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Completed

NCT Number: NCT05264558

Preparing for the Final Phase of Hepatitis C Elimination. Cairns Final 30%

The study aims to assess the impact of models of HCV care on HCV testing, treatment uptake and cure within Cairns. Point of care testing for HCV , with test and treat strategies will be offered within a primary care service.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairns and Hinterland Hospital and Health Service

Cairns, Queensland, 4870, Australia

About this study

Available testing and treatment data will be explored pre and post the intervention period of the project within Cairns Hinterland health services that provide hepatitis C care.

Test and treat strategies of the project will include:

Part A: Same day test and treat clinical trial. The study will explore a 'same day test and treat' model to determine the impact on HCV treatment initiation and cure within a primary care service that recognises that they see people at risk of hepatitis C that are transient, and struggle to return to a care provider to engage in hepatitis C testing and care.

  • HCV RNA point of care (POC) testing
  • Epclusa (Sofosbuvir/Velpatasvir 400mg/100mg) course initiated at same day of visit following a +ve HCV RNA result from the POC test.

Part B: Refresher and clinic in reach support work Primary care service/ General practitioner education and training ~1 hour in-person training for all clinic staff on hepatitis C testing, treatment, retention in HCV care cascade.

Part C: Services evaluation with incentive and peer intervention in HCV care cascade.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • attending primary health care service of CHHS aged 18 years or over

Exclusion criteria

only for intervention arm test and treat

  • Known to have hepatitis B or HIV infection
  • Known to have cirrhosis
  • Previous treatment with direct acting antivirals
  • Previously received interferon-based hepatitis C treatment that did not work
  • Women that are pregnant or breastfeeding
  • Already receiving hepatitis C treatment.

Treatment and study plan

Xpert HCV Viral load finger stick point of care test (Cepheid)

Device

Xpert HCV VL Fingerstick is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Hepatitis C Virus (HCV) RNA in human venous and capillary fingerstick EDTA whole blood. Appropriate pre and post testing counselling will be provided to participants.

Epclusa 400Mg-100Mg Tablet

Drug

Same day HCV test and treatment

Standard of care

Other

Clinical services will receive additional education and have the option of providing incentives to attendees of service.

Primary outcomes

  1. HCV testing

    Time frame: 12 months

    The number of participants who receive HCV testing in each of the arms

  2. HCV treatment

    Time frame: 12 months

    The number of participants who start HCV treatment in each of the arms

Sponsors and collaborators

Lead sponsor

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Other

Collaborators

  • Cairns Hinterland Health Hospital and Health Services
  • The University of Queensland

Registry information

Official study title

Preparing for the Final Phase of Hepatitis C Elimination in Cairns: An Implementation Trial of a Test and Treat Approach to Reach the Final 30%.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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