Major Depressive Disorder in Patients Taking PrEPSAM-PNCT06944691
Mental Health and PreP
A study testing Major depressive disorder scale in people with Major Depressive Disorder in Patients Taking PrEP, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
According to ANSM, by June 2023, almost 85,000 people living in France had initiated medical monitoring for HIV PrEP since 2016. Since 2021, HIV PrEP can be prescribed for the first time in community clinics, in addition to hospital structures such as CeGIDDs, or by doctors specialising in infectious diseases, making… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder in Patients Taking PrEP
- What is being tested?
- Major depressive disorder scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Any adult being treated for HIV PrEP at one of the centres taking part in the study
- Have French social security coverage
Who cannot join
- Follow-up to HIV
- First consultation for PrEP
- Limited understanding of French to answer questionnaires
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevalence of Major Depressive Disorder in the Population of People Followed up for HIV PREP Consulting the Infectious Diseases Department of Saint-Antoine Hospital, APHP and in General Practices
According to ANSM, by June 2023, almost 85,000 people living in France had initiated medical monitoring for HIV PrEP since 2016. Since 2021, HIV PrEP can be prescribed for the first time in community clinics, in addition to hospital structures such as CeGIDDs, or by doctors specialising in infectious diseases, making this preventive treatment for HIV more accessible. The population undergoing PrEP treatment is typically men who have sex with men (MSM), living in the Ile-De-France region, with an average age of 36 and social security cover.
In view of the growing number of people being monitored for HIV PrEP, particularly in general practice, which accounts for 80% of prescribers in private practice, and which will increase from 19% of initiations in 2021 to 42% in 2023, it seems essential not to ignore the occurrence of comorbidities, in order to better prevent or detect pathologies that may occur during the monitoring of these people. It appears that mental illnesses, and in particular major depressive disorder or anxiety disorders, as well as addictions, are present in many people receiving PrEP treatment. A study carried out in Canada found a prevalence of depressive disorders of almost 24%, alcohol use disorders for almost 32% and moderate to severe substance use for 43.3% of their study population. While some studies have highlighted the possibility of a reduction in anxiety, depression and addictions in patients using HIV PrEP, no study seems to have looked at the prevalence of depression in this specific population, which is exposed to more traumatic events, aggression or violence, and addictive behaviour, themselves associated with more depressive or anxious symptoms.
To date, there is little information on the psychiatric comorbidities of patients undergoing HIV PrEP, apart from elements purely associated with PrEP (compliance, adherence to treatment or follow-up). In the context of prevention as part of primary care monitoring, it seems necessary to better identify these comorbid pathologies in this specific population, using the opportunity of PrEP monitoring to initiate treatment where appropriate.
Read the detailed description
Given the gradual opening up of general practitioners to the initial prescription and monitoring of PrEP, their role in the identification and prevention of mental illness remains more than useful, and they can compensate for certain shortcomings in the context of hospital monitoring, boasting a certain territorial proximity, greater availability and more comprehensive patient management. Given the lack of data in France on the prevalence of mental illness, and in particular of major depressive disorder, the investigator wanted to gain a better understanding of these psychiatric illnesses in our patients undergoing PrEP in general practices and hospitals, by carrying out questionnaires recommended by the Haute Autorité de Santé (HAS) for monitoring the general population. Our study will thus make it possible to improve the data concerning the prevalence of major depressive disorder in patients being monitored for PrEP, potentially playing a role in adherence to treatment. Secondly, this study aims to provide a better description of the risk factors for these mental pathologies in this specific population by describing socio-demographic characteristics and sexual behavior, and to determine whether or not PrEP takes precedence over psychiatric management and the prevalence of psychotropic drugs in patients undergoing PrEP treatment.
The investigator want to assess the prevalence of anxiety and depressive disorders using hetero-questionnaires recommended by the French National Authority for Health, namely the Hamilton Depression Rating Scale (HDRS) for depression. Our secondary aim is to investigate the potential clinical characteristics of these disorders in patients undergoing PrEP treatment, for future, more substantial studies. Thus, by carrying out these questionnaires, screening for these disorders could be accompanied by a change in their medical management, through standardized management of depression, as described by the HAS.
- Being tested
- Major depressive disorder scale
- Keywords
- Depression, mental disorders, HIV, Pre-exposure Prophylaxis
- Medical subject headings
- Depression, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major depressive disorder scaleOther
Also called Hamilton Depression Rating Scale (HDRS)
Pass HDRS to patient taking PrEP to study prevalence of Major Depressive Disorder
| Study group | Role | What they receive |
|---|---|---|
| One group to study a prevalence | Other | Not described Receives: Other: Major depressive disorder scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Depressive Disorder
Pass questionnary to evaluate the prevalence of major depressive disorder
Measured: at inclusion visit Day 1
Secondary outcomes (4)
Describe the factors associated with this psychiatric entity in the overall study population
Pass questionary
Measured: at inclusion visit Day 1
Clinical characterization of depressive episodes
Evaluate the contribution of questionary in the screening of depressive episodes with regard to the clinician's response
Measured: at inclusion visit Day 1
Description of the the treatment plan for depressive disorders, i.e. before or after PrEP monitoring
Pass questionary
Measured: at inclusion visit Day 1
Prevalence of co-prescriptions
Describe the prevalence of co-prescriptions of HIV PrEP and psychotropic drugs (drugs used to treat mental illness).
Measured: at inclusion visit Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder in Patients Taking PrEPStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibault Chiarabini, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944691
- Sponsor's protocol ID
- APHP241798
- Acronym
- SAM-P
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 25 Apr 2025
- 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Major Depressive Disorder in the Population of People Followed up for HIV PREP Consulting the Infectious Diseases Department of Saint-Antoine Hospital, APHP and in General Practices
- ClinicalTrials.gov ID
- NCT06944691
- Acronym / sponsor ID
- SAM-P / APHP241798
- Keywords
- Depression, mental disorders, HIV, Pre-exposure Prophylaxis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 25 Apr 2025 (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.
According to ANSM, by June 2023, almost 85,000 people living in France had initiated medical monitoring for HIV PrEP since 2016. Since 2021, HIV PrEP can be prescribed for the first time in community clinics, in addition to hospital structures such as CeGIDDs, or by doctors specialising in infectious diseases, making this preventive treatment for HIV more accessible. The population undergoing PrEP treatment is typically men who have sex with men (MSM), living in the Ile-De-France region, with an average age of 36 and social security cover.
In view of the growing number of people being monitored for HIV PrEP, particularly in general practice, which accounts for 80% of prescribers in private practice, and which will increase from 19% of initiations in 2021 to 42% in 2023, it seems essential not to ignore the occurrence of comorbidities, in order to better prevent or detect pathologies that may occur during the monitoring of these people. It appears that mental illnesses, and in particular major depressive disorder or anxiety disorders, as well as addictions, are present in many people receiving PrEP treatment. A study carried out in Canada found a prevalence of depressive disorders of almost 24%, alcohol use disorders for almost 32% and moderate to severe substance use for 43.3% of their study population. While some studies have highlighted the possibility of a reduction in anxiety, depression and addictions in patients using HIV PrEP, no study seems to have looked at the prevalence of depression in this specific population, which is exposed to more traumatic events, aggression or violence, and addictive behaviour, themselves associated with more depressive or anxious symptoms.
To date, there is little information on the psychiatric comorbidities of patients undergoing HIV PrEP, apart from elements purely associated with PrEP (compliance, adherence to treatment or follow-up). In the context of prevention as part of primary care monitoring, it seems necessary to better identify these comorbid pathologies in this specific population, using the opportunity of PrEP monitoring to initiate treatment where appropriate.
Detailed description
Given the gradual opening up of general practitioners to the initial prescription and monitoring of PrEP, their role in the identification and prevention of mental illness remains more than useful, and they can compensate for certain shortcomings in the context of hospital monitoring, boasting a certain territorial proximity, greater availability and more comprehensive patient management. Given the lack of data in France on the prevalence of mental illness, and in particular of major depressive disorder, the investigator wanted to gain a better understanding of these psychiatric illnesses in our patients undergoing PrEP in general practices and hospitals, by carrying out questionnaires recommended by the Haute Autorité de Santé (HAS) for monitoring the general population. Our study will thus make it possible to improve the data concerning the prevalence of major depressive disorder in patients being monitored for PrEP, potentially playing a role in adherence to treatment. Secondly, this study aims to provide a better description of the risk factors for these mental pathologies in this specific population by describing socio-demographic characteristics and sexual behavior, and to determine whether or not PrEP takes precedence over psychiatric management and the prevalence of psychotropic drugs in patients undergoing PrEP treatment.
The investigator want to assess the prevalence of anxiety and depressive disorders using hetero-questionnaires recommended by the French National Authority for Health, namely the Hamilton Depression Rating Scale (HDRS) for depression. Our secondary aim is to investigate the potential clinical characteristics of these disorders in patients undergoing PrEP treatment, for future, more substantial studies. Thus, by carrying out these questionnaires, screening for these disorders could be accompanied by a change in their medical management, through standardized management of depression, as described by the HAS.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group to study a prevalence | Other | Other: Major depressive disorder scale |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any adult being treated for HIV PrEP at one of the centres taking part in the study
- Have French social security coverage
Key exclusion criteria (3 listed)
- Follow-up to HIV
- First consultation for PrEP
- Limited understanding of French to answer questionnaires
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 |
|---|---|---|
| Major depressive disorder scaleAlso: Hamilton Depression Rating Scale (HDRS)Pass HDRS to patient taking PrEP to study prevalence of Major Depressive Disorder | Other | One group to study a prevalence |
Primary outcome
Major Depressive Disorder
Time frame: at inclusion visit Day 1
Pass questionnary to evaluate the prevalence of major depressive disorder
4 secondary outcomes
Describe the factors associated with this psychiatric entity in the overall study population
Time frame: at inclusion visit Day 1
Clinical characterization of depressive episodes
Time frame: at inclusion visit Day 1
Description of the the treatment plan for depressive disorders, i.e. before or after PrEP monitoring
Time frame: at inclusion visit Day 1
Prevalence of co-prescriptions
Time frame: at inclusion visit Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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.
Thibault Chiarabini, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Major depressive disorder scale in people with Major Depressive Disorder in Patients Taking PrEP, run by Assistance Publique - Hôpitaux de Paris.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thibault Chiarabini, MD (01 71 97 01 19, thibault.chiarabini@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Depressive Disorder (time frame: at inclusion visit Day 1). 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 25 Apr 2025.