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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.

BackgroundYoung Black and Latinx sexual minority men (SMM) and transgender women (TW) continue to suffer some of the highest burdens of HIV in the United States. Disparities are partly attributed to suboptimal uptake of HIV prevention and treatment services negatively impacted by substance use. Adult studies have demonstrated that polysubstance use increases HIV acquisition risk through increased sexual behaviors, however there are few studies that have examined polysubstance in this population and how polysubstance use might increase young SMM and TW’s risk for HIV.MethodsCross-sectional data from 466 young Black and Latinx SMM and TW living in four US high HIV-burden cities enrolled in the PUSH Study, a status neutral randomized control trial to increase uptake of pre-exposure prophylaxis and treatment adherence. Examined data for patterns of polysubstance use comparing age differences of use; and exploring associations between substance use and HIV risk behaviors focusing on three core partnership factors - inconsistent condom use, pressure to have anal sex without a condom, and older partner.ResultsMost participants described prior substance use with alcohol and cannabis being most common (76%, respectively) and 23% describing other describing prior alcohol use, 76% (n=353) described cannabis use, and 23% described other illicit drug use (including stimulants, cocaine, hallucinogens, sedatives, opioids, and inhalants). Polysubstance use was common with nearly half (47%) of participants reported alcohol and cannabis use, 20% reporting alcohol, cannabis, and one other illicit drug use, and 19% reporting alcohol or cannabis use plus one other illicit drug use. Polysubstance use was associated with greater adjusted odds of pressure to have anal sex without a condom, having an older partner (> 5 years older), and inconsistent condom use.ConclusionsHigh levels of substance use, polysubstance use and strong associations with high-risk sexual practices and sexual partnerships that are known to be predictors of HIV acquisition or transmission among Black and Latinx sexual and gender minority youth, call for combination interventions that include substance use treatment alongside ARV-based prevention and treatment and partner-based interventions.

Pre-exposure prophylaxis (PrEP) is a promising but underutilized HIV prevention strategy for Women who Inject Drugs (WWID). Stigma and disclosure concerns have been key barriers to PrEP use among women in PrEP efficacy trials. Social support has been found to buffer against some PrEP stigma, though these factors have been largely unexplored among WWID. Investigating how WWID disclose PrEP use is important given evidence that disclosure is associated with higher adherence. We aimed to identify the impact of stigma and support on PrEP disclosure within social networks of WWID participating in a PrEP demonstration project in Philadelphia, PA, USA. PrEP-using WWID ≥ 18 years completed social network surveys. Generalized estimating equations were used to account for the correlation of network structure. Thirty-nine WWID (i.e. egos) named an average of 9.5 ± 3.3 network members (i.e. alters), for a total sample of 371 unique relationships. Egos disclosed their PrEP use to an average of 4.0 alters (SD = 2.8). Related to PrEP stigma, participants had 0.4 times decreased odds of PrEP disclosure with alters who would disapprove of them taking PrEP (95% CI: 0.1–0.9). Related to support, participants had 2.5 times higher odds of disclosure among peers who could provide PrEP advice (95% CI: 1.0–6.0). Interventions that increase social support and decrease stigma are pivotal for increasing PrEP use disclosure among WWID.

Background Increased uptake of hepatitis C virus (HCV) treatment among people who inject drugs (PWID) will be critical to achieve HCV elimination goals. There are limited data on HCV treatment uptake among PWID recruited from community-based settings in the HCV direct-acting antiviral (DAA) era. Methods We analyzed data from PWID with HCV newly recruited into the Baltimore, Maryland-based AIDS Linked to the IntraVenous Experience (ALIVE) cohort between 2015 and 2018. We characterized the HCV care continuum and evaluated factors associated with HCV treatment uptake. Results Of the 418 PWID with HCV, the median age was 49 years and most (88%) reported recent injection drug use (IDU). Overall, 23% had ever been evaluated by a provider for HCV treatment, 17% ever initiated DAA treatment, and 13% were cured of HCV infection. Treatment uptake approximately doubled between 2015 and 2018 (13% to 26%, p=0.01). In multivariable analyses, HIV infection (adjusted Odds Ratio [aOR] 2.5 [95% Confidence Interval (CI) 1.3, 4.8]), current employment (aOR 4.1 [CI 1.2, 14.4]), having a primary care provider (aOR 4.3 [CI 1.2, 14.9), and longer duration of IDU (aOR 1.3 [CI 1.1, 1.6]) were positively associated with HCV treatment. PWID with a lower annual income (≤$5,000) were less likely to have initiated HCV treatment (aOR 0.5 [CI 0.3, 0.98]). Conclusions Although HCV treatment uptake among PWID in this community-based setting in the DAA era remains suboptimal, it is encouraging that treatment uptake has increased in recent years. Innovative strategies are needed to reach all PWID infected with HCV.

In 2014, trained health care provider capacity was insufficient to deliver care to an estimated 70,000 persons in Maryland with chronic hepatitis C virus (HCV) infection. The goal of Maryland Community Based Programs to Test and Cure Hepatitis C, a public health implementation project, was to improve HCV treatment access by expanding the workforce. Sharing the Cure (STC) was a package of services deployed 10/1/14 to 9/30/18 that included enhanced information technology and public health infrastructure, primary care provider training, and practice transformation. Nine primary care sites enrolled. HCV clinical outcomes were documented among individuals who presented for care at sites and met criteria for HCV testing including risk factor or birth cohort (born between 1945 and 1965) based testing. Fifty-three providers completed the STC training. STC providers identified 3,237 HCV antibody positive patients of which 2,624 (81%) were RNA+. Of those HCV RNA+, 1,739 (66%) were staged, 932 (36%) were prescribed treatment, 838 (32%) started treatment, 721 (28%) completed treatment, and 543 (21%) achieved cure. Among 1,739 patients staged, 693 (40%) patients had a liver fibrosis assessment score < F2, rendering them ineligible for treatment under Maryland Medicaid guidelines. HCV RNA testing among HCV antibody positive people increased from 40% (baseline) to 95% amongst STC providers. Of 554 patients with virologic data reported, 543 (98%) achieved cure. Primary care practices can effectively serve as HCV treatment centers to expand treatment access. However, criteria by insurance providers in Maryland was a major barrier to treatment.

BACKGROUND: We investigated the prevalence and impact of heavy alcohol use on the hepatitis C virus (HCV) care continuum among HIV/HCV co-infected persons who use drugs. METHODS: In the CHAMPS study, 144 HIV/HCV co-infected persons were randomized to contingent cash incentives, peer-mentors, and usual care to evaluate the impact on HCV care. Alcohol use was ascertained using the 10-item AUDIT (hazardous: male ≥ 8, female ≥ 4) and phosphatidylethanol (PEth) (heavy: ≥ 50 ng/ml), an alcohol biomarker. Log binomial regression was used to evaluate the association between heavy alcohol use and failure to initiate treatment and to achieve sustained virologic response (SVR). RESULTS: Of the 135 participants with PEth data, median age was 55 years, 59% were male, 92% were Black, 91% reported a history of drug use, and 97% were on antiretroviral therapy. Hazardous drinking was reported on AUDIT by 28% of participants and 35% had heavy alcohol use by PEth. Of the 47 individuals with a PEth ≥ 50 ng/ml, 23 (49%) reported no or minimal alcohol use by AUDIT. HCV treatment was initiated in 103 of 135 participants and SVR was achieved in 92%. PEth ≥ 50 ng/ml (Relative Risk [RR] 0.72, 95% CI 0.35–1.48) was not significantly associated with failure to initiate HCV treatment or failure to achieve SVR (RR 0.85, 95% CI 0.46–1.57). CONCLUSIONS: Alcohol use was common and frequently not detected by self-report. However, heavy alcohol use, even when measured objectively, was not associated with failure to initiate HCV treatment or to achieve cure.

Although oral direct-acting agent (DAA) therapies have the potential to reduce the burden of hepatitis C virus (HCV) infection, treatment uptake remains low, particularly among people who inject drugs (PWID). This study examined the feasibility of an innovative peer-based recruitment strategy to engage PWID in HCV testing and treatment. We interviewed an initial set of HCV antibody-positive PWID as 'primary indexes' to gather demographic, drug use, health information and drug network characteristics. Primary indexes were then briefly educated on HCV and its treatment and encouraged to recruit their injection drug 'network members' for HCV testing and linkage to care. Eligible network members were enrolled as 'secondary indexes' and completed the same index study procedures. In sum, 17 of 36 primary indexes initiated the recruitment of 64 network members who were HCV antibody positive and eligible to become indexes. In multivariable analysis, successful recruitment of at least one network member was positively associated with prior HCV treatment (OR 2.80; CI [1.01, 7.72]), daily or more injection drug use (OR 2.38; CI [1.04, 5.47]), and a higher number of injection drug network members (OR 1.20; CI [1.01, 1.42]). Among the 69 participants with chronic HCV not previously linked to HCV care at enrolment, 91% (n = 63) completed a linkage to HCV care appointment, 45% (n = 31) scheduled an appointment with an HCV provider, and 20% (n = 14) initiated HCV therapy. These findings suggest a potential benefit for peer-driven, network-based interventions focused on HCV treatment-experienced PWID as a mechanism to increase HCV linkage to care.

Introduction Leveraging interpersonal communication among social networks of people who inject drugs (PWID) may be an innovative strategy to increase awareness and access to hepatitis C (HCV) care. However, little is known about HCV communication patterns among PWID and if these patterns vary by gender. Methods Egocentric network data collected at baseline from HCV-infected PWID enrolled in a randomized HCV treatment intervention trial in Baltimore, Maryland were analyzed. Logistic generalized estimating models were conducted to identify predictors of HCV communication. Results Among 227 PWID, the mean age was 43.8 (SD=10.3), 28.2% (n = 64) were women and 71.8% (n = 163) were men. Female participants reported 516 dyadic relationships and male participants 1139 dyadic relationships. While there were significant gender differences based on socio-demographics, risk behavior and network composition, there were few differences in HCV communication patterns. Both men and women had increased odds of HCV communication with alters who are currently enrolled in drug treatment (AOR 1.7, 95% CI: 1.3–2.4), alters with whom participants share drug preparation equipment (AOR 3.0, 95% CI: 1.9–4.6), alters who are sex partners compared to kin (AOR 3.0; 95% CI: 1.9–4.9) and alters with whom respondents have increased trust (AOR 1.1; 95% CI: 1.11.2) and daily/weekly interactions (AOR 1.7; 95% CI 1.3–2.1). Conclusion PWID engaged with trusted alters about HCV disclosure and information, highlighting the important role network interventions could play in this vulnerable population.

Background Eliminating hepatitis C virus (HCV) will require effective treatment delivery to persons with substance use disorders (SUDs). We evaluated the relationship between ledipasvir/sofosbuvir treatment persistence (receiving 84 tablets), adherence, and sustained virologic response (SVR) in persons with human immunodeficiency virus (HIV)/HCV coinfection. Methods Of the 144 participants with HIV/HCV and SUDs, 110 initiated a 12-week treatment course under 1 of 3 conditions (usual care, peer mentors, and cash incentives). We used self-report, pharmacy pill counts, and expected date of refill to examine adherence. Persistent participants were categorized as high adherence (taking ≥90% of doses) or low adherence (taking Results Most participants persisted on treatment after initiation (n = 105), with 95% (n = 100) achieving SVR. One third (34%) of participants had moderate/heavy alcohol use by the biomarker phosphatidylethanol ([Peth] ≥50 ng/mL), and 44% had urine toxicology positive for cocaine or heroin at enrollment. The proportion of persons with high adherence was 72% (n = 76), and the proportion of persons with low adherence was 28%. Although low adherence was associated with moderate/heavy alcohol use by PEth (relative risk = 2.77; 95% confidence interval, 1.50–5.12), SVR did not vary according to adherence (P = .702), and most participants (97%) with low adherence achieved SVR. Conclusions Treatment persistence led to high SVR rates among persons with HIV/HCV, despite imperfect adherence and SUDs.

Background Alcohol use in people who inject drugs (PWID) with hepatitis C virus (HCV) infection accelerates liver disease progression. This paper describes the prevalence and associated correlates of alcohol use among HCV antibody positive PWID. Methods In a large cohort of HCV antibody positive PWID (N = 1623) followed from 2005 to 2013, we characterized alcohol use using the AUDIT-C. We used multivariable logistic regression with generalized estimated equations to examine socio-demographic, clinical, and substance use correlates of alcohol use. Results At their initial visit, 41% reported no, 21% reported moderate, and 38% reported heavy alcohol use. The odds of moderate and heavy alcohol use increased with greater intensity of substance use represented by a composite summary variable which ranged from 0 to 3 substances (street-acquired prescription drugs, non-injection cocaine/heroin, and injection drugs) used. Compared to those who used no drugs, those who used 3 substances had 3.71 odds (95% CI: 3.07–4.48) of moderate alcohol use and 3.65 odds (95% CI: 3.20–4.16) of heavy alcohol use. Conclusions The prevalence of moderate/heavy alcohol use is high among HCV antibody positive PWID and occurs frequently in combination with other drug use. This may contribute to progressive liver fibrosis thus limiting the gains achieved from HCV cure. Public health interventions need to address the overlapping epidemics of HCV, alcohol use, and other substance use in this population.

Background Hepatitis C virus (HCV) infection is a major public health issue among people who inject drugs (PWID) with prevalence of 50–80% in the United States. Effective, simple, oral direct acting agents (DAA) of short duration with minimal side effects have been associated with cure rates > 95%. However, HCV treatment uptake among PWID remains low. We characterized the HCV care continuum, HCV treatment knowledge, as well as barriers and facilitators to HCV treatment uptake among PWID enrolled in two opioid treatment programs (OTPs) in Baltimore, Maryland, USA. Methods Between July and November 2016, 124 HCV infected PWID were recruited from two opioid treatment programs in Baltimore through convenience sampling. Participants completed a 50-item questionnaire to assess HCV treatment knowledge, attitudes, and practices. Progress through the HCV care continuum was assessed based on a series of questions assessing evaluation for HCV treatment, recommendation for HCV treatment by a provider, and HCV treatment initiation. HCV status was assessed based on participant self-report. Results The median age was 52 years (IQR 44–58), 56% were male, the majority were African American (69%), and 19% reported HIV coinfection. Participants had been tested for HCV at their primary care provider's (PCP's) office (34%), drug treatment center (20%), emergency room (11%), or prison (9%), and most (60%) had been diagnosed with HCV over 5 years prior. The majority reported that HCV was a major health concern for them (91%), were aware there were new treatments for HCV (89%), and that the new treatments cure most people (69%). More than half (60%) had seen a health professional who could treat HCV, 40% had HCV therapy recommended by their HCV specialist, and 20% had started or completed treatment. In univariable analysis, PWID were significantly more likely to have been treated if they were HIV co-infected (OR 3.4 (95% CI 1.3–9.2)) or had a partner or friend concerned about their HCV (OR 3.4 (95% CI 1.2–9.7)), and were significantly less likely to have been treated if they had used any illicit drugs in the preceding 6 months (OR 0.4 (95% CI 0.2–0.99). In multivariable analysis, having a friend or partner concerned about their HCV remained significantly associated with HCV treatment (OR 5.0 (95% CI 1.4–17.7)). When questioned about what would facilitate HCV treatment, the majority (85%) reported that a friend telling them that HCV treatment had helped them and having HCV treatment provided at their opioid treatment program would make them more likely to engage in HCV treatment. Conclusion Despite a high prevalence of HCV among opioid treatment program patients and the availability of effective treatments, uptake remains low. We identified several key barriers and facilitators that can affect HCV treatment uptake.

BACKGROUND: Despite the high prevalence of hepatitis C virus (HCV) among persons living with HIV (PWH), the prevalence of HCV screening, treatment, and sustained virologic response (SVR) is unknown. This study aims to characterize the continuum of HCV screening and treatment among PWH in HIV care. SETTING: Adult patients enrolled at 12 sites of the HIV Research Network located in 3 regions of the United States were included. METHODS: We examined the prevalence of HCV screening, HCV coinfection, direct-acting antiretroviral (DAA) treatment, and SVR-12 between 2014 and 2015. Multivariate logistic regression was performed to identify characteristics associated with outcomes, adjusted for site. RESULTS: Among 29,071 PWH (age 18–87, 74.8% male, 44.4% black), 77.9% were screened for HCV antibodies; 94.6% of those screened had a confirmatory HCV RNA viral load test. Among those tested, 61.1% were determined to have chronic HCV. We estimate that only 23.4% of those eligible for DAA were prescribed DAA, and only 17.8% of those eligible evidenced initiating DAA treatment. Those who initiated treatment achieved SVR-12 at a rate of 95.2%. Blacks and people who inject drugs (PWID) were more likely to be screened for HCV than whites or those with heterosexual risk. Persons older than 40 years, whites, Hispanics, and PWID [adjusted odds ratio (AOR) 8.70 (7.74 to 9.78)] were more likely to be coinfected than their counterparts. When examining treatment with DAA, persons older than 50 years, on antiretroviral therapy [AOR 2.27 (1.11 to 4.64)], with HIV-1 RNA

Drug use, hazardous alcohol use, and mental health disorders are prevalent among people with HIV and HCV infection. Co-occurrence of alcohol use and depression negatively impacts substance use patterns. Nevertheless, HCV treatment provides a promising opportunity to identify and address co-occurring drug use, hazardous alcohol use, and mental health disorders.

There is a critical need for the public to have trusted sources of vaccine information. A longitudinal online study assessed trust in COVID-19 vaccine information from 10 sources. A factor analysis for data reduction revealed two factors. The first factor contained politically conservative sources (PCS) of information. The second factor included eight news sources representing mainstream sources (MS). Multivariable logistic regression models were used. Trust in Dr. Fauci was also examined. High trust in MS was associated with intention to encourage family members to get COVID-19 vaccines, altruistic beliefs that more vulnerable people should have vaccine priority, and belief that racial minorities with higher rates of COVID-19 deaths should have priority. High trust in PCS was associated with intention to discourage friends from getting vaccinated. Higher trust in PCS was also associated with participants more likely to disagree that minorities with higher rates of COVID-19 deaths should have priority for a vaccine. High trust in Dr. Fauci as a source of COVID-19 vaccine information was associated with factors similar to high trust in MS. Fair, equitable, and transparent access and distribution are essential to ensure trust in public health systems’ abilities to serve the population.

The early COVID-19 pandemic has been characterized by rapid global spread. In the United States National Capital Region, over 2,000 cases were reported within three weeks of its first detection in March 2020. We aimed to use genomic sequencing to understand the initial spread of SARS-CoV-2, the virus that causes COVID-19, in the region. By correlating genetic information to disease phenotype, we also aimed to gain insight into any correlation between viral genotype and case severity or transmissibility.We performed whole genome sequencing of clinical SARS-CoV-2 samples collected in March 2020 by the Johns Hopkins Health System. We analyzed these regional SARS-CoV-2 genomes alongside detailed clinical metadata and the global phylogeny to understand early establishment of the virus within the region.We analyzed 620 samples from the Johns Hopkins Health System collected between March 11-31, 2020, comprising 37.3% of the total cases in Maryland during this period. We selected 143 of these samples for sequencing, generating 114 complete viral genomes. These genomes belong to all five major Nextstrain-defined clades, suggesting multiple introductions into the region and underscoring the diversity of the regional epidemic. We also found that clinically severe cases had genomes belonging to all of these clades.We established a pipeline for SARS-CoV-2 sequencing within the Johns Hopkins Health system, which enabled us to capture the significant viral diversity present in the region as early as March 2020. Efforts to control local spread of the virus were likely confounded by the number of introductions into the region early in the epidemic and interconnectedness of the region as a whole.

BACKGROUND. Cross-sectional studies have shown strong relationships between social network characteristics and substance use disorder (SUD) treatment engagement. The current study examined associations between longitudinal changes in egocentric social networks of male and female people who use drugs (PWUD) and engagement in drug use reduction programs, broadly defined as either formal SUD treatment or self-help groups. METHOD. Using data from an HIV prevention and care study in Baltimore, MD, this study categorized PWUD into those who engaged and did not engage in any drug use reduction programs over two follow-ups during a one-year observation window. The study used multivariate logistic generalized estimating equations (GEE) to examine associations between network composition and stability measures and drug use reduction program engagement, stratified by gender. RESULTS. Of the 176 subjects participating in drug use reduction programs at baseline, 56.3% remained engaged at one year. Among both male and female respondents, higher turnover into non-kin networks was associated with increased odds of engagement in drug use reduction programs (AOR 1.4; 95% CI: 1.1-1.9, AOR 1.3; 95% CI: 1.0–1.8, respectively). For males, retention of intimate partner networks was associated with increased odds of program engagement (AOR 2.9; 95% CI: 1.1–7.6); for females, higher turnover into kin networks was associated with decreased odds of engagement (AOR 0.8; 95% CI: 0.5–1.0). CONCLUSION. Evaluation of associations between social network characteristics and drug use reduction program engagement appears to benefit from longitudinal analyses that are stratified by gender. Efforts to improve retention in formal SUD treatment or self-help groups might consider intervening through social networks, perhaps by increasing overall levels of social support.

Men with acute hepatitis B virus (HBV) infection in the Multicenter AIDS Cohort Study from 1985 to 2013 had serological testing to determine proportions with HBV recovery or chronic hepatitis B (CHB). A similar proportion of men without human immunodeficiency virus (HIV) and men with HIV receiving HBV-active antiretroviral therapy (ART) developed CHB [8.2%, 95% confidence interval (CI) 3.8-15.0% vs. 7.7%, 95% CI 2.00-36.0%]. In contrast, 17.5% (95% CI 8.7-29.9%) of men living with HIV, not on HBV-active ART developed CHB. HBV-active ART protects against developing CHB.

BackgroundThe early COVID-19 pandemic has been characterized by rapid global spread. In the United States National Capital Region, over 2,000 cases were reported within three weeks of its first detection in March 2020. We aimed to use genomic sequencing to understand the initial spread of SARS-CoV-2, the virus that causes COVID-19, in the region. By correlating genetic information to disease phenotype, we also aimed to gain insight into any correlation between viral genotype and case severity or transmissibility.MethodsWe performed whole genome sequencing of clinical SARS-CoV-2 samples collected in March 2020 by the Johns Hopkins Health System. We analyzed these regional SARS-CoV-2 genomes alongside detailed clinical metadata and the global phylogeny to understand early establishment of the virus within the region.ResultsWe analyzed 620 samples from the Johns Hopkins Health System collected between March 11–31, 2020, comprising 37.3% of the total cases in Maryland during this period. We selected 143 of these samples for sequencing, generating 114 complete viral genomes. These genomes belong to all five major Nextstrain-defined clades, suggesting multiple introductions into the region and underscoring the diversity of the regional epidemic. We also found that clinically severe cases had genomes belonging to all of these clades.ConclusionsWe established a pipeline for SARS-CoV-2 sequencing within the Johns Hopkins Health system, which enabled us to capture the significant viral diversity present in the region as early as March 2020. Efforts to control local spread of the virus were likely confounded by the number of introductions into the region early in the epidemic and interconnectedness of the region as a whole.

Objective People who inject drugs (PWID) have high hepatitis C virus (HCV) infection prevalence but low rates of HCV treatment uptake. To better harness the potential of peer-led social network-based interventions to increase HCV treatment uptake among PWID, simple tools that can help identify individuals with the potential to function effectively as peer-mentors who support network members to get HCV tested and linked to care are needed. Methods Data from a survey administered to index PWID enrolled in a social network-based intervention, in which they were invited to recruit drug use network members for HCV testing and linkage to care, was analyzed. Constructs derived from exploratory factor analysis were validated through confirmatory factor analysis (CFA). We used logistic regression analysis to assess the association between scores in identified constructs and subsequent effectiveness in the peer mentor role, defined as recruiting at least one network member for HCV testing and linkage to care in the 12 weeks following survey completion. Results Among 100 PWID with median age 53 years, 74% male, and 71% Black, CFA resulted in a multidimensional three-factor survey with 4 questions related to opinion leadership, 3 questions related to perceived HCV-related stigma, and 3 questions related to HCV communication comfort and care support willingness. Only self-designated opinion leadership was associated with effectiveness in the peer mentor role (adjusted odds ratio 3.76 (95% Confidence interval CI 1.01, 14.0)). Conclusion We developed and validated a simple tool with potential to ease and improve the efficiency of peer-led social network interventions.

Background Hepatitis C virus (HCV) cure rates have been similar in patients with and without HIV co-infection; however, in the ION-4 study, black patients treated with ledipasvir/sofosbuvir were significantly less likely to achieve cure (90%) compared to non-black patients (99%). There are limited real world data on the effectiveness of oral direct acting antivirals (DAAs) in predominantly minority HIV/HCV co-infected populations. Methods We analyzed HCV treatment outcomes among 255 HCV co-infected patients initiating DAAs between February 2014 and March 2016 in an urban clinic in Baltimore, Maryland. To facilitate adherence, patients received standardized HIV nurse/pharmacist support which included nurse visits and telephone calls. Results The median age was 43 years, 88% were black, 73% male, 69% had a history of injection drug use, 45% a history of hazardous alcohol use and 57% a comorbid psychiatric diagnosis. Median CD4 count was 577 (IQR 397-820) cells/mm3; most (97%) were on antiretroviral therapy, had HIV RNA 3.25 (17%, cirrhosis)] and 30% were HCV treatment experienced. The majority of patients received ledipasvir/sofosbuvir with or without ribavirin (91%) and were treated for 12 weeks. Overall, the sustained virologic response rate was 97% (95% confidence interval [CI] 93-98) and did not vary by race (black, 96% [95% CI 93-98]; Non-black 97%, [95% CI 83-99]), history of injection drug use, alcohol use or psychiatric diagnosis. Conclusion HCV treatment was highly effective among HIV-infected patients who received care within an integrated nurse/pharmacist adherence support program. These results suggest that race and psychosocial comorbidity may not be barriers to HCV elimination. This article is protected by copyright. All rights reserved.

Introduction The availability of safe, effective treatments for hepatitis C virus infection has led to a call for the elimination of hepatitis C, but barriers to care persist. Methods In July 2015, the Baltimore City Health Department sexual health clinics began on-site hepatitis C virus treatment. Investigators conducted a retrospective evaluation of the first 2.5 years of this program. Data were extracted from the medical record through June 2019, and data analysis was completed in September 2019. Results Between July 2015 and December 2017, a total of 560 patients infected with hepatitis C virus accessed care at the Baltimore City Health Department sexual health clinics. Of these patients, 423 (75.5%) were scheduled for hepatitis C virus evaluation at the clinics, 347 (62.0%) attended their evaluation appointment, 266 (47.5%) were prescribed treatment, 227 (40.5%) initiated treatment, and 199 (35.5%) achieved sustained virologic response. Older age was independently associated with hepatitis C virus evaluation appointment attendance (aged 40–59 years: AOR=3.64, 95% CI=1.88, 7.06; aged ≥60 years: AOR=5.61, 95% CI=2.58, 12.21) compared with those aged 20–39 years. Among those who attended hepatitis C virus evaluation appointments, advanced liver disease was independently and positively associated with treatment initiation (AOR=11.89, 95% CI=6.35, 22.25). Conversely, illicit substance use in the past 12 months was negatively associated with hepatitis C virus treatment initiation (AOR=0.49, 95% CI=0.25, 0.96). Conclusions The integration of hepatitis C virus testing and on-site treatment in public sexual health clinics is an innovative approach to improve access to hepatitis C virus treatment for medically underserved populations.

BackgroundFatal opioid overdose is a pressing public health concern in the United States. Addressing barriers and augmenting facilitators to take-home naloxone (THN) access and administration could expand program reach in preventing fatal overdoses.MethodsTHN access (i.e., being prescribed or receiving THN) was assessed in a Baltimore, Maryland-based sample of 577 people who use opioids (PWUO) and had a history of injecting drugs. A sub-analysis examined correlates of THN administration among those with THN access and who witnessed an overdose (N = 345). Logistic generalized estimating equations with robust standard errors were used to identify facilitators and barriers to accessing and using THN.ResultsThe majority of PWUO (66%) reported THN access. In the multivariable model, decreased THN access was associated with the fear that a person may become aggressive after being revived with THN (aOR: 0.55, 95% CI: 0.35-0.85), police threaten people at an overdose event (aOR: 0.68, 95% CI: 0.36-1.00), and insufficient overdose training (aOR: 0.43, 95% CI: 0.28-0.68). Enrollment in medication-assisted treatment, personally experiencing an overdose, and graduating from high school were associated with higher access. About half (49%) of PWUO with THN access and who had witnessed an overdose reported having administered THN. THN use was positively associated with "often" or "always" carrying THN (aOR: 3.47, 95% CI: 1.99-6.06), witnessing more overdoses (aOR:5.18, 95% CI: 2.22-12.07), experiencing recent homelessness, and injecting in the past year. THN use was reduced among participants who did not feel that they had sufficient overdose training (aOR: 0.56, 95% CI: 0.32-0.96).ConclusionTHN programs must bolster confidence in administering THN and address barriers to use, such as fear of a THN recipient becoming aggressive. Normative change around carrying THN is an important component in an overdose prevention strategy.

BACKGROUND: In April 2015, in collaboration with the US Centers for Disease Control and Prevention and Gilead Sciences, the country of Georgia embarked on the world’s first hepatitis C elimination program. We aimed to assess progress toward elimination targets 3 years after the start of the elimination program. METHODS: We constructed a hepatitis C virus (HCV) care cascade for adults in Georgia, based on the estimated 150 000 persons aged ≥18 years with active HCV infection. All patients who were screened or entered the treatment program during April 2015–March 2018 were included in the analysis. Data on the number of persons screened for HCV were extracted from the national HCV screening database. For the treatment component, we utilized data from the Georgia National HCV treatment program database. Available treatment options included sofosbuvir and ledipasvir/sofosbuvir–based regimens. RESULTS: Since April 2015, a cumulative 974 817 adults were screened for HCV antibodies; 86 624 persons tested positive, of whom 61 925 underwent HCV confirmatory testing. Among the estimated 150 000 adults living with chronic hepatitis C in Georgia, 52 856 (35.1%) were diagnosed, 45 334 (30.2%) initiated treatment with direct-acting antivirals, and 29 090 (19.4%) achieved a sustained virologic response (SVR). Overall, 37 256 persons were eligible for SVR assessment; of these, only 29 620 (79.5%) returned for evaluation. The SVR rate was 98.2% (29 090/29 620) in the per-protocol analysis and 78.1% (29 090/37 256) in the intent-to-treat analysis. CONCLUSIONS: Georgia has made substantial progress in the path toward eliminating hepatitis C. Scaling up of testing and diagnosis, along with effective linkage to treatment services, is needed to achieve the goal of elimination.

Background Bolstered by the high efficacy of hepatitis C virus (HCV) treatment, the World Health Organization has called for HCV elimination by 2030. People with HIV (PWH) have been identified as a population in which elimination should be prioritized. Methods We examined progress in HCV elimination through the HCV care continuum among patients infected with HIV/HCV receiving HIV care at Johns Hopkins Hospital in Baltimore, Maryland, United States. Patients with HIV care visits in at least 2 consecutive years were followed through December 15, 2018, for referral to HCV care, treatment initiation, and cure. Results Among 593 HIV/HCV-coinfected individuals, 547 (92%) were referred for HCV care, 517 (87%) were evaluated for HCV treatment, 457 (77%) were prescribed HCV treatment, 426 (72%) initiated treatment, and 370 (62%) achieved HCV cure. In multivariable analysis, advanced liver disease (hazard ratio [HR], 1.48; 95% confidence interval [CI], 1.17–1.88) remained significantly positively associated with HCV treatment initiation. Conversely, being insured by state Medicaid (HR, 0.75; 95% CI, 0.61–0.92), having an HIV RNA >400 copies/mL (HR, 0.29; 95% CI, 0.18–0.49), and having missed 1%–24% (HR, 0.72; 95% CI, 0.54–0.97), 25%–49% (HR, 0.66; 95% CI, 0.49–0.89), and ≥50% of HIV care visits (HR, 0.39; 95% CI, 0.25–0.60) were significantly negatively associated with HCV treatment initiation. Conclusions HCV infection can be eliminated in PWH. However, HCV elimination requires unrestricted access to HCV treatment and improved methods of retaining people in medical care.

The availability of effective, oral direct acting antivirals for hepatitis C virus (HCV) treatment has fueled optimism for HCV elimination through treatment as prevention (TasP) among people who inject drugs (PWID). Identifying characteristics of individuals in transmission networks would provide critical information for the development and implementation of effective, targeted HCV TasP strategies. The AIDS linked to the IntraVenous Experience (ALIVE) cohort has followed PWID in Baltimore since 1988. Sequencing of the HCV core/E1 region (342 nucleotides) was performed on HCV viremic samples from the most recent study visit attended by ALIVE participants between August, 2005 and December, 2016. Outgroup sequences were retrieved from GenBank through a BLAST search for HCV sequences similar to study sequences to support identification of ‘local clusters’ and were aligned to study sequences using Clustal O. Phylogenetic trees were inferred for each of HCV subtype 1a and 1b separately through maximum likelihood analysis implemented in the MEGA X software using the Tamura-Nei model with gamma distribution and invariant sites. Nucleotide substitution model selection was based on the corrected Akaike information criterion scores of various models in MEGA. Robustness of the resulting tree was assessed by bootstrapping with 1,000 replicates. Clusters were identified using ClusterPicker software (70% bootstrap threshold and 0.05 maximum genetic distance threshold). Sensitivity analyses were performed by varying the genetic distance threshold between 0.025 and 0.05 to determine the effect on identification of factors associated with clustering. HCV infection clustering was defined as > 2 participants with HCV genome sequences satisfying 70 per cent bootstrap and 0.05 genetic threshold distance requirement for sequence similarity. Logistic regression was used to assess sociodemographic factors associated with being in an HCV cluster. Among 512 HCV genotype 1 viremic PWID, HCV subtype prevalence was 83 per cent genotype 1a and 17 per cent genotype 1b. The median age of participants was 54 years, 68 per cent male, 87 per cent Black, and 38 per cent HIV infected. Overall, 9 per cent (n = 44) were grouped into 21 clusters, consisting of 20 pairs and 1 triad. Of the 425 genotype 1a and 87 genotype 1b samples evaluated, 8 per cent (n = 33) and 13 per cent (n = 11) respectively, were in clusters. In unadjusted analyses, membership in a cluster, was associated with younger age (odds ratio (OR) 1.5 [95% confidence interval (CI) 1.1–2.1] per 10 year age decrease); female sex (OR 2.8 [95% CI 1.5–5.3]), HIV infection (OR 4.9 [95% CI 2.5–9.9]), and living in East Baltimore (versus outside East Baltimore, OR 2.0 [95% CI 1.0–3.9]). In adjusted analyses, female sex (OR 2.0 [95% CI 1.0–3.9] and HIV infection (OR 5.4 [95% CI 2.6–11.1] remained independently associated with being in an HCV infection cluster. HIV-infected PWID and their networks should be prioritized for HCV treatment and prevention interventions given an increased likelihood of transmission in these groups.

Background Despite access to direct-acting antivirals, barriers to a hepatitis C virus (HCV) cure persist, especially among persons living with human immunodeficiency virus (HIV) (PLWH) who use drugs. Interventions such as peer mentors or cash incentives may improve the care continuum. Methods The CHAMPS (Chronic HepAtitis C Management to ImProve OutcomeS) study randomized 144 PLWH, recruited from an outpatient clinic, with substance use disorders into three treatment groups: usual care (UC) (n = 36), UC plus cash incentives (n = 54), and UC plus peer mentors (n = 54) to evaluate HCV treatment uptake and cure. All participants received 12-weeks of ledipasvir/sofosbuvir (LDV/SOF). Trained peer mentors had well-controlled HIV and HCV. Cash incentives were contingent on visit attendance (maximum $220). The primary endpoint was HCV treatment initiation; secondary endpoints included sustained virologic response (SVR) and HCV reinfection. Results The majority of participants were male (61%), Black (93%), and unemployed (85%). Depression and active drug and alcohol use were common. Overall, 110 of 144 (76%) participants initiated LDV/SOF. Although treatment initiation rates were higher in PLWH randomized to peers (83%, 45 of 54) or cash (76%, 41 of 54) compared to UC (67%, 24 of 36), these differences were not statistically significant (P = .11). Most PLWH who initiated treatment achieved SVR (100 of 110, 91%). LDV/SOF was well tolerated; peers and cash had no effect on drug and alcohol use during therapy. One individual from the cash cohort experienced HCV reinfection. Conclusion After removal of system barriers, one-third of PLWH in UC did not initiate HCV treatment. Among those who initiated, SVR rates were high. Research involving PLWH who use drugs should focus on overcoming barriers to treatment initiation. Clinical trial information The registration data for the trial are in the ClinicalTrials.gov database, number NCT02402218., Highly efficacious therapies are necessary but not sufficient to eliminate HCV infection in persons with HIV infection. We evaluated the impact of peer-mentors and cash incentives on linkage to HCV treatment and cure in persons with HIV-HCV coinfection who had not been previously treated.

Background Social network interventions that take advantage of existing individual and group relationships may help overcome the significant patient, provider, and system level barriers that contribute to low hepatitis C Virus (HCV) treatment uptake among people who inject drugs (PWID). Methods We conducted semi-structured interviews with 20 HCV antibody positive PWID (15 male, 5 female) in Baltimore, Maryland, USA. We utilized thematic analysis and employed both inductive and deductive coding techniques to assess perceptions of barriers and facilitators of social network interventions for HCV testing, linkage to care, and treatment among PWID. Results PWID perceived a high prevalence of HCV within their social networks, especially within injection drug use networks. Overwhelmingly, participants reported a willingness to discuss HCV and provide informational, instrumental, and emotional support to their network members. Support included sharing knowledge, such as where and how to access HCV care, as well as sharing lived experiences about HCV treatment that could help peers build trust within networks. Participants who were already linked into HCV care had an increased understanding of using social network interventions to provide peer navigation, by accompanying network members to HCV related appointments. Across interviews, drug use related stigma and feeling undeserving of HCV treatment due to previous negative experiences accessing the health care system emerged as a major barrier to linkage to HCV treatment and cure. Undeservingness was often internalized and projected onto network members. To overcome this, participants supported access to low-barrier HCV treatment in alternative locations such as community-based or mobile clinics and drug treatment centers. Conclusion Social network based interventions have potential to increase HCV treatment uptake among PWID. To be successful, these interventions will need to train peers to share accurate information and personal experiences with HCV testing and treatment and enhance their ability to provide support to network members who face significant stigma related to both HCV and drug use.

Background and aims Direct-acting antivirals (DAAs) are highly effective in treating hepatitis C. However, there is concern that cure rates may be lower, and reinfection rates higher, among people who inject drugs. We conducted a systematic review of treatment outcomes achieved with DAAs in people who inject drugs (PWID). Methods A search strategy was used to identify studies that reported sustained viral response (SVR), treatment discontinuation, adherence or reinfection in recent PWID and/or opioid substitution therapy (OST) recipients. Study quality was assessed using the Newcastle-Ottawa Scale. Meta-analysis of proportions was used to estimate pooled SVR and treatment discontinuation rates. The pooled relative risk of achieving SVR and pooled reinfection rate were calculated using generalized mixed effects linear models. Results The search identified 8075 references; 26 were eligible for inclusion. The pooled SVR for recent PWID was 88% (95% CI, 83%-92%) and 91% (95% CI 88%-95%) for OST recipients. The relative risk of achieving SVR for recent PWID compared to non-recent PWID was 0.99 (95% CI, 0.94-1.06). The pooled treatment discontinuation was 2% (95% CI, 1%-4%) for both recent PWID and OST recipients. Amongst recent PWID, the pooled incidence of reinfection was 1.94 per 100 person years (95% CI, 0.87-4.32). In OST recipients, the incidence of reinfection was 0.55 per 100 person years (95% CI, 0.17-1.76). Conclusions Treatment outcomes were similar in recent PWID compared to non-PWID treated with DAAs. People who report recent injecting or OST recipients should not be excluded from hepatitis C treatment.

Background Hepatitis C virus (HCV) treatment uptake among people who inject drugs (PWID), a population with disproportionately high rates of HCV, remains low. Peers have been shown to positively impact a broad range of health outcomes for PWID. There is, however, limited data on the impact of PWID social network members on HCV treatment. Methods HCV-infected PWID enrolled in an ongoing community-based cohort were recruited as “indexes” to complete an egocentric social network survey. The survey elicited from the index PWID a list of their network members and the index's perception of network member characteristics. Logistic regression analyses were conducted to compare individual and network factors associated with HCV treatment in the index PWID. Results Among 540 HCV-infected PWID, the mean age was 55.7 years and the majority were black (87.2%) and male (69.8%). PWID reported a mean of 4.4 (standard deviation [SD] 3.2) network members, most of whom were relatives (mean 2.2 [SD 1.5]). In multivariable analysis, increasing index age and HIV infection were positively associated with HCV treatment, while drug use and homelessness in the preceding 6 months were negatively associated with HCV treatment. From a network perspective, having at least one network member who regularly talked with the index about seeing their doctor for HIV care was associated with HCV treatment (Adjusted Odds Ratio [AOR] 2.7; 95% Confidence Interval (CI) [1.3, 5.6]). Conversely, PWID who had at least one network member who helped them understand their HCV care were less likely to have been HCV treated (AOR 0.2; CI [0.1, 0.6). Conclusion HCV treatment uptake in this group of PWID appeared to be positively influenced by discussions with network members living with HIV who were in care and negatively influenced by HCV information sharing within PWID networks. These findings underscore the influence of peers on health seeking behaviors of their network members and emphasizes the importance of well-informed peers.

Recognizing the importance of timely guidance regarding the rapidly evolving field of hepatitis C management, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) developed a web-based process for the expeditious formulation and dissemination of evidence-based recommendations. Launched in 2014, the hepatitis C virus (HCV) guidance website undergoes periodic updates as necessitated by availability of new therapeutic agents and/or research data. A major update was released electronically in September 2017, prompted primarily by approval of new direct-acting antiviral agents and expansion of the guidance’s scope. This update summarizes the latest release of the HCV guidance and focuses on new or amended recommendations since the previous September 2015 print publication. The recommendations herein were developed by volunteer hepatology and infectious disease experts representing AASLD and IDSA and have been peer reviewed and approved by each society’s governing board.

Background: Baltimore is an urban center that has been highly impacted by human immunodeficiency virus (HIV) and hepatitis C virus (HCV); however, many individuals are unaware of their HIV and/or HCV status. In 2013, the Johns Hopkins Center for AIDS Research (CFAR) developed Generation Tomorrow, an HIV and HCV education, testing, and counseling program with community input and collaboration. Objectives: The aims of Generation Tomorrow are to increase HIV and HCV awareness and detection in Baltimore and engage the next generation of health professionals (students) and community members (peers) in HIV and HCV outreach services. Methods: The Generation Tomorrow educational component includes formal HIV and HCV testing and counselling training, and a lecture series for students and peers. The participants then engage in field assignments and outreach events with Johns Hopkins associated programs or community-based organizations. Results: Generation Tomorrow trained 71 students and peers in three cohorts, 70% of whom reported that they planned to stay in HIV- and/or HCV-related work. From October 2014 to May 2015, which represents the first year that Generation Tomorrow ran with the full academic calendar, Generation Tomorrow students and peers worked with partner organizations to conduct 1,104 HIV rapid antibody tests and found 19 individuals (1.72%) to be HIV positive. Additionally, 778 HCV rapid antibody tests were conducted and 175 individuals (22.5%) were HCV antibody positive. Conclusions: Generation Tomorrow has been successful in engaging students and community peers in HIV and HCV education, testing, and counseling, and has documented HIV and HCV positivity rates well above general community prevalence.