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OpenTrials
Completed

NCT Number: NCT03390023

Finding Opportunities for Clinical Care and Trial Participation Among Underrepresented Samples

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

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Key information

Conditions

Pregnancy Related

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Focus Group

Behavioral

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.

Primary outcomes

  1. Exploratory results from focus groups: access to and attitudes towards prenatal care

    Time frame: 1 year

    Qualitative description of barriers to access in prenatal care

  2. Exploratory results from focus groups: access to and attitudes towards clinical trials

    Time frame: 1 year

    Qualitative description of perceptions and beliefs regarding clinical trial research

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Acronym: ADORE FOCUS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 4, 2018
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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