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

Drug Dependence Clinical Trial

— CONSUME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709016
• Other study ID #: 2020-A02182-37
• Status: Completed
• Start date: March 18, 2021
• Est. completion date: March 25, 2022

Study information

• Verified date: May 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 25, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Dependence
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
France	SMIT - Hôpital Bichat	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare in an MSM and transgender population, the use of Chemsex depending on whether or not PrEP is taken		inclusion
Secondary	Reported adherence to PrEP		inclusion
Secondary	The existence or not of psychological comorbidity and the existence of addictological care		inclusion
Secondary	The number of sexually transmitted infections at inclusion		inclusion