An observational study in HIV Infections and STI, sponsored by Centre de santé sexuelle Le 190. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Centre de santé sexuelle Le 190 · Observational
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.
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:
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 209 is close to the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →This is the only study on the registry with Centre de santé sexuelle Le 190 as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Men who have sex with men (MSM) and transgender (TG) individuals
Exclusion Criteria:
Diagnostic Test: acceptability of a PrEP program among HIV-negative MSM and TG
STI screening by rapid tests and self-sampling after contact on a geolocated community application or a community physical place of sociability
To assess the proportion of HIV-negative participants accepting PrEP at M1 (PrEP-naive or restarting after interruption), for whom PrEP was indicated at D0
The proportion of HIV-negative participants accepting PrEP at M1 (PrEP-naive or restarting after interruption), for whom PrEP was indicated at Day 0.
Time frame: Month 1
To assess rate of acceptance of screening for STIs (HIV, Hepatitis B (HBV), Hepatitis C (HCV), syphilis) by rapid diagnostic orientation test among contacts
Use the Rapid diagnostic orientation test for STIs with INSTI multiplex HIV/Syphilis, + INSTI HCV + TOYO kit HBs Ag / antiHBS ab
Time frame: Day 0
To assess the proportion of new HIV diagnoses/known HIV-positive status
Use the Rapid diagnostic orientation test for HIV with INSTI multiplex HIV/Syphilis
Time frame: Day 0
To assess the proportion of persons with STI and type of STI (syphilis, chlamydia, gonococcus)
Use the Rapid diagnostic orientation test for HIV with INSTI multiplex HIV/Syphilis and by self-sampling for chlamydia and gonococcus
Time frame: Day 3
Plan to share: No
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