Hepatitis C Prevalence in Men Who Have Sex With Men | NCT06606197

Studies
Hepatitis C Prevalence in Men Who Have Sex With Men

NCT06606197

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Status

Completed

Last Update Posted

Feb 12, 2025Actual

Enrollment

454Actual

Phase

Not provided

Conditions

Hepatitis C

Interventions

Having sex with other men

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2022Actual

Primary Completion Date

Sep 11, 2022Actual

Completion Date

Sep 11, 2022Actual

First Submitted Date

Sep 16, 2024

First Submission Date that Met QC Criteria

Sep 18, 2024

First Posted Date

Sep 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2025

Last Update Posted Date

Feb 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

454Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Men who have sex with men			Other: Having sex with other men

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Having sex with other men	Other	Having sex with other men	Men who have sex with men

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having sex with men

Exclusion Criteria:

Refusal to participate in the trial

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Men

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sonia Albertos, MD	CSAPG	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Consorci Sanitari Alt Penedès Garraf		Vilafranca del Penedès	Barcelona	08720	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39717035	Result	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.

See Also Links

Label	URL
Trial results	View source

Available IPD Information

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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).

Types

Study Protocol
Informed Consent Form (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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided