Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals (co-EC)
|ClinicalTrials.gov Identifier: NCT02786758|
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : February 28, 2020
|Condition or disease|
|Hepatitis C HIV|
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:
- A nurse-led model of care in primary health care to increase access to PBS HCV treatment with interferon-free HCV antiviral treatment; and
- An integrated HCV/HIV surveillance system and database to deliver and monitor the impact of the program at the local and statewide level.
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:
- Achieve HCV sustained virological response (SVR12) to treatment among HIV co-infected participants in a real-world primary care or hospital clinic setting; and
- Measure the impact of treating HCV in HIV infected individuals on primary HCV and reinfection incidence and HCV prevalence in gay and bisexual men in Victoria.
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.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals: The Co-EC Study|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||July 2019|
|Actual Study Completion Date :||August 2019|
- Treatment uptake [ Time Frame: 18 months ]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.
- Sustained virological response after treatment (SVR12) [ Time Frame: Change in sustained viral response rates post-treatment (SVR12). ]Determined using any licensed qualitative HCV RNA test among all those receiving at least one dose of HCV treatment.
- HCV prevalence [ Time Frame: 12 months ]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).
- HCV incidence [ Time Frame: 12 months ]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).
- Change in HCV testing among HIV-infected gay and bisexual men [ Time Frame: 18 months ]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.
- 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. [ Time Frame: 18 months ]Number of HCV/HIV reinfections in gay and bisexual men management plan will be increased.
- Medical adherence [ Time Frame: Up to 24 weeks, documented at each study visit ]Primar care and clinic based nurses will increase medical adherence.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786758
|Melbourne Sexual Health Centre|
|Carlton, Victoria, Australia, 3053|
|Alfred Health, The Alfred Hospital|
|Melbourne, Victoria, Australia, 3004|
|North Fitzroy, Victoria, Australia, 3068|
|Melbourne Health, Royal Melbourne Hospital|
|Parkville, Victoria, Australia, 3052|
|Prahran Market Clinic|
|Prahran, Victoria, Australia, 3181|
|St Kilda, Victoria, Australia, 3182|
|Principal Investigator:||Margaret Hellard||Burnet Institute|
|Principal Investigator:||Joseph Doyle||The Alfred|