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PrEP and Consumptions

NCT03449771 — Not applicable, Terminated, 237 participants, University Hospital, Montpellier

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

RegistryNCT03449771, acronym PrEP
StatusTerminated - Inclusion of the last patient
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, other
Enrollment237 (Actual)
SponsorUniversity Hospital, Montpellier (Other)
ConditionsPsychoactive Substance Use, Mood Disorders
Interventionsself-administered questionnaire (Other)
Datesstart 2018-01-03, primary completion 2019-07-03, completion 2019-11-03, first posted 2018-02-28, last updated 2021-12-30
Locations5 sites in France

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Single ArmExperimentalOther: self-administered questionnaireTo 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.
  • self-administered questionnaire (Other): 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).

+Outcome measures

Primary outcomes

  • 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

Sex: All, ages: 18 Years to any

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

+Locations (5)

FacilityCityCountryStatus
Hospital of AlèsAlèsFrance
Uh MontpellierMontpellierFrance
CEGIDDNîmesFrance
UH NIMESNîmesFrance
Hospital of PerpignanPerpignanFrance

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