NCT03249649

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,736

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

2.9 years

First QC Date

August 10, 2017

Last Update Submit

January 8, 2020

Conditions

Female Genital Mutilation Type I StatusFemale Genital Mutilation Type II StatusFemale Genital Mutilation Type III Status

Keywords

defibulationhealthcare needs assessmentCBPR

Outcome Measures

Primary Outcomes (4)

  • Comprehensive Healthcare Needs Assessment (CHNA)

    Measure of patient-provider communication, patient healthcare services, and provider treatment of Somali Refugee women.

    7/1/2016-12/31/2017

  • Gaps, Barriers, and Assets in FGC Related Healthcare

    Report on gaps, barriers, and/or assets in FGC-related health care and social services for women in Arizona.

    1/1/2018-6/30/2018

  • Provider Education and Training

    Report on FGC education efforts to improve culturally competent care in healthcare and social service settings for FGC-affected women.

    7/1/2018-6/30/19

  • Community Education and Training

    Report on comprehensive community outreach and education about FGC- related health issues, prevention, and services available.

    7/1/2018-6/30/19

Study Arms (2)

Phoenix Cohort

Somali Refugee women ages 15 and older

Behavioral: Comprehensive Healthcare Needs Assessment

Tucson Cohort

Somali Refugee women ages 15 and older

Behavioral: Comprehensive Healthcare Needs Assessment

Interventions

Comprehensive Healthcare Needs AssessmentBEHAVIORAL

Questionnaire focused on existing healthcare communication, treatment and services plus community needs in those three areas.

Phoenix CohortTucson Cohort

Eligibility Criteria

Age15 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSomali and Somali Bantu Refugee females ages 15 and older
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • males
  • non-Somali Refugee women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Interdisciplinary Research Center

Phoenix, Arizona, 85004, United States

Location

Related Publications (4)

  • Johnson-Agbakwu CE, Michlig GJ, Koukoui S, Akinsulure-Smith AM, Jacobson DS. Health outcomes and female genital mutilation/cutting: how much is due to the cutting itself? Int J Impot Res. 2023 May;35(3):218-227. doi: 10.1038/s41443-022-00661-6. Epub 2023 Jan 4.

    PMID: 36599966DERIVED

  • Johnson-Agbakwu CE, Fox KA, Banke-Thomas A, Michlig GJ. Influence of Female Genital Mutilation/Cutting on Health Morbidity, Health Service Utilization and Satisfaction with Care among Somali Women and Teenage Girls in the United States. J Racial Ethn Health Disparities. 2023 Apr;10(2):788-796. doi: 10.1007/s40615-022-01266-x. Epub 2022 Mar 8.

    PMID: 35258838DERIVED

  • Marea CX, Warren N, Glass N, Johnson-Agbakwu C, Perrin N. Assessing the reliability and validity of attitudes and confidence scales for the care of women and girls affected by female genital mutilation/cutting. BMC Public Health. 2021 Jul 17;21(1):1415. doi: 10.1186/s12889-021-11455-8.

    PMID: 34273951DERIVED

  • Marea CX, Warren N, Glass N, Johnson-Agbakwu C, Perrin N. Factors Associated with Health Care Provider Attitudes, and Confidence for the Care of Women and Girls Affected by Female Genital Mutilation/Cutting. Health Equity. 2021 May 19;5(1):329-337. doi: 10.1089/heq.2020.0130. eCollection 2021.

    PMID: 34036217DERIVED

Study Officials

  • Crista Johnson-Agbakwu, MD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 15, 2017

Study Start

July 1, 2016

Primary Completion

May 15, 2019

Study Completion

June 30, 2019

Last Updated

January 10, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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.

Locations

US(1)