Hepatitis CNCT06606197
Hepatitis C Prevalence in Men Who Have Sex With Men
An observational study of Hepatitis C, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial summary
This is an observational study aimed at determining the prevalence of hepatitis C in a specific population: men who have sex with men. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Having sex with other men
- How many people
- 454 participants
- Where
- 1 siteSpain
- Study dates
- 9 Sep 2022to 11 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Population attending the \"International Bears Sitges Week\" festival in September 2022 in Sitges, Barcelona.
Who may be able to join
- Having sex with men
Who cannot join
- Refusal to participate in the trial
Trial locations and contacts
1 site in 1 country.
Spain1 site
Consorci Sanitari Alt Penedès Garraf
Vilafranca del Penedès, Barcelona, 08720
About this study
Official title: CRIBADO DE VIRUS DE LA HEPATITIS C en Hombres Que Tienen Sexo Con Hombres (HSH) Sitges
This is an observational study aimed at determining the prevalence of hepatitis C in a specific population: men who have sex with men.
- Conditions
- Hepatitis C
- Being tested
- Having sex with other men
- Keywords
- Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Having sex with other menOther
Having sex with other men
| Study group | Role | What they receive |
|---|---|---|
| Men who have sex with men | Not described Receives: Other: Having sex with other men |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Hepatitis C screening positive
A positive result will be defined as a positive outcome in both the serological test and the viral load test
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start9 Sep 2022
- Primary completion11 Sep 2022
- Study completion11 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Cross-sectional
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonia Albertos, MD, Principal investigator, CSAPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606197
- Sponsor's protocol ID
- CSAPG_34
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Publications
Albertos S, Majo FX, Esteban R, Colom J, Buti M. A large-scale screening of hepatitis C among men who have sex with men in the community using saliva point-of-care testing. Front Public Health. 2024 Dec 9;12:1478195. doi: 10.3389/fpubh.2024.1478195. eCollection 2024.
PubMed 39717035
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRIBADO DE VIRUS DE LA HEPATITIS C en Hombres Que Tienen Sexo Con Hombres (HSH) Sitges
- ClinicalTrials.gov ID
- NCT06606197
- Acronym / sponsor ID
- CSAPG_34
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 11 Sep 2022 (actual)
- Study completion
- 11 Sep 2022 (actual)
- First posted
- 20 Sep 2024 (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.
This is an observational study aimed at determining the prevalence of hepatitis C in a specific population: men who have sex with men.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men who have sex with men | – | Other: Having sex with other men |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population attending the \"International Bears Sitges Week\" festival in September 2022 in Sitges, Barcelona.
Key inclusion criteria (1 listed)
- Having sex with men
Key exclusion criteria (1 listed)
- Refusal to participate in the trial
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 |
|---|---|---|
| Having sex with other menHaving sex with other men | Other | Men who have sex with men |
Primary outcome
Number of participants with Hepatitis C screening positive
Time frame: Baseline
A positive result will be defined as a positive outcome in both the serological test and the viral load test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Results publication: PubMed 39717035Albertos S, Majo FX, Esteban R, Colom J, Buti M. A large-scale screening of hepatitis C among men who have sex with men in the community using saliva point-of-care testing. Front Public Health. 2024 Dec 9;12:1478195. doi: 10.3389/fpubh.2024.1478195. eCollection 2024.
- Trial resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
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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. This study is not recruiting at the moment.
Sonia Albertos, MD principal investigator
CSAPG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Hepatitis C screening positive (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606197, which also lists 1 linked publication.
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 12 Feb 2025.