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CompletedNCT03290755HEPCSEXUpdated Nov 14, 2018

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

An observational study in Human Immunodeficiency Virus (HIV) and Hepatitis c, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-14.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
29
Ages
18 Years and older
Sex
Male
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Human Immunodeficiency Virus (HIV)
  • Hepatitis c

Keywords

  • Hepatitis C
  • sexual network
  • sexual transmitted
  • men who have sex with men
  • HIV positive
  • sexual behaviour
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • Transfusion contamination
  • Substance abuse IV out of SLAM context
  • Refusal to consent to research.
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
29 participants (actual)
Patient registry
No

Groups and cohorts

  • MSM co-infected HIV-HCV

    Behavioral: semi-directed interviews

Interventions

  • Behavioralsemi-directed interviews

    semi-directed interviews in order to collect socio-behavioral data

05

What researchers measure

Primary outcomes

  1. Analyse sexual behaviours among HIV positive MSM in Bordeaux, through semi-directed interviews

    Time frame: At inclusion (day 0)

Secondary outcomes

  1. Identifying socio-sexual networks through phylogenetic analysis

    Time frame: At inclusion (day 0)

  2. Describing the natural history of sexual hepatitis C in HIV positive MSM

    Time frame: At inclusion (day 0)

06

Study locations

1 site
  • Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin
    Bordeaux, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03290755
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Nov 8, 2017
Primary completion
Mar 13, 2018
Completion
Mar 13, 2018
Last update
Nov 14, 2018

Study contacts

Linda WITTKOP, MD, PhD
study chair · Université de Bordeaux - ISPED - Inserm 2129 - CHU de Bordeaux
Charles CAZANAVE, Prof
principal investigator · University Hospital Bordeaux, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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