HIVPAN-TESTATENCT07085715
Pan-Viral Screening and Linkage to Care Among GBMSM and Trans Women in Spain
An observational study of HIV and Hepatitis B, run by Fundació Institut Germans Trias i Pujol.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Hepatitis B, Hepatitis C
- What is being tested?
- Online self-sampling testing strategy to enhance pan-viral testing (HBV, HCV, HIV)
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Gay, bisexual, and other men who have sex with men (GBMSM) and transgender women residing in Spain
Who may be able to join
- 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
- 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).
Who cannot join
- <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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Andreu Colom, PhD contact
About this study
Official title: Optimizing Pan-Viral Screening and Linkage to Treatment and Vaccination Among GBMSM and Trans Women in Spain, Including PrEP Users and Those Awaiting Access: An Online Self-Sampling Pilot Study
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.
Read more
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.
Read the detailed description
Background: The World Health Organization (WHO) aims to eliminate viral hepatitis as a public health threat by 2030, targeting significant reductions in incidence and mortality for hepatitis B and C. Despite these goals, hepatitis C virus (HCV) transmission and acute infection rates have risen among gay, bisexual, and other men who have sex with men (GBMSM), especially those with HIV. Chemsex, particularly involving drug injection, is a notable risk factor. Hepatitis B virus (HBV) also poses a significant public health challenge, with chronic hepatitis B leading to severe liver damage in a significant portion of those infected. Hepatitis D virus (HDV), which requires HBV co-infection, adds further complexity to the management of viral hepatitis. Integrating evidence-based interventions for HIV and STI prevention, including effective screening and linkage to care, is urgently needed.
Objectives: 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. Specific objectives include:
- Designing and implementing an online self-sampling pilot intervention for HBV, HIV, and viremic HCV detection using dried blood spot (DBS) samples, and following up on positive HBV cases for HDV co-infection.
- Analyzing the intervention's effectiveness in reaching and identifying undiagnosed infections among GBMSM and TW not recently tested for HIV and viral hepatitis.
- Identifying individuals who have not vaccine-induced protective levels against HBV and linking them to vaccination (or revaccination) services.
- Evaluating the intervention's acceptability among GBMSM and TW inSpain.
- To identify the number of individuals with HIV infection while they are waiting PrEP (missed opportunities to prevent HIV infection) A secondary objective is to validate DBS samples for detecting HBV surface antigen (HBsAg).
Methods: This non-randomized single-arm prospective and national study will recruit adult GBMSM and TW through PrEP services, social media, gay dating apps, NGOs, and outreach interventions. Participants will complete a risk assessment using the HCV-MOSAIC algorithm, and eligible individuals will receive a self-sampling kit for HBV, HCV, and HIV testing. The kits will include instructions, a lancet, a Whatman card for DBS collection, and a pre-paid return envelope. Samples will be analyzed by a reference laboratory for HBsAg, HIV antibodies, and HCV RNA. Participants will receive their results online, with follow-up for those testing positive to confirm diagnoses and linkage to care. Those who test positive for HBsAg will be further tested for other tests, including HBV DNA, and HDV infection.
Expected Outcomes: The study will estimate HBV, HDV, HCV, and HIV prevalences, assess linkage to care and treatment outcomes, and evaluate the acceptability and usability of the self-sampling intervention. Additionally, the validation of DBS for HBsAg detection will provide crucial data for future screening strategies.
Conclusion: This study will provide valuable insights into the effectiveness of self-sampling interventions for viral hepatitis and HIV among GBMSM and TW, contributing to public health efforts to reduce the burden of these infections in Spain. To identify the number of individuals with HIV infection while they are waiting PrEP (missed opportunities to prevent HIV infection)
- Conditions
- HIV, Hepatitis B, Hepatitis C
- Being tested
- Online self-sampling testing strategy to enhance pan-viral testing (HBV, HCV, HIV)
- Keywords
- Self-sampling, Screening
- Medical subject headings
- Hepatitis B, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: October 2025 - September 2026
Linkage to Care_1
- Number and proportion of participants with positive results linked to appropriate care and follow-up.
Measured: October 2025 - September 2026
Linkage to care_2
- Follow-up and cure rates for HCV infection among participants with positive results.
Measured: October 2025 - September 2026
Linkage to care_3
- Number of individuals identified as not vaccinated against hepatitis B and linked to vaccination services.
Measured: October 2025 - September 2026
Intervention Usability and Acceptability_1
- Number of participants consulting their results.
Measured: October 2025 - September 2026
Intervention Usability and Acceptability_2
- Participant satisfaction with the intervention, perceived advantages and disadvantages, suggestions for improvement..
Measured: October 2025 - September 2026
Intervention Usability and Acceptability_3
- Percentage of participants repeating HIV/HBV/HCV screening.
Measured: October 2025 - September 2026
Secondary outcomes (5)
Effectiveness of DBS Screening_1
Proportion of participants with confirmed positive results for HBV, HCV, and HIV using DBS self-samples.
Measured: October 2025 - September 2026
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.
Measured: October 2025 - September 2026
Missed Opportunities for HIV Prevention
- Number of participants on the waiting list for PrEP who are diagnosed with HIV.
Measured: October 2025 - September 2026
Sociodemographic and Risk Behavior Analysis_1
- Comparison of sociodemographic characteristics and risk behaviors between positive and negative participants.
Measured: October 2025 - September 2026
Sociodemographic and Risk Behavior Analysis_2
- Data disaggregated by gender, migratory status, and sexual orientation.
Measured: October 2025 - September 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study startOct 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina Agusti, MSc, PhD, Study director, ico oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085715
- Sponsor's protocol ID
- PAN-TESTATE
- Other IDs
- 2024-9767
- Acronym
- PAN-TESTATE
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pan-Viral Screening and Linkage to Treatment and Vaccination Among GBMSM and Trans Women in Spain, Including PrEP Users and Those Awaiting Access: An Online Self-Sampling Pilot Study
- ClinicalTrials.gov ID
- NCT07085715
- Acronym / sponsor ID
- PAN-TESTATE / PAN-TESTATE
- Conditions
- HIV, Hepatitis B, Hepatitis C
- Keywords
- Self-sampling, Screening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: The World Health Organization (WHO) aims to eliminate viral hepatitis as a public health threat by 2030, targeting significant reductions in incidence and mortality for hepatitis B and C. Despite these goals, hepatitis C virus (HCV) transmission and acute infection rates have risen among gay, bisexual, and other men who have sex with men (GBMSM), especially those with HIV. Chemsex, particularly involving drug injection, is a notable risk factor. Hepatitis B virus (HBV) also poses a significant public health challenge, with chronic hepatitis B leading to severe liver damage in a significant portion of those infected. Hepatitis D virus (HDV), which requires HBV co-infection, adds further complexity to the management of viral hepatitis. Integrating evidence-based interventions for HIV and STI prevention, including effective screening and linkage to care, is urgently needed.
Objectives: 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. Specific objectives include:
- Designing and implementing an online self-sampling pilot intervention for HBV, HIV, and viremic HCV detection using dried blood spot (DBS) samples, and following up on positive HBV cases for HDV co-infection.
- Analyzing the intervention's effectiveness in reaching and identifying undiagnosed infections among GBMSM and TW not recently tested for HIV and viral hepatitis.
- Identifying individuals who have not vaccine-induced protective levels against HBV and linking them to vaccination (or revaccination) services.
- Evaluating the intervention's acceptability among GBMSM and TW inSpain.
- To identify the number of individuals with HIV infection while they are waiting PrEP (missed opportunities to prevent HIV infection) A secondary objective is to validate DBS samples for detecting HBV surface antigen (HBsAg).
Methods: This non-randomized single-arm prospective and national study will recruit adult GBMSM and TW through PrEP services, social media, gay dating apps, NGOs, and outreach interventions. Participants will complete a risk assessment using the HCV-MOSAIC algorithm, and eligible individuals will receive a self-sampling kit for HBV, HCV, and HIV testing. The kits will include instructions, a lancet, a Whatman card for DBS collection, and a pre-paid return envelope. Samples will be analyzed by a reference laboratory for HBsAg, HIV antibodies, and HCV RNA. Participants will receive their results online, with follow-up for those testing positive to confirm diagnoses and linkage to care. Those who test positive for HBsAg will be further tested for other tests, including HBV DNA, and HDV infection.
Expected Outcomes: The study will estimate HBV, HDV, HCV, and HIV prevalences, assess linkage to care and treatment outcomes, and evaluate the acceptability and usability of the self-sampling intervention. Additionally, the validation of DBS for HBsAg detection will provide crucial data for future screening strategies.
Conclusion: This study will provide valuable insights into the effectiveness of self-sampling interventions for viral hepatitis and HIV among GBMSM and TW, contributing to public health efforts to reduce the burden of these infections in Spain. To identify the number of individuals with HIV infection while they are waiting PrEP (missed opportunities to prevent HIV infection)
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Gay, bisexual, and other men who have sex with men (GBMSM) and transgender women residing in Spain
Key inclusion criteria (5 listed)
- 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
- 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).
Key exclusion criteria (5 listed)
- <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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
Reach and Identification of Undiagnosed HBV/HCV/HIV Infections
Time frame: October 2025 - September 2026
Number of GBMSM and TW reached by the intervention Number of undiagnosed HBV, HCV, and HIV infections identified among participants
Linkage to Care_1
Time frame: October 2025 - September 2026
• Number and proportion of participants with positive results linked to appropriate care and follow-up.
Linkage to care_2
Time frame: October 2025 - September 2026
• Follow-up and cure rates for HCV infection among participants with positive results.
Linkage to care_3
Time frame: October 2025 - September 2026
• Number of individuals identified as not vaccinated against hepatitis B and linked to vaccination services.
Intervention Usability and Acceptability_1
Time frame: October 2025 - September 2026
• Number of participants consulting their results.
Intervention Usability and Acceptability_2
Time frame: October 2025 - September 2026
• Participant satisfaction with the intervention, perceived advantages and disadvantages, suggestions for improvement..
Intervention Usability and Acceptability_3
Time frame: October 2025 - September 2026
• Percentage of participants repeating HIV/HBV/HCV screening.
5 secondary outcomes
Effectiveness of DBS Screening_1
Time frame: October 2025 - September 2026
Effectiveness of DBS Screening_2
Time frame: October 2025 - September 2026
Missed Opportunities for HIV Prevention
Time frame: October 2025 - September 2026
Sociodemographic and Risk Behavior Analysis_1
Time frame: October 2025 - September 2026
Sociodemographic and Risk Behavior Analysis_2
Time frame: October 2025 - September 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreu Colom, PhD contact
Cristina Agusti, MSc, PhD study director
ico oncologia
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Hepatitis B, run by Fundació Institut Germans Trias i Pujol.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Agusti, MSc, PhD (+34934978891, cagusti@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach and Identification of Undiagnosed HBV/HCV/HIV Infections (time frame: October 2025 - September 2026). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.