NCT03449771

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2019

Completed
Last Updated

December 30, 2021

Status Verified

December 1, 2021

Enrollment Period

1.5 years

First QC Date

February 22, 2018

Last Update Submit

December 9, 2021

Conditions

Psychoactive Substance UseMood Disorders

Keywords

HIVPre-exposure prophylaxisRecreational drugsChemsexMental disorders

Outcome Measures

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

    1 year after the study start date

Study Arms (1)

Single Arm

EXPERIMENTAL

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

self-administered questionnaireOTHER

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).

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subject not speaking French / illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital of Alès

Alès, 30100, France

Location

Uh Montpellier

Montpellier, 34090, France

Location

CEGIDD

Nîmes, 30900, France

Location

UH NIMES

Nîmes, 30900, France

Location

Hospital of Perpignan

Perpignan, 66000, France

Location

MeSH Terms

Conditions

Mood DisordersChemsexMental Disorders

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

January 3, 2018

Primary Completion

July 3, 2019

Study Completion

November 3, 2019

Last Updated

December 30, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)