Drug DependenceCONSUMENCT04709016
Drug Use During Sex and Its Impact on Taking PrEP (Pre-Exposure Prophylaxis) : CONSUME
An observational study of Drug Dependence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This is a cross-sectional, single-center observational study conducted from October 2020 to March 2021 in Ile de France at the infectious disease of CHU Bichat (PrEP and CeGIDD(Free Center for Information, Screening and Diagnosis of Infections by Human Immunodeficiency Viruses, Viral Hepatitis and Sexually Transmitted… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Drug Dependence
- What is being tested?
- self-questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2021to 25 Mar 2022
- 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: The study concerns subjects of male or transgender sex, of MSM or bi-sexual sexual orientation, consulting in sexual health centers.
Who may be able to join
- age> 18
- male or transgender
- MSM or bi-sexual orientation
- adult consultant at Bichat Hospital (CeGIDD or PrEP consultation)
- adult with a Smartphone (online self-questionnaire)
Who cannot join
- For the group "taking PrEP": adult taking PrEP for less than 3 months
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Chemsex (Drug Use in a Sexual Context) Among MSM (Men Who Have Sex With Men) and Transgender People in France, Whether or Not Taking PrEP, and Its Impact on PrEP Adherence
This is a cross-sectional, single-center observational study conducted from October 2020 to March 2021 in Ile de France at the infectious disease of CHU Bichat (PrEP and CeGIDD(Free Center for Information, Screening and Diagnosis of Infections by Human Immunodeficiency Viruses, Viral Hepatitis and Sexually Transmitted Infections) consultation). It concerns adult subjects of male or transgender sex, of MSM (men having sex with men) or bi-sexual orientation. The data are collected by self-questionnaire evaluating the consumption of Chemsex (drug use in a sexual context) over the last 12 months, the existence or not of addiction treatment, the history of STIs (sexually transmitted infections) and adherence to PrEP (for subjects taking PrEP) during the last sexual intercourse (ANRS questionnaire, used in the PREVENIR study).
- Conditions
- Drug Dependence
- Being tested
- self-questionnaire
- Keywords
- Chemsex, PrEP
- Medical subject headings
- Substance-Related Disorders, Chemsex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-questionnaireBehavioural
self-questionnaire assessing Chemsex's (drug use in a sexual context) consumption over the last 12 months
| Study group | Role | What they receive |
|---|---|---|
| male or transgender patients | of sexual orientation MSM (men having sex with men) or bi-sexual, consultant in sexual health centers Receives: Behavioral: self-questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare in an MSM and transgender population, the use of Chemsex depending on whether or not PrEP is taken
Measured: inclusion
Secondary outcomes (3)
Reported adherence to PrEP
Measured: inclusion
The existence or not of psychological comorbidity and the existence of addictological care
Measured: inclusion
The number of sexually transmitted infections at inclusion
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start18 Mar 2021
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug DependenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709016
- Sponsor's protocol ID
- 2020-A02182-37
- Acronym
- CONSUME
- Status last verified
- May 2021
- First submitted
- 7 Jan 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Chemsex (Drug Use in a Sexual Context) Among MSM (Men Who Have Sex With Men) and Transgender People in France, Whether or Not Taking PrEP, and Its Impact on PrEP Adherence
- ClinicalTrials.gov ID
- NCT04709016
- Acronym / sponsor ID
- CONSUME / 2020-A02182-37
- Conditions
- Drug Dependence
- Keywords
- Chemsex, PrEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 14 Jan 2021 (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.
This is a cross-sectional, single-center observational study conducted from October 2020 to March 2021 in Ile de France at the infectious disease of CHU Bichat (PrEP and CeGIDD(Free Center for Information, Screening and Diagnosis of Infections by Human Immunodeficiency Viruses, Viral Hepatitis and Sexually Transmitted Infections) consultation). It concerns adult subjects of male or transgender sex, of MSM (men having sex with men) or bi-sexual orientation. The data are collected by self-questionnaire evaluating the consumption of Chemsex (drug use in a sexual context) over the last 12 months, the existence or not of addiction treatment, the history of STIs (sexually transmitted infections) and adherence to PrEP (for subjects taking PrEP) during the last sexual intercourse (ANRS questionnaire, used in the PREVENIR study).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| male or transgender patients | – | Behavioral: self-questionnaireof sexual orientation MSM (men having sex with men) or bi-sexual, consultant in sexual health centers |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study concerns subjects of male or transgender sex, of MSM or bi-sexual sexual orientation, consulting in sexual health centers.
Key inclusion criteria (5 listed)
- age> 18
- male or transgender
- MSM or bi-sexual orientation
- adult consultant at Bichat Hospital (CeGIDD or PrEP consultation)
- adult with a Smartphone (online self-questionnaire)
Key exclusion criteria (2 listed)
- For the group "taking PrEP": adult taking PrEP for less than 3 months
- Refusal of participation
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 |
|---|---|---|
| self-questionnaireself-questionnaire assessing Chemsex's (drug use in a sexual context) consumption over the last 12 months | Behavioural | male or transgender patients |
Primary outcome
compare in an MSM and transgender population, the use of Chemsex depending on whether or not PrEP is taken
Time frame: inclusion
3 secondary outcomes
Reported adherence to PrEP
Time frame: inclusion
The existence or not of psychological comorbidity and the existence of addictological care
Time frame: inclusion
The number of sexually transmitted infections at inclusion
Time frame: inclusion
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 30 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Drug Dependence, run by Assistance Publique - Hôpitaux de Paris 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 5 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: finished, as of the sponsor's last update on 30 Aug 2022. 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?
compare in an MSM and transgender population, the use of Chemsex depending on whether or not PrEP is taken (time frame: inclusion). 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 30 Aug 2022.