HepC Micro-elimination on MSM and TGW Population.

February 21, 2025 updated by: Projecte dels NOMS Hispanosida

HepC Micro-elimination on MSM Comunity

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

13161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08015
        • BCN Checkpoint

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  1. All BCN Checkpoint and BCN PreP·Point clients.
  2. 18 years and older.
  3. HIV uninfected or diagnosticated in the center in the last 7 days prior to the study inclusion.
  4. Men that have sex with men or transgender women.
  5. Signature of written consent form.
  6. Ability to comply with the requirements of the study protocol.

Exclusion Criteria:

  1. Knowledge of HIV infection from more than 7 days
  2. Knowledge of active HCV infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MSM and TGW HIV negative PrEP User.
MSM and TGW HIV negative non PrEP User.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatitis C active infection
Time Frame: August 2021 o September 2023
Confirmed Hepatitis C active infection
August 2021 o September 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Projecte dels NOMS Hispanosida

Collaborators

Germans Trias i Pujol Hospital
Fundació Lluita contra les Infeccions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSM-HCV-MicroElimination
  • IN-ES-987-5997 (Other Grant/Funding Number: Gilead Sciences, S.L.U)
  • PI-21-206 (Registry Identifier: IEC Germans Trias i Pujol)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data requisition will be individually evaluated. After that IEC will be required to evaluate data sharing.

IPD Sharing Time Frame

IPD will be availeble up to 5 years after Data publication

IPD Sharing Access Criteria

Data acces under private requisition and after individual evaluation.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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