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临床试验/NCT05949814
NCT05949814已完成不适用

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.

Centre de santé sexuelle Le 1901 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2023年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
209
试验地点
1
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)
  • 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)

研究者

发起方
Centre de santé sexuelle Le 190
申办方类型
Other
责任方
Sponsor

研究点 (1)

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