HepC Micro-elimination on MSM and TGW Population.

NCT ID: NCT06847958

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-23

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C PrEP Drugs of Abuse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MSM and TGW HIV negative PrEP User.

No interventions assigned to this group

MSM and TGW HIV negative non PrEP User.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundació Lluita contra les Infeccions

UNKNOWN

Sponsor Role collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role collaborator

Projecte dels NOMS Hispanosida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BCN checkpoint

Barcelona, , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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IN-ES-987-5997

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI-21-206

Identifier Type: REGISTRY

Identifier Source: secondary_id

MSM-HCV-MicroElimination

Identifier Type: -

Identifier Source: org_study_id

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