Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05949814 |
| Other study ID # |
CSS1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 30, 2023 |
| Est. completion date |
December 15, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Centre de santé sexuelle Le 190 |
| Contact |
Anton Eremin |
| Phone |
+33 01 42 16 01 42 |
| Email |
anton.eremin[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Acceptability of a PrEP program among MSM and TG visiting a geolocated community application
or a community physical place of sociability and having accepted a targeted screening for
HIV, Hepatitis B, C and STIs.
Description:
HIV infection is a transmissible infection that remains a major public health concern in
2021, with an estimated 38.4 million people living with HIV worldwide and around 2.5 million
new infections. Despite therapeutic progress, wide access to screening, in France in
particular, HIV infection continues to spread among the populations most exposed to this
virus.
In France, 5,000 people discovered their HIV seropositivity in 2021. 44% of them are men who
have sex with men (MSM), of whom more than a quarter (27%) were born abroad. 2% of new
diagnoses concern transgender people2. Nearly half of people who discover their HIV status
live in Paris and Île de France.
The incidence of HIV infection remains high among the key population of men who have sex with
men. That of sexually transmitted infections (STIs) is increasing with more frequent
screening, in particular with the introduction of HIV pre-exposure prophylaxis (PrEP). A
national assessment in 2022 shows that PrEP remains mainly used by MSM, urban, educated and
economically advantaged. The large number of new HIV infections each year among MSM
encourages the identification of preventive actions to go to those who do not protect
themselves from HIV by PrEP, do not screen themselves for STIs.
Strategies for screening and prevention of STIs and HIV must be massively encouraged and
facilitated by various innovative approaches. It is important to reach out to populations who
rarely see caregivers for various reasons such as social/administrative vulnerability,
psychological vulnerability, non-disclosure of conditions of sexual exposure (sex workers,
MSM) . The various studies show that about 40% of MSM do not report their sexual orientation
to their general practitioner, and find themselves faced with a presumption of
heterosexuality in the primary care system.
The 190 center is the first sexual health center created in France, in 2010. Since then, it
has continued to develop expertise in Lesbian, Gay, Bisexual, Trans (LGBT+) health and, more
particularly, geared towards gay health. It is one of the main centers to have implemented
PrEP, as part of a range of care combining screening and treatment of STIs, specialized
monitoring of HIV infection, management of the mental health of users, support for users of
psychoactive products in a sexual context (Chemsex He opened THE ANTENNA in the premises of
SPOT with the aim of developing innovative strategies in partnership with community guides.
The AIDES association, created in 1984, is one of the most important associations in the
fight against HIV in the world, and the main one in France. It has developed many strategies,
largely based on the knowledge that people most at risk/concerned by HIV-AIDS have of their
communities. AIDES has opened Le SPOT in Paris, a free reception center for sexual health and
harm reduction, primarily targeting an MSM population highly vulnerable to HIV infection or
viral hepatitis.
Combining the activities of SPOT and L'ANTENNE makes it possible to combine the know-how of a
place of community intervention and, beyond that, of the employees and volunteers of the
AIDES association, with the practice of caring for a sexual health center that is today a
reference in its field of expertise. The two structures focus their development on the
implementation of new actions aimed at reducing the hidden epidemic of HIV infection and
viral hepatitis.
The clinical research team of the Infectious Diseases department has extensive historical
experience in HIV, invested in clinical research since the 1990s, and experience acquired in
sexual health (PrEP, STI) with participation in studies national ANRS PREVENIR, DOXYVAC,
Ganymede.
In total, taking into account the data from different studies, taking into account our
respective experiences and know-how, we postulate the following hypotheses:
1. MSM and TG community dating applications and places of sociability constitute an
interface of great interest for reaching an audience that does not spontaneously go to
places of care adapted to their specificities in terms of health risk vis-à-vis -vis HIV
and STIs.
2. The experience of the community guides, employees or volunteers, of the AIDES
association makes it possible to recruit, on these applications and places, the public
sought following spear-phishing strategies.
3. The screening proposal as it is designed (use of Rapid Diagnostic Orientation Tests for
serological screening, bacteriological self-sampling with dematerialized rendering),
responds well to a request from these users who, in fact, do not would not use
mainstream offerings or places identified as offering and prescribing PrEP.
4. Through an "all-in-one" facilitated screening proposal, in a single place, free of
charge, without an appointment, with immediate results, it becomes possible to bring
users who would be remote, through ignorance, lack of interest, or because of negative
representations of the tool or the related monitoring.
Based on a conversion rate of 3% of contacts into appointments, the objective of 24,333
contacts over one year is realistic given the difference in population density between the
Center Val de Loire region (65, 7 inhabitants per km2) and the Île-de-France region (1020.8
inhabitants per km2).
This is an observational, prospective study, over 6 months, offering MSM and TG attending a
geolocated community application or a community physical place of sociability, targeted
screening for HIV infection, hepatitis B, C and STIs and their management in the PrEP
strategy and treatment/prevention of STIs adapted to the results.
