NCT04709016

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

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

First Submitted

Initial submission to the registry

January 7, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 18, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
Last Updated

August 30, 2022

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

January 7, 2021

Last Update Submit

August 29, 2022

Conditions

Keywords

ChemsexPrEP

Outcome Measures

Primary Outcomes (1)

  • compare in an MSM and transgender population, the use of Chemsex depending on whether or not PrEP is taken

    inclusion

Secondary Outcomes (3)

  • Reported adherence to PrEP

    inclusion

  • The existence or not of psychological comorbidity and the existence of addictological care

    inclusion

  • The number of sexually transmitted infections at inclusion

    inclusion

Study Arms (1)

male or transgender patients

of sexual orientation MSM (men having sex with men) or bi-sexual, consultant in sexual health centers

Behavioral: self-questionnaire

Interventions

self-questionnaire assessing Chemsex's (drug use in a sexual context) consumption over the last 12 months

male or transgender patients

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale or transgender MSM or bi-sexual orientation
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study concerns subjects of male or transgender sex, of MSM or bi-sexual sexual orientation, consulting in sexual health centers.

You may qualify if:

  • 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)

You may not qualify if:

  • For the group "taking PrEP": adult taking PrEP for less than 3 months
  • Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMIT - Hôpital Bichat

Paris, 75018, France

Location

MeSH Terms

Conditions

Substance-Related DisordersChemsex

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersSexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 14, 2021

Study Start

March 18, 2021

Primary Completion

March 25, 2022

Study Completion

March 25, 2022

Last Updated

August 30, 2022

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations