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The effectiveness, acceptability and feasibility of offering Hepatitis C testing to adults attending community laboratories

A pilot to assess the effectiveness, acceptability and feasibility of two models of verbal consent for Hepatitis C testing at community laboratory collection sites in the Northern Region

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000219583
Enrollment
1600
Registered
2024-03-05
Start date
2024-04-29
Completion date
2024-06-03
Last updated
2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project is designed as a pilot study that will provide insights into the feasibility, acceptability and best approach for using verbal consent in a laboratory setting to inform a larger scale hepatitis C screening programme. Policy Objectives The project is conducted within a framework of assessing the feasibility, acceptability and effectiveness of two models of verbal consent for hepatitis C screening in the general population of the Northern region. This project sits within the wider regional and national hepatitis C elimination strategy. Primary Research Objective: To determine effectiveness of two models of verbal consent for hepatitis C screening (measured by proportion of people who consent, decline, or withdraw). Secondary Research Objectives: To determine the feasibility and acceptability of utilising verbal consent for hepatitis C screening

Interventions

This study is testing obtaining verbal consent by the phlebotomist for screening for Hepatitis C virus (HCV) infection in community laboratory settings. Staff at the study sites will undergo training prior to the start of the study and be asked to attend a 1 hour workshop conducted by the study project and clinical leads which will cover the purpose of the study, study procedures, informed consent, and study documentation. Potential study participants will be informed about the study through

This study is testing obtaining verbal consent by the phlebotomist for screening for Hepatitis C virus (HCV) infection in community laboratory settings. Staff at the study sites will undergo training prior to the start of the study and be asked to attend a 1 hour workshop conducted by the study project and clinical leads which will cover the purpose of the study, study procedures, informed consent, and study documentation. Potential study participants will be informed about the study through posters and participant information sheets made available for the two weeks preceding the study and during the study period at each collection site. A free phone number will be provided for participants wanting more information about the study to be able to discuss this with the study team. Verbal consent will be obtained during a brief face-to-face interaction with a phlebotomist to potential participants attending a study sites (community laboratories) during the 2 week study period. The consent process is documented on a study form for each potential participant. A small number of potential participants will be approached via phone call and verbal consent obtained by a research assistant to participate in a phone interview (a single 10-15 minute discussion) about their experience of being offered hep C testing in a community laboratory setting. Laboratory staff (phlebotomists and laboratory leadership) will be offered the opportunity to participate focus groups to share their experience of the acceptability and feasibility of the intervention. Consent for focus group participation will be obtained by a research assistant and documented. Focus groups will be offered in staff workplaces and will be a single 30-60 minute discussion. Fidelity to the intervention will be assessed using the study form which records who obtained consent at each study site and records of attendance at the study site during the study period provided by the laboratory. Study Procedure for those tested: A separate blood tube will be collected for participants that verbally consent, this allows the sample to be processed separately and the results managed separately by the study clinical results management team. All results will be returned to participants by study staff. Any participant that has a positive test will be counselled, assessed, and offered treatment for HCV as indicated by their test results. Participants with chronic HCV infection detected will be offered the option of being treated by their own primary care provider, another community provider, or the study team clinicians. All treatment for HCV in New Zealand is fully funded and free of charge to the patient.

Sponsors

Te Whatu Ora Service Innovation and Improvement
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
35 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Adults 35 years and older attending one of the study sites for blood collection

Exclusion criteria

people under 35 years of age, inability to consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026