HCV infection Infection with the hepatitis C virus
Conditions
Interventions
Eligible patients are instructed on the use of a capillary blood
self-collection kit. They receive 2 kits per year for 2 consecutive years to
allow them to send plasma to the virology lab of the Era
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Cured of HCV defined as an SVR (=documented negative HCV RNA test) at least 12 weeks after the end of DAA therapy and no new documented positive HCV RNA test after the date of the SVR, OR, Spontaneous clearance of HCV infection defined as two consecutive negative HCV RNA tests at least 3 months apart after a positive HCV RNA test. , - In care for an HIV infection in an HIV clinic in the Netherlands or Belgium or HIV negative and receiving PrEP at a PrEP clinic, - Able and willing to perform the self-test at home after viewing the instruction video, - Willing to fill out a questionnaire on risk behavior at the time of home-based HCV testing , - At risk of HCV reinfection according to a short questionnaire, in other words, patients should have one of the following risk factors (19): o Receptive unprotected (condomless) anal intercourse in the last 6 months o Fisting or being fisted without gloves in the last 6 months o Sharing toys in the last 6 months o Syfilis or LGV in the last 12 months, o Slamming (injecting drug use) in the last 12 months o Sharing sniffing straws or other objects to sniff drugs in the last 12 months
Exclusion criteria
Exclusion criteria: - Age 1x/year, - Patients that are expected to be tested by ALT at their HIV or PREP clinic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the time to HCV re-infection diagnosis in patients using the HCV RNA self-test (intervention) with the time to HCV re-infection diagnosis with the standard diagnostic approach (virtual control) in the modified intention to treat population. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of the time to HCV re-infection diagnosis in patients using the HCV RNA self-test (intervention) with the time to HCV re-infection diagnosis with the standard diagnostic approach (control) in the subpopulation that sent in all planned self-tests during their entire follow-up (Per protocol analysis). 2. Of the HIV+MSM that were offered to participate in the study, the percentage that accepted to participate and eventually self-collected and sent in at least one plasma sample in each 12-month period of study participation. 3. Overall incidence of HCV re-infection in the entire study population regardless of the type of HCV diagnostic test that was used. 4. Number of newly diagnosed HCV infections at the time of the screening visit as a result of a positive HCV RNA test at the screening visit. | — |
Countries
Netherlands
Outcome results
None listed