Consequences of Sexual Violence Among Women Living in Democratic Republic of Congo

NCT ID: NCT05731297

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

742 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-09-30

Brief Summary

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In conflict situations, sexual violence (SV) used can take various forms, including rape and female genital mutilation (FGM). SV is used as a strategic weapon to shake, terrorize, and displace communities and thus take control of a particular population or territory. For two decades, the Great Lakes region of Central Africa, which includes the eastern part of the Democratic Republic of the Congo (DRC), has experienced a high degree of instability due to various armed conflicts. The attacks on civilians are illustrated by SV. In 2011, studies in DRC estimated that 1 150 women are raped every day and that 30% of women have experienced conflict-related sexual violence (CRSV) over the past 16 years. In addition to physical suffering, survivors of CRSV must live with psychological consequences. Traumatic fistula, one of the most extreme consequences of SV, is well described in the literature, as its surgical management. In contrast, the literature and the government illustrate a lack of accurate data on the physical consequences such as pelvic dysfunction and psychologic disorders following these attacks. To be able to put in place adequate care, it is necessary to identify the conditions and needs of the victims.

Detailed Description

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The project to collaborate with the DRC is initiated from an ambition of the pelvic-perineal rehabilitation unit of the Department of Physical Medicine and Rehabilitation (Faculty of Medicine, University of Kinshasa) to change the situation in relation to women and to be able to offer adequate care for this population. The project is part of collaboration with two investigators: Professor Miangindula (Université de Kinshasa, UNIKIN) in DRC and Professor Bertuit (HESAV-HES-SO) in Lausanne (Switzerland). Four partners will take part in the project enabling a competent and strong team: Professor Feipel and Professor Foucart (Université Libre de Bruxelles, ULB) in Brussels (Belgium), Doctor Abdulcadir (Hôpital Universitaire de Genève, HUG) and Professor Mukwege in Bukavu (DRC). This project pursues two objectives: firstly, to assess clinical data of pelvic floor dysfunction (pelvic floor muscle function and urinary, sexual, gynaecological, and anal function) and psychological level in women victims of CRSV compared to women not victims of CRSV in the DRC. Secondly, to investigate the current care modalities and to analyse their needs (access to care, community integration, physiotherapy, etc.) and to understand the global context of care in DRC. The project will contribute to scientific capacity building by involving two PhD students in this research. A mixed method research will include a quantitative design, an observational study in a sample of women victims of CRSV (n = 371) and a control group of women not victims of CRSV (n = 371). Outcomes on urinary, sexual, gynaecological, anorectal and psychological aspects will be collected. This study includes a qualitative study with a phenomenological approach. Individual semi-structured interviews will be conducted with women victims of CRSV (n=10). Interview topics will be complemented with quantitative data and will lead to the following themes: experiences of CRSV, consequences of CRSV on body image, and modalities and needs for caring of these consequences. Two focus groups including eight medical health professionals will complete the qualitative data collection. The project will be realized over three years in the most affected provinces of the DRC: South and North Kivu. The method for cross-referencing data will be the Sequential Explanatory Method described by Creswell (2013).

Conditions

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Sexual Violence Woman Abuse Perineal Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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women victims of CRSV

* Inclusion criteria: Women victims of CRSV living in the places of enrolment in RDC, aged over 18 years and giving their consent to participate to this study.
* Exclusion criteria: Pregnant women and women under 18 years old.

No interventions assigned to this group

women without a history of CRSV

* Inclusion criteria: women without a history of CRSV living in the places of enrolment in RDC, aged over 18 years and giving their consent to participate to this study.
* Exclusion criteria: Pregnant women and women under 18 years old.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Kinshasa

OTHER

Sponsor Role collaborator

Bertuit Jeanne

OTHER

Sponsor Role lead

Responsible Party

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Bertuit Jeanne

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Betty Miangindula

Kinshasa, , Democratic Republic of the Congo

Site Status RECRUITING

Countries

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Democratic Republic of the Congo

Central Contacts

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Jeanne Bertuit, PhD

Role: CONTACT

+41633738178

Jeanne.bertuit Bertuit, PhD

Role: CONTACT

+41633738178

Facility Contacts

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Betty Miangindula, PhD

Role: primary

Jeanne Bertuit, PhD

Role: backup

+41633738178

Other Identifiers

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2021-01

Identifier Type: -

Identifier Source: org_study_id

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