An observational study in Hepatitis C and HIV, sponsored by Macfarlane Burnet Institute for Medical Research and Public Health Ltd. Completed at 6 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-28.
Sponsored by Macfarlane Burnet Institute for Medical Research and Public Health Ltd · Observational
This study will offer proof of concept that scaling up treatment for Hepatitis C virus (HCV) in individuals co-infected with HIV could lead to elimination of HCV/HIV co-infection in gay and bisexual men by treating prevalent infection, thereby reducing new primary infections and re-infection.
The co-EC study aims to to enhance HCV care and treatment among HIV-infected individuals through a predominantly nurse-led model of care in primary care as well as hospital settings. It involves:
The study is based in Victoria, Australia where the highest prevalence of HIV/HCV co-infection is in gay and bisexual men (GBM). HCV infection is a significant health issue among individuals with HIV infection and has been associated with more rapid progression to HCV-related liver disease and increased risk for cirrhosis and liver cancer. Hepatitis C is a major cause of hospital admissions and is a leading cause of death among HIV-infected persons.
The advent of directly acting antiviral (DAA) treatment provides us with a unique opportunity to increase the number of people accessing hepatitis C treatment. Importantly it is likely that the treatment could be administered in the primary health care setting improving treatment capacity and accessibility, whilst potentially reducing treatment costs.
The primary objectives of co-EC Study are:
The study design involves an open label, non-randomised clinical trial of hepatitis C treatment for people with HIV coinfection. Treatment will involve any combination of hepatitis C antiviral therapy approved for use in Australia appropriate for the participants' hepatitis C genotype and selected at the decision of their treating clinicians.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 200 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Macfarlane Burnet Institute for Medical Research and Public Health Ltd is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Any HCV/HIV co-infected individuals attending any of the six clinical sites involved in this study will be eligible to participate. While the study's objective are to focus on HCV among HIV infected gay and bisexual men, females and men not identifying as gay or bisexual will also be able to participate and receive HCV treatment.
Subjects must meet routine clinical care criteria for commencing HCV treatment, in accordance with Australian licensing, prescribing restrictions, manufacturers' recommendations and best- practice clinical care.
Exclusion Criteria:
Treatment uptake
The number of individuals receiving at least one dose of HCV treatment among all HCV/HIV coinfection individuals in care (seen within the previous 12 months) at that health service.
Time frame: 18 months
Sustained virological response after treatment (SVR12)
Determined using any licensed qualitative HCV RNA test among all those receiving at least one dose of HCV treatment.
Time frame: Change in sustained viral response rates post-treatment (SVR12).
HCV prevalence
The proportion HCV RNA positive of all HIV infected individuals in care (seen within the previous 12 months) at that health service. Statewide HCV prevalence will be determined as a proportion of all HIV infected individuals in care (determined by at least one HIV RNA within the previous 12 months).
Time frame: 12 months
HCV incidence
The number of newly detected HCV RNA cases occurring among all HIV infected individuals during the time in care (determined by clinical visit or HIV RNA test within the previous 12 months).
Time frame: 12 months
Change in HCV testing among HIV-infected gay and bisexual men
Hypothesized that primary care and clinic-based nurses will increase the proportion of people in care receiving HCV testing annually and repeat testing at intervals recommended by national guidelines.
Time frame: 18 months
Change in number of HIV/HCV infected gay and bisexual men who have a complete management plan including HCV RNA status, FibroScan and liver function tests.
Number of HCV/HIV reinfections in gay and bisexual men management plan will be increased.
Time frame: 18 months
Medical adherence
Primar care and clinic based nurses will increase medical adherence.
Time frame: Up to 24 weeks, documented at each study visit
Plan to share: Undecided
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Macfarlane Burnet Institute for Medical Research and Public Health Ltd