Men Having Sex With Other MenChemsexNCT03956758
HIV Prevention During Chemsex
An observational study of Men Having Sex With Other Men, run by University Hospital, Montpellier.
Trial summary
In 2016, the number of discoveries of HIV seropositivity is estimated at about 6000 in France. Men who have sex with men (MSM) account for 44% of these infections (68% in the Occitanie region). For the past ten years, there have been new practices of sexual drug use among MSM referred to as Chemsex. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Men Having Sex With Other Men
- What is being tested?
- Semi-directed interview
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Apr 2019
- 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 to 80 years
- Men only
- Adult, Older adult
Study population: MSM living in Montpellier with negative HIV status, having at least one sexual intercourse under drug use during the last 12 months
Who may be able to join
- Men who have sex with men (MSM)
- living in Montpellier
- using chemsex drugs at least one during sexual intercourse
Who cannot join
- under 18 years
- seropositive HIV
About this study
Official title: The Reflexive Logics Structuring the Report to HIV Prevention of MSM Practicing ChemSex in the Context of Circulation of the PreP
In 2016, the number of discoveries of HIV seropositivity is estimated at about 6000 in France. Men who have sex with men (MSM) account for 44% of these infections (68% in the Occitanie region). For the past ten years, there have been new practices of sexual drug use among MSM referred to as Chemsex. These practices expose to sexual risks but also to those related to the consumption of drugs making this population more at risk to get infectious contaminations. In the "PREVAGAY study" conducted in Montpellier in 2015, about 30% of MSM included said they had consumed at least one psychoactive product before or during sex during the last 12 months. In addition, this percentage was significantly higher among HIV-positive men (51% versus 24% of HIV-negative men) and 1% (N = 9) had practiced Slam (Sexual Injection). The results of this study also showed that PreP (Prophylaxis Pre-exposure to HIV) was known by 52% of MSM included and 4% (N = 4) had already used it in the last 12 months. Several observations are needed: many ChemSex users do not use the PreP despite the fact that its effectiveness has been proven in many studies.
The social sciences have been studying the HIV epidemic since its emergence. In the era of HIV chronic disease, the sociologist Gabriel Girard wanted to question the pessimistic observation of epidemiological studies in his thesis work. Some contradictory logics explains this epidemiology of HIV which is maintained, particularly in Montpellier despite the arrival of the PreP.
The main objective of our study is to explore the reflexive logic structuring the report to HIV prevention by MSM practicing ChemSex in Montpellier, in the context of the appearance and dissemination of the PreP.
- Conditions
- Men Having Sex With Other Men
- Being tested
- Semi-directed interview
- Keywords
- MSM, Chemical sex, HIV prevention, HIV pre-exposure prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-directed interviewOther
Semi-directed interview on ChemSex practice
What is being measured
The primary outcome is the main question the study is designed to answer.
report to HIV
report to HIV contamination during Chemsex
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Apr 2019
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Why it stopped: Reclassification by Ethics Committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Men Having Sex With Other MenStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clemence GIRARD, Medical intern, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956758
- Sponsor's protocol ID
- RECHMPL19_0233
- Acronym
- Chemsex
- Status last verified
- Nov 2019
- First submitted
- 16 May 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reflexive Logics Structuring the Report to HIV Prevention of MSM Practicing ChemSex in the Context of Circulation of the PreP
- ClinicalTrials.gov ID
- NCT03956758
- Acronym / sponsor ID
- Chemsex / RECHMPL19_0233
- Conditions
- Men Having Sex With Other Men
- Keywords
- MSM, Chemical sex, HIV prevention, HIV pre-exposure prophylaxis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Reclassification by Ethics Committee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 21 May 2019 (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.
In 2016, the number of discoveries of HIV seropositivity is estimated at about 6000 in France. Men who have sex with men (MSM) account for 44% of these infections (68% in the Occitanie region). For the past ten years, there have been new practices of sexual drug use among MSM referred to as Chemsex. These practices expose to sexual risks but also to those related to the consumption of drugs making this population more at risk to get infectious contaminations. In the "PREVAGAY study" conducted in Montpellier in 2015, about 30% of MSM included said they had consumed at least one psychoactive product before or during sex during the last 12 months. In addition, this percentage was significantly higher among HIV-positive men (51% versus 24% of HIV-negative men) and 1% (N = 9) had practiced Slam (Sexual Injection). The results of this study also showed that PreP (Prophylaxis Pre-exposure to HIV) was known by 52% of MSM included and 4% (N = 4) had already used it in the last 12 months. Several observations are needed: many ChemSex users do not use the PreP despite the fact that its effectiveness has been proven in many studies.
The social sciences have been studying the HIV epidemic since its emergence. In the era of HIV chronic disease, the sociologist Gabriel Girard wanted to question the pessimistic observation of epidemiological studies in his thesis work. Some contradictory logics explains this epidemiology of HIV which is maintained, particularly in Montpellier despite the arrival of the PreP.
The main objective of our study is to explore the reflexive logic structuring the report to HIV prevention by MSM practicing ChemSex in Montpellier, in the context of the appearance and dissemination of the PreP.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- MSM living in Montpellier with negative HIV status, having at least one sexual intercourse under drug use during the last 12 months
Key inclusion criteria (3 listed)
- Men who have sex with men (MSM)
- living in Montpellier
- using chemsex drugs at least one during sexual intercourse
Key exclusion criteria (2 listed)
- under 18 years
- seropositive HIV
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 interviewSemi-directed interview on ChemSex practice | Other | – |
Primary outcome
report to HIV
Time frame: 1 day
report to HIV contamination during Chemsex
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: Undecided. NC
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.
Clemence GIRARD, Medical intern principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
An observational study of Men Having Sex With Other Men, run by University Hospital, Montpellier.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
report to HIV (time frame: 1 day). 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 19 Nov 2019.