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 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 917. Accessible HCV Care for People Who Inject Drugs: Randomized Clinical Trial Comparing Low-Threshold Treatment at a Syringe Service Program Versus Facilitated Referral

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S550-S550
Author(s):  
Benjamin Eckhardt ◽  
Yesenia Aponte-Melendez ◽  
Chunki Fong ◽  
Shashi Kapadia ◽  
La Davis ◽  
...  
Keyword(s):  
Usual Care ◽  
People Who Inject Drugs ◽  
Treatment Programs ◽  
Hcv Rna ◽  
Hcv Treatment ◽  
Service Program ◽  
Research Support ◽  
The Past ◽  
Care Cascade ◽  
Low Threshold

Abstract Background To achieve hepatitis C virus (HCV) elimination, treatment programs need to be developed to engage, treat, and cure people who inject drugs (PWID). Methods We present final data from the Accessible Care Trial for curing HCV in PWID. The randomized clinical trial compared on-site, low-threshold HCV treatment with care-coordination at a NYC syringe service program (Accessible Care) with facilitated referral to local providers through a patient navigation program (Usual Care). Eligible participants were HCV RNA+ and had injected drugs in the past 90 days. Participants were randomized 1:1 to the Accessible Care or Usual Care arm. The primary endpoint was achievement of sustained virologic response (SVR12) within 12 months of enrollment. Secondary endpoints examined rates HCV care cascade step completion from referral to clinician, attending clinical visit, baseline lab testing, treatment initiation, and cure. Results Among the 572 participants screened, 167 met eligibility criteria and were enrolled, with two excluded post-randomization (N=165). Demographics were similar with a median age of 41 years; 22% women; 59% Hispanic and 5% non-Hispanic black. At baseline, 84% of participants had injected drugs in the past 30 days with those averaging 22 injections/month, 70% were receiving either methadone or buprenorphine, 57% were recently homeless, 7% were HIV+, and 11% were HCV treatment experienced. In the intention-to-treat analysis, 55/82 (67.1%) of the Accessible Care arm and 19/83 (22.9%) of the Usual Care arm achieved SVR12 (p< 0.001). The SVR12 rates of those starting therapy were 55/64 (85.9%) and 19/22 (86.3%) in the two arms (p=0.96). Loss to follow-up (12.2% and 16.9%, p=0.51) was similar in the two arms. 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 clinician and attending clinical visit. Conclusion Among HCV RNA+ PWID significantly higher rates of cure were achieved using the Accessible Care model focused on low-threshold, destigmatized, flexible HCV care compared to facilitated referral. To achieve HCV elimination, expansion of treatment programs specifically geared toward engaging PWID is paramount. 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 A Prospective Randomized Trial of Imipenem-Cilastatin Versus Clindamycin/Tobramycin in the Treatmentof Intra-Abdominal and Pelvic Infections

1993 ◽  
Vol 4 (5) ◽  
pp. 279-287 ◽  
Author(s):  
Lionel A Mandell ◽  
Pierre L Turgeon ◽  
Allan R Ronalds ◽  
The Canadian Clinical Trials Group
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Study Drug ◽  
Efficacy And Safety ◽  
Bacteriological Response ◽  
Intention To Treat ◽  
Days Of Therapy ◽  
Dichotomous Outcomes ◽  
Bacterial Superinfection ◽  
Treat Analysis

Objective: A Canadian multicentre clinical trial in the treatment of intra-abdominal and pelvic infections to compare the efficacy and safety of monotherapy using imipenem-cilastatin (imipenem) (500 mg intravenously every 6 h) versus combination therapy with clindamycin/tobramycin (clindamycin 600 mg intravenously every 6 h and tobramycin 1.7 mg/kg intravenously every 8 h).Methods: Two hundred and fifty patients were entered (88 definite and 162 possible infections) and all were evaluable for analysis of adverse events and intention to treat analysis of efficacy. Dichotomous outcomes used were: cured versus noncured (improved, failed, relapsed).Results: No statistically significant differences were found with the intention to treat analysis (P=0.88) or with definite infections (P=0.81). For overall bacteriological response, no significant differences were noted (P=0.1). Eleven and 15 patients on imipenem and clindamycin/tobramycin, respectively, were colonized with bacteria. Enterococci colonized four of 11 imipenem cases and five of 15 clindamycin/tobramycin cases while fungi colonized six patients on imipenem and four on clindamycin/tobramycin. Five patients on imipenem and seven on clindamycin/tobramycin developed superinfection. In the imipenem group, one case had a bacterial superinfection while four cases were due toCandida albicans.Seven of seven superinfections on clindamycin/tobramycin were bacterial. Three bacteria initially sensitive to the assigned study drug developed resistance. In two patients on imipenem,Enterococcus faecalisandPseudomonas aeruginosabecame resistant after 14 and 10 days of therapy, respectively. On clindamycin/tobramycin, one instance ofBacteroides fragilisresistance after eight days of therapy was seen. Eighty-three adverse events occurred; 47 in the imipenem group and 36 in the clindamycin/tobramycin group. This resulted in discontinuation of antibacterial therapy in 13 patients, seven of whom were on imipenem and six on clindamycin/tobramycin. Comparison of adverse effects showed statistically significant differences for nausea (P=0.02) and hepatotoxicity (P=0.05) occurring with greater frequency in the imipenem and clindamycin/tobramycin groups, respectively.Conclusions: These data support the conclusion that monotherapy with imipenem (500 mg intravenously every 6 h) is as efficacious as clindamycin/tobramycin for treatment of intra-abdominal and pelvic infections. Both regimens are well tolerated.

Effectiveness of a conversational chatbot in the smartphone to cease smoking in the adult population: pragmatic, controlled, randomized clinical trial in primary care (Dejal@). (Preprint)

2021 ◽  
Author(s):  
EDUARDO OLANO-ESPINOSA ◽  
Jose Francisco Avila-Tomas ◽  
Cesar Minue-Lorenzo ◽  
Blanca Matilla Pardo ◽  
Encarnación Serrano-Serrano ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Trial ◽  
Clinical Practice ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Evidence Based ◽  
Intention To Treat ◽  
Usual Clinical Practice ◽  
Treat Analysis

BACKGROUND The magnitude and severity of smoking, the benefits of quitting, and the existence of effective and efficient interventions make it a priority problem. Health professionals intervene less than they should, and the most effective interventions are more expensive, require specific training and more time, which is a disadvantage for the service provider and for the accessibility of the services. Information and communication technologies avoid these problems thanks to their accessibility, privacy, customization possibilities, access to social support, and scalability. OBJECTIVE To assess the effectiveness of an evidence-based intervention to cease smoking via a chatbot in the smartphone compared to usual clinical practice in primary care. METHODS Pragmatic randomized clinical trial in 34 primary healthcare centers within the Madrid Health Service (Spain). Smokers over 18 years of age who attended on-site consultation and accepted help to quit tobacco were recruited by their doctor or nurse and randomly allocated to receive usual care (control group, CG) or an evidence-based chatbot intervention (intervention group, IG). The interventions in both arms were based on the 5A´s by the US clinical practice guideline, which combines behavioral and pharmacological treatments and is structured in several follow-up appointments. The primary outcome was continuous abstinence from smoking that was biochemically validated after 6 months by the collaborators. The outcome analysis was blinded to allocation of subjects although participants were unblinded to group assignment. An intention-to-treat analysis, entering the basal observation carried forward in cases of missing data, and logistic regression models with robust estimators were employed for assessing the primary outcomes. RESULTS The trial was conducted between October 1st of 2018 and March 31st of 2019. The sample comprised 513 patients (242 in the IG and 271 in the CG), with an average age of 49.8 years (SD 10.82) and gender ratio of 59.3% women and 40.7% men. Of them, 232 patients (45.2%) completed the follow-up, 104 (42.9%) in the IG and 128 (47.2%) in the CG. Main outcome: In the intention-to-treat analysis, the biochemically-validated abstinence rate at 6 months was higher in the IG with 26.03% (63/242) versus 18.82% (51/271) in the CG (odds ratio (OR)=1.52, 95% CI: 1.00–2.31, P=.05). After adjusting for basal CO-oxymetry and bupropion intake, no substantial changes were observed (OR=1.52, 95% CI 0.99–2.33 P= .053; pseudo R2=0.045). In the IG, 61.16% (148/242) of users accessed the chatbot, average bot-patient interaction time was 121 minutes (CI 95% 121.1–140.0), and average number of contacts was 45.56 (SD 36.32). CONCLUSIONS A treatment including a chatbot for helping in tobacco cessation was more effective than usual clinical practice in primary care. CLINICALTRIAL ClinicalTrials.gov, reference number NCT 03445507.

The Consolidated Standards of Reporting Trials (CONSORT): Better Presentation of Surgical Trials in the Journal of Hand Surgery

2004 ◽  
Vol 29 (6) ◽  
pp. 621-624 ◽  
Author(s):  
S. SAUERLAND ◽  
T. R. C. DAVIS
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Hand Surgery ◽  
Controlled Trials ◽  
Scientific Validity ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Study Results ◽  
Methodological Aspects ◽  
Treat Analysis

To assure readers that study results are scientifically valid, the methods of a clinical trial should be described adequately. Since randomization, blinding, and intention-to-treat-analysis are major bias-reducing techniques, these aspects should be reported most accurately. The Consolidated standards of reporting trials (CONSORT) are recommendations to improve the reporting of trials. CONSORT requires that trial authors describe basic methodological aspects that readers need to appraise the strengths of report ed clinical trials. This article presents the CONSORT recommendations and explains some of their main aspects. From now on, the Journal of Hand Surgery will use CONSORT to assist authors of randomized controlled trials in improving the description of their studies. We believe that this decision increases the scientific validity of study reports and helps readers when critically appraising articles.

Suicidality and Treatment Experience Among Young People Who Inject Drugs

2020 ◽  
Author(s):  
Mary Ellen Mackesy-Amiti ◽  
Lawrence J. Ouellet
Keyword(s):  
Mental Health ◽  
Substance Use ◽  
Young People ◽  
Mental Disorders ◽  
Mental Health Treatment ◽  
People Who Inject Drugs ◽  
Multivariable Analysis ◽  
Psychiatric Research ◽  
Health Treatment ◽  
The Past

Background. We examined correlates of past year suicidal thoughts and behavior (STB) and described past year treatment experiences among young people who inject drugs (PWID). Methods. Participants were 570 adults (18-25 years) who injected primarily heroin. Interviews were conducted at field stations operated by Community Outreach Intervention Projects in Chicago, Illinois (USA). Interviewers administered the Psychiatric Research Instrument for Substance and Mental Disorders. Substance use and mental disorders were based on DSM-IV diagnostic criteria. Past year STB was based on multiple questions. Results. Sixteen percent of men and 25% of women reported STB in the past year. In multivariable analysis, STB was associated with non-heterosexual orientation, foster care, and being raised by two parents. Primary major depression, post-traumatic stress disorder, other anxiety disorders, and borderline personality disorder had independent effects on suicidality. Among those reporting past year STB (n=111), 83% ever received mental health treatment, while 44% did so in the past year. While 24% of respondents indicated that at least one treatment matched their needs very well, 30% reported treatment that did not match their needs at all. The most common reason for ending treatment was program completion (about 50%) while getting better was endorsed by about 25%. Nearly half reported ending treatment due to a bad experience, logistical issues, or expense. Conclusions. Young PWID are at high risk for suicidal behavior and their mental health treatment experiences often do not meet their needs. There is a pressing need for more integrated substance use and mental health treatment.

Manual therapies for pain relief in patients with headache

2015 ◽  
Vol 23 (1) ◽  
pp. 89-96
Author(s):  
Débora Wanderley ◽  
Andrea Lemos ◽  
Larissa de Andrade Carvalho ◽  
Daniella Araújo de Oliveira
Keyword(s):  
Treatment Effect ◽  
Cervicogenic Headache ◽  
Allocation Concealment ◽  
Tension Type Headache ◽  
Manual Therapies ◽  
Osteopathic Manipulation ◽  
Intention To Treat ◽  
Headache Relief ◽  
Type Headache ◽  
Treat Analysis

Objective. This systematic review aimed to assess the efficacy of manual therapies for headache relief. Method. A systematic search in MEDLINE, LILACS, Cochrane, CINAHL, Scopus and Web of Sci­ence databases was conducted for randomized and quasi-randomized trials, with no restrictions for language or year of publication. The de­scriptors were ‘Headache’, ‘Headache disorders’ and ‘Musculoskeletal manipulations’, in addition to the keyword ‘Manual therapy’ and its equivalents in Portuguese. We included studies that compared mas­sage, chiropractic manipulation, osteopathic manipulation and other spinal manipulation to groups with no intervention, other physiother­apeutic modalities or to a sham group. Results. Seven of the 567 ar­ticles initially screened were selected, including patients with tension type headache, cervicogenic headache or migraine. It was not possible to assess the magnitude of the treatment effect on the findings of this review. The main limitations were the absence of randomization and adequate allocation concealment, the lack of blinded evaluators and intention-to-treat analysis and inadequate statistical analysis. Conclu­sions. We were unable to determine the size of the treatment effect due to the selective description of findings. Owing to the high risk of bias in the articles included, the available evidence regarding the ef­ficacy of manual therapies for headache relief is insufficient.

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