HIVCHEMSEXNCT03687281
Practice of "Chemical Sex" by HIV Patients in Reunion Island
An observational study of HIV, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
The term "CHEMSEX", short for "chemicals" and "sex", is used to define the consumption, regardless of the route of administration, of drugs or substances for recreational use, in a sexual context. No published data is currently available concerning this practice in Reunion Island. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV
- What is being tested?
- Survey
- How many people
- 245 participants
- Where
- 1 siteReunion
- Study dates
- 1 Jan 2018to 1 Jul 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: Patients living with HIV followed in Clinical Immunology service of Universitary Hospital Centre in Reunion Island
Who may be able to join
- Age greater than or equal to 18 years;
- Man having sex with men;
- Patients living with HIV;
- Followed at Universitary Hospital Center of Reunion Island;
- Able to answer a self-questionnaire in French;
- Having agreed to participate
Who cannot join
- Subject under legal protection;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on Practice of "Chemical Sex" by Men Having Sex With Men Living With HIV Followed at Reunion Island University Hospital Center
The term "CHEMSEX", short for "chemicals" and "sex", is used to define the consumption, regardless of the route of administration, of drugs or substances for recreational use, in a sexual context.
No published data is currently available concerning this practice in Reunion Island. However, an upsurge in cases of acute hepatitis C was observed at the end of 2016 (4 in 6 months) of which 3 were related to the practice of chemsex (data CeGGID Réunion) and the recent years have been marked by many cases related to drug trafficking and the arrival of substances still unknown on the island.
Given the rapid emergence of the phenomenon in metropolitan France and in the rest of the world, serious consequences that are both psychological, addictological and infectious, to take stock of this practice among MSM patients followed in Reunion Island seems essential. to establish a rapid, adequate and effective prevention and action plan.
Read the detailed description
The term "CHEMSEX", short for "chemicals" and "sex", is used to define the consumption, regardless of the route of administration, of drugs or substances for recreational use, in a sexual context.
Although the use of drugs and narcotics is not a novelty in sexual practice, however, there is a change in behavior. Indeed, the advent of synthetic products such as cathinones, easily obtained via the internet and at affordable prices has attracted a wider audience and has allowed in less than ten years, the amplification of this worrying phenomenon.
The described effects of cathinones are just as powerful as the classic drugs that were quickly supplanted: intellectual stimulation, exacerbation of the senses, euphoria, disinhibition, sexual arousal, relaxation.
These initially ingested or inhaled products are quickly injected for a greater rapidity of their hallucinogenic and psychostimulant effects. SLAM ("slap"), is the Anglo-Saxon term commonly used to describe the intravenous use of drugs in the context of sexual practices. The subjects are gradually led to modify and increase their consumption, for ever more effect.
The consequences of this practice are multiple and serious: addiction with all the risks incurred, psychiatric and infectious complications related to the sharing of contaminated material (endocarditis, hepatitis ...) and unprotected sex ratios favoring the transmission of STIs.
In the literature, all the studies on the subject concern men having sex with men, and more particularly patients living with HIV. Indeed, the prevalence of HIV is 70 to 82% among these practitioners.
European studies, particularly in London gay festive environnement, show the increasing use of these substances resulting in risky behavior. In recent years, STIs have been increasing and more particularly in the men having sex with men population.
No published data is currently available concerning this practice in Reunion Island. However, an upsurge in cases of acute hepatitis C was observed at the end of 2016 (4 in 6 months) of which 3 were related to the practice of chemsex (data CeGGID Réunion) and the recent years have been marked by many cases related to drug trafficking and the arrival of substances still unknown on the island.
Given the rapid emergence of the phenomenon in metropolitan France and in the rest of the world, serious consequences that are both psychological, addictological and infectious, to take stock of this practice among MSM patients followed in Reunion Island seems essential. to establish a rapid, adequate and effective prevention and action plan.
- Conditions
- HIV
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Also called CHEMSEX questionnaire
The questionnaire consists of three parts:
- knowledge assessment;
- socio-demographic, medical and lifestyle data;
- use of "Chemsex".
| Study group | Role | What they receive |
|---|---|---|
| Male patients living with HIV and having sex with men | Male patients living with HIV and having sex with men followed at Universitary Hospital Center of Reunion Island Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of recent chemsex practice
Proportion of subjects practicing chemsex on and off department (practice over the last 12 months)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Jan 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Prospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687281
- Sponsor's protocol ID
- 2017/CHU/03
- Acronym
- CHEMSEX
- Status last verified
- Sep 2018
- First submitted
- 26 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Practice of "Chemical Sex" by Men Having Sex With Men Living With HIV Followed at Reunion Island University Hospital Center
- ClinicalTrials.gov ID
- NCT03687281
- Acronym / sponsor ID
- CHEMSEX / 2017/CHU/03
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 27 Sep 2018 (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 term "CHEMSEX", short for "chemicals" and "sex", is used to define the consumption, regardless of the route of administration, of drugs or substances for recreational use, in a sexual context.
No published data is currently available concerning this practice in Reunion Island. However, an upsurge in cases of acute hepatitis C was observed at the end of 2016 (4 in 6 months) of which 3 were related to the practice of chemsex (data CeGGID Réunion) and the recent years have been marked by many cases related to drug trafficking and the arrival of substances still unknown on the island.
Given the rapid emergence of the phenomenon in metropolitan France and in the rest of the world, serious consequences that are both psychological, addictological and infectious, to take stock of this practice among MSM patients followed in Reunion Island seems essential. to establish a rapid, adequate and effective prevention and action plan.
Detailed description
The term "CHEMSEX", short for "chemicals" and "sex", is used to define the consumption, regardless of the route of administration, of drugs or substances for recreational use, in a sexual context.
Although the use of drugs and narcotics is not a novelty in sexual practice, however, there is a change in behavior. Indeed, the advent of synthetic products such as cathinones, easily obtained via the internet and at affordable prices has attracted a wider audience and has allowed in less than ten years, the amplification of this worrying phenomenon.
The described effects of cathinones are just as powerful as the classic drugs that were quickly supplanted: intellectual stimulation, exacerbation of the senses, euphoria, disinhibition, sexual arousal, relaxation.
These initially ingested or inhaled products are quickly injected for a greater rapidity of their hallucinogenic and psychostimulant effects. SLAM ("slap"), is the Anglo-Saxon term commonly used to describe the intravenous use of drugs in the context of sexual practices. The subjects are gradually led to modify and increase their consumption, for ever more effect.
The consequences of this practice are multiple and serious: addiction with all the risks incurred, psychiatric and infectious complications related to the sharing of contaminated material (endocarditis, hepatitis ...) and unprotected sex ratios favoring the transmission of STIs.
In the literature, all the studies on the subject concern men having sex with men, and more particularly patients living with HIV. Indeed, the prevalence of HIV is 70 to 82% among these practitioners.
European studies, particularly in London gay festive environnement, show the increasing use of these substances resulting in risky behavior. In recent years, STIs have been increasing and more particularly in the men having sex with men population.
No published data is currently available concerning this practice in Reunion Island. However, an upsurge in cases of acute hepatitis C was observed at the end of 2016 (4 in 6 months) of which 3 were related to the practice of chemsex (data CeGGID Réunion) and the recent years have been marked by many cases related to drug trafficking and the arrival of substances still unknown on the island.
Given the rapid emergence of the phenomenon in metropolitan France and in the rest of the world, serious consequences that are both psychological, addictological and infectious, to take stock of this practice among MSM patients followed in Reunion Island seems essential. to establish a rapid, adequate and effective prevention and action plan.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male patients living with HIV and having sex with men | – | Other: SurveyMale patients living with HIV and having sex with men followed at Universitary Hospital Center of Reunion Island |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients living with HIV followed in Clinical Immunology service of Universitary Hospital Centre in Reunion Island
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years;
- Man having sex with men;
- Patients living with HIV;
- Followed at Universitary Hospital Center of Reunion Island;
- Able to answer a self-questionnaire in French;
Key exclusion criteria (1 listed)
- Subject under legal protection;
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 |
|---|---|---|
| SurveyAlso: CHEMSEX questionnaireThe questionnaire consists of three parts: * knowledge assessment; * socio-demographic, medical and lifestyle data; * use of "Chemsex". | Other | Male patients living with HIV and having sex with men |
Primary outcome
Prevalence of recent chemsex practice
Time frame: Day 1
Proportion of subjects practicing chemsex on and off department (practice over the last 12 months)
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 28 Sep 2018.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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 HIV, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 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 28 Sep 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 Reunion. 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?
Prevalence of recent chemsex practice (time frame: Day 1). 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 28 Sep 2018.