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NCT06944691Not yet recruiting

Mental Health and PreP

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

Source: ClinicalTrials.gov · Last updated 25 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
600 (estimated)
First submitted
9 Apr 2025
Start date
Apr 2025
Primary completion date
Sept 2025
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Diseases
Depression, HIV
NCT number
NCT06944691

What you commit to

  • Study type: Interventional
  • Planned participants: 600
  • From Apr 2025 to the primary completion date, Sept 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Follow-up to HIV

Other

  • First consultation for PrEP
  • Limited understanding of French to answer questionnaires

Who the study is looking for

  • Any adult being treated for HIV PrEP at one of the centres taking part in the study
  • Have French social security coverage

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.