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Contact tracing in acute hepatitis C: The source patient identification and group overlap therapy proof-of-concept pilot program

Eckhardt, Benjamin; Aponte-Melendez, Yesenia; Kapadia, Shashi N; Mateu-Gelabert, Pedro
PMCID:9405500
PMID: 36033428
ISSN: 2046-2484
CID: 5319462

Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial

Eckhardt, Benjamin; Kapadia, Shashi N; Mateu-Gelabert, Pedro; Pai, Melinda; Fong, Chunki; Aponte-Melendez, Yesenia; Marks, Kristen M
Background/UNASSIGNED:Young people who inject drugs (PWID) have high hepatitis C virus (HCV) incidence and low treatment initiation rates. Novel, simplified care models need to be developed to engage, treat, and cure hard-to-reach patient populations, such as young PWID. We present final data from the randomized pilot clinical trial "HCV-Seek Test and Rapid Treatment" for curing HCV in young PWID. Methods/UNASSIGNED:participant. Results/UNASSIGNED: = .01). Conclusions/UNASSIGNED:PWID, significantly higher rates of cure were achieved using the Rapid Treatment model compared with facilitated referral. Providing easy access to HCV treatment for young PWID in low-threshold settings and initiating HCV treatment quickly appears to be a promising strategy for treating this hard-to-reach population.
PMCID:9272437
PMID: 35821731
ISSN: 2328-8957
CID: 5267602

Severe bacterial infections in people who inject drugs: the role of injection-related tissue damage

Hrycko, Alexander; Mateu-Gelabert, Pedro; Ciervo, Courtney; Linn-Walton, Rebecca; Eckhardt, Benjamin
BACKGROUND:In the context of the current U.S. injection drug use epidemic, targeted public health harm reduction strategies have traditionally focused on overdose prevention and reducing transmission of blood-borne viral infections. Severe bacterial infections (SBI) associated with intravenous drug use have been increasing in frequency in the U.S. over the last decade. This qualitative study aims to identify the risk factors associated with SBI in hospitalized individuals with recent injection drug use. METHODS:Qualitative analysis (n = 15) was performed using an in-depth, semi-structured interview of participants admitted to Bellevue Hospital, NYC, with SBI and recent history of injection drug use. Participants were identified through a referral from either the Infectious Diseases or Addition Medicine consultative services. Interviews were transcribed, descriptively coded, and analyzed for key themes. RESULTS:Participants reported a basic understanding of prevention of blood-borne viral transmission but limited understanding of SBI risk. Participants described engagement in high risk injection behaviors prior to hospitalization with SBI. These practices included polysubstance use, repetitive tissue damage, nonsterile drug diluting water and multipurpose use of water container, lack of hand and skin hygiene, re-use of injection equipment, network sharing, and structural factors leading to an unstable drug injection environment. Qualitative analysis led to the proposal of an Ecosocial understanding of SBI risk, detailing the multi-level interplay between individuals and their social and physical environments in producing risk for negative health outcomes. CONCLUSIONS:Structural factors and injection drug use networks directly impact drug use, injection drug use practices, and harm reduction knowledge, ultimately resulting in tissue damage and inoculation of bacteria into the host and subsequent development of SBI. Effective healthcare and community prevention efforts targeted toward reducing risk of bacterial infections could prevent long-term hospitalizations, decrease health care expenditures, and reduce morbidity and mortality.
PMID: 35501854
ISSN: 1477-7517
CID: 5203332

Accessible Hepatitis C Care for People Who Inject Drugs: A Randomized Clinical Trial

Eckhardt, Benjamin; Mateu-Gelabert, Pedro; Aponte-Melendez, Yesenia; Fong, Chunki; Kapadia, Shashi; Smith, Melinda; Edlin, Brian R; Marks, Kristen M
Importance/UNASSIGNED:To achieve hepatitis C elimination, treatment programs need to engage, treat, and cure people who inject drugs. Objective/UNASSIGNED:To compare a low-threshold, nonstigmatizing hepatitis C treatment program that was colocated at a syringe service program (accessible care) with facilitated referral to local clinicians through a patient navigation program (usual care). Design, Setting, and Participants/UNASSIGNED:This single-site randomized clinical trial was conducted at the Lower East Side Harm Reduction Center, a syringe service program in New York, New York, and included 167 participants who were hepatitis C virus RNA-positive and had injected drugs during the prior 90 days. Participants enrolled between July 2017 and March 2020. Data were analyzed after all patients completed 1 year of follow-up (after March 2021). Interventions/UNASSIGNED:Participants were randomized 1:1 to the accessible care or usual care arm. Main Outcomes and Measures/UNASSIGNED:The primary end point was achieving sustained virologic response within 12 months of enrollment. Results/UNASSIGNED:Among the 572 participants screened, 167 (mean [SD] age, 42.0 [10.6] years; 128 (77.6%) male, 36 (21.8%) female, and 1 (0.6) transgender individuals; 8 (4.8%) Black, 97 (58.5%) Hispanic, and 53 (32.1%) White individuals) met eligibility criteria and were enrolled, with 2 excluded postrandomization (n = 165). Baseline characteristics were similar between the 2 arms. In the intention-to-treat analysis, 55 of 82 participants (67.1%) in the accessible care arm and 19 of 83 participants (22.9%) in the usual care arm achieved a sustained virologic response (P < .001). Loss to follow-up (12.2% [accessible care] and 16.9% [usual care]; P = .51) was similar in the 2 arms. Of the participants who received therapy, 55 of 64 (85.9%) and 19 of 22 (86.3%) achieved a sustained virologic response in the accessible care and usual care arms, respectively (P = .96). Significantly more participants in the accessible care arm achieved all steps in the care cascade, with the greatest attrition in the usual care arm seen in referral to hepatitis C virus clinician and attending clinical visit. Conclusions and Relevance/UNASSIGNED:In this randomized clinical trial, among people who inject drugs with hepatitis C infection, significantly higher rates of cure were achieved using the accessible care model that focused on low-threshold, colocated, destigmatized, and flexible hepatitis C care compared with facilitated referral. To achieve hepatitis C elimination, expansion of treatment programs that are specifically geared toward engaging people who inject drugs is paramount. Trial Registration/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03214679.
PMCID:8922207
PMID: 35285851
ISSN: 2168-6114
CID: 5185542

Hepatitis C virus risk among young people who inject drugs

Mateu-Gelabert, Pedro; Sabounchi, Nasim S; Guarino, Honoria; Ciervo, Courtney; Joseph, Kellie; Eckhardt, Benjamin J; Fong, Chunki; Kapadia, Shashi N; Huang, Terry T K
Background:Injection drug use (IDU) is the leading risk factor for hepatitis C virus (HCV) transmission in the U.S. While the general risk factors for HCV transmission are known, there is limited work on how these factors interact and impact young people who inject drugs (YPWID). Methods:rapid antibody testing. Integrating the observed statistical associations with extant literature on HCV risk, we also developed a qualitative system dynamics (SD) model to use as a supplemental data visualization tool to explore plausible pathways and interactions among key risk and protective factors for HCV. Results:Results showed a 31% HCV antibody prevalence with an overall incidence of 10 per 100 person-years. HCV status was independently correlated with having shared cookers with two or more people (AOR = 2.17); injected drugs 4-6 years (AOR = 2.49) and 7 or more years (AOR = 4.95); lifetime homelessness (AOR = 2.52); and having been incarcerated two or more times (AOR = 1.99). These outcomes along with the extant literature on HCV risk were used to develop the qualitative SD model, which describes a causal hypothesis around non-linearities and feedback loop structures underlying the spread of HCV among YPWID. Conclusions:Despite ongoing harm reduction efforts, close to a third of YPWID in the community sample have been exposed to HCV, have risks for injection drug use, and face challenges with structural factors that may be preventing adequate intervention. The qualitative SD model explores these issues and contributes to a better understanding of how these various risk factors interact and what policies could potentially be effective in reducing HCV infections.
PMCID:9372473
PMID: 35968435
ISSN: 2296-2565
CID: 5299762

The impact of COVID-19 on people who inject drugs in New York City: increased risk and decreased access to services

Aponte-Melendez, Yesenia; Mateu-Gelabert, Pedro; Fong, Chunki; Eckhardt, Benjamin; Kapadia, Shashi; Marks, Kristen
BACKGROUND:While people who inject drugs (PWID) are vulnerable to the adverse outcomes of events like COVID-19, little is known regarding the impact of the current pandemic on PWID. We examine how COVID-19 has affected PWID in New York City across four domains: substance use, risk behaviors, mental health, and service utilization. METHODS:As part of a randomized trial to improve access to HCV treatment for PWID, we recruited 165 participants. Eligibility criteria included detectable HCV RNA and recent drug injection. The present cross-sectional analysis is based on a subsample of 106 participants. We compared responses between two separate samples: 60 participants interviewed prior to the pandemic (pre-COVID-19 sample) and 46 participants interviewed during the pandemic (COVID-19 sample). We also assessed differences by study group [accessible care (AC) and usual care (UC)]. RESULTS:Compared to the pre-COVID-19 sample, those interviewed during COVID-19 reported higher levels of mental health issues, syringe reuse, and alcohol consumption and greater reductions in syringe-service programs and buprenorphine utilization. In the analysis conducted by study group, the UC group reported significantly higher injection risk behaviors and lower access to buprenorphine treatment during COVID-19, while during the same period, the AC group reported lower levels of substance use and injection risk behaviors. CONCLUSION:The current study provides insight on how COVID-19 has negatively affected PWID. Placing dispensing machines of harm-reduction supplies in communities where PWID live and increasing secondary exchange, mobile services, and mail delivery of supplies may help maintain access to lifesaving supplies during big events, such as COVID-19. Trial registration ClinicalTrials.gov NCT03214679. Registered July 11 2017. https://clinicaltrials.gov/ct2/show/NCT03214679 .
PMCID:8611635
PMID: 34819070
ISSN: 1477-7517
CID: 5063722

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

Fong, Chunki; Mateu-Gelabert, Pedro; Ciervo, Courtney; Eckhardt, Benjamin; Aponte-Melendez, Yesenia; Kapadia, Shashi; Marks, Kristen
BACKGROUND:Stigmatizing attitudes towards people who use drugs (PWUD) impact their access and retention in health care. Current measures of PWUD stigma in medical settings are limited. Therefore, we developed and validated theMedical Provider Stigma Experienced by PWUD (MPS-PWUD) scale. METHODS:As part of an ongoing clinical trial, we recruited HCV RNA positive people who inject drugs in New York City. Based on 164 participants, principal component analysis (PCA) was conducted on fifteen stigma items answered on a 5-point Likert scale. We evaluated internal consistency using Cronbach's alpha coefficient and assessed construct validity by comparing stigma levels with willingness to communicate health concerns with medical providers and likelihood to seek HCV treatment. RESULTS:PCA identified a 9-item scale with two components of stigmatization that explained 60.8 % of the total variance and overall high internal consistency (alpha = 0.90). Theenacted stigma (alpha = 0.90) consisted of 6 scale items related to the medical providers' stigmatizing actions or perceptions. The internalized stigma component (alpha = 0.84) included 3 scale items related to PWUD's shame or drug use disclosure. As hypothesized, higher levels of either stigma were associated with less likelihood to openly communicate with medical providers (p < 0.005). Participants with a higher level of enacted stigma were less likely to seek HCV treatment (p = 0.011). CONCLUSIONS:The validated MPS-PWUD scale could help healthcare providers, harm reduction services and researchers measure stigma experienced by PWUD in medical settings in efforts to minimize the impact of stigma on limiting access to and retention of care for PWUD.
PMID: 33621804
ISSN: 1879-0046
CID: 4790012

Hepatitis C Testing and Treatment Uptake among Young People who Use Opioids in New York City: A Cross-Sectional Study

Kapadia, Shashi N; Katzman, Caroline; Fong, Chunki; Eckhardt, Benjamin J; Guarino, Honoria; Mateu-Gelabert, Pedro
Young people who use drugs have a rising hepatitis C (HCV) incidence in the United States, but they may face barriers to testing and treatment adoption due to stigma.We conducted a cross-sectional study of New York City residents aged 18-29 years who reported non-medical prescription opioid and/or heroin use in the past 30 days. Participants were recruited from the community between 2014-2016 via respondent-driven sampling. Participants completed an in-person structured survey that included questions about HCV-testing and treatment and received HCV antibody testing. There were 539 respondents: 353 people who inject drugs (PWID) and 186 non-PWID. For PWID, median age was 25 years, 65% were male, and 73% non-Hispanic White. For non-PWID, median age was 23 years, 73% were male, and 39% non-Hispanic White. 20% of PWID and 54% of non-PWID had never been tested for HCV (p<0.001). Years since first injection (aOR 1.16, CI: 1.02-1.32, p=0.02) and history of substance use treatment (aOR 3.17, CI: 1.53-6.61, p=0.02) were associated with prior testing among PWID. The seroprevalence of HCV among PWID was 25%, adjusted for sampling weights. Of the 75 who were aware of their HCV-positive status, 53% had received HCV-related medical care, and 28% had initiated treatment.HCV prevalence among young PWID is high and many have never been tested. Injection experience and treatment engagement is associated with testing. Interventions to increase testing earlier in injection careers, and to improve linkage to HCV treatment, will be critical for young PWID.
PMID: 33141503
ISSN: 1365-2893
CID: 4661732

RAPID HEPATITIS C TREATMENT INITIATION IN YOUNG PEOPLE WHO INJECT DRUGS: FINAL RESULTS FROM THE HCV-SEEK, TEST & RAPID TREATMENT (HCV-ST&RT) RANDOMIZED PILOT CLINICAL TRIAL. [Meeting Abstract]

Eckhardt, Benjamin; Kapadia, Shashi; Pai, Melinda; Aponte-Melendez, Yesenia; Fong, Chunki; Mateu-Gelabert, Pedro; Marks, Kristen
ISI:000707188000098
ISSN: 0270-9139
CID: 5267612

Remdesivir for the Treatment of Covid-19 - Final Report

Beigel, John H; Tomashek, Kay M; Dodd, Lori E; Mehta, Aneesh K; Zingman, Barry S; Kalil, Andre C; Hohmann, Elizabeth; Chu, Helen Y; Luetkemeyer, Annie; Kline, Susan; Lopez de Castilla, Diego; Finberg, Robert W; Dierberg, Kerry; Tapson, Victor; Hsieh, Lanny; Patterson, Thomas F; Paredes, Roger; Sweeney, Daniel A; Short, William R; Touloumi, Giota; Lye, David Chien; Ohmagari, Norio; Oh, Myoung-Don; Ruiz-Palacios, Guillermo M; Benfield, Thomas; Fätkenheuer, Gerd; Kortepeter, Mark G; Atmar, Robert L; Creech, C Buddy; Lundgren, Jens; Babiker, Abdel G; Pett, Sarah; Neaton, James D; Burgess, Timothy H; Bonnett, Tyler; Green, Michelle; Makowski, Mat; Osinusi, Anu; Nayak, Seema; Lane, H Clifford; Ahn, Jenny; Ahuja, Neera; Alaaeddine, Ghina; Ali, Farhana; Amin, Alpesh N; Angus, Brian; Antoniadou, Anastasia; Arguinchona, Christa; Arguinchona, Henry; Atmar, Robert L; Babiker, Abdel G; Barmparessou, Zafeiria; Beigel, John H; Bell, Taison D; Benfield, Thomas; Benson, Constance A; Billings, Joanne; Boesecke, Christoph; Bonnett, Tyler; Branche, Angela R; Burgess, Timothy H; Cantos, Valeria D; Cao, Huyen; Chambers, Susan E; Chary, Aarthi; Chrysanthidis, Theofilos; Chu, Helen Y; Chung, Kevin K; Cohen, Stuart H; Colombo, Christopher J; Colombo, Rhonda E; Creech, C Buddy; Crouch, Pierre-Cedric B; Davey, Richard T; Dempsey, Walla; Dierberg, Kerry; Dodd, Lori E; Duncan, Christopher J A; Eckhardt, Benjamin; El Sahly, Hana M; Elsafy, Mohamed; Engel, Theresa; Erdmann, Nathaniel; Falsey, Ann R; Fatkenheuer, Gerd; Ferreira, Jennifer L; Finberg, Robert W; Follmann, Dean; Frank, Maria; Ganesan, Anuradha; George, Sarah L; Germain Seymour, Jack David; Gerstoft, Jan; Gettinger, Nikki; Gioukari, Vicky; Goepfert, Paul; Goodman, Anna; Green, Margaret; Green, Michelle; Grein, Jonathan; Grossberg, Robert; Helleberg, Marie; Hewlett, Angela; Hohmann, Elizabeth; Holodniy, Mark; Hsieh, Lanny; Huprikar, Nikhil; Hynes, Noreen A; Jackson, Patrick E H; Jang, Hannah; Javeri, Heta; Jensen, Tomas; Jilg, Nikolaus; Johansen, Isik; Jung, Jongtak; Jurao, Robert; Kalil, Andre C; Kalomenidis, Ioannis; Kim, Eu Suk; Kline, Susan; Knudsen, Lene; Koehler, Philipp; Koo, Hyung; Kortepeter, Mark G; Kotloff, Karen L; Koulouris, Nikolaos; Krueger, Karen; Lalani, Tahaniyat; Lane, H Clifford; Larson, LuAnn; Lee, Marina; Lee, Tida; Lindegaard, Birgitte; Lindholm, David A; Llewelyn, Martin; Lopez de Castilla, Diego; Luetkemeyer, Annie; Lundgren, Jens; Lye, David Chien; Madsen, Lone W; Makowski, Mat; Malin, Jakob J; Marks, G Lynn; Martinez-Orozco, Jose Arturo; Mateu, Lourdes; Maves, Ryan C; McGill, Fiona; McLellan, Susan L F; Mehta, Aneesh K; Mende, Katrin; Merrick, Blair; Metallidis, Simeon; Mikami, Ayako; Minton, Jane; Munoz, Jose; Nadeau, Kari; Nayak, Seema; Neaton, James D; Neumann, Henry J; Nielsen, Henrik; Nomicos, Effie; Noren, Brooke; Novak, Richard M; Oh, Myoung-Don; Ohmagari, Norio; Ong, Sean W X; Ortiz, Justin R; Osinusi, Anu; Ostergaard, Lars; Paredes, Roger; Park, Wan Beom; Patterson, Thomas F; Paules, Catharine I; Pett, Sarah; Philips, Barbara; Pikaart-Tautges, Rhonda; Ponce de Leon, Alfredo; Price, D Ashley; Proschan, Michael; Protopapas, Konstantinos; Rajme, Sandra; Regalado Pineda, Justino; Rice, Todd W; Riedo, Francis X; Riska, Paul F; Roldan, Montserrat; Rouphael, Nadine G; Ruiz-Palacios, Guillermo M; Sauer, Lauren M; Short, William R; Staerke, Nina; Stephan, Christoph; Stephens, David S; Sutterwala, Fayyaz; Sweeney, Daniel A; Swiatlo, Edwin; Taiwo, Babafemi; Tapson, Victor; Tebas, Pablo; Tennant, Janice; Thompson, George R 3rd; Thomsen, Isaac; Tomashek, Kay M; Torgersen, Jessie; Torres-Soto, Mariam; Touloumi, Giota; Traenkner, Jessica J; Utz, Gregory C; Uyeki, Timothy M; Van Winkle, Jason W; Voell, Jocelyn D; Vu, Trung; Wald, Anna; Walker, Robert; Walter, Emmanuel B; Wang, Jennifer P; Wang, Jing; Wasmuth, Jan-Christian; Weise, Lothar; Wendrow, Andrea; Wessolossky, Mireya; Whitaker, Jennifer; Widmer, Kyle; Wierzbicki, Michael R; Wolf, Timo; Wolfe, Cameron; Wolff, Peter; Yang, Otto O; Young, Heather; Zakynthinos, Spyros G; Zingman, Barry S
BACKGROUND:Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious. METHODS:We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. RESULTS:A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%). CONCLUSIONS:Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).
PMID: 32445440
ISSN: 1533-4406
CID: 4637302