국립 호주 HCV 현장 진료 검사 프로그램 - 최소 데이터 세트
국립 호주 HCV 현장 진료 검사 프로그램: HCV 감염의 진단 및 치료를 강화하기 위한 핑거스틱 현장 진료 C형 간염 검사의 사용을 평가하기 위한 관찰 코호트 연구 - 최소 데이터 세트
The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). All participants who undergo HCV point-of-care testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.
연구 개요
상세 설명
The advent of simple direct-acting antiviral hepatitis C (HCV) therapies with cure rates >95% is one of the greatest medical advances in decades, having led to a reversal in liver-related mortality. In Australia, treatment uptake has declined between 2016 (32,000 treated) and 2019/20 (2019: 11,500; 2020: 8,500).1 Progress towards HCV elimination has been impeded by COVID-19, affecting the delivery of national and state-based HCV strategies. Improving HCV treatment uptake to reduce disease burden is a key aim of global, national and state-based HCV strategies.2-4
Scale-up of HCV testing and treatment will be required to achieve elimination by 2030. Current diagnostic pathways require multiple visits to a practitioner reducing the proportion who receive a diagnosis. In Australia, 81% of people have had HCV antibody testing (indicates exposure), but only 47% have been HCV RNA tested (indicates active infection and the need for HCV treatment).5 Mathematical modelling suggests that HCV RNA testing needs to increase by at least 50% annually to achieve elimination in Australia by 2030.6
The Kirby Institute is an international leader in research evaluating the Xpert HCV assay (Grebely Lancet Gastro Hep 2017), having built a large network of Xpert platforms for HCV testing in needle and syringe programs, prisons, drug treatment clinics, tertiary hospitals, and Aboriginal Community Controlled Health Service. In Kirby-led research, point-of-care HCV testing interventions in needle and syringe programs and prisons have resulted in high HCV treatment uptake (70-90%). The Kirby Institute and Flinders University also have a strong track record of implementing point-of-care testing for STIs and COVID-19, providing an ideal foundation to scale-up Xpert HCV testing in Australia.
The Kirby Institute and Flinders University will establish the Australian National HCV Point-of-care Testing Program for the scale-up of point-of-care HCV RNA testing in services with high prevalence of HCV infection, including community health centres, drug treatment clinics, needle and syringe programs, and prisons. This program will include the development of standard operating procedures, logistics/deployment, initial set-up, an operator training program, and quality assurance and competency assessment program.
An observational cohort study will be established to evaluate HCV treatment uptake following scale-up of point-of-care HCV testing among people with a risk factor for acquisition of HCV infection or people attending a service caring for people with risk factors for the acquisition of HCV infection.
Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. All participants who undergo point-of-care HCV testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care for any other clinical assessments and treatment initiation.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Simon Comben, BSc, MN
- 전화번호: +6193480777
- 이메일: scomben@kirby.unsw.edu.au
연구 연락처 백업
- 이름: David Silk, BSc
- 전화번호: +61293850900
- 이메일: dsilk@kirby.unsw.edu.au
연구 장소
-
-
New South Wales
-
Sydney, New South Wales, 호주
- 모집하지 않고 적극적으로
- Justice Health and Forensic Mental Health Network
-
-
Queensland
-
Aldershot, Queensland, 호주, 4650
- 모병
- Maryborough Correctional Centre
-
연락하다:
- Ashley Willman
- 전화번호: (07) 4123 7600
- 이메일: ashley.willmann@health.qld.gov.au
-
Brisbane, Queensland, 호주, 4000
- 모병
- QuIHN
-
연락하다:
- Nicholas Alexander
- 전화번호: 3620 8111
- 이메일: nalexander@quihn.org
-
Cairns, Queensland, 호주
- 모병
- Lotus Glen Correctional Centre
-
연락하다:
- Darren Russell
-
수석 연구원:
- Darren Russell
-
Coorparoo, Queensland, 호주, 4151
- 완전한
- Hepatitis Queensland
-
Ipswich, Queensland, 호주
- 모병
- West Moreton Hospital and Health Service
-
연락하다:
- Blake Ponting
-
수석 연구원:
- Blake Ponting
-
Rathdowney, Queensland, 호주, 4287
- 아직 모집하지 않음
- Palen Creek Correctional Centre
-
연락하다:
- Mike Hurley
- 전화번호: (07) 5544 3700
- 이메일: mike.hurley@corrections.qld.gov.au
-
Townsville, Queensland, 호주
- 모병
- Townsville Correctional Centre
-
연락하다:
- John Morey
-
수석 연구원:
- John Morey
-
Woodford, Queensland, 호주
- 모병
- Woodford Correctional Centre
-
연락하다:
- Rajendra Prakash
-
수석 연구원:
- Rajendra Prakash
-
-
South Australia
-
Hackney, South Australia, 호주, 5069
- 모병
- Hepatitis SA
-
연락하다:
- Lisa Carter
- 전화번호: (08) 8362 8443
- 이메일: lisa@hepatitissa.asn.au
-
Marden, South Australia, 호주, 5070
- 아직 모집하지 않음
- South Australian Prison Health Service
-
연락하다:
- Tom Turnbull
-
수석 연구원:
- Tom Turnbull
-
Mount Gambier, South Australia, 호주, 5290
- 모병
- Mount Gambier Priosn
-
연락하다:
- William Galloway
-
수석 연구원:
- William Galloway
-
-
Victoria
-
Fitzroy, Victoria, 호주, 3065
- 모집하지 않고 적극적으로
- St Vincent's Correctional Health Services
-
Melbourne, Victoria, 호주, 3000
- 모병
- Medically Supervised Injecting Room
-
연락하다:
- Nathan Stam
-
수석 연구원:
- Nathan Stam
-
Ravenhall, Victoria, 호주, 3023
- 모병
- Dame Phyllis Frost Centre
-
연락하다:
- Katelyn Mannix
- 전화번호: 1300 492 202
- 이메일: katelyn.mannix@wh.org.au
-
Ravenhall, Victoria, 호주, 3023
- 모병
- Geo Healthcare - The Geo Group Australia Pty Ltd
-
연락하다:
- David Grace
-
수석 연구원:
- David Grace
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection, including drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, homelessness services, and other appropriate settings nationally. It is anticipated approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.
설명
Inclusion Criteria:
- ≥ 18 years of age.
- Received point-of-care HCV testing.
Exclusion Criteria:
- Nil
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
People at risk of HCV acquisition
Clinic staff will offer HCV point-of-care testing to participants as they access services. Testing will be performed using point-of-care HCV RNA testing. |
Participants will be offered finger-stick point-of-care testing for HCV |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The proportion of HCV infected participants who initiate HCV treatment at 12 weeks
기간: 12 Weeks from enrolment
|
To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing. |
12 Weeks from enrolment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The proportion of participants who accept point-of-care testing
기간: 2 years from recruitment commencement
|
To evaluate the proportion of people who accept point-of-care testing among those offered testing. |
2 years from recruitment commencement
|
|
The prevalence of HCV infection amongst study participants tested
기간: 2 years from recruitment commencement
|
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested. |
2 years from recruitment commencement
|
|
To evaluate the time to HCV treatment uptake among HCV RNA positive participants
기간: 52 weeks
|
To evaluate the length of time participants take to initiate HCV treatment after diagnosis |
52 weeks
|
|
To evaluate proportion of HCV RNA positive participants who initiate HCV treatment
기간: 52 weeks
|
To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing. |
52 weeks
|
|
To evaluate the proportion of participants who complete HCV (DAA) treatment
기간: 52 weeks
|
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment. |
52 weeks
|
|
To evaluate the proportion of participants who achieve an SVR
기간: 12 weeks
|
To evaluate the proportion of participants who achieve an SVR (defined as HCV RNA below the lower limit of quantitation at post treatment week 12). |
12 weeks
|
|
To evaluate the proportion of participants who are HCV RNA negative at 12 months
기간: 52 weeks
|
To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing. |
52 weeks
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- VHCRP2104
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Request to share IPD will be considered by the protocol steering committee on individual basis
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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