Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux (HEPCSEX)

November 12, 2018 updated by: University Hospital, Bordeaux
The main objective of this study is to analyse sexual behavior of HIV + MSM in Bordeaux, who have sexually contracted hepatitis C between January 1st 2013, to January 31, 2017. These data will bring some improvement about prevention and maybe reduced the hepatitis C incidence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hepatitis C (HCV) is considered in part as a sexually transmitted infection (STI). A marked decrease in its incidence has been observed for several years, coinciding with the availability of new direct acting antiviral treatments (DAA). However, people are increasingly infected with the hepatitis C virus, especially HIV-positive MSM. This increase is explained by new sexual practices that are particularly at high level of risk, despite the widening accessibility of new DAA. Prevention also plays an important role in implementing an effective risk reduction policy. New methods of prevention must therefore be developed. For this purpose, it is imperative to know the natural history of acute hepatitis C, the different behaviours at risk of HCV transmission, and the demonstration of socio-sexual networks (clusters) thanks to virological phylogenetic studies. In order to improve hepatitis C prevention, we wish to establish a descriptive study focusing on :

  • Descriptive analysis of the natural history of hepatitis C,
  • Identification of patient clusters (phylogenetic analysis)
  • Description of the sexual behaviors of infected patients, through a semi-directed interview.

Study Type

Observational

Enrollment (Actual)

29

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

  • France
      • Bordeaux, France
        • Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Men who have sex with Men co-infected HIV-HCV

Description

Inclusion Criteria:

  • Patient older than 18 years
  • HIV-1 and/or HIV-2 confirmed Infection
  • Men who have sex with Men
  • Patients included in the "ANRS CO3Aquitaine cohort".
  • HCV contamination documented over the period 01/01/2013 to 01/31/2017 (A positive HCV serology and a HCV plasma RNA positive) AND a negative HCV serology OR a positive HCV serology and a negative plasma RNA before inclusion period
  • A person who has received information about the protocol and has given oral consent and that his / her non-opposition is documented in his / her medical file.

Exclusion Criteria:

  • Transfusion contamination
  • Substance abuse IV out of SLAM context
  • Refusal to consent to research.

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
Intervention / Treatment
MSM co-infected HIV-HCV
Behavioral: semi-directed interviews
semi-directed interviews in order to collect socio-behavioral data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analyse sexual behaviours among HIV positive MSM in Bordeaux, through semi-directed interviews
Time Frame: At inclusion (day 0)
At inclusion (day 0)

Secondary Outcome Measures

Outcome Measure
Time Frame
Identifying socio-sexual networks through phylogenetic analysis
Time Frame: At inclusion (day 0)
At inclusion (day 0)
Describing the natural history of sexual hepatitis C in HIV positive MSM
Time Frame: At inclusion (day 0)
At inclusion (day 0)

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Chair: Linda WITTKOP, MD, PhD, Université de Bordeaux - ISPED - Inserm 2129 - CHU de Bordeaux
  • Principal Investigator: Charles CAZANAVE, Prof, University Hospital Bordeaux, France

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)

November 8, 2017

Primary Completion (Actual)

March 13, 2018

Study Completion (Actual)

March 13, 2018

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2017/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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