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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Le SPOT

    Paris, Île-de-France Region, 75011

Other trials in France

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:

  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.

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 groups in NCT05949814
Study groupRoleWhat they receive
HIV-negative men who have sex with men (MSM) and transgender personsNot 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.

  1. 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)
  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

    Measured: Day 0

  2. 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

  3. 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.

  1. First posted18 Jul 2023
  2. Study start30 Jul 2023
  3. Primary completion15 Apr 2025
  4. Study completion15 Jul 2025

Resources

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)
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

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.

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