PrEP and Consumptions (PrEP)

Screening of Psychoactive Substances Use and Anxio-depressive Disorders in Consultation for HIV Pre-exposure Prophylaxis

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.

Study Overview

• Status: Terminated
• Conditions: Mood Disorders; Psychoactive Substance Use
• Intervention / Treatment: Other: self-administered questionnaire

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 Type: Interventional
• Enrollment (Actual): 237
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alès, France, 30100
    • Hospital of Alès
  • Montpellier, France, 34090
    • UH Montpellier
  • Nîmes, France, 30900
    • CeGIDD
  • Nîmes, France, 30900
    • UH Nîmes
  • Perpignan, France, 66000
    • Hospital of Perpignan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; 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.	Other: self-administered questionnaire; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): July 3, 2019
• Study Completion (Actual): November 3, 2019

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: HIV; Pre-exposure prophylaxis; Recreational drugs; Chemsex; Mental disorders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Mood Disorders
• Other Study ID Numbers: 9878 (Other Identifier: CTEP)

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
• product manufactured in and exported from the U.S.: No