Hepatitis C Virus Self-testing (HCVST) in Sexual and Gender Minorities in Rio de Janeiro

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)