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

NCT06203925 | Unknown FDA Device

• 1 other identifier: 69747223.4.0000.5262
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hepatitis C

Keywords

Hepatitis C virus self-test; Sexual and Gender Minorities

Outcome Measures

Primary Outcomes (3)

• Number of SGM living in Rio de Janeiro (Brazil) who requested an HCVST kit through a web-based platform

  Captured datas obtained from a web-based plataform

  1 month

• Number of SGM living in Rio de Janeiro (Brazil) who received and performed the test.

  Captured datas obtained from a web-based plataform

  1 month

• Proportion of MSM/TGW who correctly performed HCVST with oral-fluid and blood-based kits without assistance of a healthcare worker

  Captured datas obtained from a web-based plataform

  1 day

Secondary Outcomes (18)

• Socio-demographic characteristics through the data obtained from the study.

  2 months

• Type-preference test through the data obtained from the study.

  2 months

• Participants who reported Easy test.

  2 months

• Possible outcomes through the data obtained from the study.

  2 months

• Participants through the data obtained from the study.

  2 months

Study Arms (2)

Primary Study

The study will be a cohort study. Adult SGM living in the metropolitan area of Rio de Janeiro who voluntary want to perform HCV testing ordered through a web-based platform will be eligible for this study. SGM will be defined by gay, bisexual and other cisgender MSM, TGW, transgender men, and gender nonbinary/diverse individuals.

Diagnostic Test: Hepatitis C virus self-test (oral fluid HCVST); Diagnostic Test: Hepatitis C virus self-test (blood-based HCVST)

Ancillary Study

The study will be a cross-sectional study. Adult MSM or TGW attending a presential visit for PrEP (initiation or follow-up) at INI/FIOCRUZ will be eligible for this study.

Diagnostic Test: Hepatitis C virus self-test (oral fluid HCVST); Diagnostic Test: Hepatitis C virus self-test (blood-based HCVST)

Interventions

Hepatitis C virus self-test (oral fluid HCVST) DIAGNOSTIC_TEST

The participant will be able to choose between oral-fluid or blood-based HCVST. The package will include an HCV OraQuick ® HCV Self-Test kit, (OraSure Technologies, Inc, Bethlehem, PA) or a Wondfo® HCV Self-Test (Guangzhou, P.R. China) at Primary Study. At Ancyllary study, the individuals attending PrEP consultations at INI/FIOCRUZ will be invited to perform HCVST using blood-based and oral-fluid kits.

Also known as: OraSure Technologies, Inc, Bethlehem, PA

Ancillary Study; Primary Study

Hepatitis C virus self-test (blood-based HCVST) DIAGNOSTIC_TEST

The participant will be able to choose between oral-fluid or blood-based HCVST. The package will include an HCV OraQuick ® HCV Self-Test kit, (OraSure Technologies, Inc, Bethlehem, PA) or a Wondfo® HCV Self-Test (Guangzhou, P.R. China) at Primary Study. At Ancylary Study, the individuals attending PrEP consultations at INI/FIOCRUZ will be invited to perform HCVST using blood-based and oral-fluid kits.

Also known as: Wondfo® HCV Self-Test (Guangzhou, P.R. China)

Ancillary Study; Primary Study

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Self-identification as gay, bisexual and other cisgender MSM, TGW, transgender men, and gender nonbinary/diverse individuals
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Study: Participants reported residence in the metropolitan area of Rio de Janeiro (municipalities of Rio de Janeiro, Duque de Caxias, São João de Meriti, Belford Roxo, Nilópolis, Mesquita, Nova Iguaçu, Queimados, Japeri, Paracambi, Seropédica, Itaguaí, Magé, Guapimirim, Niterói, São Gonçalo, Itaboraí, Seropédica, Rio Bonito, Tanguá and Maricá) Ancillary Study: 2\. Self-identification as MSM or TGW 3. Presential visit for PrEP (initiation or follow-up) at INI/FIOCRUZ

You may qualify if:

• Age ≥ 18 years old with knowledge of the Portuguese language
• Self-identification as gay, bisexual and other cisgender MSM, TGW, transgender men, and gender nonbinary/diverse individuals
• Reported residence in the metropolitan area of Rio de Janeiro (municipalities of Rio de Janeiro, Duque de Caxias, São João de Meriti, Belford Roxo, Nilópolis, Mesquita, Nova Iguaçu, Queimados, Japeri, Paracambi, Seropédica, Itaguaí, Magé, Guapimirim, Niterói, São Gonçalo, Itaboraí, Seropédica, Rio Bonito, Tanguá and Maricá)

You may not qualify if:

• \. Unable or not willing to provide informed consent

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead
• World Health Organization: collaborator
• UNITAID: collaborator

Study Sites (1)

Evandro Chagas National Institute of Infectious Diseases

Rio de Janeiro, Rio de Janeiro/RJ, 21040-360, Brazil

Location

MeSH Terms

Conditions

Hepatitis C; Coitus

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Sexual Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 12, 2024
• Study Start: January 8, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)