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.

NCT05949814 | Completed DMC

• 1 other identifier: CSS1
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; STI

Keywords

HIV; Test; Pre-exposure prophylaxis

Outcome Measures

Primary Outcomes (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.

  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

  Day 0

• To assess the proportion of new HIV diagnoses/known HIV-positive status

  Day 0

• To assess the proportion of persons with STI and type of STI (syphilis, chlamydia, gonococcus)

  Day 3

Study Arms (1)

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

Interventions

acceptability of a PrEP program among HIV-negative MSM and TG DIAGNOSTIC_TEST

STI screening by rapid tests and self-sampling after contact on a geolocated community application or a community physical place of sociability

HIV-negative men who have sex with men (MSM) and transgender persons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men who have sex with men (MSM) and transgender (TG) individuals

You may qualify if:

• 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

You may not qualify if:

• Planned stay in France \<1 month
• Person under legal guardianship

Sponsors & Collaborators

• Centre de santé sexuelle Le 190: lead
• Pitié-Salpêtrière Hospital: collaborator

Study Sites (1)

Le SPOT

Paris, Île-de-France Region, 75011, France

Location

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michel Ohayon, Dr

  Sexual Health Center 'Le 190'

  PRINCIPAL INVESTIGATOR

• Christine Katlama, Pr

  Pitié-Salpêtrière Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: July 30, 2023
• Primary Completion: April 15, 2025
• Study Completion: July 15, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)