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Mental Health and PreP

NCT06944691 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-04-25

No results posted yet for this study

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 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.

Conditions

  • Major Depressive Disorder in Patients Taking PrEP

Interventions

OTHER

Major depressive disorder scale

Pass HDRS to patient taking PrEP to study prevalence of Major Depressive Disorder

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Thibault Chiarabini, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-09-30
Completion
2025-09-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06944691 on ClinicalTrials.gov