Pan-Viral Screening and Linkage to Care Among GBMSM and Trans Women in Spain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorFundació Institut Germans Trias i Pujol
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men self-reporting being gay, bisexual, and other men who have sex with men (GBMSM) or transgender women
18 years old or older
Residing in Spain
Accepting to participate and signing the informed consent
Disqualifiers
<18 years old
No GBMSM or transgender women
Non-residents in Spain
No signing the informed consent
Trial population
Gay, bisexual, and other men who have sex with men (GBMSM) and transgender women residing in Spain
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Online self-sampling testing strategy to enhance pan-viral testing (HBV, HCV, HIV)
Diagnostic testThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
October 2025 - September 20262
Linkage to Care_1
• Number and proportion of participants with positive results linked to appropriate care and follow-up.
Time frame
October 2025 - September 20263
Linkage to care_2
• Follow-up and cure rates for HCV infection among participants with positive results.
Time frame
October 2025 - September 20264
Linkage to care_3
• Number of individuals identified as not vaccinated against hepatitis B and linked to vaccination services.
Time frame
October 2025 - September 2026Secondary outcomes
1
Effectiveness of DBS Screening_1
Proportion of participants with confirmed positive results for HBV, HCV, and HIV using DBS self-samples.
Time frame
October 2025 - September 20262
Effectiveness of DBS Screening_2
Validation metrics for DBS samples in detecting HBsAg, including the area under the ROC curve and the 95% confidence interval.
Time frame
October 2025 - September 20263
Missed Opportunities for HIV Prevention
• Number of participants on the waiting list for PrEP who are diagnosed with HIV.
Time frame
October 2025 - September 20264
Sociodemographic and Risk Behavior Analysis_1
• Comparison of sociodemographic characteristics and risk behaviors between positive and negative participants.
Time frame
October 2025 - September 2026Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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