HIV InfectionsEASY-TESTSNCT05949814
EASY-TESTS: Evaluation of the Acceptability of Pre-exposure Prophylaxis (PrEP) Among Men Who Have Sex With Men (MSM) Who Accepted Targeted HIV/STI Testing, Recruited Through a Community-based Outreach Approach, Both Digital and In-person.
An observational study of HIV Infections and STI, run by Centre de santé sexuelle Le 190 at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, STI
- What is being tested?
- acceptability of a PrEP program among HIV-negative MSM and TG
- How many people
- 209 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2023to 15 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men who have sex with men (MSM) and transgender (TG) individuals
Who may be able to join
- Cisgender men, transgender men, and transgender women reporting sexual relations with men
- Age 18 years old
- Accepting an STIs screening after contact through a geolocated community application or a physical place of community sociability
- Given oral non-opposition to the anonymized use of the collected data
Who cannot join
- Planned stay in France <1 month
- Person under legal guardianship
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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:
- 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.
- 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.
- 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.
- 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.
- Conditions
- HIV Infections, STI
- Being tested
- acceptability of a PrEP program among HIV-negative MSM and TG
- Keywords
- HIV, Test, Pre-exposure prophylaxis
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acceptability of a PrEP program among HIV-negative MSM and TGDiagnostic test
STI screening by rapid tests and self-sampling after contact on a geolocated community application or a community physical place of sociability
| Study group | Role | What they receive |
|---|---|---|
| HIV-negative men who have sex with men (MSM) and transgender persons | Not described Receives: Diagnostic Test: acceptability of a PrEP program among HIV-negative MSM and TG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 1
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start30 Jul 2023
- Primary completion15 Apr 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de santé sexuelle Le 190
- Sponsor type
- University, hospital or other
- Collaborators
- Pitié-Salpêtrière Hospital
- Responsible party
- Sponsor
- Investigators
- Michel Ohayon, Dr, Principal investigator, Sexual Health Center 'Le 190'Christine Katlama, Pr, Study chair, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949814
- Sponsor's protocol ID
- CSS1
- Acronym
- EASY-TESTS
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EASY-TESTS: Evaluation of the Acceptability of Pre-exposure Prophylaxis (PrEP) Among Men Who Have Sex With Men (MSM) Who Accepted Targeted HIV/STI Testing, Recruited Through a Community-based Outreach Approach, Both Digital and In-person.
- ClinicalTrials.gov ID
- NCT05949814
- Acronym / sponsor ID
- EASY-TESTS / CSS1
- Conditions
- HIV Infections, STI
- Keywords
- HIV, Test, Pre-exposure prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Centre de santé sexuelle Le 190University, hospital or other
- Collaborators
- Pitié-Salpêtrière Hospital
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 18 Jul 2023 (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.
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.
Detailed 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:
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-negative men who have sex with men (MSM) and transgender persons | – | Diagnostic Test: acceptability of a PrEP program among HIV-negative MSM and TG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men who have sex with men (MSM) and transgender (TG) individuals
Key inclusion criteria (4 listed)
- Cisgender men, transgender men, and transgender women reporting sexual relations with men
- Age 18 years old
- Accepting an STIs screening after contact through a geolocated community application or a physical place of community sociability
- Given oral non-opposition to the anonymized use of the collected data
Key exclusion criteria (2 listed)
- Planned stay in France <1 month
- Person under legal guardianship
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 |
|---|---|---|
| acceptability of a PrEP program among HIV-negative MSM and TGSTI screening by rapid tests and self-sampling after contact on a geolocated community application or a community physical place of sociability | Diagnostic test | HIV-negative men who have sex with men (MSM) and transgender persons |
Primary outcome
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
Time frame: Month 1
The proportion of HIV-negative participants accepting PrEP at M1 (PrEP-naive or restarting after interruption), for whom PrEP was indicated at Day 0.
3 secondary outcomes
To assess rate of acceptance of screening for STIs (HIV, Hepatitis B (HBV), Hepatitis C (HCV), syphilis) by rapid diagnostic orientation test among contacts
Time frame: Day 0
To assess the proportion of new HIV diagnoses/known HIV-positive status
Time frame: Day 0
To assess the proportion of persons with STI and type of STI (syphilis, chlamydia, gonococcus)
Time frame: Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michel Ohayon, Dr principal investigator
Sexual Health Center 'Le 190'
Christine Katlama, Pr study chair
Pitié-Salpêtrière Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and STI, run by Centre de santé sexuelle Le 190 at 1 site in France.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Month 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 4 Sep 2025.