Hepatitis Cco-ECNCT02786758

Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals

An observational study of Hepatitis C and HIV, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 6 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, HIV
How many people: 200 participants
Where: 6 sitesAustralia
Study dates: Apr 2016to Aug 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

Aged ≥18 years;
Attendance for medical care of HIV at any study site;
Evidence of chronic HCV infection (HCV antibody or RNA positive for ≥6 months and HCV RNA positive);
HIV infected;
Willing and able to provide written informed consent;
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.

Who cannot join

Pregnancy or breastfeeding at time of HCV antiviral treatment;
Evidence of any condition, therapy, laboratory abnormality or other circumstance (current or prior) that may confound the study's results, or interfere with participation for the full duration of the study, such that it is not in the best interest of the participant

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Australia6 sites

Melbourne Sexual Health Centre
Carlton, Victoria, 3053
Northside Clinic
Fitzroy North, Victoria, 3068
Alfred Health, The Alfred Hospital
Melbourne, Victoria, 3004
Melbourne Health, Royal Melbourne Hospital
Parkville, Victoria, 3052
Prahran Market Clinic
Prahran, Victoria, 3181
Centre Clinic
St Kilda, Victoria, 3182

Other trials in Australia

About this study

Official title: Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals: The Co-EC Study

Read the detailed description

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.

Conditions: Hepatitis C, HIV
Medical subject headings: Hepatitis C

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 12 months

Secondary outcomes (3)

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.
Measured: 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.
Measured: 18 months
Medical adherence
Primar care and clinic based nurses will increase medical adherence.
Measured: Up to 24 weeks, documented at each study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Aug 2019

First posted1 Jun 2016 (estimated)
Study startApr 2016
Primary completionJul 2019
Study completionAug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02786758
Sponsor's protocol ID: burnet_coec_2016
Acronym: co-EC
Status last verified: Feb 2020
First submitted: 3 May 2016
Last updated: 28 Feb 2020
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Doyle JS, van Santen DK, Iser D, Sasadeusz J, O'Reilly M, Harney B, Traeger MW, Roney J, Cutts JC, Bowring AL, Winter R, Medland N, Fairley CK, Moore R, Tee BK, Asselin J, El-Hayek C, Hoy JF, Matthews GV, Prins M, Stoove MA, Hellard ME. Microelimination of Hepatitis C Among People With Human Immunodeficiency Virus Coinfection: Declining Incidence and Prevalence Accompanying a Multicenter Treatment Scale-up Trial. Clin Infect Dis. 2021 Oct 5;73(7):e2164-e2172. doi: 10.1093/cid/ciaa1500.
PubMed 33010149

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals: The Co-EC Study
ClinicalTrials.gov ID: NCT02786758
Acronym / sponsor ID: co-EC / burnet_coec_2016
Conditions: Hepatitis C, HIV
Study type: Observational
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Macfarlane Burnet Institute for Medical Research and Public Health LtdUniversity, hospital or other
Collaborators: The Alfred
Study start: Apr 2016 (actual)
Primary completion: Jul 2019 (actual)
Study completion: Aug 2019 (actual)
First posted: 1 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 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.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (6 listed)

Aged ≥18 years;
Attendance for medical care of HIV at any study site;
Evidence of chronic HCV infection (HCV antibody or RNA positive for ≥6 months and HCV RNA positive);
HIV infected;
Willing and able to provide written informed consent;

Key exclusion criteria (2 listed)

Pregnancy or breastfeeding at time of HCV antiviral treatment;
Evidence of any condition, therapy, laboratory abnormality or other circumstance (current or prior) that may confound the study's results, or interfere with participation for the full duration of the study, such that it is not in the best interest of the participant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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).

3 secondary outcomes

Change in HCV testing among HIV-infected gay and bisexual men
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.
Time frame: 18 months
Medical adherence
Time frame: Up to 24 weeks, documented at each study visit

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
Derived from this study: PubMed 33010149Doyle JS, van Santen DK, Iser D, Sasadeusz J, O'Reilly M, Harney B, Traeger MW, Roney J, Cutts JC, Bowring AL, Winter R, Medland N, Fairley CK, Moore R, Tee BK, Asselin J, El-Hayek C, Hoy JF, Matthews GV, Prins M, Stoove MA, Hellard ME. Microelimination of Hepatitis C Among People With Human Immunodeficiency Virus Coinfection: Declining Incidence and Prevalence Accompanying a Multicenter Treatment Scale-up Trial. Clin Infect Dis. 2021 Oct 5;73(7):e2164-e2172. doi: 10.1093/cid/ciaa1500.
Individual participant dataSharing planned: Undecided

Related trials for Hepatitis C

RecruitingObservational study
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Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Margaret Hellard principal investigator

Burnet Institute

Joseph Doyle principal investigator

The Alfred

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C and HIV, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 6 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment uptake (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02786758, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.