HepC Micro-elimination on MSM and TGW Population.

NCT06847958 | Completed

• 3 other identifiers: MSM-HCV-MicroEliminationIN-ES-987-5997PI-21-206
• Study Type: observational
• Target: 13,161
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study, in which a single visit will be carried out, which includes a questionnaire on sexual habits and in which the possibility of carrying out a screening for Hepatitis C will be offered. Depending on the score obtained in the questionnaire, the screening will be carried out using a rapid serology test or viral load. During the first year, a SCORE will be developed to classify the risk of positive results. This SCORE will be used during phase 2 to offer users of the centres a targeted screening based on the Pre-test score.

Conditions

Hepatitis C; PrEP; Drugs of Abuse

Keywords

MSM; TGW; PrEP; Hepatitis C Transmision; micro-elimination

Outcome Measures

Primary Outcomes (1)

• Hepatitis C active infection

  Confirmed Hepatitis C active infection

  August 2021 o September 2023

Study Arms (2)

MSM and TGW HIV negative PrEP User.

MSM and TGW HIV negative non PrEP User.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male and TGW
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men who have sex with other men or transgender women, that are HIV negative and comes to get tested in our center or are under controls in our center. Estimated enrollment first Phase 6000-7000 participants. Second phase 2000-3000 participants.

You may qualify if:

• All BCN Checkpoint and BCN PreP·Point clients.
• years and older.
• Men that have sex with men or transgender women.
• Signature of written consent form.
• Ability to comply with the requirements of the study protocol.

You may not qualify if:

• Knowledge of HIV infection from more than 7 days
• Knowledge of active HCV infection

Sponsors & Collaborators

• Projecte dels NOMS Hispanosida: lead
• Fundació Lluita contra les Infeccions: collaborator
• Germans Trias i Pujol Hospital: collaborator

Study Sites (1)

BCN checkpoint

Barcelona, 08015, Spain

Location

Related Publications (1)

• Rivero A, Dalmau-Bueno A, Perez F, Coll P, Cabrera JM, Lucejko M, Fernandez J, Reguant J, Calderon J, Romero J, Caballero F, Marazzi G, Oro C, Michael Jacobs D, Vicioso H, Moises L, Taboada H, Saz J, Pujol F, Meulbroek M, Paredes R. HCV infection, risk factors and PrEP use among HIV-negative MSM and TW at a community health centre. J Infect Public Health. 2026 Feb;19(2):103086. doi: 10.1016/j.jiph.2025.103086. Epub 2025 Dec 4.

  PMID: 41380408 DERIVED

MeSH Terms

Conditions

Hepatitis C; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: August 23, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be availeble up to 5 years after Data publication
• Access Criteria: Data acces under private requisition and after individual evaluation.

Locations

ES (1)