PrEP and Consumptions

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Terminated

CT.gov ID

NCT03449771

Collaborator

(none)

237

Enrollment

Locations

Arm

Actual Duration (Months)

47.4

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychoactive Substance Use Mood Disorders	Other: self-administered questionnaire	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

237 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 3, 2018

Actual Primary Completion Date :

Jul 3, 2019

Actual Study Completion Date :

Nov 3, 2019

Arms and Interventions

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).

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hospital of Alès	Alès	France	30100
2	Uh Montpellier	Montpellier	France	34090
3	CEGIDD	Nîmes	France	30900
4	UH NIMES	Nîmes	France	30900
5	Hospital of Perpignan	Perpignan	France	66000