Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT01605656
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2012-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D017144', 'term': 'Focus Groups'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-28', 'studyFirstSubmitDate': '2012-05-18', 'studyFirstSubmitQcDate': '2012-05-21', 'lastUpdatePostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "HIV Positive Women's Perceived Barriers to Cervical Cancer Screening", 'timeFrame': '1 day', 'description': 'Participants rank Nominal Group Technique (NGT) items (cervical cancer screening barriers and strategies to improve screening) from 1-5 (1-least important: 5-most important). Once two coders have calculated rankings, the 5 items receiving the highest number of points will be deemed the 5 barriers to cervical cancer screening. Similarly, the 5 strategy-based items receiving highest number of points will be deemed essential strategies to improving cervical cancer screening at Thomas Street Health Center (TSHC).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer Prevention', 'Cervix', 'Questionnaires', 'Focus groups', 'Surveys', 'Interviews'], 'conditions': ['Cancer Prevention', 'Cervix']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to better understand the factors that might prevent HIV-positive women from having routine pap smear screenings. Researchers also want to learn what might make it easier or encourage women to have these screenings.', 'detailedDescription': "Cognitive Interviews:\n\nIf 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.\n\nDuring the interview, a research staff member will use a questionnaire to ask you about many different health and social topics.\n\nAs 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.\n\nThe cognitive interview should take up to 45 minutes to complete.\n\nLength of Study:\n\nYour participation in this study will be over after you complete the cognitive interview.\n\nThis is an investigational study.\n\nUp to 10 participants will be enrolled in this part of the study. All will take part at Thomas Street Health Center.\n\nPhase I:\n\nIf 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.\n\nAfter 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.\n\nIn 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.\n\nThe information discussed in the focus groups may be sensitive, so you will be asked to keep the information discussed in the group private.\n\nLength of Study:\n\nYour participation in this study will be over after you complete the questionnaire and participate in the focus group discussion.\n\nThis is an investigational study.\n\nUp to 40 participants will be enrolled in this part of the study. All will take part at Thomas Street Health Center.\n\nPhase II:\n\nIf 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.\n\nThe second questionnaire will ask about many different health and social topics. This questionnaire should take up to 45 minutes to complete.\n\nLength of Study:\n\nYour participation in this study will be over after you complete the 2 questionnaires.\n\nThis is an investigational study.\n\nUp to 200 participants will be enrolled in this part of the study. All will take part at Thomas Street Health Center."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-positive women seeking care at Thomas Street Health Center (TSHC) of the Harris County Hospital District (HCHD).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. English speaking\n2. Patient receiving HIV/AIDS care at Thomas Street Health Center\n3. Female\n4. 18 years of age or older\n5. Able to provide written informed consent to participate\n\nExclusion Criteria:\n\n1\\) Physically deemed ineligible based on medical (HIV related or other condition) or psychiatric condition'}, 'identificationModule': {'nctId': 'NCT01605656', 'briefTitle': 'A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women', 'orgStudyIdInfo': {'id': '2012-0240'}, 'secondaryIdInfos': [{'id': 'R25T CA57730', 'type': 'REGISTRY', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Focus Groups + Interviews + Questionnaires', 'description': 'HIV-positive women recruited from the population of individuals seeking care at Thomas Street Health Center (TSHC) of the Harris County Hospital District (HCHD).', 'interventionNames': ['Behavioral: Cognitive Interview', 'Behavioral: Questionnaires', 'Behavioral: Focus Groups']}], 'interventions': [{'name': 'Cognitive Interview', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Focus Groups + Interviews + Questionnaires']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'otherNames': ['Surveys'], 'description': 'Phase I: Completion of a questionnaire about age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete.\n\nPhase 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.\n\nThe second questionnaire will ask about many different health and social topics. This questionnaire should take up to 45 minutes to complete.', 'armGroupLabels': ['Focus Groups + Interviews + Questionnaires']}, {'name': 'Focus Groups', 'type': 'BEHAVIORAL', 'description': 'Phase I: There will be up to 8 women in each of the 5 focus groups.\n\nParticipants 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.', 'armGroupLabels': ['Focus Groups + Interviews + Questionnaires']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Thomas Street Health Center, Harris County Hospital District', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Damon Vidrine, MS, DRPH, BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}