Study on Violence Against Vulnerable Women and Optimizing Support Services

NCT07701629 | Not Yet Recruiting

• 1 other identifier: APITHEM/2025/SR-01
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sexual and gender-based violence in France primarily affects women, who make up 88% of victims, with 670,000 affected annually. Many suffer abuse from partners, including 94,000 rape cases, and minors are heavily impacted. Despite frequent emergency visits, medical follow-up is inconsistent, and these violences significantly reduce women's healthy life expectancy. The study aims to assess quality of life improvements six months after multidisciplinary care in specialized centers like "La Maison des Femmes" (The Women's House).

Conditions

Female Genital Mutilation; Woman Abuse; Abuse, Sexual; Spouse Abuse

Keywords

Violence against women; Domestic violence; Quality of life; Women's health services; Women's house

Outcome Measures

Primary Outcomes (2)

• Change in quality of life

  Difference in quality of life between initial care and at 6 months, measured using the WHOQoL-BREF self-report questionnaire. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely"

  Baseline

• Change in quality of life

  Difference in quality of life between initial care and at 6 months, measured using the WHOQoL-BREF self-report questionnaire. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely"

  At 6 months

Secondary Outcomes (14)

• Change in quality of life at 3 months

  Baseline

• Change in quality of life at 3 months

  At 3 months

• Change in sleep quality at 3 and 6 months compared to baseline.

  Baseline

• Change in sleep quality at 3 and 6 months compared to baseline.

  At 3 months

• Change in sleep quality at 3 and 6 months compared to baseline.

  At 6 months

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: People with vaginas
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women, victims of domestic violence frequenting the Maison des Femmes (Women's House) in Nîmes. La Maison Des Femmes serves many migrant women whose health has deteriorated due to the hardships in their home countries, their migration journey, and upon arrival in France. Barriers to accessing care are linked to administrative, legal, linguistic, and cultural obstacles, as well as economic circumstances. They may come to the center on their own or be referred by a healthcare provider, an organization, a Medical and Psychological Center or Medical and Social Center, law enforcement, healthcare professionals, or anyone else who is aware of the existence of the facility. It has been open since January 2025 and has served 146 patients, scheduled 498 appointments (356 of which were kept) conducted 291 consultations, and provided 65 outpatient hospitalizations. It supports women from various backgrounds, many of whom are in vulnerable situations and/or have experienced violence.

You may qualify if:

• Adult women receiving care at the MDF in the Gard department;
• Women in situations of vulnerability and violence
• Women who agree to participate in the study and have signed the consent form;
• Non-French-speaking women who can be assisted in understanding through the midwife's intervention and telephone interpretation
• Note: Pregnant and breastfeeding women may be included. Indeed, pregnancy is a trigger or aggravating factor for domestic violence and can further exacerbate the precarious situation of women seeking services at the MDF.
• Article L1121-1 of the Public Health Code (CSP) and Decree No. 2016-1537 of November 16, 2016, stipulate that biomedical research must protect vulnerable individuals, including pregnant women, but authorize clinical trials if the benefits outweigh the risks.
• Note: Patients who are not covered by social security will be recruited in accordance with Article L1121-8-1 of the Public Health Code\*
• Individuals who are not enrolled in a social security program or who are not beneficiaries of such a program may be recruited to participate in non-interventional research.
• As an exception, the Human Subjects Protection Committee may authorize a person who is not enrolled in or a beneficiary of a social security system to participate in research referred to in paragraphs 1 or 2 of Article L. 1121-1. This authorization must be justified.

You may not qualify if:

• All persons under guardianship or conservatorship
• All persons incapable of giving consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Central Study Contacts

Sylvie RIPART, Dr.

CONTACT

+336.87.70.13.02; sylvie.ripart@chu-nimes.fr

Clémence CASARA, Midwife

CONTACT

+334.66.68.67.52; clemence.casara@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): May 15, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share