Finding Opportunities for Clinical Care and Trial Participation Among Underrepresented Samples

Study Overview
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Brief Summary
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Focus groups for Hispanic women who are pregnant and their close family members to assess attitudes, barriers and cultural beliefs involved in participation in clinical trials

Detailed Description
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This is a qualitative study conducted with Hispanic pregnant women and their families. Focus groups for Hispanic pregnant women will run concurrent to groups for their close family member, but in separate rooms. Each focus group session of approximately 8-10 participants is expected to last 60-90 minutes and will be led by an experienced moderator who is fluent in Spanish. All discussions will be audio taped and will be kept confidential. Information learned will be used to refine clinical trial procedures and ensure our model of recruitment and retention in the parent ADORE Trial (NCT02626299) is culturally and linguistically acceptable and feasible.

Official Title
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Finding Opportunities for Clinical Care and Trial Participation Among Underrepresented Samples: An Administrative Supplement to the ADORE Trial

Conditions
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Pregnancy Related

Intervention / Treatment
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* Behavioral: Focus Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hispanic women between the ages of 18.0-49.99 yrs old who have been pregnant within the past 5 years OR a close family member Speak and understand Spanish Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hispanic Women<br>Hispanic women who have been pregnant within the past 5 years. | Behavioral: Focus Group<br>* Groups will last 60 to 90 minutes. Focus groups will be moderated by KUMC Juntos staff who are formally trained to conduct focus groups. General topics to be covered in focus groups include: attitudes, preferences and knowledge about prenatal care, clinical trial participation, and nutritional supplement use. Focus groups will be conducted in Spanish.<br>|
| Close Family Member<br>Close family member of participants in Group 1 - Hispanic Women. | Behavioral: Focus Group<br>* Groups will last 60 to 90 minutes. Focus groups will be moderated by KUMC Juntos staff who are formally trained to conduct focus groups. General topics to be covered in focus groups include: attitudes, preferences and knowledge about prenatal care, clinical trial participation, and nutritional supplement use. Focus groups will be conducted in Spanish.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory results from focus groups: access to and attitudes towards prenatal care | Qualitative description of barriers to access in prenatal care | 1 year | 
| Exploratory results from focus groups: access to and attitudes towards clinical trials | Qualitative description of perceptions and beliefs regarding clinical trial research | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prenatal Care, Barriers, Clinical Trials