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Female Genital Cutting in the Arizona Somali Refugee Community (FGC)

This study is currently recruiting participants.
Verified August 2017 by Crista Johnson-Agbakwu, Arizona State University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03249649
First Posted: August 15, 2017
Last Update Posted: August 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Catholic Charities Phoenix
Phoenix International Refugee Committee
Refugee Focus Phoenix
Refugee Focus Tucson
Catholic Charities Tucson
Somali American United Council
Somali Association of Arizona
Somali Bantu Community of Greater Phoenix
Somali Community Development
Horizons Refugee Families
Information provided by (Responsible Party):
Crista Johnson-Agbakwu, Arizona State University
  Purpose

The focus of this project is to elucidate the gaps in care and enhance the provision of FGC-related health care and social services for women in Arizona who have experienced FGC; engaging the Somali and Somali Bantu communities. As of 2012, Arizona ranked 7th in the US for Somali refugee resettlement. The Refugee Women's Health Clinic (RWHC) is a nationally recognized best practice model for refugee women's health, providing specialized care for women with FGC. The project will accomplish four outcomes throughout its three-year duration: 1: Identify specific FGC-related health care needs and available health and social services for women in Arizona who have experienced FGC to improve services to FGC-affected communities; 2: Identify gaps, barriers, and/or assets in FGC-related health care and social services for women in Arizona who have experienced FGC to provide improved services to FGC-affected communities; 3: Create and implement FGC education efforts so that providers improve culturally competent care for women who have experienced FGC in health care and social service settings; and, 4: Create and implement community outreach and educational programs among communities affected by FGC to increase awareness of FGC-related health issues, prevention and services available. To inform these initiatives, an established infrastructure exists through the Refugee Women's Health Community Advisory Coalition (RWHCAC), a team of more than 60 stakeholders from various local ethnic organizations, refugee resettlement and voluntary agencies, mental health and social services agencies, and academic partners and including local voluntary resettlement agencies (VOLAGs) and Ethnic Community-Based Organizations (ECBOs). RWHCAC will be (a) involved in the planning/design of the project, (b) encouraged to assume responsibility to identify additional Community Mobilizers, (c) engaged in aligning educational material content to cultural standards, and (d) engaged in evaluating the project processes and outcomes.

Project strategies include: (1) identifying specific FGC-related health care needs and available health and social services for FGC-affected women including identification of gaps, barriers, and/or assets in FGC-related care (year 1); (2) utilizing results from the Community Health Needs Assessment (CHNA) to refine existing educational materials and implement educational outreach efforts across the state to improve culturally competent care among providers (years 2 and 3); (3) promoting outreach and education among FGC-affected communities through development of culturally appropriate materials and community education sessions (years two and three); and, (4) partnering with Arizona Department of Health Services, the University of Arizona, and African Women's Health Center, Brigham and Women's Hospital during year 2 to deliver inter-professional training workshops for health and social service providers on FGC, and with Johns Hopkins University for FGC teleECHO™ video conferencing clinics to promote sustainability via links to online resources, educational materials, and webinars (years 2 and 3). Emergent products include online learning components, community education sessions, FGC teleECHO™ sessions, and capacity building trainings for all partners.


Condition Intervention
Female Genital Mutilation Type I Status Female Genital Mutilation Type II Status Female Genital Mutilation Type III Status Behavioral: Comprehensive Healthcare Needs Assessment

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Enhancing Culturally-Informed Health Care Services for Women Affected by Female Genital Cutting in Arizona

Further study details as provided by Crista Johnson-Agbakwu, Arizona State University:

Primary Outcome Measures:
  • Comprehensive Healthcare Needs Assessment (CHNA) [ Time Frame: 7/1/2016-12/31/2017 ]
    Measure of patient-provider communication, patient healthcare services, and provider treatment of Somali Refugee women.

  • Gaps, Barriers, and Assets in FGC Related Healthcare [ Time Frame: 1/1/2018-6/30/2018 ]
    Report on gaps, barriers, and/or assets in FGC-related health care and social services for women in Arizona.

  • Provider Education and Training [ Time Frame: 7/1/2018-6/30/19 ]
    Report on FGC education efforts to improve culturally competent care in healthcare and social service settings for FGC-affected women.

  • Community Education and Training [ Time Frame: 7/1/2018-6/30/19 ]
    Report on comprehensive community outreach and education about FGC- related health issues, prevention, and services available.


Estimated Enrollment: 2150
Actual Study Start Date: July 1, 2016
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Phoenix Cohort
Somali Refugee women ages 15 and older
Behavioral: Comprehensive Healthcare Needs Assessment
Questionnaire focused on existing healthcare communication, treatment and services plus community needs in those three areas.
Tucson Cohort
Somali Refugee women ages 15 and older
Behavioral: Comprehensive Healthcare Needs Assessment
Questionnaire focused on existing healthcare communication, treatment and services plus community needs in those three areas.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Somali and Somali Bantu Refugee females ages 15 and older
Sampling Method:   Non-Probability Sample
Study Population
Somali and Somali Bantu Refugee females ages 15 and older who have been resettled to Arizona and who have received healthcare, health services, and/or social services from Arizona providers.
Criteria

Inclusion Criteria:

  • live and receive healthcare treatment and social services in Arizona
  • meet the age criteria

Exclusion Criteria:

  • males
  • non-Somali Refugee women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249649


Contacts
Contact: Crista Johnson-Agbakwu, MD 602-496-0700 cejohn11@asu.edu
Contact: Shannon Johnson, MAdmin 602-496-0700 shannon.k.johnson@asu.edu

Locations
United States, Arizona
Southwest Interdisciplinary Research Center Recruiting
Phoenix, Arizona, United States, 85004
Contact: Crista Johnson-Agbakwu, MD    602-496-0700    cejohn11@asu.edu   
Contact: Patricia Dustman, EdD    602-496-0700    patricia.dustman@asu.edu   
Sponsors and Collaborators
Arizona State University
Catholic Charities Phoenix
Phoenix International Refugee Committee
Refugee Focus Phoenix
Refugee Focus Tucson
Catholic Charities Tucson
Somali American United Council
Somali Association of Arizona
Somali Bantu Community of Greater Phoenix
Somali Community Development
Horizons Refugee Families
Investigators
Principal Investigator: Crista Johnson-Agbakwu, MD Arizona State University
  More Information

Responsible Party: Crista Johnson-Agbakwu, Principal Investigator, Arizona State University
ClinicalTrials.gov Identifier: NCT03249649     History of Changes
Other Study ID Numbers: 5252
First Submitted: August 10, 2017
First Posted: August 15, 2017
Last Update Posted: August 15, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available for use by qualified individuals within the scientific community after publication. The quantitative data will be made available in SPSS (.sav format), after removing from the file any information personally identifying human subjects. A codebook, produced in SPSS, and a brief summary of the original study, including information on sampling and design, will accompany the dataset. Qualitative data that contain no identifiers will be made available in text files (.txt format). Requests for the data will be made in writing directly to the principal investigator. Requestors must indicate the research question to be addressed. Users will not be permitted to share the requested data with other users unless they have the express permission of the principal investigator. Users' acknowledgement of these requirements will be recorded in a signed Use Agreement, to be kept on file at the principal investigator's offices.
Supporting Materials: Analytic Code
Time Frame: Data will become available following publication of all manuscripts reporting outcomes of primary and secondary aims. It is anticipated that these data will be available beginning year 7 and for 7 years following.
Access Criteria: Access criteria are identified in the plan to share IPD.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Crista Johnson-Agbakwu, Arizona State University:
defibulation
healthcare needs assessment
CBPR