Pan-Viral Screening and Linkage to Care Among GBMSM and Trans Women in Spain

NCT07085715 | Not Yet Recruiting

• 2 other identifiers: PAN-TESTATE2024-9767
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The World Health Organization (WHO) aims to eliminate viral hepatitis as a public health threat by 2030, with major reductions in hepatitis B and C incidence and mortality. However, hepatitis C virus (HCV) transmission has increased among gay, bisexual, and other men who have sex with men (GBMSM), especially those living with HIV. Practices such as chemsex, particularly involving injection drug use, have contributed to this rise. Hepatitis B virus (HBV) also remains a public health challenge due to the potential for chronic infection and severe liver damage. Hepatitis D virus (HDV), which requires HBV co-infection, further complicates clinical management. This study aims to design, implement, and evaluate an online self-sampling testing strategy to enhance pan-viral testing (HBV, HCV, HDV, HIV) and improve linkage to care among GBMSM and transgender women (TW) in Spain. The intervention will involve self-collected dried blood spot (DBS) samples for testing HBV surface antigen (HBsAg), HIV antibodies, and HCV RNA. Individuals testing positive for HBsAg will undergo further testing for HBV DNA and HDV infection. Those lacking protective levels of HBV antibodies will be referred for vaccination or revaccination. The study will also assess the number of HIV-positive individuals who acquired the infection while waiting for access to PrEP, identifying missed prevention opportunities. This non-randomized, single-arm, prospective national study will recruit adult GBMSM and TW through PrEP services, dating apps, NGOs, social media, and community outreach. Participants will complete an online risk assessment (using the HCV-MOSAIC algorithm) and receive self-sampling kits with instructions, lancets, Whatman cards, and prepaid envelopes. Results will be provided online, and those testing positive will be linked to confirmatory diagnosis and care. Outcomes include estimates of HIV, HBV, HCV, and HDV prevalence; effectiveness of linkage to care; acceptability and usability of the intervention; and validation of DBS for HBsAg detection. This study will provide critical evidence on the effectiveness of online self-sampling strategies for viral hepatitis and HIV among GBMSM and TW, supporting Spain's public health goals for prevention, early diagnosis, and linkage to care.

Conditions

HIV; Hepatitis B; Hepatitis C

Keywords

Self-sampling; Screening

Outcome Measures

Primary Outcomes (7)

• Reach and Identification of Undiagnosed HBV/HCV/HIV Infections

  Number of GBMSM and TW reached by the intervention Number of undiagnosed HBV, HCV, and HIV infections identified among participants

  October 2025 - September 2026

• Linkage to Care_1

  • Number and proportion of participants with positive results linked to appropriate care and follow-up.

  October 2025 - September 2026

• Linkage to care_2

  • Follow-up and cure rates for HCV infection among participants with positive results.

  October 2025 - September 2026

• Linkage to care_3

  • Number of individuals identified as not vaccinated against hepatitis B and linked to vaccination services.

  October 2025 - September 2026

• Intervention Usability and Acceptability_1

  • Number of participants consulting their results.

  October 2025 - September 2026

• Intervention Usability and Acceptability_2

  • Participant satisfaction with the intervention, perceived advantages and disadvantages, suggestions for improvement..

  October 2025 - September 2026

• Intervention Usability and Acceptability_3

  • Percentage of participants repeating HIV/HBV/HCV screening.

  October 2025 - September 2026

Secondary Outcomes (5)

• Effectiveness of DBS Screening_1

  October 2025 - September 2026

• Effectiveness of DBS Screening_2

  October 2025 - September 2026

• Missed Opportunities for HIV Prevention

  October 2025 - September 2026

• Sociodemographic and Risk Behavior Analysis_1

  October 2025 - September 2026

• Sociodemographic and Risk Behavior Analysis_2

  October 2025 - September 2026

Interventions

Online self-sampling testing strategy to enhance pan-viral testing (HBV, HCV, HIV) DIAGNOSTIC_TEST

The TESTATE website (https://testate.org/) will be expanded to include the offer of free HBV/HCV/HIV self-sampling kit. Users will log in and complete a sociodemographic, behavioral and hepB vaccination survey, which will include the HCVMOSAIC questionnaire. Users identified at HCV risk will be sent a DBS collection kit by post to detect HCV RNA, HBsAg and HIV Ab. Participants will self-collect the DBS sample by finger prick at home and send them to the laboratory by post. The results will be delivered online. All participants who return samples will receive an acceptance survey by email. All participants recruited into the study will be provided with online information about the study and given the opportunity to ask questions and clarify queries to the field coordinator by email or phone.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gay, bisexual, and other men who have sex with men (GBMSM) and transgender women residing in Spain

You may qualify if:

• Men self-reporting being gay, bisexual, and other men who have sex with men (GBMSM) or transgender women
• years old or older
• Residing in Spain
• Accepting to participate and signing the informed consent
• Including those who are in PrEP or waiting access to PrEP; regardless of their HIV status (HIV-negative or HIV-positive), and considered at risk for HCV acute infection using the MOSAIC validated algorithm (score of 2 or higher).

You may not qualify if:

• \<18 years old
• No GBMSM or transgender women
• Non-residents in Spain
• No signing the informed consent
• Not considered at risk for HCV acute infection using the MOSAIC validated algorithm (score lower than 2).

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead

MeSH Terms

Conditions

Hepatitis B; Hepatitis C

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

• Cristina Agusti, MSc, PhD

  ico oncologia

  STUDY DIRECTOR

Central Study Contacts

Cristina Agusti, MSc, PhD

CONTACT

+34934978891; cagusti@iconcologia.net

Andreu Colom, PhD

CONTACT

acolom@igtp.cat

Study Design

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

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 25, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share