MedTrace Logo

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

NCT07085715 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-07-25

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

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.

Sponsors & Collaborators

  • Fundació Institut Germans Trias i Pujol

    lead OTHER

Principal Investigators

  • Cristina Agusti, MSc, PhD · ico oncologia

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-09-30
Completion
2026-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085715 on ClinicalTrials.gov