Sexual ViolenceINCIDAVINCT05007431
Violence Sexual Incidence During the First Year of Residence on Asylum Seekers
An observational study of Sexual Violence, run by Assistance Publique Hopitaux De Marseille at 2 sites in France.
Trial summary
Asylum seekers women are particularly exposed to sexual violence. One in seven women in France and one in three in the world say they have been a victim of sexual violence at least once in her life. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Violence
- What is being tested?
- Questionnaires
- How many people
- 360 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Oct 2021to 6 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women asylum seekers victims of sexual violence
Who may be able to join
- Age> 18 years old
- Major arrival (> 18 years old) on French territory
- In the asylum application procedure with the GUDA in Marseille or Nice
- Having a decline of residence on French soil of twelve months over the last 2 years.
- No objection to participating in the study
Who cannot join
- Existence of cognitive disorders (dementia, mental retardation) limiting the collection of criteria for judgment
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Violence Sexual Incidence During the First Year of Residence in the French Territory on Asylum Seekers in Marseille and Nice
Asylum seekers women are particularly exposed to sexual violence. One in seven women in France and one in three in the world say they have been a victim of sexual violence at least once in her life.
The main objective of this study is to measure the incidence of sexual violence suffered by women in asylum proceedings during their first year of stay on French territory, in Marseille and Nice.
Read the detailed description
Introduction: One in seven women in France and one in three in the world say they have been a victim of sexual violence at least once in his life. They are exacerbated in vulnerable populations, marginalized, in post-conflict situations or population displacement.
Therefore asylum seekers women are particularly exposed to sexual violence. This is why OFPRA and the Ministry of Solidarity and Health have protected these women with regard to sexual violence, one of the priority issues for public health. Yet, the investigators do not know the proportion of women seeking asylum who have suffered violence on French soil. In addition, the investigators did not find an international study of the incidence of violence sexual abuse suffered in the host country by women seeking asylum. Objective: Determine the incidence of sexual violence that occurred in the year following the arrival on French soil of adult women in the asylum process in Marseille and Nice.
Methodology: Multicentric longitudinal observational study (Marseille and Nice) based on a historical cohort of sexual violence among women in the application process asylum. 1,800 adult women seeking asylum were registered in 2019 in Marseille and Nice. The number of subjects required is 450 women (1: 4 sample of the target population).
Data collection will be carried out by hetero-questionnaire carried out in the presence of the questioned.
- Conditions
- Sexual Violence
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Data collection will be carried out by hetero-questionnaire carried out in the presence of the questioned.
| Study group | Role | What they receive |
|---|---|---|
| Women asylum seekers | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaires on sexual violence suffered v1.1
The incidence of any of the following four events: rape or attempted rape or sexual assault or sexual exhibition that occurred on French soil during the first year of residence in France with women in the asylum procedure in France, defined by at least one positive response on the questionnaire.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start6 Oct 2021
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ViolenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007431
- Sponsor's protocol ID
- 2021-05
- Acronym
- INCIDAVI
- Status last verified
- Jun 2023
- First submitted
- 29 Jul 2021
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Violence Sexual Incidence During the First Year of Residence in the French Territory on Asylum Seekers in Marseille and Nice
- ClinicalTrials.gov ID
- NCT05007431
- Acronym / sponsor ID
- INCIDAVI / 2021-05
- Conditions
- Sexual Violence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asylum seekers women are particularly exposed to sexual violence. One in seven women in France and one in three in the world say they have been a victim of sexual violence at least once in her life.
The main objective of this study is to measure the incidence of sexual violence suffered by women in asylum proceedings during their first year of stay on French territory, in Marseille and Nice.
Detailed description
Introduction: One in seven women in France and one in three in the world say they have been a victim of sexual violence at least once in his life. They are exacerbated in vulnerable populations, marginalized, in post-conflict situations or population displacement.
Therefore asylum seekers women are particularly exposed to sexual violence. This is why OFPRA and the Ministry of Solidarity and Health have protected these women with regard to sexual violence, one of the priority issues for public health. Yet, the investigators do not know the proportion of women seeking asylum who have suffered violence on French soil. In addition, the investigators did not find an international study of the incidence of violence sexual abuse suffered in the host country by women seeking asylum. Objective: Determine the incidence of sexual violence that occurred in the year following the arrival on French soil of adult women in the asylum process in Marseille and Nice.
Methodology: Multicentric longitudinal observational study (Marseille and Nice) based on a historical cohort of sexual violence among women in the application process asylum. 1,800 adult women seeking asylum were registered in 2019 in Marseille and Nice. The number of subjects required is 450 women (1: 4 sample of the target population).
Data collection will be carried out by hetero-questionnaire carried out in the presence of the questioned.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women asylum seekers | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women asylum seekers victims of sexual violence
Key inclusion criteria (5 listed)
- Age> 18 years old
- Major arrival (> 18 years old) on French territory
- In the asylum application procedure with the GUDA in Marseille or Nice
- Having a decline of residence on French soil of twelve months over the last 2 years.
- No objection to participating in the study
Key exclusion criteria (1 listed)
- Existence of cognitive disorders (dementia, mental retardation) limiting the collection of criteria for judgment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesData collection will be carried out by hetero-questionnaire carried out in the presence of the questioned. | Other | Women asylum seekers |
Primary outcome
Questionnaires on sexual violence suffered v1.1
Time frame: 6 months
The incidence of any of the following four events: rape or attempted rape or sexual assault or sexual exhibition that occurred on French soil during the first year of residence in France with women in the asylum procedure in France, defined by at least one positive response on the questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Violence, run by Assistance Publique Hopitaux De Marseille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaires on sexual violence suffered v1.1 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.