Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04961723 |
Other study ID # |
HC022 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 10, 2021 |
Est. completion date |
August 2022 |
Study information
Verified date |
July 2021 |
Source |
Foundation for Innovative New Diagnostics, Switzerland |
Contact |
Sonjelle Shilton |
Phone |
+41 (22) 710 05 90 |
Email |
Sonjelle.Shilton[@]finddx.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Self-testing with easy-to-use rapid diagnostic tests has been successfully used for diseases
such as HIV. The availability of self-testing has been shown to increase testing rates and
testing acceptability in diverse populations around the world, in large part due to its
convenience and privacy advantages.7 Self-testing has also been effectively used to reach key
populations who may not be covered by traditional healthcare programs, such as persons who
inject drugs (PWID) and men who have sex with men (MSM). In Georgia, HIV self-testing has
been offered to MSM through an online platform promoting their uptake.11-12 In the present
study aims to evaluate the acceptability and impact of using an online platform to enable
home delivery of HCV self-testing in Georgia for PWID and MSM.
Description:
Georgia, a middle-income country with an estimated population of 3.7 million people, is among
the world's highest-burden countries for HCV, with an estimated sero-prevalence of 7.7% in
the general population and a higher burden of disease in high-risk populations such as
persons who inject drugs. In 2015, Georgia embarked on an elimination program for HCV which
includes the expansion of HCV testing, linkage to care, and treatment.
The country made a substantial progress in HCV testing, linkage to care and treatment during
the last five years, but the gap still remains that needs to be addressed through testing of
different screening modalities to reach marginalized groups of the population.
Self-testing with easy-to-use rapid diagnostic tests has been successfully used for diseases
such as HIV. The availability of self-testing has been shown to increase testing rates and
testing acceptability in diverse populations around the world, in large part due to its
convenience and privacy advantages. The present study aims to evaluate the acceptability and
impact of an online program enabling home delivery of HCV self-testing (HCVST) for people who
inject drugs (PWID) and men who have sex with men (MSM) in Georgia.
The National Centres for Disease Control (NCDC) and FIND, in conjunction with the Georgian
national HCV elimination program, Batumi Imedi, Equality Movement, Tanadgoma, and Tbilisi New
Way are evaluating HCV self-testing as a way to expand outreach, improve HCV testing rates,
and increase linkage to care among HCV-infected PWID and MSM. The ability to utilize an
existing online platform promoting HIV self-testing, selftest.ge, will enable the study to
examine how offering HCV self-testing may help Georgia reach its goal of nationwide
elimination of HCV
The study aims to describe the acceptability and impact of an online platform offering home
delivery of HCV self-tests to PWID and MSM. Since HCV self-tests detect the presence of
antibodies to HCV, indicating exposure to HCV, any individual reporting a positive HCV
self-test will be referred to HCV RNA confirmatory testing in order to identify active HCV
infection. Those confirmed to have active HCV infection with a positive HCV RNA test will be
linked to HCV treatment and care. Rates of testing and linkage to care will be measured,
along with knowledge, attitudes, and practices around HCV testing and care
This is a randomized controlled trial comparing an online platform providing home-delivery of
HCV self-tests to referral to standard of care community-based HCV testing sites in PWID and
MSM in Georgia.
Study participants will be recruited through an existing HIV self-testing program using an
online platform to promote the study. Interested participants will sign up to be contacted
for study eligibility screening and consent. All study participants will complete a baseline
survey collecting demographics and knowledge and attitudes towards HCV testing.
Randomization will be done among participants who primarily identify as MSM (arm 1, 2 and 3)
and separately among participant who primarily identify as PWID
- Arm 1: MSM postal delivery Participants who identify primarily as MSM will receive a
home delivered HCV self-test kit in non-identifiable packaging. The kit will include the
test, instructions for use (IFU), and information about additional supporting materials,
such as access to live chat and a call center for questions about testing
- Arm 2: MSM peer delivery Participants who identify primarily as MSM will schedule a peer
delivery of the HCV self-test kit and IFU. The peer will provide basic information about
the test, what to do if the test is reactive, and how to access to live chat and a call
center for questions about testing
- Arm 3: MSM control Participants who identify primarily as MSM will receive information
about standard of care HCV antibody testing available at local testing sites in their
community. Participants will also have access to live chat and a call center for
questions about HCV testing
- Arm 4: PWID peer delivery Participants who identify primarily as PWID will schedule a
peer delivery of the HCV self-test kit and IFU. The peer will provide basic information
about the test, what to do if the test is reactive, and how to access to live chat and a
call center for questions about testing
- Arm 5: PWID control Participants who identify primarily as PWID will receive information
about standard of care HCV antibody testing available at local testing sites in their
community. Participants will also have access to live chat and a call center for
questions about HCV testing All participants will be sent a telephone reminder Follow-up
survey #1 which includes the opportunity to upload any testing result approximately 2-4
weeks after enrolment. A second Follow-up survey will be sent after the closure of the
first survey. Up to 3 reminders may be sent for each survey if a survey has not been
completed. Participants will receive 10 GEL phone credit (~3 USD) for completion of the
first follow up questionnaire to enter test result and an additional 10 GEL for
completion of the follow-up survey.
Any participants who report HCV antibody positive result through the study will be contacted
by the project staff and offered confirmatory testing and appropriate linkage to care through
the national HCV program. For all arms study staff will contact to the participants who
report HCV antibody positive result via the online platform and will provide information
about the next steps for diagnostic and treatment, information about the treatment
facilities. Those participants will be contacted again after 6 weeks and will be asked if
they received the next HCV care.
The HCV test used in the intervention group is an oral fluid test (OraQuick® HCV Self-Test).
Although use as a self-test is still research use only, it has been validated by the
manufacturer for self-testing. The test has also already been CE marked and WHO pre-qualified
as an in vitro diagnostic for professional use by healthcare workers.