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

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ClinicalTrials.gov Identifier: NCT03290755
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus (HIV) Hepatitis c Behavioral: semi-directed interviews

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
Estimated Enrollment : 72 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Analyse sexual behaviours among HIV positive MSM in Bordeaux, through semi-directed interviews [ Time Frame: At inclusion (day 0) ]

Secondary Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men who have sex with Men co-infected HIV-HCV
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290755


Contacts
Contact: Charles CAZANAVE, Prof (0)5 56 79 55 23 ext +33 charles.cazanave@chu-bordeaux.fr
Contact: Olivier LELEUX (0)5 57 57 45 44 ext +33 olivier.leleux@u-bordeaux.fr

Locations
France
Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin Recruiting
Bordeaux, France
Contact: Charles CAZANAVE, Prof    (0)5 56 79 55 23 ext +33    charles.cazanave@chu-bordeaux.fr   
Contact: Olivier LELEUX    (0)5 57 57 45 44 ext +33    olivier.leleux@u-bordeaux.fr   
Principal Investigator: Charles CAZANAVE, Prof         
Sponsors and Collaborators
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

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03290755     History of Changes
Other Study ID Numbers: CHUBX 2017/01
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Hepatitis C
sexual network
sexual transmitted
men who have sex with men
HIV positive
sexual behaviour

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Seropositivity
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases