PrEVE: Evaluation of the Acceptability and Impact of a Sexual Health Screening and Prevention Program for Vulnerable Women in the Greater Paris Region

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
France
Pitie-Salpetriere Hospital
RECRUITING
Paris
IKAMBERE Association
RECRUITING
Saint-denis
Contact Information
Primary
Yasmine DUDOIT, Project manager
yasmine.dudoit@aphp.fr
+33 (0)1 42 16 41 81
Backup
Christine KATLAMA, Professor
christina.katlama@aphp.fr
+33 (0)1 42 16 01 71
Time Frame
Start Date: 2025-03-21
Estimated Completion Date: 2028-06-15
Participants
Target number of participants: 200
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Collaborators: Gilead Sciences

This content was sourced from clinicaltrials.gov