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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02786758
Registration number
NCT02786758
Ethics application status
Date submitted
3/05/2016
Date registered
1/06/2016
Date last updated
28/02/2020
Titles & IDs
Public title
Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals
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Scientific title
Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals: The Co-EC Study
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Secondary ID [1]
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burnet_coec_2016
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Universal Trial Number (UTN)
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Trial acronym
co-EC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
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HIV
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment uptake
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Assessment method [1]
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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.
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Timepoint [1]
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18 months
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Primary outcome [2]
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Sustained virological response after treatment (SVR12)
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Assessment method [2]
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Determined using any licensed qualitative HCV RNA test among all those receiving at least one dose of HCV treatment.
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Timepoint [2]
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Change in sustained viral response rates post-treatment (SVR12).
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Primary outcome [3]
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HCV prevalence
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Assessment method [3]
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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).
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Timepoint [3]
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12 months
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Primary outcome [4]
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HCV incidence
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Assessment method [4]
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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).
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Timepoint [4]
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12 months
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Secondary outcome [1]
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Change in HCV testing among HIV-infected gay and bisexual men
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Assessment method [1]
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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.
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Timepoint [1]
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18 months
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Secondary outcome [2]
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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.
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Assessment method [2]
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Number of HCV/HIV reinfections in gay and bisexual men management plan will be increased.
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Timepoint [2]
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18 months
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Secondary outcome [3]
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Medical adherence
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Assessment method [3]
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Primar care and clinic based nurses will increase medical adherence.
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Timepoint [3]
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Up to 24 weeks, documented at each study visit
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Eligibility
Key inclusion criteria
1. Aged =18 years;
2. Attendance for medical care of HIV at any study site;
3. Evidence of chronic HCV infection (HCV antibody or RNA positive for =6 months and HCV
RNA positive);
4. HIV infected;
5. 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Pregnancy or breastfeeding at time of HCV antiviral treatment;
2. 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2019
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Sample size
Target
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Accrual to date
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Final
200
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Melbourne Sexual Health Centre - Carlton
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Recruitment hospital [2]
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Alfred Health, The Alfred Hospital - Melbourne
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Recruitment hospital [3]
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Northside Clinic - North Fitzroy
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Recruitment hospital [4]
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Melbourne Health, Royal Melbourne Hospital - Parkville
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Recruitment hospital [5]
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Prahran Market Clinic - Prahran
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Recruitment hospital [6]
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Centre Clinic - St Kilda
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Recruitment postcode(s) [1]
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3053 - Carlton
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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3068 - North Fitzroy
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Recruitment postcode(s) [4]
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3052 - Parkville
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Recruitment postcode(s) [5]
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3181 - Prahran
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Recruitment postcode(s) [6]
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3182 - St Kilda
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Funding & Sponsors
Primary sponsor type
Other
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Name
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Alfred
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02786758
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Margaret Hellard
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Address
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Burnet Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02786758
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