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

August 29, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • SMIT - Hôpital Bichat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
compare in an MSM and transgender population, the use of Chemsex depending on whether or not PrEP is taken
Time Frame: inclusion
inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Reported adherence to PrEP
Time Frame: inclusion
inclusion
The existence or not of psychological comorbidity and the existence of addictological care
Time Frame: inclusion
inclusion
The number of sexually transmitted infections at inclusion
Time Frame: inclusion
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2021

Primary Completion (Actual)

March 25, 2022

Study Completion (Actual)

March 25, 2022

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02182-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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