Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 4:24 AM
Study NCT ID:
NCT06784960
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2024-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Communication Strategies to Increase HPV Vaccination Intention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D000088823', 'term': 'Vaccination Hesitancy'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000072758', 'term': 'Vaccination Refusal'}, {'id': 'D016312', 'term': 'Treatment Refusal'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3689}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2025-01-16', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intention to Vaccinate', 'timeFrame': 'Immediately after the intervention', 'description': 'Validated 3-item likert scale assessing HPV vaccination intention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Papilloma Viral Infection', 'Vaccine Hesitancy', 'Communication']}, 'descriptionModule': {'briefSummary': 'This research aims to identify communication strategies to improve the uptake of vaccines using an experimental design, focusing on the Human Papillomavirus (HPV) vaccine, which is highly effective in preventing HPV-related cancers. However, low HPV vaccination rates among adults remain a significant public health challenge. Although randomized controlled trials (RCTs) have demonstrated that interventions can increase vaccine uptake in children, few RCTs have been conducted on adults. To address this gap, a multidisciplinary investigative team with expertise in communication, medicine, nursing, and behavior-change intervention research, and a history of extensive collaboration, will conduct a survey experiment on a national sample of over 3,689 adults to identify the most promising theory-based messages to strengthen HPV vaccine intentions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45 years old\n\nExclusion Criteria:\n\n* Under 18 and over 45 years old\n* Received HPV vaccine or unsure about receipt'}, 'identificationModule': {'nctId': 'NCT06784960', 'briefTitle': 'Communication Strategies to Increase HPV Vaccination Intention', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Cluster Randomized Controlled Trial Testing Communication Strategies to Increase HPV Vaccination Intention: a Survey Experiment', 'orgStudyIdInfo': {'id': '856892'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Theory-Based Message Condition 1', 'interventionNames': ['Behavioral: Messages']}, {'type': 'EXPERIMENTAL', 'label': 'Theory-Based Message Condition 2', 'interventionNames': ['Behavioral: Messages']}, {'type': 'EXPERIMENTAL', 'label': 'Theory-Based Message Condition 3', 'interventionNames': ['Behavioral: Messages']}, {'type': 'EXPERIMENTAL', 'label': 'Theory-Based Message Condition 4', 'interventionNames': ['Behavioral: Messages']}, {'type': 'EXPERIMENTAL', 'label': 'Theory-Based Message Condition 5', 'interventionNames': ['Behavioral: Messages']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Theory-Based Message Condition 6', 'interventionNames': ['Behavioral: Messages']}], 'interventions': [{'name': 'Messages', 'type': 'BEHAVIORAL', 'description': 'We will randomly assign participants in equal numbers to one of five theory-based HPV vaccine message conditions or an attention-matched control arm.', 'armGroupLabels': ['Theory-Based Message Condition 1', 'Theory-Based Message Condition 2', 'Theory-Based Message Condition 3', 'Theory-Based Message Condition 4', 'Theory-Based Message Condition 5', 'Theory-Based Message Condition 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Florence Momplaisir', 'role': 'CONTACT', 'email': 'florence.momplaisir@pennmedicine.upenn.edu', 'phone': '215-746-8555'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Florence Momplaisir', 'role': 'CONTACT', 'email': 'florence.momplaisir@pennmedicine.upenn.edu', 'phone': '215-746-8555'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Florence Momplaisir, MD', 'investigatorAffiliation': 'University of Pennsylvania'}}}}