's injecting partner to be HCV positive was associated with decreased odds of engaging in receptive needle/syringe sharing (RNS) or ancillary equipment sharing (AES) with that partner. Design Cross sectional study. Setting 2003 to 2007 in San Francisco. Participants 212 young (under age 30) IDU who were HCV antibody negative reported on 492 injecting partnerships. Measurements Self-reported RNS and AES within injecting partnerships. Findings RNS and AES (in the absence of RNS) occurred in 23% and 64% of injecting partnerships in the prior month. The odds of engaging in RNS were significantly lower for relationships in which the participant reported that his/her partner was HCV positive (odds ratio [OR] 0.49; 95% confidence interval [CI] 0.25-0.95). This association was attenuated when adjusted for reusing one's own needle/syringe (adjusted OR 0.57; 95% CI 0.28-1.15). The odds of engaging in AES were lower for participants who did not know the HCV status of their partner, only among non-sexual partnerships (OR 0.47; 95% CI 0.29-0.76). Conclusions Because perceiving one's partner to be HCV positive was associated with decreased RNS, increased HCV testing and partner disclosure may be warranted. AES was common and was decreased only among non-sexual partnerships in which the HCV status of the partner was not known. This suggests that interventions to reduce AES in young IDU must be widespread.

Background. Hepatitis C virus (HCV) infection, clearance, and reinfection are best studied in injection drug users (IDUs), who have the highest incidence of HCV and are likely to represent most infections. Methods. A prospective cohort of HCV-negative young IDUs was followed up from January 2000 to September 2007, to identify acute and incident HCV and prospectively study infection outcomes. Results. Among 1,191 young IDUs screened, 731 (61.4%) were HCV negative, and 520 (71.1%) of the 731 were enrolled into follow-up. Cumulative HCV incidence was 26.7/100 person-years of observation (95% confidence interval [CI], 21.5-31.6). Of 135 acute/incident HCV infections, 95 (70.4%) were followed; 20 (21.1%) of the 95 infections cleared. Women had a significantly higher incidence of viral clearance than did men (age-adjusted hazard ratio, 2.91 [95% CI, 1.68-5.03]) and also showed a faster rate of early HCV viremia decline (P< .01). The estimated reinfection rate was 24.6/100 person-years of observation (95% CI, 11.7-51.6). Among 7 individuals, multiple episodes of HCV reinfection and reclearance were observed. Conclusions. In this large sample of young IDUs, females show demonstrative differences in their rates of viral clearance and kinetics of early viral decline. Recurring reinfection and reclearance suggest possible protection against persistent infection. These results should inform HCV clinical care and vaccine development.

Studies of injection drug use cessation have largely sampled adults in drug treatment settings. Little is known about injection cessation and relapse among young injection drug users (IDU) in the community.A total of 365 HCV-negative IDU under age 30 years were recruited by street outreach and interviewed quarterly for a prospective cohort between January 2000 and February 2008. Participants were followed for a total of 638 person-years and 1996 visits. We used survival analysis techniques to identify correlates of injection cessation (or =3 months) and relapse to injection.67% of subjects were male, median age was 22 years (interquartile range (IQR) 20-26) and median years injecting was 3.6 (IQR 1.3-6.5). 28.8% ceased injecting during the follow-up period. Among those that ceased injecting, nearly one-half resumed drug injection on subsequent visits, one-quarter maintained injecting cessation, and one-quarter were lost to follow-up. Participating in a drug treatment program in the last 3 months and injecting less than 30 times per month were associated with injection cessation. Injecting heroin or heroin mixed with other drugs, injecting the residue from previously used drug preparation equipment, drinking alcohol, and using benzodiazepines were negatively associated with cessation. Younger age was associated with relapse to injection.These results suggest that factors associated with stopping injecting involve multiple areas of intervention, including access to drug treatment and behavioral approaches to reduce injection and sustain cessation. The higher incidence of relapse in the younger subjects in this cohort underscores the need for earlier detection and treatment programs targeted to adolescents and transition-age youth.

To describe temporal trends in methamphetamine use among young injection drug users (IDU) in San Francisco.Secondary analysis of cross-sectional baseline data collected for a longitudinal study of young IDU from 1998 to 2004. Participants were 1445 young IDU (30 years old) who reported injection in the previous month, English-speaking, and recruited by street outreach methods. We examined trends for: lifetime (ever) and recent (30-day) methamphetamine use, including injected and non-injected, and by age group and sexual risk behaviour [men who have sex with men injecting drug users (MSM-IDU), male IDU (non-MSM) and female IDU].In 1998, 1999, 2000, 2001, 2003 and 2004 we interviewed 237, 276, 431, 310, 147 and 44 participants, respectively. Overall, median age was 22 years [interquartile range (IQR) 20-25], 30.3% were women and median duration of injecting was 4.4 years (IQR 2-7). Prevalence of methamphetamine use was high, with 50.1% reporting recent injection, but overall there were no temporal increases in reported 'ever' injected use. Recent methamphetamine injection (past 30 days) increased significantly, and peaked at 60% in 2003. MSM-IDU had higher methamphetamine injection ever (92.3%) and recently (59.5%) compared to heterosexual male (non-MSM) IDU (81.6% and 47.3%, respectively) and to female IDU (78.4% and 46.1%, respectively).Despite reports of ubiquitous increases in methamphetamine use, there were no significant increases in 6 years in ever injecting methamphetamine overall among young IDU. MSM-IDU who reported the highest methamphetamine use overall reported some increases in recent injected use. The methamphetamine 'epidemic' was probably under way among young IDU earlier than other populations.

Hepatitis B virus (HBV) infection is common among injection drug users (IDU). Younger IDU, however, may be less susceptible to infection due to the implementation of public health interventions, such as universal immunization programs and syringe exchange programs. To investigate the current epidemiology of HBV infection and control among a new generation of drug users in the United States, we conducted interviews and examined HBV serologic markers in a cross-section of street-recruited IDU under age 30 in San Francisco, CA. Of the 831 persons studied, 21% showed serologic evidence of current or past infection; 22% had isolated antibodies to hepatitis B surface antigen consistent with vaccine-mediated immunity; and 56% had no HBV markers. In multivariate analyses, HBV infection was associated with drug use behaviour in heterosexual males; sexual behaviour in males who have sex with males; and both drug use and sexual behaviour in females. Vaccine-mediated immunity was independently associated with female sex and younger age. In conclusion, HBV transmission persists among young IDU in San Francisco. Few young injectors show evidence of successful immunization and the majority remains susceptible to disease. Until the broad effects of universal vaccination are seen, targeted and innovative approaches to immunizing young IDU in the US are needed to prevent a substantial number of new HBV infections.

Substance use complicates HIV care and prevention. Primary care clinics are an ideal setting to screen for and offer interventions for unhealthy alcohol and drug use; however, few HIV clinics routinely screen for substance use. We enrolled 208 clinic patients at an urban underserved HIV primary care clinic. We screened the patients for substance use with the Alcohol, Smoking, and Substance Involvement Score Test and measured urine toxicology. Of the 168 participants who completed screening, the majority reported tobacco or nonprescribed substance use in the previous 3 months. More African American participants reported low or no risk amphetamine use compared to Hispanic, White, or Other race participants (p

© 2015, Springer Science+Business Media New York. Substance use among people living with HIV is high, and screening, brief intervention, and referral to treatment (SBIRT) is an evidence-based approach to addressing the issue. We examined whether patients would participate in a technology-based SBIRT program in an urban HIV clinic. An SBIRT intervention was programmed into the clinic’s web-based patient portal linked to their personal health record. We examined: demographic, health, HIV, and substance use characteristics of participants who completed the web-based intervention compared to those who did not. Fewer than half of the 96 participants assigned to the web-based SBIRT completed it (n = 39; 41 %). Participants who completed the web-based intervention had significantly higher amphetamine SSIS scores than those who did not complete the intervention. Participants whose substance use is more harmful may be more motivated to seek help from a variety of sources. In addition, it is important that technology-based approaches to behavioral interventions in clinics take into consideration feasibility, client knowledge, and comfort using technology.

Background The 5As for smoking cessation is an evidence-based intervention to aid providers in counseling patients to quit smoking. While most providers "ask" patients about their tobacco use patterns and "advise" them to quit, fewer patients report being "assessed" for their interest in quitting, and even fewer report subsequent "assistance" in a quit attempt and having follow-up "arranged". Purpose This article describes the design of an implementation study testing a computer tablet intervention to improve provider adherence to the 5As for smoking cessation. Findings will contribute to the existing literature on technology acceptance for addressing addictive behaviors, and how digital tools may facilitate the broader implementation of evidence-based behavioral counseling practices without adversely affecting clinical flow or patient care. Methods This project develops and tests a computer-facilitated 5As (CF-5As) model that administers the 5As intervention to patients with a computer tablet, then prompts providers to reinforce next steps. During the development phase, 5As' content will be programmed onto computer tablets, alpha and beta-testing of the service delivery model will be done, and pre-intervention interview and questionnaire data will be collected from patients, providers, and clinic staff about 5As fidelity and technology adoption. During the program evaluation phase, a randomized controlled trial comparing a group who receives the CF-5As intervention to one that does not will be conducted to assess 5As fidelity. Using the technology acceptance model, a mixed methods study of contextual and human factors influencing both 5As and technology adoption will also be conducted. Conclusions Technology is increasingly being used in clinical settings. A technological tool that connects patients, providers, and clinic staff to facilitate the promotion of behavioral interventions such as smoking cessation may provide an innovative platform through which to efficiently and effectively implement evidence-based practices.

Introduction Despite how often medical trainees witness the spectrum of unhealthy substance use, disproportionately little curricular time is devoted to this topic. This lack of curricular time and shortage of actionable skills often leads to feelings of hopelessness and cynicism when caring for affected patients. Towards the goals of helping medical residents learn practical skills and gain confidence in detecting, diagnosing, and managing patients with unhealthy substance use, we developed this 4-week, 16-hour SBIRT (Screening, Brief Intervention, Referral, and Treatment) curriculum. SBIRT is a public health approach to the delivery of early intervention and treatment services for people with, or at risk of developing, substance use disorders. Methods The curriculum is intended for second or third-year postgraduate primary care residents during a 1-month ambulatory block. Teaching elements include traditional didactics, experiential and case-based learning, skills-based practice with feedback, and peer-peer feedback. Slide decks, handouts for reflection exercises and skills practice, educational posters, individual pocket-cards, and instructor guides for each module are provided. For skills reinforcement, this curriculum also includes content for “booster” sessions that can be offered later in the year. Results This curriculum has been a core component of our ambulatory training for a track of internal medicine residents at the University of California, San Francisco. This 4-week curriculum has been very well-received by our residents, and we have demonstrated significant improvements in knowledge and confidence in the management of substance-use disorders from self-administered survey data. Discussion SBIRT is a public health approach to the delivery of early intervention and treatment services for people with or at risk of developing substance-use disorders. Evidence for SBIRT's efficacy in persons with non-dependent, unhealthy alcohol use has led to universal screening recommendations from the United States Preventive Services Task Force for use in primary care settings.

Background: We describe incarceration history (jail or prison) among a community‐based sample of young injection drug users (IDU) (age