PrEVE: Evaluation of the Acceptability and Impact of a Sexual Health Screening and Prevention Program for Vulnerable Women in the Greater Paris Region
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of women in vulnerable situations who accepted sexual health testing the HIV/Syphilis
研究概览
简要总结
Globally, women accounted for more than half of people living with HIV (53%) in 2022. In France, 54% of new infections were heterosexual in 2022, 71% of whom were born abroad, mainly in sub-Saharan Africa (74%). Among women, 80% of new cases were born abroad, of which at least 30% contracted HIV after arriving in France, often in connection with social vulnerability as shown by the French study Parcours. In the Paris region, 1,243 new cases among women were registered between 2018 and 2021 (about 300 per year).
Unstable housing, experiences of violence, lack of residence permits and sex trade increase the risk of HIV among women. Positive test migrants often report a higher frequency of forced sex. These women also face high risks of other STIs, unwanted pregnancies, violence and mental health problems.
PrEP is a means of preventing HIV infection by taking an antiretroviral drug, which has been fully proven to be effective in the form of tablets or injections. Pre-Exposure Prophylaxis (PrEP) is part of a comprehensive prevention service pathway.
Despite the free availability of PrEP in France from 2027 and essential monitoring tools for men and women at high risk, women at risk remain largely uncovered by prevention initiatives, making them a "hidden population" under-studied. In France, recent data show that only 5% of PrEP users are women, compared to 95% of men, mainly men who have sex with men (MSM).
Several factors hinder access to PrEP, including limited knowledge of available services, misperceptions of risk (because women rarely initiate sexual intercourse), fear of stigma and lack of resources. In addition, France lacks comprehensive programs that integrate health care, sexual health, mental health and social and legal support for these women.
The PrEVE study aims to demonstrate that the involvement of community-based organizations can play an important role in engaging and retaining women in vulnerable situations in a sexual health program. This program provides information, screening and prophylaxis to meet the specific sexual health needs of vulnerable women.
详细描述
Overall, HIV prevalence among girls and women is higher than that of boys and men since the 2000s. For example, UNAIDS data in 2022 shows that 53% of people living with HIV (PLHIV) are girls and women, or about 21 million people, and 46% of new HIV infections are girls and women.
This difference is due to a higher risk of HIV infection among girls and young women, especially in Africa : UNAIDS pointed out in 2018 that HIV infections among girls and young women aged 15-19 are about twice as high globally as among boys and young men of the same age.
In France, women represent about 35% of PLHIV. Data from the French national hospital cohort of HIV infection show that 1,243 women were newly treated between 2018 and 2021 in Ile de France (IDF), which is about 300 new women taken care of per year. If you consider the population from sub-Saharan Africa, it represents 76% of women living with HIV (FVVIH) in IDF.
Women are at greater risk than men of HIV and other sexually transmitted infections (STIs) because of biological, anatomical characteristics that make transmission from male to female easier. Women have a larger mucous membrane area exposed to pathogens and infectious fluids during heterosexual sex and are likely to experience greater tissue damage.
Girls and women often face multiple, interconnected social, cultural and economic inequalities and are at increased risk of acquiring HIV and sexually transmitted infections (STIs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, 18 years of age or older
- •Living in Ile de France
- •In a vulnerable situation with at least one of the following two situations:
- •Social/economic vulnerability (without personal residence or residence permit of less than 2 years or expiring in less than 1 year or without social security/AME/PUMA (ex CMU)
- •Sexual vulnerability: occasional paid sex worker
- •Able to understand the objectives of the study
- •Having been informed of the study objectives and not opposed to participating in the study.
- •Having signed the consent form prior to any examination being performed in the study.
排除标准
- •Person protected by law, or not in a position to express their consent or subject to a measure of guardianship or safeguard of justice
研究组 & 干预措施
Vulnerable women
This is a prospective study, designed to evaluate the use of a sexual health prevention pathway including screening by rapid diagnostic orientation tests (TROD) HIV, Hepatitis, syphilis and the use of a sexual health prevention course for women in vulnerable situations (VF) living in the Île-de-France region.
干预措施: Rapid diagnostic orientation tests (TROD) HIV, Hepatitis, syphilis (Diagnostic Test)
结局指标
主要结局
Number of women in vulnerable situations who accepted sexual health testing the HIV/Syphilis
时间窗: between Day 0 and Month 6
Measure HIV/Syphilis assessed by rapid test using INSTI multiplex
Number of women in vulnerable situations who accepted sexual health testing the VHB
时间窗: between Day 0 and Month 6
Measure VHB assessed by rapid test using TOYO Ag HBs/ac anti-HBS
Number of women in vulnerable situations who accepted sexual health testing the VHC
时间窗: between Day 0 and Month 6
Measure VHC assessed by rapid test using INSTI HCV
次要结局
未报告次要终点