Psychoactive Substance UsePrEPNCT03449771
PrEP and Consumptions
A study testing self-administered questionnaire in people with Psychoactive Substance Use and Mood Disorders, run by University Hospital, Montpellier at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychoactive Substance Use, Mood Disorders
- What is being tested?
- self-administered questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 5 sitesFrance
- Study dates
- 3 Jan 2018to 3 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subject not speaking French / illiterate
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hospital of Alès
Alès, 30100
Uh Montpellier
Montpellier, 34090
CEGIDD
Nîmes, 30900
UH NIMES
Nîmes, 30900
Hospital of Perpignan
Perpignan, 66000
About this study
Official title: Screening of Psychoactive Substances Use and Anxio-depressive Disorders in Consultation for HIV Pre-exposure Prophylaxis
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.
- Conditions
- Psychoactive Substance Use, Mood Disorders
- Being tested
- self-administered questionnaire
- Keywords
- HIV, Pre-exposure prophylaxis, Recreational drugs, Chemsex, Mental disorders
- Medical subject headings
- Mood Disorders, Chemsex, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after the study start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start3 Jan 2018
- Primary completion3 Jul 2019
- Study completion3 Nov 2019
Why it stopped: Inclusion of the last patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychoactive Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449771
- Sponsor's protocol ID
- 9878
- Acronym
- PrEP
- Status last verified
- Dec 2021
- First submitted
- 22 Feb 2018
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Psychoactive Substances Use and Anxio-depressive Disorders in Consultation for HIV Pre-exposure Prophylaxis
- ClinicalTrials.gov ID
- NCT03449771
- Acronym / sponsor ID
- PrEP / 9878
- Conditions
- Psychoactive Substance Use, Mood Disorders
- Keywords
- HIV, Pre-exposure prophylaxis, Recreational drugs, Chemsex, Mental disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion of the last patient
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Nov 2019 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subject not speaking French / illiterate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-administered questionnaireThe 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). | Other | Single Arm |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Inclusion of the last patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-administered questionnaire in people with Psychoactive Substance Use and Mood Disorders, run by University Hospital, Montpellier at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusion of the last patient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.