Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-04-08 @ 8:56 AM
Study NCT ID:
NCT05458869
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2022-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Human Papillomavirus Self-Collection Experience in Individuals Who Have Experienced Sexual Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], '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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-23', 'studyFirstSubmitDate': '2022-07-12', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experience of cervical cancer screening in patients with a history of sexual trauma', 'timeFrame': 'Up to 12 months', 'description': "Data analysis of interview transcripts will occur concurrent with data collection. The transcripts will be analyzed using Taguette, a qualitative software program. The coding scheme to analyze interview transcripts will be developed through an iterative and reflective process using grounded theory. A comparative, iterative, and interactive method, grounded theory follows a cyclical research process of collecting, analyzing and coding data, memo-writing and theoretical sampling to the point of saturation, where no new ideas, theories or constructs emerge. The research team will thoroughly explore the data and develop a comprehensive list of categories. The categories will be used to identify themes and make connections both between and across interview subjects. Thematic analysis will be basis of the study's findings."}, {'measure': 'Utility of HPV self-collection among patients with a history of sexual trauma', 'timeFrame': 'Up to 12 months', 'description': "Data analysis of interview transcripts will occur concurrent with data collection. The transcripts will be analyzed using Taguette, a qualitative software program. The coding scheme to analyze interview transcripts will be developed through an iterative and reflective process using grounded theory. A comparative, iterative, and interactive method, grounded theory follows a cyclical research process of collecting, analyzing and coding data, memo-writing and theoretical sampling to the point of saturation, where no new ideas, theories or constructs emerge. The research team will thoroughly explore the data and develop a comprehensive list of categories. The categories will be used to identify themes and make connections both between and across interview subjects. Thematic analysis will be basis of the study's findings."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Carcinoma', 'Human Papillomavirus Infection']}, 'descriptionModule': {'briefSummary': 'This study explores the human papillomavirus (HPV) self-collection experience among individuals with a history of sexual trauma. Cervical cancer is the fourth most common cancer in women worldwide and is the second leading cause of cancer-related death in women ages 29-39. Despite programs to improve accessibility of cervical cancer screening and overall high screening rates, disparities in routine surveillance have been demonstrated in certain populations, such as victims of intimate partner violence and sexual trauma. One barrier to participating in cervical cancer screening for this population is the office-based visit which necessitates the individual to undress, sit with their legs in stirrups, and undergo speculum examination for specimen collection. This type of visit may cause distress for participants who have experienced sexual violence. HPV self-collection has been studied with favorable outcomes in effectiveness and ease of use. This study evaluates the experience of HPV self-collection among individuals who have experienced sexual trauma.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To explore the HPV self-collection experience among individuals with a history of sexual trauma.\n\nOUTLINE:\n\nParticipants complete a survey, use an HPV self-collection kit, and attend an interview over 30 minutes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with a history of intimate partner violence (IPV), sexual abuse, or sexual trauma and who are eligible for primary HPV based cervical cancer screening.', 'genderDescription': 'Females are individuals with a cervix including women, gender non-forming, non-binary and transgender (trans) persons', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with a cervix who are eligible for primary HPV testing (age 25 and older) according to national cervical cancer screening guidelines\n* Identify themselves as having a history of IPV, sexual abuse, or sexual trauma\n* Participants will also need to have access to a smartphone, tablet, or computer with video capability\n* English speaking\n* Reside in the State of Oregon\n* Patients who have participated in prior HPV self-collection study (reference Institutional Review Board \\[IRB\\] number- IRB# 23478) will also be eligible to participate in the interview if they meet the remaining eligibility requirements (i.e. history of IPV, sexual abuse, sexual trauma)\n\nExclusion Criteria:\n\n* Individuals who are not English speaking\n* Individuals \\< 25 years old or no longer eligible/recommended to undergo cervical cancer screening\n* Resides outside the state of Oregon\n* Adults who are unable to consent or are decisionally impaired\n* Individuals without a cervix (i.e. prior hysterectomy)'}, 'identificationModule': {'nctId': 'NCT05458869', 'briefTitle': 'Evaluating the Human Papillomavirus Self-Collection Experience in Individuals Who Have Experienced Sexual Trauma', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'Qualitative Study of HPV Self-Collection Experience and Cervical Cancer Screening in Patients With a History of Sexual Trauma', 'orgStudyIdInfo': {'id': 'STUDY00024429'}, 'secondaryIdInfos': [{'id': 'NCI-2022-05454', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STUDY00024429', 'type': 'OTHER', 'domain': 'OHSU Knight Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (survey, HPV self-collection, interview)', 'description': 'Participants complete a survey, use an HPV self-collection kit, and attend an interview over 30 minutes.', 'interventionNames': ['Procedure: HPV Self-Collection', 'Other: Interview', 'Other: Survey Administration']}], 'interventions': [{'name': 'HPV Self-Collection', 'type': 'PROCEDURE', 'otherNames': ['At-home HPV Self Collection', 'HPV Self Collection', 'Human Papillomavirus Self-Collection'], 'description': 'Use HPV self-collection kit', 'armGroupLabels': ['Observational (survey, HPV self-collection, interview)']}, {'name': 'Interview', 'type': 'OTHER', 'description': 'Attend interview', 'armGroupLabels': ['Observational (survey, HPV self-collection, interview)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Complete surveys', 'armGroupLabels': ['Observational (survey, HPV self-collection, interview)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Amanda S Bruegl', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amanda Bruegl, MD', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}