Trial Summary
What is the purpose of this trial?The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral intervention to increase hepatitis C (HCV) treatment initiation among adult people who inject drugs (PWID).
Is the Partner Navigation treatment for Hepatitis C a promising treatment?Yes, the Partner Navigation treatment for Hepatitis C is promising. It helps people start and stick with their treatment, leading to high cure rates. This approach is especially helpful for those who face challenges in accessing healthcare, like low-income or minority groups.367811
What safety data is available for the Partner Navigation for Hepatitis C treatment?The provided research articles do not contain specific safety data for the Partner Navigation for Hepatitis C treatment or its related interventions. They focus on general safety assessments and adverse event evaluations in different clinical settings and treatments. Therefore, specific safety data for this treatment would need to be sourced from studies directly evaluating the Partner Navigation Intervention or related behavioral interventions for HCV treatment initiation.1591012
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop your current medications.
What data supports the idea that Partner Navigation for Hepatitis C is an effective treatment?The available research shows that Partner Navigation for Hepatitis C is effective. In the Check Hep C program, 91% of those who started treatment achieved a successful outcome, indicating high cure rates. Additionally, patient navigation increased the number of people starting treatment and receiving necessary medication, especially in underserved communities. Compared to other methods, Partner Navigation helps more people begin and stick with their treatment, leading to better health outcomes.234711
Eligibility Criteria
This trial is for adults who have used injection drugs in the past month, share their injecting activities with a primary partner, and have been diagnosed with hepatitis C at a community-based clinical site.Treatment Details
The study is testing a 'Partner Navigation Intervention' to see if it helps people who inject drugs start treatment for hepatitis C. It's an RCT, meaning participants are randomly assigned to either receive the intervention or not.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
In addition to standard HCV results disclosure for the comparator arm, intervention participants will have two counseling sessions:
Session 1: Immediately after HCV results disclosure, a staff-facilitated session with the index to (1) Establish HCV Treatment Goals, fostering commitment, and (2) Engage the Injecting Partner, identifying ways to support treatment initiation.
Session 2: One week later, involving both the index and injecting partner, to (1) Enhance Partner Support with specific strategies for HCV treatment initiation and (2) Collaborative Navigation Mapping, using a "navigation map" tool. By Session 2's end, both will have a completed navigation map, a visual guide for the HCV treatment journey.
Both sessions stress communication and dyadic coordination. The "navigation map" tool ensures a personalized plan for the index's treatment initiation and the partner's supportive navigator role.
Group II: ControlActive Control1 Intervention
Standard of care HCV disclosure. This staff-facilitated session follows the California HIV/HCV test counselor certification protocol with the Index alone.
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Research locations nearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]This article describes a working tool for clinicians in an inpatient oncology unit, aimed at preventing adverse events and increasing the clinical safety of patients with cancer. With the development of a catalog of adverse events and a risk map, healthcare providers are able to implement safe, best practices in daily activities.
Project P.E.A.C.H. (Pathway and Education Toward Adherence and Completion in Hepatitis C Therapy): A Nurse-Driven Evidence-Based Protocol. [2017]Chronic hepatitis C virus (HCV) remains a major healthcare concern. The 24-48 week treatment of pegylated interferon and ribavirin therapy requires a tremendous amount of commitment from patients and providers. Thus, there has been a huge focus on health-related quality of life and various measures to support patient adherence and completion of the recommended HCV treatment regimen. This quality improvement project aimed to develop and test a nurse-driven evidence-based pathway that supports the care of patients receiving hepatitis C medication therapy in a tertiary, academic hepatology practice. All adult patients, 18 years and older, who were started on HCV treatment from January 20 to February 15, 2011, were included in the testing of a nurse-driven HCV pathway for the first 12 weeks of treatment. The majority of the patients treated were male (71.8% prepathway and 83.3% postpathway), of White ethnic background (61.5% prepathway and 58.3% postpathway), genotype 1 (69% prepathway and 91.7% postpathway), and had comorbid conditions classified as "other" (38.5% prepathway and 33.3% postpathway). As for treatment status, the majority of the patients were "treatment naive" in prepathway or had never received prior HCV treatment (59.0%) or "had recurrent HCV after liver transplantation" (41.7%). The 4-week treatment completion rate was 94.9% for the prepathway group and 100.0% for the postpathway group; 12-week completion rate was 87.2% (prepathway) and 58.3% for the postpathway group. The mean 4-week adherence score for the prepathway group was 2.46 and the postpathway group was 2.92. Mean lag time to treatment was decreased with 26 days in the postpathway and 43 in the prepathway. Providers and nurses expressed overall satisfaction with the nurse-driven pathway.
From Care to Cure: Demonstrating a Model of Clinical Patient Navigation for Hepatitis C Care and Treatment in High-Need Patients. [2022]The NYC Department of Health implemented a patient navigation program, Check Hep C, to address patient and provider barriers to HCV care and potentially lifesaving treatment. Services were delivered at two clinical care sites and two sites that linked patients to off-site care. Working with a multidisciplinary care team, patient navigators provided risk assessment, health education, treatment readiness and medication adherence counseling, and medication coordination. Between March 2014 and January 2015, 388 participants enrolled in Check Hep C, 129 (33%) initiated treatment, and 119 (91% of initiators) had sustained virologic response (SVR). Participants receiving on-site clinical care had higher odds of initiating treatment than those linked to off-site care. Check Hep C successfully supported high-need participants through HCV care and treatment, and SVR rates demonstrate the real-world ability of achieving high cure rates using patient navigation care models.
Multidisciplinary managed care networks-Life-saving interventions for hepatitis C patients. [2018]Successful hepatitis C virus (HCV) therapy depends on effective pathways of care. Over two decades, we have developed four sequential models of care latterly using a multidisciplinary managed care network to improve HCV testing, care and treatment. This was a cohort study to evaluate the effectiveness of care pathways, carried out using all HCV antibody-positive individuals tested in a geographical region between 1994 and 2014. The study involved 3122 HCV-positive patients. They were divided into four subgroups representing different care pathways defined by their date of HCV antibody diagnosis. The number who accessed treatment services within 1 year of diagnosis increased from 77 of 292 (26.3%) to 521 of 821 (72.9%). The rate of treatment starts within 1 year of diagnosis increased from 6 of 292 (2.0%) to 133 of 821 (16.2%), and the sustained viral response rate improved from 61.6% to 77.4%. All-cause mortality decreased from 232 of 688 (33.7%) in subgroup A to 55 of 1207 (4.5%) in subgroup D, and multivariate analysis showed that pathway type was an independent predictor of mortality irrespective of age, sex, SVR status or HIV co-infection with pathway in D having an odds ratio of 0.53(0.40-0.77; P
The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients. [2020]To describe the process of translation, adaptation, and validation of the Brazilian Portuguese version of the Pediatric Trigger Toolkit: Measuring Adverse Drug Events in the Children's Hospital.
Care2Cure: A randomized controlled trial protocol for evaluating nurse case management to improve the hepatitis C care continuum within HIV primary care. [2020]Co-infection with HIV and hepatitis C virus (HCV) results in a threefold increase in relative risk of progression to end stage liver disease and cirrhosis compared to HCV alone. Although curative treatments exist, less than one quarter of people with HCV are linked to care, and even fewer have received treatment. The Care2Cure study is a single-blinded, randomized controlled trial to improve the HCV care continuum among people co-infected with HIV. This ongoing study was designed to test whether a nurse case management intervention can (i) improve linkage to HCV care and (ii) decrease time to HCV treatment initiation among 70 adults co-infected with HIV who are not engaged in HCV care. The intervention is informed by the Andersen Behavioral Model of Health Services Use and consists of nurse-initiated referral, strengths-based education, patient navigation, appointment reminders, and care coordination for drug-drug interactions in the setting of HIV primary care. Validated instruments are used to measure participant characteristics including HCV knowledge, substance use, and depression. The primary outcome is linkage to HCV care (yes/no) within 60 days. In this protocol paper, we describe the first clinical trial to examine the effects of a nurse case management intervention to improve the HCV care continuum among people co-infected with HIV/HCV in the era of all-oral HCV treatment. We describe our work in progress, challenges encountered, and strategies to engage this hard-to-reach population.
Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study. [2020]Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) - results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (
Disparities in Hepatitis C Linkage to Care in the Direct Acting Antiviral Era: Findings From a Referral Clinic With an Embedded Nurse Navigator Model. [2020]Background: Direct acting antivirals (DAAs) have simplified and expanded access to Hepatitis C virus (HCV) treatment. Only 17% of the 2.4 million Americans with HCV have linked to HCV care. We aimed to evaluate linkage to care (LTC) in a non-urban HCV referral clinic with a nurse navigator model and identify disparities in LTC. Methods: A single-center retrospective cohort analysis was performed among all patients referred to an infectious diseases HCV clinic between 2014 and 2018. The primary outcome was LTC, defined as attendance at a clinic appointment. A multivariable Poisson regression model estimated the association of variables with LTC. Results: Among 824 referred patients, 624 (76%) successfully linked to care and 369 (45%) successfully achieved sustained virologic response. Forty-six percent of those referred were uninsured. On multivariable analysis, LTC rates were higher among women (Incidence Rate Ratio [IRR] 1.11, 95% CI 1.03-1.20, p-value = 0.01) and people with cirrhosis (IRR 1.20, 95% CI 1.11-1.30, p-value < 0.001). Lower LTC rates were found for young people (<40 years; IRR 0.88, 95% CI 0.79-0.98, p-value = 0.02) and uninsured people (IRR 0.85, 95% CI 0.77-0.94, p-value = 0.002). Among those without LTC, 10% were incarcerated. Race, proximity to care, substance use, and HIV status were not associated with LTC. Conclusions: Using an embedded nurse navigator model, high LTC rates were achieved despite the prevalence of barriers, including a high uninsured rate. Disparities in LTC based on age, sex, and insurance status are present. Substance use was not associated with LTC. Future interventions to improve care should include expanded access to insurance and programs bridging care for incarcerated populations.
Frequency and Clinical Impact of Serious Adverse Events on Post-Stroke Recovery with NeuroAiD (MLC601) versus Placebo: The CHInese Medicine Neuroaid Efficacy on Stroke Recovery Study. [2020]Most comparative clinical trials are designed to assess the treatment effect for efficacy endpoints, with less emphasis on the analysis of safety outcomes. However, an extensive analysis of safety data could demonstrate beneficial results in terms of effectiveness by reducing serious adverse events (SAEs), and their unfavourable clinical impact on the study population. We aimed to conduct an exploratory analysis of the CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study safety database comparing the frequency of SAEs and their clinical impacts among subjects having received MLC601 or placebo during the first 3 months post-stroke.
Prospective adverse event risk evaluation in clinical trials. [2022]Proactive and objective regulatory risk management of ongoing clinical trials is limited, especially when it involves the safety of the trial. We seek to prospectively evaluate the risk of facing adverse outcomes from standardized and routinely collected protocol data. We conducted a retrospective cohort study of 2860 Phase 2 and Phase 3 trials that were started and completed between 1993 and 2017 and documented in ClinicalTrials.gov. Adverse outcomes considered in our work include Serious or Non-Serious as per the ClinicalTrials.gov definition. Random-forest-based prediction models were created to determine a trial's risk of adverse outcomes based on protocol data that is available before the start of a trial enrollment. A trial's risk is defined by dichotomic (classification) and continuous (log-odds) risk scores. The classification-based prediction models had an area under the curve (AUC) ranging from 0.865 to 0.971 and the continuous-score based models indicate a rank correlation of 0.6-0.66 (with p-values
Patient Navigation Increases Linkage to Care and Receipt of Direct-acting Antiviral Therapy in Patients with Hepatitis C. [2023]Patient navigation interventions can improve health outcomes in underserved, low-income, and racial and ethnic minority groups, who often experience health disparities. We examined the effectiveness of patient navigation to improve linkage to hepatitis C virus (HCV) treatment receipt in a socioeconomically disadvantaged, racially diverse patient population.
Using the Global Trigger Tool in surgical and neurosurgical patients: A feasibility study. [2023]The Global Trigger Tool (GTT) has become a worldwide used method for estimating adverse events through a retrospective patient record review. However, little is known about the facilitators and the challenges in the GTT-implementation process. Thus, this study followed two aims: First, to apply a comprehensive set of feasibility criteria to qualitatively and systematically assess the GTT-implementation process in three departments of German university hospitals. Second, to identify the facilitators and the obstacles met in the GTT-implementation process and to derive recommendations for supporting other hospitals in implementing the GTT in clinical practice.