Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:09 AM
Study NCT ID:
NCT07453459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-01', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants who returned HPV samples', 'timeFrame': 'Up to eight weeks after enrollment', 'description': "Feasibility of the distribution methods between groups will be measured by the return rate of at home, self-collected HPV samples. Outcome will be reported via Pearson's chi-square test."}, {'measure': 'Proportion of participants with completed referral visits', 'timeFrame': 'Up to eight weeks after enrollment', 'description': "Outcome will be reported via Pearson's chi-square test."}, {'measure': 'Time to sample return', 'timeFrame': 'Up to eight weeks after enrollment', 'description': 'Outcome will be analyzed by nominal regression model.'}, {'measure': 'Time to referral', 'timeFrame': 'Up to eight weeks after enrollment', 'description': 'Outcome will be analyzed by nominal regression model.'}, {'measure': 'Thematic findings addressing opportunity', 'timeFrame': 'Eight weeks after enrollment', 'description': 'Will be assessed during semi-structured interviews with participants and analyzed according to the Capability, Opportunity, Motivation, Behavior (COM-B) model. Questions during the semi-structure interview will follow a guide. Answers to the questions will be analyzed for thematic findings.\n\nThe following questions on the guide asked to the returners of kits:\n\n* What was your reaction for when you were offered the Teal kit?\n* How did the support from event staff, the virtual care visit, or people in your life influence your decision about using the kit?\n\nThe following questions on the guide asked to the non-returners of kits:\n\n* What, if any, were the barriers that prevented you from completing it?\n\n \\*Probe: For example, finding the time to use the kit or understanding the instructions\n* Was there anything that changed between the time you enrolled in the study and receiving the kit that made you decide to not complete the kit?'}, {'measure': 'Thematic findings addressing capability', 'timeFrame': 'Eight weeks after enrollment', 'description': 'Will be assessed during semi-structured interviews with participants \\& analyzed according to the COM-B model. Questions during the semi-structure interview will follow a guide. Answers will be analyzed for thematic findings.\n\nThe following will be asked to returners of kits:\n\n* How confident are you in the results you received? Do you trust them? Why/why not?\n* Did you feel like you received enough information when you got the kit to know what to do?\n* How did you feel about your ability to correctly use the self-sampling kit?\n* Were there any physical difficulties or health issues that made it challenging for you to use the kit? If so, can you describe them?\n* Do you have any recommendations for improving access to Teal kits for at-home cervical cancer screening?\n\nThe following will be asked to non-returners of kits:\n\n* What suggestions/changes do you think would make it easier for you to use the kit in the future?'}, {'measure': 'Thematic findings addressing motivation', 'timeFrame': 'Eight weeks after enrollment', 'description': 'Will be assessed during semi-structured interviews with participants \\& analyzed according to COM-B model. Questions will follow a guide. Answers will be analyzed for thematic findings.\n\nThe following will be asked to returners of kits:\n\n* Feelings about cervical cancer screening?\n* Previous pap smear/HPV test for cervical cancer screening? Describe the experience.\n* Any concerns/uncertainties you had about using the kit?\n* What made you decide to use the kit?\n* What did you like/not like about using the kit?\n* What things got in the way of using the kit or made it easier?\n* Would you recommend the kit to a friend?\n* Would you use the kit in the future?\n* Thoughts on the importance/urgency of completing the kit?\n* Explanation of your beliefs about the potential benefits/downsides of using the kit?\n\nThe following will be asked to non-returners of kits:\n\n-Can you describe any situations/experiences/barriers that influenced your decision not to complete \\& return the kit?'}, {'measure': 'Thematic findings addressing behavior', 'timeFrame': 'Eight weeks after enrollment', 'description': 'Will be assessed during semi-structured interviews with participants and analyzed according to the COM-B model. Questions during the semi-structure interview follow a guide. Answers to the questions will be analyzed for thematic findings.\n\nThe following questions on the guide asked to all participants:\n\n-Before receiving the kit, what were some of the reasons you were overdue for cervical cancer screening?'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with positive results who completed follow-up', 'timeFrame': 'Up to eight weeks after results available', 'description': "Outcome will be reported via Pearson's chi-square test."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical cancer screening', 'Self-collection', 'At-home HPV test'], 'conditions': ['Cervical Cancer', 'HPV Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': "This study is testing and implementing an equity-focused, community-based intervention that improves women's access to cervical cancer screening and adherence to follow up after an abnormal result. The study's objective is to assess and compare the feasibility of different methods of distributing at-home HPV testing kits for cervical cancer screening among individuals who are under-screened."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are age 25-65\n* Has an intact cervix\n* Self-reports that they have not been screened for cervical cancer within the last 3 years\n* Has a smartphone\n* Has access to the internet to engage with the Teal Health mobile app and complete a Zoom interview\n* Can read, speak, write and understand English well enough to take a survey and complete an interview\n\nExclusion Criteria:\n\n* Abnormal vaginal bleeding or discharge\n* A history of cancer of the reproductive system\n* A compromised immune system\n* Prior Diethylstilbestrol (DES) exposure\n* Currently pregnant or are within 6 weeks of giving birth\n* Treatment for a cervical precancer (e.g., loop electrosurgical excision procedure or conization) in the last 25 years.'}, 'identificationModule': {'nctId': 'NCT07453459', 'briefTitle': 'Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Feasibility of Community-based Distribution of HPV Self-Collection Kits for At Home Cervical Cancer Screening', 'orgStudyIdInfo': {'id': '26-x045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aim 1: Standard instructions', 'description': 'Participants will complete a sociodemographic questionnaire and will receive the standard instructions. After approximately 8 weeks, participants will be asked to participate in the qualitative interview.', 'interventionNames': ['Behavioral: Qualitative Interview', 'Behavioral: Virtual Visit Standard Instructions']}, {'type': 'EXPERIMENTAL', 'label': 'Aim 1: Standard instructions + in-person guidance', 'description': 'Participants will complete a sociodemographic questionnaire and will receive the standard instructions and in-person navigation for registering for a consult to receive the at-home testing kit. After approximately 8 weeks, participants will be asked to participate in the qualitative interview.', 'interventionNames': ['Behavioral: Qualitative Interview', 'Behavioral: Virtual Visit Standard Instructions + In-Person Registration Navigation']}], 'interventions': [{'name': 'Qualitative Interview', 'type': 'BEHAVIORAL', 'description': 'Participants will participate in a semi-structured qualitative interview conducted with a research coordinator and guided by the Capability, Opportunity, Motivation, Behavior model (COM-B).', 'armGroupLabels': ['Aim 1: Standard instructions', 'Aim 1: Standard instructions + in-person guidance']}, {'name': 'Virtual Visit Standard Instructions', 'type': 'BEHAVIORAL', 'description': 'Participants will be given information about the self-collection kit along with a QR code they can use to register with Teal and request the telehealth appointment needed to receive their Teal At-Home cervical cancer screening kit.', 'armGroupLabels': ['Aim 1: Standard instructions']}, {'name': 'Virtual Visit Standard Instructions + In-Person Registration Navigation', 'type': 'BEHAVIORAL', 'description': 'Participants will be given information about the self-collection kit along with a QR code they can use to register with Teal and request the telehealth appointment needed to receive their Teal At-Home cervical cancer screening kit. Participants will scan the QR code and complete the registration process onsite with a study coordinator, leaving the event with a scheduled date and time for their telehealth appointment.', 'armGroupLabels': ['Aim 1: Standard instructions + in-person guidance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'contacts': [{'name': 'Michelle Silver, PhD, ScM', 'role': 'CONTACT', 'email': 'michelle.silver@wustl.edu', 'phone': '314-454-7903'}, {'name': 'Ashley Housten, OTD, MSCI', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lindsay Kuroki, MD, MSCI', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Meera Muthukrishnan, PhD, MPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Trena Depel, VP', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Michelle Silver, PhD, ScM', 'role': 'CONTACT', 'email': 'michelle.silver@wustl.edu', 'phone': '314-454-7903'}], 'overallOfficials': [{'name': 'Michelle Silver, PhD, ScM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teal Health, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}