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

NCT06996938 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-05-30

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

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

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-21
Primary Completion
2027-12-30
Completion
2028-06-15

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06996938 on ClinicalTrials.gov