Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634342
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
One-step HCV RNA Testing Among SSP Participants HOT Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
One-step HCV RNA Testing Among SSP Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOT
Brief Summary:
The HOT HCV One-step Test Study is an observational prospective study to evaluate the use of a recently FDA-approved point-of-care RNA test for hepatitis C virus HCV in a sample of clients of a syringe services program SSP We aim to answer the following questions
1 How will point-of-care HCV RNA testing with Xpert provided at an SSP effect how people who use drugs receive their results get linked to HCV care services and initiate and complete HCV treatmentgt Aim 2 What are the most effective ways to implement point of care HCV RNA testing in syringe services programs
1 How will point-of-care HCV RNA testing with Xpert provided at an SSP effect how people who use drugs receive their results get linked to HCV care services and initiate and complete HCV treatmentgt Aim 2 What are the most effective ways to implement point of care HCV RNA testing in syringe services programs
Detailed Description:
This study would be conducted in partnership with the Public Health - Seattle King County SSP which is the SSP that the project principal investigator is affiliated with in Seattle WA The PHSKC SSP will be provided with a Cepheid Xpert HCV RNA machine and testing cartridges Staff will be trained by Cepheid staff on the one-step HCV RNA testing protocol including collecting blood from participants using the test machine interpreting results and returning results to participants
HCV testing and linkage to care activities will be monitored for six months as part of this study Once all training and protocol development is complete the PHSKC SSP will make the one-step HCV testing algorithm available to their clients and invite them to participate SSP staff will conduct the one-step HCV testing and linkage algorithm according to the project protocol
Clients who choose to be tested will participate in an informed consent process for study procedures Participants who complete the HCV test and receive their results will receive a 15 incentive All quantitative data related to the study will be entered directly into REDCap data collection tools SSP staff who conduct testing will record a participants HCV test result whetherwhen they received their result and whetherwhen they received a referral to HCV care Participants will need to provide identifying information eg name and birthdate and sign a release of information form to facilitate longitudinal data collection on linkage to care and treatment initiation SSP staff will use this information to follow up with providers to indicate whetherwhen participants attended an HCV care visit whetherwhen participants began HCV treatment and if they achieved cure ie sustained viral response at 4 weeks No other information will be requested or recorded from health care providers
We will ask the PHSKC SSP to gather data on prior HCV testing and linkage efforts for the 6 months prior to the implementation of the one-step algorithm standard of care This will include any data that are available related to volume of HCV screening and RNA testing participant receipt of results and linkage to care efforts
During the six months of the testing project we will also conduct qualitative data collection First UW staff will conduct 12 in-depth interviews with participants who were involved in the testing component of the study These interviews will be conducted with participants who received negative HCV RNA results both those who were and were not linked to care and those who started HCV treatment The goal of these interviews will be to understand the participants previous testing experiences and interest in HCV care present testing experiences and interest in care and overall impressions of the one-step testing algorithm Staff will use purposive sampling to recruit participants and conduct private interviews using a semi-structured interview guide Participants who complete these interviews will receive a 40 incentive
Second UW staff will conduct in-depth interviews with all staff at the PHSKC SSP who were involved with the HCV testing study to understand the experiences of staff who conducted the one-step testing algorithm compared to previous testing algorithms eg HCV rapid screening andor laboratory-based HCV RNA testing Specific questions will assess facilitators and barriers to providing one-step HCV testing in SSPs as well as recommendations for implementing similar protocols in other SSPs
HCV testing and linkage to care activities will be monitored for six months as part of this study Once all training and protocol development is complete the PHSKC SSP will make the one-step HCV testing algorithm available to their clients and invite them to participate SSP staff will conduct the one-step HCV testing and linkage algorithm according to the project protocol
Clients who choose to be tested will participate in an informed consent process for study procedures Participants who complete the HCV test and receive their results will receive a 15 incentive All quantitative data related to the study will be entered directly into REDCap data collection tools SSP staff who conduct testing will record a participants HCV test result whetherwhen they received their result and whetherwhen they received a referral to HCV care Participants will need to provide identifying information eg name and birthdate and sign a release of information form to facilitate longitudinal data collection on linkage to care and treatment initiation SSP staff will use this information to follow up with providers to indicate whetherwhen participants attended an HCV care visit whetherwhen participants began HCV treatment and if they achieved cure ie sustained viral response at 4 weeks No other information will be requested or recorded from health care providers
We will ask the PHSKC SSP to gather data on prior HCV testing and linkage efforts for the 6 months prior to the implementation of the one-step algorithm standard of care This will include any data that are available related to volume of HCV screening and RNA testing participant receipt of results and linkage to care efforts
During the six months of the testing project we will also conduct qualitative data collection First UW staff will conduct 12 in-depth interviews with participants who were involved in the testing component of the study These interviews will be conducted with participants who received negative HCV RNA results both those who were and were not linked to care and those who started HCV treatment The goal of these interviews will be to understand the participants previous testing experiences and interest in HCV care present testing experiences and interest in care and overall impressions of the one-step testing algorithm Staff will use purposive sampling to recruit participants and conduct private interviews using a semi-structured interview guide Participants who complete these interviews will receive a 40 incentive
Second UW staff will conduct in-depth interviews with all staff at the PHSKC SSP who were involved with the HCV testing study to understand the experiences of staff who conducted the one-step testing algorithm compared to previous testing algorithms eg HCV rapid screening andor laboratory-based HCV RNA testing Specific questions will assess facilitators and barriers to providing one-step HCV testing in SSPs as well as recommendations for implementing similar protocols in other SSPs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None