scholarly journals 297. Accessible Care Intervention for Engaging People Who Inject Illicit Drugs in Hepatitis C Virus Care: Preliminary Results from a Randomized Clinical Trial

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S161-S161
Author(s):  
Benjamin Eckhardt ◽  
Yesenia Aponte-Meledez ◽  
Chunki Fung ◽  
Shashi Kapadia ◽  
La Davis ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hepatitis C ◽  
Usual Care ◽  
Randomized Clinical Trial ◽  
Illicit Drugs ◽  
Treatment Initiation ◽  
Linkage To Care ◽  
Hcv Rna ◽  
Service Program ◽  
Care Intervention

Abstract Background To achieve hepatitis C elimination, treatment programs need to be developed to engage, treat, and cure people who are actively injecting drugs. Methods We present preliminary data from the first 65 participants in the Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C (HCV) care. The randomized clinical trial compares the effectiveness of Accessible Care (low-threshold care in a syringe service program located in New York City) with Usual Care (referral to existing services) in facilitating linkage, engagement, and retention in HCV care. Eligible participants were HCV RNA positive and had injected drugs in the past 90 days. We compared the percentage of participants in each arm linked to HCV care (defined as one visit with HCV treatment provider), and initiated direct-acting antiviral (DAA) treatment within 6 months of enrollment. Results Among the 65 participants, the mean age is 41.2 years; 28% are females; 73% homeless; 6% black, 51% Latina/o and 39% white. 82% of participants had injected drugs in the last 30 days, with an average of 13.2 injections/month (median 10). Nearly all participants had health insurance, 88% public insurance, 6% uninsured. Thirty-two participants were randomized to the Accessible Care arm. Within 6 months of enrollment 79% of the Accessible Care arm and 25% of the Usual Care arm had linked to HCV care, and 69% and 13% had been started on DAA therapy, respectively. Of the 26 participants in the Accessible Care arm started on DAA therapy, the median time from enrollment to treatment initiation was 87.5 days [range 22–180]. Conclusion Among HCV-infected PWID enrolled at a syringe service program, higher rates of linkage to care and treatment initiation were seen in the Accessible Care arm where stigma- and shame-free treatment was located within a community-based location. Disclosures All authors: No reported disclosures.

scholarly journals 911. Rapid Hepatitis C Treatment Initiation in Young People Who Inject Drugs: Final Results from the HCV-Seek, Test and Rapid Treatment (HCV-ST&RT) Randomized Pilot Clinical Trial

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S547-S547
Author(s):  
Benjamin Eckhardt ◽  
Shashi Kapadia ◽  
Melinda Smith ◽  
Yesenia Aponte-Melendez ◽  
Chunki Fong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Young People ◽  
Usual Care ◽  
People Who Inject Drugs ◽  
Treatment Initiation ◽  
Hcv Rna ◽  
Research Support ◽  
Intention To Treat ◽  
Treat Analysis ◽  
Rapid Treatment

Abstract Background Young people who inject drugs (PWID) have higher HCV incidence and lower treatment initiation rates compared to their older peers. Novel, simplified care models need to be developed to engage, treat and cure hard to reach patient populations, such as young PWID. Methods We present final data from the randomized pilot clinical trial HCV-Seek Test & Rapid Treatment (HCV-ST&RT) for curing HCV in young PWID. Eligible participants were 18-29 years of age, HCV Ab+, treatment naïve, and had injected drugs in the past 30 days. Participants were randomized 1:1 to the Rapid Treatment or Usual Care arm. Participants randomized to Rapid Treatment received a same-day medical evaluation, confirmatory and baseline lab testing, and 7-day starter pack of sofosbuvir/velpatasvir. Participants in Usual Care received same-day HCV confirmatory testing and, if positive, facilitated referral to local providers. The primary endpoint was sustained virologic response (SVR12) in RNA+ participant within 12 months of enrollment. Results Among 47 eligible participants, 38 were enrolled and randomized. 14/18 in the Rapid Treatment arm and 11/20 in the Usual Care arm were confirmed HCV RNA+ and included in the intention-to-treat analysis. Demographics of the RNA+ participants were similar in the two arms with a mean age of 26 years; 24% women; 36% Hispanic and 4% non-Hispanic black. At baseline 24% were homeless, 52% received medication for opioid use disorder in the prior 90 days, and participants injected a median of 20 of the last 30 days. In the intention-to-treat analysis, 9/14 (64%) of the Rapid Treatment arm and 2/11 (18%) of the Usual Care arm had confirmed SVR12 (p=0.042). Of the 5 participants in the Rapid Treatment arm who did not achieve SVR12, 1 had treatment failure, 1 never started DAA therapy, 1 had an on-treatment response with pending SVR12 confirmation, and 2 were lost to follow-up. Conclusion Among young HCV RNA+ PWID, significantly higher rates of cure were achieved using the Rapid Treatment model with same day, low-threshold, simplified HCV care compared to facilitated referral. Meeting young PWID where they’re at and initiating HCV treatment ‘in the moment’ without the need for repeat visits appears to be a promising strategy for treating this hard to reach population. Disclosures Benjamin Eckhardt, MD, MS, Gilead Sciences (Grant/Research Support) Shashi Kapadia, MD, Gilead Sciences Inc (Grant/Research Support) Kristen Marks, MD, Gilead Sciences (Grant/Research Support)

scholarly journals Plasma interferon-alpha is associated with double-positivity for autoantibodies but is not a predictor of remission in early rheumatoid arthritis—a spin-off study of the NORD-STAR randomized clinical trial

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Marit Stockfelt ◽  
Anna-Carin Lundell ◽  
Merete Lund Hetland ◽  
Mikkel Østergaard ◽  
Till Uhlig ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Disease Activity ◽  
Randomized Clinical Trial ◽  
Early Rheumatoid Arthritis ◽  
Treatment Initiation ◽  
Certolizumab Pegol ◽  
Type I ◽  
Protein Levels ◽  
Early Ra

Abstract Background The type I interferon (IFN) gene signature is present in a subgroup of patients with early rheumatoid arthritis (RA). Protein levels of IFNα have not been measured in RA and it is unknown whether they associate with clinical characteristics or treatment effect. Methods Patients with early untreated RA (n = 347) were randomized to methotrexate combined with prednisone, certolizumab-pegol, abatacept, or tocilizumab. Plasma IFNα protein levels were determined by single molecular array (Simoa) before and 24 weeks after treatment initiation and were related to demographic and clinical factors including clinical disease activity index, disease activity score in 28 joints, swollen and tender joint counts, and patient global assessment. Results IFNα protein positivity was found in 26% of the patients, and of these, 92% were double-positive for rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA). IFNα protein levels were reduced 24 weeks after treatment initiation, and the absolute change was similar irrespective of treatment. IFNα protein positivity was associated neither with disease activity nor with achievement of CDAI remission 24 weeks after randomization. Conclusion IFNα protein positivity is present in a subgroup of patients with early RA and associates with double-positivity for autoantibodies but not with disease activity. Pre-treatment IFNα positivity did not predict remission in any of the treatment arms, suggesting that the IFNα system is distinct from the pathways of TNF, IL-6, and T-cell activation in early RA. A spin-off study of the NORD-STAR randomized clinical trial, NCT01491815 (ClinicalTrials), registered 12/08/2011, https://clinicaltrials.gov/ct2/show/NCT01491815.

scholarly journals Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

2021 ◽  
Author(s):  
Maj Siercke ◽  
Sanne Pagh Moller ◽  
Lau Caspar Thygesen ◽  
Henrik Sillesen ◽  
Dorthe Overgaard
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Clinical Trial ◽  
Mixed Methods ◽  
Usual Care ◽  
Randomized Clinical Trial ◽  
Intermittent Claudication ◽  
Walking Distance ◽  
Significant Difference

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.

scholarly journals 932. Universal Hepatitis C Virus Screening in a Tennessee Tertiary Care Emergency Department

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S31-S32 ◽  
Author(s):  
Cody A Chastain ◽  
Jakea Johnson ◽  
Karen Miller ◽  
Katie Moore ◽  
Amanda Lako ◽  
...  
Keyword(s):  
Emergency Department ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Tertiary Care ◽  
Linkage To Care ◽  
Hcv Rna ◽  
Grant Recipient ◽  
Age Cohort ◽  
Hcv Antibody ◽  
Hcv Screening

Abstract Background Despite hepatitis C virus (HCV) age cohort and risk factor screening recommendations, many at-risk individuals remain undiagnosed. Current screening practices may not adequately capture those at high risk for infection, especially in regions with increasing injection drug use (IDU). Universal HCV screening in a Tennessee tertiary care emergency department (ED) was introduced to help define regional epidemiology and to improve diagnosis and linkage to care. Methods This screening program was implemented in the Vanderbilt University Medical Center ED. Adult patients who underwent phlebotomy for clinical purposes were offered HCV screening. Samples were initially tested for HCV antibodies; if positive, samples were reflexed for HCV RNA testing. Patients with positive HCV RNA tests (i.e., active HCV infection) were notified, counseled, and offered linkage to care. Results A total of 11,637 screening tests were performed between April 1, 2017 and March 31, 2018, with 1,008 (8.7%) HCV antibody positive and 488 (4.2%) RNA positive. Of note, 81 (0.7%) were HCV antibody positive but RNA testing could not be performed due to insufficient sample volume. Several notable populations had high rates of HCV (Table 1). Importantly, 3.9% of people not born between 1945 and 1965 were HCV RNA positive, and they were the majority (63.5%) of patients with active HCV (Table 2). A minority (31.6%) of those with active HCV had a known history of IDU (Table 2). Conclusion HCV is common among patients presenting for emergency care at a Tennessee tertiary care ED. Universal screening identified many infections that would have been missed using age cohort and risk factors alone. ED HCV screening may be a useful method to augment guideline-based testing and intervene among populations not consistently screened. Disclosures C. A. Chastain, Gilead Sciences, Inc.: Grant Investigator and Research Contractor, Grant recipient and Research support. J. Johnson, Gilead Sciences, Inc.: Grant Investigator, Grant recipient. K. Miller, Gilead Sciences, Inc.: Grant Investigator, Grant recipient. J. H. Han, Gilead Sciences, Inc.: Grant Investigator, Grant recipient. W. H. Self, Gilead Sciences, Inc.: Grant Investigator, Grant recipient.

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