PrEP and Consumptions

Mood Disorders Clinical Trial

— PrEP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03449771
• Other study ID #: 9878
• Status: Terminated
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: November 3, 2019

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 237
• Est. completion date: November 3, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mood Disorders
• Psychoactive Substance Use
• Substance-Related Disorders

Intervention

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).

Locations

Country	Name	City	State
France	Hospital of Alès	Alès
France	Uh Montpellier	Montpellier
France	CEGIDD	Nîmes
France	UH NIMES	Nîmes
France	Hospital of Perpignan	Perpignan

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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