PrEP and Consumptions

Not Applicable

Terminated

• Conditions: Mood Disorders; Psychoactive Substance Use
• Interventions: Other: self-administered questionnaire

• Registration Number: NCT03449771
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

HIV pre-exposure prophylaxis (PrEP) with Truvada®, a combination of two antiretrovirals (tenofovir \& emtricitabine) is a prevention strategy for HIV-negative people at high risk of acquiring HIV. PrEP has thus been integrated as a new tool to significantly reduce the risk of HIV infection, especially among men who have sex with men (MSM). Since its introduction, an increase in sexually transmitted infections (STIs) has been observed, particularly in relation to the use of psychoactive substances in a sexual context (Chemsex).

In this context, the description and evaluation of these practices seem necessary, as well as the impact on the risk of addiction and mental health.

Detailed Description

Interventional, multi-center pilot study, including all subjects aged 18 years or older presenting in consultation for a PrEP renewal.

The newsletter and a self-questionnaire will be systematically given in the waiting room to any PrEP consultant to evaluate the consumption of psychoactive substances (ASSIST questionnaire) and to identify anxio-depressive disorders (HAD questionnaire - Hospital Anxiety and Depression). scale). After consent, the answers will be discussed with the doctor during the consultation for appropriate care, including a referral to a psychiatrist and / or addictologist if necessary.

The duration of the inclusions will be 6 months and the number of patients to include is 250.

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-02-28
• Primary Completion: 2019-07-03
• Study Completion: 2019-11-03
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Subject aged over 18,
• Subject seen in consultation in one of the centers of the study for a renewal of the Prep
• Subject having agreed to participate in the study

Exclusion Criteria

• Subject not speaking French / illiterate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	self-administered questionnaire	To estimate the acceptability and the impact on the management of a systematic identification of the use of psychoactive substances and / or anxio-depressive disorders by self-questionnaire.

Primary Outcome Measures

Name	Time	Method
Estimate the acceptability and the impact on the management of a systematic identification of the use of psychoactive substances and / or anxio-depressive disorders by self-questionnaire in PrEP consultants	1 year after the study start date

Trial Locations

Locations (5)

Uh Montpellier; 🇫🇷 Montpellier, France

Hospital of Alès; 🇫🇷 Alès, France

CEGIDD; 🇫🇷 Nîmes, France

UH NIMES; 🇫🇷 Nîmes, France

Hospital of Perpignan; 🇫🇷 Perpignan, France