Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06203925 |
| Other study ID # |
69747223.4.0000.5262 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 8, 2024 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
December 2023 |
| Source |
Oswaldo Cruz Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Sexual and gender minorities (SGM), such as gay, bisexual and other men who have sex with men
(MSM) and transgender women (TGW), are at high risk of HCV infection. A recently released
guideline by the WHO recommended HCVST to scale-up HCV screening. However, data on
delivery-services of HCVST kits and uptake of HCV testing using HCVST remain scarce in Latin
American countries. Additionally, data on the usability of HCVST in MSM/TGW, especially
blood-based tests, still lacking in Brazil. To evaluate the uptake of HCV testing by the
strategy of using HCVST ordered by the internet and delivery by the post in key populations
(SGM) living in the metropolitan region of Rio de Janeiro (Brazil). Additionally, an
Ancillary study will assess the usability of different kits of HCVST in MSM/TGW using PrEP.
Study Design and Population: This protocol will be composed of two studies that will be
conducted in parallel. The primary study will be a cohort study in which SGM ≥ 18 years old
living in the metropolitan area of Rio de Janeiro who request HCVST will be included. The
Ancillary study will be a cross-sectional study where adult MSM or TGW attending a presential
visit for PrEP (initiation or follow-up) at INI/FIOCRUZ will be eligible for this study. The
investigators estimate that 3,000 persons will request home-delivery of HCVST (Primary study)
and 250 participants will be included in the Ancillary study.Study Design and Population:
This protocol will be composed of two studies that will be conducted in parallel. The primary
study will be a cohort study in which SGM ≥ 18 years old living in the metropolitan area of
Rio de Janeiro who request HCVST will be included. The Ancillary study will be a
cross-sectional study where adult MSM or TGW attending a presential visit for PrEP
(initiation or follow-up) at INI/FIOCRUZ will be eligible for this study. The investigators
estimate that 3,000 persons will request home-delivery of HCVST (Primary study) and 250
participants will be included in the Ancillary study.
Methods: For the Primary Study, a web-based platform will be built for this project and an
educational campaign will be developed in dating apps to encourage HCV testing. The web
platform will contain modules with information on HCV infection and a log-in to request HCV
self-tests that can be delivered by the post or collected in the centralized pharmacy for HCV
testing. People will be encouraged to report their HCVST results in the online platform.
People with positive HCV antibody will be linked-to-care for HCV infection confirmation and
treatment initiation. For the Ancillary Study, MSM/TGW attending presential visits for PrEP
at INI/FIOCRUZ will be invited to perform HCVST (blood-based and oral fluid tests) under
supervision of a trained healthcare worker. Participants will read written instructions and
watch a video explaining the procedures step-by-step for HCVST. A second HCV test using the
same kit will be performed by the healthcare worker for concordance analysis. People with
positive HCV antibodies will be linked to HCV infection confirmation and treatment
initiation.
Data analysis: Descriptive statistical analysis will be used to evaluate the characteristics
of people seeking HCVST, participant's preferences, uptake of HCV testing using self-test
kits and internet technologies, as well as acceptability, usability and result interpretation
of HCVST in a sub-sample of participants. Ethical considerations: Locally, ethics approval
will be obtained from the INI/FIOCRUZ. International ethics clearance will be obtained from
the World Health Organization Ethics Review Committee (WHO ERC). All participants will be
informed of risks and benefits of the procedures and that their participation is voluntary.
All participants will be required to sign the informed consent (an online agreement for
Primary Study) as required by Brazilian regulations to participate in research studies. All
data collected will respect The Brazilian General Data Protection Law (Law nº 13.709/2018).
Description:
Chronic hepatitis C is a major health issue in Brazil where it is estimated that up to
650,000 people are living with HCV infection. Despite the availability of rapid tests as well
as universal access to safe and highly effective drugs for HCV treatment for free of charge,
the HCV HCV continuum of care remains unsatisfactory. HCV transmission due to sexual
activities are increasing in Brazil, especially among young men. It is well known that MSM
and/or TGW are at high risk for HCV infection. HCV infection in these key populations might
occur mainly in the context of traumatic sex practices that increase the risk of blood-blood
contact. The use of drug prior to or during sex (chem-sex) might be associated with HCV
infection. Few studies have reported the prevalence of HCV infection among SGM in Brazil.
Firstly, a single center study that included a limited sample (n=522) using Respondent-Driven
Sampling reported a prevalence of anti-HCV positive of 1.3% (95%CI: 0.3-5.5) in MSM in
Central region. All people with anti-HCV positive reported high-risk sexual behaviors,
condomless use at anal intercourse and frequent chem-sex [39]. More recently, the
prospective, single-arm, open-label, multicentre PrEP implementation study conducted in
Brazil (14 sites), Mexico (4 sites), and Peru (10 sites) included 9,509 HIV-negative MSM and
TGW for daily oral initiation of PrEP. Prevalence of hepatitis C increased from the enrolment
to week-52 among participants from Mexico and Peru, cisgender men, and those aged 25-30
years. In Brazil (n=3,928), the prevalence of HCV infection was 0.34% (95%CI 0.16-0.52) and
0.58% (95%CI 0.24-0.91) at enrolment and week-52, respectively [40]. Similarly, a Brazilian
study reported an HCV prevalence of 0.66% (anti-HCV positive in 340 from 51,486 tests) in key
populations (MSM, transgender people, people who inject drugs, and sex workers) in Curitiba
(Southern region) [24] Similar to other countries, HIV coinfection and injection drug use
have been associated with increased risk of HCV infection/reinfection in Brazil. Prevalence
of HCV infection (2.7%) was mostly associated with injection drug use in the last year
[OR=10.33 (95%CI 4.74-22.52)] and HIV infection [OR=4.74 (95%CI 1.82-12.36)] in Brazilian men
prisoners (n=2,848)[41].
Large scale screening for hepatitis C in high-risk people and linkage-to-care are
cornerstones towards to HCV elimination. HCVST can decrease the barriers to traditional
testing by increasing convenience and privacy. Lesson learned with HIVST can be informative
and suggest that this new/additional testing approach may help to increase HCV testing and
linkage to care and treatment. A recently released guideline by the WHO recommended HCVST to
scale-up HCV screening [6]. In brief, this guideline recommends that HCVST should be offered
as an additional approach to facility-based HCV testing. Additionally, HCVST needs to be
followed by confirmation of viremic infection (HCV-RNA), and linkage-to-treatment, and HCVST
service delivery should be adapted to local context, which includes community preferences.
However, the usability of HCVST kits, cost-effective, non-discriminatory and inclusive
service delivery and optimal position of HCVST in national HCV programs must be addressed.
Stigma is an important element in the experience of living with chronic HCV infection,
especially in SGM persons. This stigma impacts in healthcare access and uptake as well as
health outcomes. The use of HCVST can help to mitigate the stigma along the HCV continuum of
care. Additionally, the immediate linkage to care after a positive HCVST using telehealth
might reduce mental distress from positive results.
Recent studies have evaluated the usability, acceptability, and rates of interpretation of
results from different kits (blood-based and oral fluid) of HCVST worldwide. Few studies
reported high acceptability and usability of oral-fluid HCVST in key populations (mostly
MSM), especially in the USA, European countries and Asia. However, data on delivery-services
of HCVST kits and uptake of HCV testing using HCVST remain scarce in Latin American
countries. Additionally, data on the usability of HCVST in MSM/TGW, especially blood-based
tests, still lacking in Brazil. This study will evaluate the uptake of HCV testing by the
strategy of using HCVST that would be able to be ordered by the internet and delivery by the
post in key populations (SGM) living in the metropolitan region of Rio de Janeiro (Brazil).
Additionally, a sub-study will assess the acceptability, usability and result interpretation
of different kits of HCVST in MSM/TGW using PrEP in a reference center in Rio de Janeiro
(Brazil).
This project will assess operational research priorities about HCVST in Brazil. The
investigators expect to fulfill gaps of knowledge on product optimization (acceptability and
usability of blood-based and oral fluid HCVST kits), service delivery and linkage pathways to
confirmatory testing and treatment after reactive HCVST results in one of the largest
agglomerations worldwide, such as the metropolitan area of Rio de Janeiro (Brazil). The
investigators expect to increase HCV testing by using an online platform to inform about HCV
infection where people will be able to order HCVST that can be delivered by the post.
Additionally, our strategy will include an offer of HIVST with HCVST (combo HIV/HCVST) to
increase interest for HCV testing and a massive advertising campaign in dating-apps used by
SGM (e.g. Grindr, Scruff and Hornet). In addition, the investigators expect that HCVST will
be highly accepted and easy to be performed among PrEP users in Rio de Janeiro (Brazil).
This protocol will be composed by a Primary Study and an Ancillary Study that will be
conducted in parallel.
OBJECTIVES:
The Primary Study will assess HCVST using internet-technologies among SGM. The main
hypothesis of the Primary Study is that HCVST ordered in an online platform and delivered by
the post will increase HCV testing uptake among SGM.
The Ancillary Study will assess the acceptability and usability of different kits of HCVST in
MSM/TGW under PrEP. The main hypothesis of the Ancillary Study is that blood-based and oral
fluid HCVST will be well accepted and easily to be performed among MSM/TGW under PrEP in a
referral center in Rio de Janeiro (Brazil)
2.1. Overall objectives Overall objective of the Primary Study: To evaluate the uptake of HCV
testing using HCVST ordered through a web-based platform among SGM living in Rio de Janeiro
(Brazil) Overall objective of the Ancillary Study: To evaluate the acceptability, usability,
results interpretation and participant's perspectives of HCVST with blood-based and
oral-fluid kits among MSM and TGW who are attending a PrEP visit in a reference center in Rio
de Janeiro (Brazil).
2.2 Specific objectives
Specific objectives of the Primary Study:
1. To describe socio-demographic characteristics of people seeking HCV self-testing
2. To evaluate preference for oral fluid or blood-based HCV self-tests
3. To evaluate the proportion of people using home-based delivery vs pick up of HCV
self-tests
4. To evaluate the proportion of people reporting HCV self-test results
5. To evaluate the proportion of people attending a consultation when HCV self-test is
reactive or invalid
6. To evaluate the knowledge of SGM about HCV infection and/or treatment
7. To evaluate cost per case of HCV infection detected using HCV self-testing and internet
technologies
8. To evaluate the proportion of people with reactive HCVST who had HCV-RNA test for
confirmation and who started HCV treatment (linkage to HCV continuum of care)
9. To evaluate the proportion of people who ordered HCVST to receive an HIVST kit
Specific objectives of the Ancillary Study:
1. To describe socio-demographic characteristics of people under PrEP performing HCVST
2. To evaluate the proportion of people who correctly perform HCVST
3. To evaluate the proportion of people who do not need assistance to correctly perform
HCVST
4. To evaluate the proportion of people who correctly report HCVST results (re-read by a
trained healthcare worker)
5. To evaluate the concordance of HCVST with re-testing by a trained healthcare worker
6. To evaluate the preference for oral-fluid or blood-based HCVST kits
7. To evaluate the proportion of people attending a consultation when HCV self-test is
reactive or invalid
8. To evaluate the knowledge of people under PrEP about HCV infection and/or treatment
9. To evaluate cost per case of HCV infection detected using HCVST in PrEP users
10. To evaluate the proportion of people with reactive HCVST who had HCV-RNA test for
confirmation and who started HCV treatment (linkage to HCV continuum of care)
