Evaluation of the Acceptability and Impact of a Sexual Health Screening and Prevention Program for Vulnerable Women

NCT06996938 | Recruiting DMC

• 2 other identifiers: CREPATS 182024-A01338-39
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Vulnerable Population

Outcome Measures

Primary Outcomes (3)

• Number of women in vulnerable situations who accepted sexual health testing the HIV/Syphilis

  Measure HIV/Syphilis assessed by rapid test using INSTI multiplex

  between Day 0 and Month 6

• Number of women in vulnerable situations who accepted sexual health testing the VHB

  Measure VHB assessed by rapid test using TOYO Ag HBs/ac anti-HBS

  between Day 0 and Month 6

• Number of women in vulnerable situations who accepted sexual health testing the VHC

  Measure VHC assessed by rapid test using INSTI HCV

  between Day 0 and Month 6

Study Arms (1)

Vulnerable women

EXPERIMENTAL

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.

Diagnostic Test: Rapid diagnostic orientation tests (TROD) HIV, Hepatitis, syphilis

Interventions

Rapid diagnostic orientation tests (TROD) HIV, Hepatitis, syphilis DIAGNOSTIC_TEST

The following information will be collected : * Socio-demographic characteristics * Lifestyle * Health status * Access to care and support in care * Life events/violence Knowledge of HIV prevention will be assessed It will be proposed to screen for potentially serious STIs in the absence of specific management. If one of these infections is detected, the women will be referred and accompanied to a specialized consultation in the medical centers participating in the study Women's needs in terms of health and access to care will be assessed: infections, gynecology, psychology, management of individual violence, sexual in particular, prophylaxis with regard to HIV

Vulnerable women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Person protected by law, or not in a position to express their consent or subject to a measure of guardianship or safeguard of justice

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead
• Gilead Sciences: collaborator

Study Sites (2)

Pitie-Salpetriere Hospital

Paris, 75013, France

RECRUITING

IKAMBERE Association

Saint-Denis, Île-de-France Region, 93200, France

RECRUITING

MeSH Terms

Interventions

Seroconversion

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Central Study Contacts

Yasmine DUDOIT, Project manager

CONTACT

+33 (0)1 42 16 41 81; yasmine.dudoit@aphp.fr

Christine KATLAMA, Professor

CONTACT

+33 (0)1 42 16 01 71; christina.katlama@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The PrEVE study is a prospective, community-based study conducted in the Île-de-France region. It assesses the acceptability of a sexual health prevention pathway including screening by rapid diagnostic orientation tests (TROD) HIV, hepatitis and syphilis among women in vulnerable situations, by consulting at a place dedicated to the precarious.

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: May 30, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 15, 2028
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)