---
title: PrEP and Consumptions
nct_id: NCT03449771
overall_status: TERMINATED
phase: NA
sponsor: University Hospital, Montpellier
study_type: INTERVENTIONAL
primary_condition: Psychoactive Substance Use
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03449771.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03449771"
ct_last_update_post_date: 2021-12-30
last_seen_at: "2026-05-12T06:34:39.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# PrEP and Consumptions

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

**NCT ID:** [NCT03449771](https://clinicaltrials.gov/study/NCT03449771)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Inclusion of the last patient
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 237
- **Lead Sponsor:** University Hospital, Montpellier
- **Conditions:** Psychoactive Substance Use, Mood Disorders
- **Start Date:** 2018-01-03
- **Completion Date:** 2019-11-03
- **CT.gov Last Update:** 2021-12-30

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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:

* Subject not speaking French / illiterate
```

## Arms

- **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.

## Interventions

- **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).

## 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** _(time frame: 1 year after the study start date)_

## Locations (5)

- Hospital of Alès, Alès, France
- Uh Montpellier, Montpellier, France
- CEGIDD, Nîmes, France
- UH NIMES, Nîmes, France
- Hospital of Perpignan, Perpignan, France

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital of alès|alès||france` — added _(2026-05-12)_
- `locations.uh montpellier|montpellier||france` — added _(2026-05-12)_
- `locations.cegidd|nîmes||france` — added _(2026-05-12)_
- `locations.uh nimes|nîmes||france` — added _(2026-05-12)_
- `locations.hospital of perpignan|perpignan||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03449771.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03449771*  
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