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Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior (ANCHOR)

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ClinicalTrials.gov Identifier: NCT03221309
Recruitment Status : Enrolling by invitation
First Posted : July 18, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Elena Rosenthal, University of Maryland, College Park

Brief Summary:
This is an open label, non-randomized, observational pilot study to evaluate a model of care for treatment of hepatitis C in people with ongoing injection drug use. Participants will be treated with direct-acting antivirals (DAA) as per standard of care and will concomittantly be offered pre-exposure prophylaxis for HIV prevention and buprenorphine for treatment of opioid use disorder when clinically indicated.

Condition or disease Intervention/treatment
HCV Burpenorphine PreP Other: Evaluate model of care for HCV-infected adults with on-going injection drug use

Detailed Description:

Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The development of directly acting antivirals (DAA) has dramatically improved the cure rate of HCV treatment. However, despite the availability of effective therapy, the global epidemic of HCV infection continues to be driven by people with ongoing injection drug use (PWID), who are largely excluded from HCV therapy. Several critical barriers exist preventing high-risk patients' entry to care, including (1) lack of engagement in the traditional healthcare system by marginalized patient populations, and (2) insurance restrictions due to concerns regarding treatment adherence and HCV reinfection. Furthermore, ongoing injection drug use places these individuals at high risk of HIV acquisition. However, studies have repeatedly demonstrated that pre-exposure prophylaxis (PrEP) reduces HIV acquisition and opioid substitution therapy with buprenorphine reduces HIV and HCV acquisition in PWID.

As such, we propose a comprehensive model of care to engage individuals with ongoing injection drug use in treatment of HCV, in conjunction with collocated services to prevent HIV acquisition and HCV reinfection, including pre-exposure prophylaxis and opioid substitution therapy. This pilot trial will demonstrate whether a comprehensive model of care can simultaneously treat HCV, and prevent HCV reinfection, HIV acquisition and effectively treat opioid use disorder.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Model of Hepatitis C Treatment as Anchor to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Adults infected with HCV
HCV-infected adults with on-going injection drug use with opioids
Other: Evaluate model of care for HCV-infected adults with on-going injection drug use
Participants will be treated with direct-acting antivirals per standard of care and will be concomittantly be offered PreP for HIV prevention and buprenorphine for treatment of opioid-use disorder when clinically indicated




Primary Outcome Measures :
  1. SVR12 [ Time Frame: 24 weeks ]
    Rate of SVR12 in study group


Secondary Outcome Measures :
  1. Uptake of Prep [ Time Frame: 24 weeks ]
    Number of participants who update PreP

  2. Adherence of Prep [ Time Frame: 52 weeks ]
    Number of participants who adhere to PrEP

  3. Uptake of buprenorphine [ Time Frame: 24 weeks ]
    Number of participants who update buprenorphine when clinical indicated

  4. Retention in buprenorphine program [ Time Frame: 52 weeks ]
    Number of participants who remain buprenorphine program


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults infected with HCV and have on-going injection drug use with opioids
Criteria

Inclusion Criteria:

  1. Age 18 years old
  2. Able and willing to sign informed consent
  3. Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).
  4. Willing to have samples stored for future use
  5. Ongoing injection drug use, defined as self-report of injection non-prescription drug use within three months of screening visit

Exclusion Criteria:

  1. Decompensated liver disease (Childs Pugh B or C)
  2. Unable to comply with research study visits
  3. Poor venous access not allowing screening laboratory collection
  4. Have any condition that the investigator considers a contraindication to study participation
  5. Pregnant or breastfeeding woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221309


Locations
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United States, District of Columbia
HIPS
Washington, District of Columbia, United States, 20002
United States, Maryland
University of Maryland Drug Treatment Center
Baltimore, Maryland, United States, 21223
Sponsors and Collaborators
University of Maryland, College Park
Investigators
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Principal Investigator: Elana Rosenthal, MD University of Maryland, College Park

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Responsible Party: Elena Rosenthal, Principal Investigator, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT03221309     History of Changes
Other Study ID Numbers: HP-00071577
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents