Sexual; Sexual DesireChemsexNCT04584229
Chemsex, Perceived Risks and Coping Strategies.
An observational study of Sexual; Sexual Desire and Illicit Drugs, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The research hypothesis is that access to prevention and harm and risk reduction associated with the use of psychoactive substances in a sexual context is insufficient for MSM practicing chemsex. This would lead to a lack of awareness of the risks taken and insufficient or inadequate strategies to protect themselves. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sexual; Sexual Desire, Illicit Drugs, MSM
- What is being tested?
- Intervention
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2019to 30 Dec 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: men who have sex with other men
Who may be able to join
- an age greater than or equal to 18 years
- being a man having sex with men
- having used psychoactive substances in a sexual context at least once in the past 12 months.
Who cannot join
- to refuse to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chemsex Among Men Who Have Sex With Men : Perceived Risks and Coping Strategies, a Qualitative Study.
The research hypothesis is that access to prevention and harm and risk reduction associated with the use of psychoactive substances in a sexual context is insufficient for MSM practicing chemsex. This would lead to a lack of awareness of the risks taken and insufficient or inadequate strategies to protect themselves.
This qualitative study has a comprehensive objective. The aim is to identify the risks perceived by MSM practicing Chemsex and their coping strategies. The study is based on individual semi-directed interviews and focus group. The criteria for inclusion are: an age greater than or equal to 18 years, being a man having sex with men and having used psychoactive substances in a sexual context at least once in the past 12 months. Participants were recruited through a gay geo-social networking app on mobile phones on a voluntary basis. At the same tim+e, flyers presenting the study are also distributed to the "chemsex" consultations at the Montpellier University Hospital in France as well as to an association fighting against AIDS in Montpellier.
Data are subjected to an inductive method analysis, bringing out by constant comparison conceptualizing categories illustrating the experience and making it possible to identify and understand the risks felt and the coping strategies.
- Conditions
- Sexual; Sexual Desire, Illicit Drugs, MSM
- Being tested
- Intervention
- Keywords
- screening, MSM, Qualitative research, HIV transmission, men who have sex with men, Risk Reduction Behavior, Harm Reduction, recreational drugs, Sexualised drug use
- Medical subject headings
- Coitus, Substance-Related Disorders, Homosexuality, Risk Reduction Behavior, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Intervention: comprehensive individual or collective interview, recorded and transcribed
| Study group | Role | What they receive |
|---|---|---|
| question not suitable for study | question not suitable for study Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemsex Paretic Risk Assessment
Chemsex Paretic Risk Assessment
Measured: 1 day
Secondary outcomes (1)
Description of the population leaving Chemsex
Description of the population leaving 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 posted12 Oct 2020
- Study start30 Oct 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual; Sexual DesireStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Donnadieu-Rigole, MD, PHD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584229
- Sponsor's protocol ID
- RECHMPL19_0091
- Acronym
- Chemsex
- Status last verified
- Nov 2020
- First submitted
- 6 Oct 2020
- Last updated
- 18 Nov 2020
- 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 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemsex Among Men Who Have Sex With Men : Perceived Risks and Coping Strategies, a Qualitative Study.
- ClinicalTrials.gov ID
- NCT04584229
- Acronym / sponsor ID
- Chemsex / RECHMPL19_0091
- Conditions
- Sexual; Sexual Desire, Illicit Drugs, MSM
- Keywords
- screening, MSM, Qualitative research, HIV transmission, men who have sex with men, Risk Reduction Behavior, Harm Reduction, recreational drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 12 Oct 2020 (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 research hypothesis is that access to prevention and harm and risk reduction associated with the use of psychoactive substances in a sexual context is insufficient for MSM practicing chemsex. This would lead to a lack of awareness of the risks taken and insufficient or inadequate strategies to protect themselves.
This qualitative study has a comprehensive objective. The aim is to identify the risks perceived by MSM practicing Chemsex and their coping strategies. The study is based on individual semi-directed interviews and focus group. The criteria for inclusion are: an age greater than or equal to 18 years, being a man having sex with men and having used psychoactive substances in a sexual context at least once in the past 12 months. Participants were recruited through a gay geo-social networking app on mobile phones on a voluntary basis. At the same tim+e, flyers presenting the study are also distributed to the "chemsex" consultations at the Montpellier University Hospital in France as well as to an association fighting against AIDS in Montpellier.
Data are subjected to an inductive method analysis, bringing out by constant comparison conceptualizing categories illustrating the experience and making it possible to identify and understand the risks felt and the coping strategies.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| question not suitable for study | – | Other: Interventionquestion not suitable for study |
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 other men
Key inclusion criteria (3 listed)
- an age greater than or equal to 18 years
- being a man having sex with men
- having used psychoactive substances in a sexual context at least once in the past 12 months.
Key exclusion criteria (1 listed)
- to refuse to participate to the study
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 |
|---|---|---|
| InterventionIntervention: comprehensive individual or collective interview, recorded and transcribed | Other | question not suitable for study |
Primary outcome
Chemsex Paretic Risk Assessment
Time frame: 1 day
Chemsex Paretic Risk Assessment
1 secondary outcome
Description of the population leaving Chemsex
Time frame: 1 day
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 18 Nov 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Hélène Donnadieu-Rigole, MD, PHD study director
University Hospital, Montpellier
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 Sexual; Sexual Desire and Illicit Drugs, run by University Hospital, Montpellier 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 3 inclusion and 1 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 18 Nov 2020. 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?
Chemsex Paretic Risk Assessment (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 18 Nov 2020.