Human Immunodeficiency Virus (HIV)HEPCSEXNCT03290755
Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux
An observational study of Human Immunodeficiency Virus (HIV) and Hepatitis c, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Hepatitis c
- What is being tested?
- semi-directed interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2017to 13 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men who have sex with Men co-infected HIV-HCV
Who may be able to join
- 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.
Who cannot join
- Transfusion contamination
- Substance abuse IV out of SLAM context
- Refusal to consent to research.
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin
Bordeaux
About this study
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.
- Conditions
- Human Immunodeficiency Virus (HIV), Hepatitis c
- Being tested
- semi-directed interviews
- Keywords
- Hepatitis C, sexual network, sexual transmitted, men who have sex with men, HIV positive, sexual behaviour
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis C, Homosexuality, HIV Seropositivity, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-directed interviewsBehavioural
semi-directed interviews in order to collect socio-behavioral data
| Study group | Role | What they receive |
|---|---|---|
| MSM co-infected HIV-HCV | Not described Receives: Behavioral: semi-directed interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyse sexual behaviours among HIV positive MSM in Bordeaux, through semi-directed interviews
Measured: At inclusion (day 0)
Secondary outcomes (2)
Identifying socio-sexual networks through phylogenetic analysis
Measured: At inclusion (day 0)
Describing the natural history of sexual hepatitis C in HIV positive MSM
Measured: At inclusion (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start8 Nov 2017
- Primary completion13 Mar 2018
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda WITTKOP, MD, PhD, Study chair, Université de Bordeaux - ISPED - Inserm 2129 - CHU de BordeauxCharles CAZANAVE, Prof, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290755
- Sponsor's protocol ID
- CHUBX 2017/01
- Acronym
- HEPCSEX
- Status last verified
- Nov 2018
- First submitted
- 19 Sep 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux
- ClinicalTrials.gov ID
- NCT03290755
- Acronym / sponsor ID
- HEPCSEX / CHUBX 2017/01
- Conditions
- Human Immunodeficiency Virus (HIV), Hepatitis c
- Keywords
- Hepatitis C, sexual network, sexual transmitted, men who have sex with men, HIV positive, sexual behaviour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSM co-infected HIV-HCV | – | Behavioral: semi-directed interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men who have sex with Men co-infected HIV-HCV
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Transfusion contamination
- Substance abuse IV out of SLAM context
- Refusal to consent to research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semi-directed interviewssemi-directed interviews in order to collect socio-behavioral data | Behavioural | MSM co-infected HIV-HCV |
Primary outcome
Analyse sexual behaviours among HIV positive MSM in Bordeaux, through semi-directed interviews
Time frame: At inclusion (day 0)
2 secondary outcomes
Identifying socio-sexual networks through phylogenetic analysis
Time frame: At inclusion (day 0)
Describing the natural history of sexual hepatitis C in HIV positive MSM
Time frame: At inclusion (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda WITTKOP, MD, PhD study chair
Université de Bordeaux - ISPED - Inserm 2129 - CHU de Bordeaux
Charles CAZANAVE, Prof principal investigator
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus (HIV) and Hepatitis c, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyse sexual behaviours among HIV positive MSM in Bordeaux, through semi-directed interviews (time frame: At inclusion (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.