NCT03290755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

September 19, 2017

Last Update Submit

November 12, 2018

Conditions

Keywords

Hepatitis Csexual networksexual transmittedmen who have sex with menHIV positivesexual behaviour

Outcome Measures

Primary Outcomes (1)

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

    At inclusion (day 0)

Secondary Outcomes (2)

  • Identifying socio-sexual networks through phylogenetic analysis

    At inclusion (day 0)

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

    At inclusion (day 0)

Study Arms (1)

MSM co-infected HIV-HCV

Behavioral: semi-directed interviews

Interventions

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

MSM co-infected HIV-HCV

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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".
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin

Bordeaux, France

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHepatitis CHomosexualityHIV SeropositivityCoitus

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System DiseasesSexualitySexual BehaviorBehavior

Study Officials

  • Linda WITTKOP, MD, PhD

    Université de Bordeaux - ISPED - Inserm 2129 - CHU de Bordeaux

    STUDY CHAIR
  • Charles CAZANAVE, Prof

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 25, 2017

Study Start

November 8, 2017

Primary Completion

March 13, 2018

Study Completion

March 13, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations