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

Hepatitis c Clinical Trial

— HEPCSEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290755
• Other study ID #: CHUBX 2017/01
• Status: Completed
• Start date: November 8, 2017
• Est. completion date: March 13, 2018

Study information

• Verified date: November 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV Infections
• HIV Seropositivity
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Intervention

Behavioral:
• semi-directed interviews
semi-directed interviews in order to collect socio-behavioral data

Locations

Country	Name	City	State
France	Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analyse sexual behaviours among HIV positive MSM in Bordeaux, through semi-directed interviews		At inclusion (day 0)
Secondary	Identifying socio-sexual networks through phylogenetic analysis		At inclusion (day 0)
Secondary	Describing the natural history of sexual hepatitis C in HIV positive MSM		At inclusion (day 0)