A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women
NCT ID: NCT01605656
Last Updated: 2016-03-29
Study Results
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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COMPLETED
188 participants
OBSERVATIONAL
2012-07-31
2015-04-30
Brief Summary
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Detailed Description
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If you agree to take part in this study, you will be take part in a cognitive interview. A cognitive interview is a process that helps researchers test out questions on a few people so the questions can improved.
During the interview, a research staff member will use a questionnaire to ask you about many different health and social topics.
As the questions are read to you, please answer them, but also tell the research staff member what you're thinking. Please try to think out loud and say everything that comes to mind, whether it seems important or not. You will be asked how you came up with your answers and how you understood the questions. If any question seems unclear or hard to answer, please tell the research staff member. A member of the research staff will be taking notes during the interview.
The cognitive interview should take up to 45 minutes to complete.
Length of Study:
Your participation in this study will be over after you complete the cognitive interview.
This is an investigational study.
Up to 10 participants will be enrolled in this part of the study. All will take part at Thomas Street Health Center.
Phase I:
If you agree to take part in this study, you will complete a questionnaire about your age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete.
After completing the questionnaire, you will take part in a focus group discussion with other women who are patients at Thomas Street Health Center. There will be up to 8 women in each of the 5 groups.
In the focus group, you will be asked questions about personal and clinic-related factors that might make it more difficult to receive pap smear screenings. You will also be asked to discuss what might make it easier or encourage women to receive pap smear screenings. The focus group discussion should last 60-90 minutes.
The information discussed in the focus groups may be sensitive, so you will be asked to keep the information discussed in the group private.
Length of Study:
Your participation in this study will be over after you complete the questionnaire and participate in the focus group discussion.
This is an investigational study.
Up to 40 participants will be enrolled in this part of the study. All will take part at Thomas Street Health Center.
Phase II:
If you agree to take part in this study, you will complete 2 questionnaires. The first questionnaire will ask about your age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete.
The second questionnaire will ask about many different health and social topics. This questionnaire should take up to 45 minutes to complete.
Length of Study:
Your participation in this study will be over after you complete the 2 questionnaires.
This is an investigational study.
Up to 200 participants will be enrolled in this part of the study. All will take part at Thomas Street Health Center.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Focus Groups + Interviews + Questionnaires
HIV-positive women recruited from the population of individuals seeking care at Thomas Street Health Center (TSHC) of the Harris County Hospital District (HCHD).
Cognitive Interview
A research staff member will use a questionnaire to ask about many different health and social topics. The cognitive interview should take up to 45 minutes to complete.
Questionnaires
Phase I: Completion of a questionnaire about age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete.
Phase II: Completion of 2 questionnaires. The first questionnaire will ask about age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete.
The second questionnaire will ask about many different health and social topics. This questionnaire should take up to 45 minutes to complete.
Focus Groups
Phase I: There will be up to 8 women in each of the 5 focus groups.
Participants asked questions about personal and clinic-related factors that might make it more difficult to receive pap smear screenings. Participants also asked to discuss what might make it easier or encourage women to receive pap smear screenings. The focus group discussion should last 60-90 minutes.
Interventions
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Cognitive Interview
A research staff member will use a questionnaire to ask about many different health and social topics. The cognitive interview should take up to 45 minutes to complete.
Questionnaires
Phase I: Completion of a questionnaire about age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete.
Phase II: Completion of 2 questionnaires. The first questionnaire will ask about age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete.
The second questionnaire will ask about many different health and social topics. This questionnaire should take up to 45 minutes to complete.
Focus Groups
Phase I: There will be up to 8 women in each of the 5 focus groups.
Participants asked questions about personal and clinic-related factors that might make it more difficult to receive pap smear screenings. Participants also asked to discuss what might make it easier or encourage women to receive pap smear screenings. The focus group discussion should last 60-90 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient receiving HIV/AIDS care at Thomas Street Health Center
3. Female
4. 18 years of age or older
5. Able to provide written informed consent to participate
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Damon Vidrine, MS, DRPH, BA
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Thomas Street Health Center, Harris County Hospital District
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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R25T CA57730
Identifier Type: REGISTRY
Identifier Source: secondary_id
2012-0240
Identifier Type: -
Identifier Source: org_study_id
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