To assess the effectivity and feasibility of HCV RNA self-testing in reducing the time to diagnosis of HCV re-infection in MSM previously cured of an HCV infection, compared to the current diagnostic standard of care. To evaluate whether the uptake…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Elimination of HCV was recently formulated as a WHO target and was set for the
year 2030. Globally, approximately 6.2% of HIV-infected patients are
co-infected with HCV. Of the patients living with HIV, people who inject drugs
(PWID) and men who have sex with men (MSM) are at particularly high risk of HCV
co-infection. However, as a result of the early adaptation of opioid
substitution and needle exchange programs in the Netherlands, the number of
PWID co-infected with HIV and HCV is limited. This is unfortunately not the
case for HIV-infected MSM. Until recently, the prevalence of chronic HCV in
Dutch HIV+MSM was very high at 4,8% (compared with 0.2% in the Dutch population
in general). However, after the restrictions on the use of direct-acting
antivirals against HCV (DAA) were lifted in 2015, the prevalence of chronic HCV
in HIV+MSM decreased rapidly. With this decreasing prevalence of chronic HCV a
decrease in the incidence of acute HCV infections in Dutch HIV+MSM was observed
as well. Indeed, while the incidence of acute HCV in HIV+MSM in care in the
Netherlands was 1.1% in 2014, this decreased by 51% in 2016. However, no
further decline in the number of acute HCV infections was observed in 2017.
Also, the incidence of HCV re-infections in HIV+MSM that were cured of a
previous HCV infection continues to be very high in the DAA era with reported
rates varying between 5-10% per year.
The continuously high re-infection risk and the lack of a further decline in
the HCV incidence after 2016 illustrates that universal DAA therapy for all
patients diagnosed with a chronic HCV infection on its own will not result in
HCV elimination. Other interventions are needed to reach the WHO goal of HCV
elimination by 2030. One of these additional interventions may be decreasing
the time to diagnosis of HCV re-infections in order to decrease the duration
that these re-infected patients may transmit their HCV to sex partners. Indeed,
if the diagnosis of HCV re-infection is made earlier, counseling on
transmission risk in combination with the prompt initiation of HCV therapy will
prevent transmission to sex partners and prevent new HCV infections on the
population level.
The study we describe here was designed to evaluate the effect and feasibility
of more frequent and home-based testing for HCV on the time to diagnosis and
treatment of HCV re-infections.
Study objective
To assess the effectivity and feasibility of HCV RNA self-testing in reducing
the time to diagnosis of HCV re-infection in MSM previously cured of an HCV
infection, compared to the current diagnostic standard of care.
To evaluate whether the uptake of self-testing is sufficient and warrants the
use of HCV RNA self-testing in clinical practice.
Study design
Prospective controlled intervention trial. MSM cured of an HCV infection who
are at continued risk for an HCV re-infection (based on the results of a short
questionnaire) are offered HCV RNA self-testing and asked to use the test every
6 months for 2 consecutive years.
Intervention
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 Erasmus MC every 6 months
by regular post mail.
Study burden and risks
The burden associated with participation in the study consists of taking a
finger prick blood sample for the home-based test 4 times in 2years and sending
the sample to the laboratory by regular post mail. No costs will have to be
made for mailing the sample. Capillary finger-prick blood sampling is used as a
standard diagnostic test for many diseases (e.g. glucose monitoring in
diabetes) and is associated with a negligible risk. The study may potentially
be beneficial for those participants in which a HCV reinfection is diagnosed as
they will be referred for counseling and HCV therapy, so that transmission to
sex partners could be avoided.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
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
- Age <18 years old, - Patients that are tested by HCV RNA as a standard of
care test (e.g. in the context of PREP use) > 1x/year, - Patients that are
expected to be tested by ALT at their HIV or PREP clinic <1x/year
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67745.078.18 |