None listed
Conditions
Brief summary
This study is investigating the effectiveness of two models of obtaining verbal consent for hepatitis c testing at community laboratories in New Zealand. Adult attendees will be offered hepatitis c testing in addition to the blood tests they are attending for. The two consent models are verbal consent by a phlebotomist working in the community laboratory, or verbal consent by a research assistant. This study will assess the feasibility, acceptability, and effectiveness of these two models of offering hepatitis C testing to the general population and inform the development of a national screening programme.
Interventions
The intervention group is offering Hepatitis C virus (HCV) testing by a community laboratory phlebotomist working in a community laboratory collection centre (study site) with documented verbal consent. Staff at the study site will undergo training prior to the start of the study which will be a 1-hour workshop conducted by the study project and clinical leads. This training 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 patient information sheets made available for the two weeks preceding the study and during the study before at each study site. A free phone number will be provided for potential participants wanting more information about the study to be able to discuss 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 site during the 2-week study period. The consent process is documented on a study form for each potential participant. Attendees who decline HCV testing will be offered the opportunity to provide feedback on their experience of the study through an online survey, a one-time offer of participation will be made via text message with a link to the online survey. Laboratory staff [phlebotomists and leadership) will be offered the opportunity to participate in 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 via videoconference and be a single 30–60-minute discussion, Fidelity to the intervention will be assessed using the study form which records who obtained the consent and attendance records for the study period provided by the community laboratory provider. Study procedure for those tested: Separate blood tubes will be collected for participants who consent to HCV testing, allowing the study samples to be processed separately and results managed by the study clinicians. All results will be returned to participants by study staff. Any participant that has a positive HCV test will be counselled, assessed and offered treatment for HCV as indicated by their test results. Participants with chronic HCV infection detected will be linked through to treatment with their own primary care provider, another community provider, or a Health New Zealand clinician. All treatment for HCV in New Zealand is fully funded and free of charge. For participants tested as part of the study, the community laboratories will provide records of HCV testing since 1/1/2020 for analysis. Participants who were tested will be offered the opportunity to participate in an online survey about their experiences of the study.
Sponsors
Study design
Eligibility
Inclusion criteria
Adults aged 16 years and older attending a study site during the recruitment period
Exclusion criteria
Children aged <16 years Inability to consent Not eligible for publicly funded healthcare in New Zealand. Already attending the laboratory for HCV testing