Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06996938

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

Led by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida · Updated on 2025-05-30

200

Participants Needed

2

Research Sites

168 weeks

Total Duration

On this page

Sponsors

C

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

Lead Sponsor

G

Gilead Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, 18 years of age or older
  • Living in Ile de France
  • In a vulnerable situation with at least one of the following: social/economic vulnerability (no personal residence or residence permit less than 2 years or expiring in less than 1 year or without social security coverage)
  • Or sexual vulnerability as an occasional paid sex worker
  • Able to understand the study objectives
  • Informed about the study and not opposed to participating
  • Signed consent form prior to any study examinations
Not Eligible

You will not qualify if you...

  • Person protected by law or unable to give consent
  • Subject to guardianship or safeguard of justice measures

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Pitie-Salpetriere Hospital

Paris, France, 75013

Actively Recruiting

2

IKAMBERE Association

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

Actively Recruiting

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Research Team

Y

Yasmine DUDOIT, Project manager

CONTACT

C

Christine KATLAMA, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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