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TerminatedNCT03449771PrEPUpdated Dec 30, 2021

PrEP and Consumptions

An interventional study of self-administered questionnaire in Psychoactive Substance Use and Mood Disorders, sponsored by University Hospital, Montpellier. Terminated at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-30.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other

Why this study was terminated
Inclusion of the last patient
Phase
Not applicable
Study type
Interventional
Enrollment
237
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Psychoactive Substance Use
  • Mood Disorders

Keywords

  • HIV
  • Pre-exposure prophylaxis
  • Recreational drugs
  • Chemsex
  • Mental disorders
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Subject not speaking French / illiterate
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
237 participants (actual)

Study arms

  • 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

Interventions

  • Otherself-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).

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year after the study start date

06

Study locations

5 sites
  • Hospital of Alès
    Alès, 30100, France
  • Uh Montpellier
    Montpellier, 34090, France
  • CEGIDD
    Nîmes, 30900, France
  • UH NIMES
    Nîmes, 30900, France
  • Hospital of Perpignan
    Perpignan, 66000, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03449771
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Jan 3, 2018
Primary completion
Jul 3, 2019
Completion
Nov 3, 2019
Last update
Dec 30, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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