Clinical trial NCT06226818: Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Official title: Assessing the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's or Traditional Health Centres: a Prospective, Quasi-experimental, Multicentre, National Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Domestic and/or Sexual Violence
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be identified by a doctor at one of the participating centres, on the basis of their response to the AAS questionnaire during the initial consultation.

Brief summary: Gender-based or sexual violence, or violence against women (VAW), is a global public health problem affecting around 30% of women over the age of 15, with significant consequences for physical and mental health, including depression and post-traumatic stress disorder (PTSD).

In 2019, the French National Authority for Health (HAS) published recommendations in two parts, one for identifying women who are victims of domestic violence, and the other for dealing with a woman who has been exposed to such violence. But violence against women is not limited to the marital sphere. VAW can simply be detected in a consultation using a translated version of the Abuse Assessment Screen (AAS) questionnaire.

Women who are victims of VAW have specific needs linked to the often repeated nature of the violence they experience, and the complex trauma that can ensue. They also tend to combine other risk factors for poor mental health, such as economic insecurity and social isolation. In France, dealing with the specific medical, psychosocial and legal needs of victims-survivors of VAW has come up against a number of obstacles, including a lack of dedicated care facilities, a lack of trained professionals and a lack of coordination between the various parties. Health professionals rarely receive the training they need to deal with VAW-related issues with confidence and professionalism, and often lack the resources to refer female victims to appropriate care.

"La Maison des Femmes" (MdF) was set up in 2016 in Saint-Denis, located in a department where a quarter of the women who consult a family planning centre (FPC) has suffered from VAW. It is a hospital service specifically dedicated to the individualised, multidisciplinary care of victims-survivors of VAW, offering health, social and legal support within the same facility. The MdF comprises 4 units: a FPC, a violence management unit (involving doctors, midwives, psychologists, social workers, lawyers, police officers and support groups), a female genital mutilation management unit (surgeons and sexologists) and a 24/7 reception unit for victims of sexual violence.

Several MdF-inspired care structures have been set up in France. The service provided by these facilities needs to be evaluated, particularly in terms of their ability to improve the physical and mental health, including post-traumatic stress, of women who have been victims of VAW.


Eligibility criteria: Inclusion Criteria:

* Women who have not objected to taking part in the trial
* Adult women (≥18 years),
* Victim of domestic and/or sexual violence, consulting at one of our study centres. Exposure to violence, whatever the initial reason for consultation, will be determined by a positive response to at least one question on the French version of the Abuse Assessment Screen, a standardised screening tool which has the advantage of not being limited to domestic violence.
* Ability to understand the objectives of the study and to answer the questionnaires

Exclusion Criteria:

* Not affiliated to the national health insurance system
* Person under legal protection (curatorship, guardianship)
* Person under court order
* Adult who is unable to express his/her non-opposition
* Minor

Primary outcomes:
measure: Change in mean PCL-5 score
timeFrame: Through study completion, an average of 6 months
measure: Change in the proportion of women with a PCL-5 score < 33 (validated threshold for absence of overt PTSD)
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: