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Drug Use During Sex and Its Impact on Taking PrEP (Pre-Exposure Prophylaxis) : CONSUME

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT04709016
Collaborator
(none)
100
Enrollment
1
Location
12.2
Actual Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: self-questionnaire

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Mar 18, 2021
Actual Primary Completion Date :
Mar 25, 2022
Actual Study Completion Date :
Mar 25, 2022

Arms and Interventions

Arm Intervention/Treatment
male or transgender patients

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

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

Outcome Measures

Primary Outcome Measures

  1. compare in an MSM and transgender population, the use of Chemsex depending on whether or not PrEP is taken [inclusion]

Secondary Outcome Measures

  1. Reported adherence to PrEP [inclusion]

  2. The existence or not of psychological comorbidity and the existence of addictological care [inclusion]

  3. The number of sexually transmitted infections at inclusion [inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

  • Refusal of participation

Contacts and Locations

Locations

Site City State Country Postal Code
1 SMIT - Hôpital Bichat Paris France 75018

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04709016
Other Study ID Numbers:
  • 2020-A02182-37
First Posted:
Jan 14, 2021
Last Update Posted:
Apr 4, 2022
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Chemsex
PrEP
Additional relevant MeSH terms:
Substance-Related Disorders

Study Results

No Results Posted as of Apr 4, 2022