Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03221309
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-10-07
First Post:
2017-07-13
Brief Title:
Hepatitis C Treatment to Prevent HIV Initiate Opioid Substitution Therapy and Reduce Risky Behavior
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Novel Model of Hepatitis C Treatment as Anchor to Prevent HIV Initiate Opioid Substitution Therapy and Reduce Risky Behavior
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANCHOR
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None