NCT04584229

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

October 6, 2020

Last Update Submit

November 16, 2020

Conditions

Keywords

screeningMSMQualitative researchHIV transmissionmen who have sex with menRisk Reduction BehaviorHarm Reductionrecreational drugsSexualised drug use

Outcome Measures

Primary Outcomes (1)

  • Chemsex Paretic Risk Assessment

    Chemsex Paretic Risk Assessment

    1 day

Secondary Outcomes (1)

  • Description of the population leaving Chemsex

    1 day

Study Arms (1)

question not suitable for study

question not suitable for study

Other: Intervention

Interventions

Intervention: comprehensive individual or collective interview, recorded and transcribed

question not suitable for study

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

men who have sex with other men

You may qualify if:

  • 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.

You may not qualify if:

  • \- to refuse to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

CoitusSubstance-Related DisordersHomosexualityRisk Reduction BehaviorHarm Reduction

Interventions

Methods

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorChemically-Induced DisordersMental DisordersSexuality

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Hélène Donnadieu-Rigole, MD, PHD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 12, 2020

Study Start

October 30, 2019

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations