Back to results

PrEP and Consumptions (PrEP)

Primary Purpose

Psychoactive Substance Use, Mood Disorders

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

self-administered questionnaire

About this trial

This is an interventional other trial for Psychoactive Substance Use focused on measuring HIV, Pre-exposure prophylaxis, Recreational drugs, Chemsex, Mental disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital of Alès
Uh Montpellier
CEGIDD
UH NIMES
Hospital of Perpignan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

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.

Outcomes

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03449771

First Posted

February 22, 2018

Last Updated

December 9, 2021

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT03449771

Brief Title

PrEP and Consumptions

Acronym

PrEP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Terminated

Why Stopped

Inclusion of the last patient

Study Start Date

January 3, 2018 (Actual)

Primary Completion Date

July 3, 2019 (Actual)

Study Completion Date

November 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychoactive Substance Use, Mood Disorders

Keywords

HIV, Pre-exposure prophylaxis, Recreational drugs, Chemsex, Mental disorders

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

237 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

self-administered questionnaire

Intervention Description

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).

Primary Outcome Measure Information:

Title

Time Frame

1 year after the study start date

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Hospital of Alès

City

Alès

ZIP/Postal Code

30100

Country

France

Facility Name

Uh Montpellier

City

Montpellier

ZIP/Postal Code

34090

Country

France

Facility Name

CEGIDD

City

Nîmes

ZIP/Postal Code

30900

Country

France

Facility Name

UH NIMES

City

Nîmes

ZIP/Postal Code

30900

Country

France

Facility Name

Hospital of Perpignan

City

Perpignan

ZIP/Postal Code

66000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

PrEP and Consumptions

We'll reach out to this number within 24 hrs