NCT06606197

Brief Summary

This is an observational study aimed at determining the prevalence of hepatitis C in a specific population: men who have sex with men.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2022

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2024

Completed
Last Updated

February 12, 2025

Status Verified

September 1, 2024

Enrollment Period

2 days

First QC Date

September 16, 2024

Last Update Submit

February 10, 2025

Conditions

Keywords

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Study Arms (1)

Men who have sex with men

Other: Having sex with other men

Interventions

Having sex with other men

Men who have sex with men

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population attending the \"International Bears Sitges Week\" festival in September 2022 in Sitges, Barcelona.

You may qualify if:

  • Having sex with men

You may not qualify if:

  • Refusal to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari Alt Penedès Garraf

Vilafranca del Penedès, Barcelona, 08720, Spain

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Sonia Albertos, MD

    CSAPG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 20, 2024

Study Start

September 9, 2022

Primary Completion

September 11, 2022

Study Completion

September 11, 2022

Last Updated

February 12, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After publication of main results of the study.
Access Criteria
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations