Clinical Research Directory

The Australian HCV Point-of-Care Testing Program

The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). Participants will attend a single visit to have their HCV RNA status tested and complete a self-administered survey. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.

Evaluation of Patients With Liver Disease

The proposed study aims to evaluate, investigate, and follow-up patients suffering from acute and chronic liver disease. The study will focus on understanding diseases affecting the liver. Patients participating in the study will first undergo a routine check-up as an outpatient. They will be asked to provide blood and urine samples for laboratory testing and will undergo an ultrasound of the liver. Ultrasound examinations use sound waves to determine the size and texture of the liver. After the initial visit subjects will be requested to follow-up once a year at the outpatient department for a similar check-up. Additional tests may be requested throughout the study to provide information for other research studies and individual consent will be requested. These tests may include liver biopsies, skin biopsies, and / or specialized blood, plasma, and lymphocyte examinations. Subjects that qualify for medications presently being studied may be offered the opportunity to benefit from experimental therapy.

The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing

The purpose of this study is to collect DNA samples from patients undergoing routine care at the University of Chicago. These samples will be tested for differences in genes that may suggest greater risk of side effects or chance of increased benefit from certain medications. The results will be made available to the patient's treating physician and the researchers will track whether or not this information is used in routine health care.

Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants

The overarching goal of this study is to develop a peer-based care coordination intervention for individuals with Hepatitis C Virus (HCV) who were recently released from correctional settings to promote linkage to and retention in HCV care. The investigators will assess the existing barriers and facilitators of HCV treatment initiation, HCV treatment completion, and sustained virologic response among individuals recently released from a U.S. jail or prisons in a randomized control trial. This study will assess the feasibility and process measures of a peer-enhanced HCV care coordination intervention among recently incarcerated individuals.

Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot

The aim of the study is to screen for hepatitis B, hepatitis C and AIDS viruses using a Dried Blood Spot in drug users

A Phase 1 Clinical Trial of Adjuvanted Protein-based HCV Vaccine Candidates (HCV Vaccine Trial)

The purpose of this study is to investigate the safety and antibody (germ fighters) response of the experimental (investigational) vaccine against HCV when injected into the arm of healthy adults.

Tele-Harm Reduction

The purpose of this study is to test 2 different methods for offering medications that treat HIV, cure Hepatitis C Virus (HCV) (if applicable) and treat substance use disorder (if desired) to people who inject drugs.

Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV

This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection (acute or chronic) with or without HIV and to evaluate safety for their infants through 10 weeks postpartum.

The Hepatitis C Transplant Collaborative

In this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing HCV NAT+ donor organs as currently performed are acceptable.

C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV

The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.

Feasibility and Acceptability of HCV Treatment in Pregnancy

Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug use Participant Duration: Approximately 1 year. Aims: Aim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs. Aim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy.

Use of a Patient-Centered Electronic App to Increase ED Patient's Knowledge on HCV to Improve the HCV Care Continuum

The investigators will conduct a randomized controlled clinical trial study in an urban emergency department in Baltimore to determine the impact of an educational app which is based on Leventhal's Common-Sense Model of Illness Representations framework, on HCV-infected ED patient's hepatitis C virus (HCV) health belief and knowledge as well as the downstream outcomes of the HCV Continuum of Care (linkage to care rate, initiation of HCV antiviral treatment, and sustained virologic response). First, the investigators will develop a blueprinted prototype personalized HCV educational app which will (1) provide individualized liver fibrosis staging information, (2) pre-test HCV knowledge, perception of barriers to HCV care, and motivation to receive HCV care survey, (3) provide personalized HCV knowledge, facilitators and supporting information for HCV care via video clips and information sheets based on the pre-test results, and (4) provide post-test knowledge, perception, and motivation to receive HCV care. Second, the investigators will conduct a series of focus group discussion sessions to fine-tune the HCV educational app. Third, the investigators will enroll ED patients who have anti-HCV (newly diagnosed or previously diagnosed) but without HCV RNA testing information for a pilot randomized controlled clinical trial of the personalized HCV educational app.

A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients

This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.

Expanding the Pool in Orthotopic Heart Transplantation

This is an open-label, pilot trial to test the safety and efficacy of transplantation of hearts from HCV seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the heart transplant waitlist. Treatment and prophylaxis will be administered, using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

Therapy for Hepatitis C Virus (HCV) in Primary Treatment Failure in Pakistan

This trial is linked to a largescale observational study determining the efficacy of sofosbuvir/daclatasvir in people in Pakistan (involving a separate protocol). The observational study will identify a cohort of patients who have not responded to first-line antiviral therapy (sofosbuvir plus daclatasvir) and the optimal treatment for these patients is unclear. This trial will address this issue by comparing two second-line treatment regimens to determine the preferred treatment option.

ED Patient's Perceptions and Acceptability Toward a Novel POC HCV Viral Load Testing

Hepatitis C virus (HCV) infection has become the leading fatal infectious disease in the United States. Approximately 75% of individuals who have been infected with HCV are chronically infected with the virus. Untreated chronic infection will lead to severe sequelae such as cirrhosis and hepatocellular carcinoma. Even though the availability of rapid HCV antibody (HCV Ab) screening assay and highly effective antiviral treatment, most people infected with HCV are not aware of the infection status. This gap mainly comes from the current gold standard confirmatory testing for chronic HCV infection, the Polymerase Chain Reaction (PCR)-based HCV RNA viral load assay which requires an experienced trained laboratory technician to perform relatively complicated PCR assay with a turn-around-time of 1 to 2 days (from provider's order to the test resulting). The investigators' rapid HCV Screening and Linkage to Care program has demonstrated that many patients in the investigators' emergency department (ED) are unaware of patient's chronic HCV infection status due to the barriers to receive the gold standard viral load testing. Recently, a novel Xpert HCV Viral Load (VL) Finger-stick (FS) \[Xpert HCV VL FS\] point-of-care (POC) test (Cepheid) has been developed. In an observational cohort in Australia, HCV RNA was detected in 40% of participants (85 of 210) enrolled at 3 drug treatment clinics and 1 homelessness service. Sensitivity of the Xpert HCV VL FS assay for HCV RNA quantification in samples collected by finger-stick was 100.0% (95% Confidence Interval (CI), 93.9%-100.0%) and specificity was 100.0% (95% CI, 96.6%-100.0%). The Xpert HCV VL FS test can accurately detect active infection from a finger-stick sample in 1 hour allowing single-visit HCV diagnosis. In this protocol, the investigators seek to determine the needs and acceptability of a novel POC HCV viral load testing assay among ED HCV Ab positive patients. For this project, the investigators will identify and enroll ED patients with HCV Ab positive but without HCV viral information. The investigators will conduct a randomized study to assign eligible and consented patients to either to POC Testing Group or Standard of Care (SOC) Group. All participants will take a short survey regarding HCV care and treatment. As part of the investigators' ED HCV Screening and Linkage to Care Program, all participants will receive the standard-of-care clinical laboratory-based HCV RNA viral load testing via whole blood (i.e. patient will receive blood drawn). This standard-of-care HCV viral load testing result will be provided to participant when it is available (usually 1-2 days later). Participants in the POC Testing Group will receive the novel POC HCV RNA viral load testing and the result of the novel test will be disclosed to the patients approximately within 2 hours of the testing. Linkage to care information after the ED visit will be compared between two groups. Finally, accuracy of this POC HCV RNA viral load testing in the acute care setting will be determined as compared to the standard-of-care clinical laboratory-based HCV RNA viral load testing. The investigators will also ask all of participants to grant permission to use the remnant blood specimens for an evaluation of future in-house HCV RNA viral load assay.

The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients

This is an open-label, pilot trial to test the safety and efficacy of transplantation of kidneys from hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the kidney transplant waitlist. Treatment and prophylaxis will be administered using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

Liver Disease and Other Systemic Diseases

Examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis, and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation.

Blood Collection Biorepository for Liver Disease Research

The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

This study will test two active evidence-based "practice coaching" (PC) interventions to improve opioid treatment programs' (OTPs') provision and sustained implementation of on-site 1) HIV testing and linkage to care and 2) HIV/Hepatitis C virus (HCV) testing and linkage to care among patients seeking/receiving substance use disorder treatment. Aims are: Aim 1: To evaluate the effectiveness of the PC interventions on improving patient uptake of HIV testing in OTPs including the incremental impact of the HIV/HCV intervention on HIV testing. Aim 2: To examine, using mixed-methods, the impact of the PC interventions on the initiation and sustained provision of HIV testing and timely linkage to care. Aim 3: To evaluate the health outcomes, health care utilization, and cost-effectiveness of the PC interventions compared incrementally to one another and to the control condition. Primary Hypothesis: 1. The two PC interventions will result in significantly higher proportions of patients tested for HIV than the information control condition during the "initial impact" period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Primary) and during the "sustained impact" period, 13-18 months post-randomization or T4 (Secondary). 2. The HIV/HCV PC intervention will result in significantly higher proportions of patients tested for HIV than the HIV PC intervention during the initial impact period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Secondary) and during the "sustained impact" period, 13-18 months post-randomization or T4 (Secondary).

Pan-Viral Screening and Linkage to Care Among GBMSM and Trans Women in Spain

The World Health Organization (WHO) aims to eliminate viral hepatitis as a public health threat by 2030, with major reductions in hepatitis B and C incidence and mortality. However, hepatitis C virus (HCV) transmission has increased among gay, bisexual, and other men who have sex with men (GBMSM), especially those living with HIV. Practices such as chemsex, particularly involving injection drug use, have contributed to this rise. Hepatitis B virus (HBV) also remains a public health challenge due to the potential for chronic infection and severe liver damage. Hepatitis D virus (HDV), which requires HBV co-infection, further complicates clinical management. This study aims to design, implement, and evaluate an online self-sampling testing strategy to enhance pan-viral testing (HBV, HCV, HDV, HIV) and improve linkage to care among GBMSM and transgender women (TW) in Spain. The intervention will involve self-collected dried blood spot (DBS) samples for testing HBV surface antigen (HBsAg), HIV antibodies, and HCV RNA. Individuals testing positive for HBsAg will undergo further testing for HBV DNA and HDV infection. Those lacking protective levels of HBV antibodies will be referred for vaccination or revaccination. The study will also assess the number of HIV-positive individuals who acquired the infection while waiting for access to PrEP, identifying missed prevention opportunities. This non-randomized, single-arm, prospective national study will recruit adult GBMSM and TW through PrEP services, dating apps, NGOs, social media, and community outreach. Participants will complete an online risk assessment (using the HCV-MOSAIC algorithm) and receive self-sampling kits with instructions, lancets, Whatman cards, and prepaid envelopes. Results will be provided online, and those testing positive will be linked to confirmatory diagnosis and care. Outcomes include estimates of HIV, HBV, HCV, and HDV prevalence; effectiveness of linkage to care; acceptability and usability of the intervention; and validation of DBS for HBsAg detection. This study will provide critical evidence on the effectiveness of online self-sampling strategies for viral hepatitis and HIV among GBMSM and TW, supporting Spain's public health goals for prevention, early diagnosis, and linkage to care.

Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania

The goal of this non-randomised, quasi-experimental, prospective comparative trial is to trial simplified care pathways for hepatitis C testing and treatment for people who inject drugs in Armenia, Georgia, and Tanzania. The main questions it aims to answer are: 1. What is the feasibility of implementing a hepatitis C simplified care and same-day treatment care model in community and harm reduction settings in the three study countries? 2. Does a same-day treatment initiation model involving only POC antibody tests (with a shortened read-time) increase hepatitis C treatment uptake and SVR12 outcome (cure) among people who inject drugs compared with a simplified care model involving POC antibody followed by a confirmatory RNA test? 3. What is the comparative cost-effectiveness between a same-day antibody only hepatitis C testing and treatment model and the simplified care model (POC antibody/confirmatory RNA test) model? Participants will: * be enrolled in a new simplified model of care in each country (Arm 1). After the enrolment target is met for Arm 1 (approx. 3-9 months into implementation) new participants will be enrolled into a same-day treatment trial, using presumptive treatment after a reactive POC test result at shortened read-time (5minutes) (Arm 2) * if in Arm 1, participants will commence SOF-VEL DAA treatment after receiving an RNA test to confirm current hepatitis C infection. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure. * if in Arm 2, participants will begin SOF-VEL DAA treatment on the same day as the 5 minute RDT testing. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure. Researchers will compare cure and participant retention rates between the two groups.

Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs

This project aims to evaluate two strategies of Hepatitis C virus (HCV) testing compared to standard of care among people who inject drugs at needle and syringe program (NSP) services in Australia, to see if it can improve the number of people who start treatment following an HCV diagnosis: 1. HCV testing from collected dried blood spots sent to a central laboratory 2. HCV testing using a point-of-care device at the NSP site 3. HCV testing using standard of care at the NSP site

The HOPE Study: Characterizing Patients With Hepatitis B and C

This is an observational, longitudinal, prospective study for sample collection and evaluation for future therapy or disease progression of chronic hepatitis B and C. Participants will be seen on an annual basis with optional additional visits for up to 10 years and provide samples for research and evaluation of disease progression. In addition, there is a longitudinal sub-study for treatment of hepatitis B that will involve 2 years of treatment with tenofovir alafenamide and blood collections with optional liver biopsies.