Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
Study NCT ID:
NCT06640868
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2024-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promotion of RSV Immunization Through Multiple Efforts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001296', 'term': 'Audiovisual Aids'}], 'ancestors': [{'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-09-30', 'studyFirstSubmitQcDate': '2024-10-11', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaccinated for RSV by delivery', 'timeFrame': 'Between 32 weeks and delivery, usually around 40 weeks gestation', 'description': 'Vaccinated for RSV by delivery'}, {'measure': 'Feasibility Outcomes', 'timeFrame': 'From time of randomization through delivery; at most will be 15 weeks', 'description': 'Percent of patients eligible for Tier 1 randomization receiving randomization; Percent of patients eligible for Tier 2 randomization receiving randomization; Number of patients delivered prior to Tier 2 randomization, Number of patients assigned in Tier 1 and Tier 2 randomization receiving assignment, Number of patients declining assignment, Timeline for completion of N=50'}], 'secondaryOutcomes': [{'measure': 'Vaccinated for RSV by 34 weeks', 'timeFrame': 'Pregnancy by 34 weeks', 'description': 'Vaccinated for RSV by 34 weeks'}, {'measure': 'Receipt of Tdap during pregnancy', 'timeFrame': 'Between 27 weeks and delivery, usually around 40 weeks gestation', 'description': 'Receipt of Tdap during pregnancy'}, {'measure': 'Receipt of Flu vaccine during pregnancy', 'timeFrame': 'During pregnancy, usually 40 weeks long', 'description': 'Receipt of Flu vaccine during pregnancy'}, {'measure': 'Receipt of COVID vaccine during pregnancy', 'timeFrame': 'During pregnancy, usually 40 weeks long', 'description': 'Receipt of COVID vaccine during pregnancy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RSV vaccine in pregnancy', 'vaccine uptake in pregnancy', 'sequential multiple assignment randomized trial'], 'conditions': ['Pregnancy', 'Vaccination']}, 'descriptionModule': {'briefSummary': 'Central hypothesis: a multimodal approach is needed to enhance RSV vaccine uptake in pregnancy rather than the current standard of care that relies solely on physician recommendations at routine prenatal visits and/or mass messaging to the public. The investigators propose a pilot sequential multiple assignment randomized trial (SMART) to evaluate the effectiveness of a bundle of evidence-based and sequential strategies to test early (28-30 weeks gestation) and late (34-36 weeks gestation efficacy) to increase RSV vaccination during pregnancy.', 'detailedDescription': "Respiratory syncytial virus (RSV) is the leading cause of hospitalization and death among infants. Each year, up to 80,000 children are hospitalized due to RSV-associated lower respiratory tract infection, with infants having the highest risk. 50% of childhood deaths from RSV are in infants \\<6 months old. 1 in every 28 deaths among children aged 28 days to 6 months are attributed to RSV. Childhood RSV is also associated with long-term morbidity particularly a 12-fold higher risk of developing asthma. RSV prevention strategies are urgently needed to protect young infants particularly given their vulnerable immunity at birth. Passive immunity via transfer of IgG antibodies from immunized pregnant women offers an evidence-based solution and is endorsed by the American College of Obstetricians and Gynecologists and the Centers for Disease Control. In 2023, the FDA approved the RSVpreF vaccine for use during 32-36 weeks of pregnancy to protect infants from RSV-associated respiratory infection.\n\nDespite the availability of the RSVpreF vaccine and formal guidelines recommending this vaccine in pregnancy during the 2023 RSV season, RSV vaccine uptake among pregnant individuals at our center was astoundingly low. In a review of 676 eligible patients, less than 10% received the RSV vaccine. Similar trends were seen with the COVID-19 and influenza vaccines in pregnancy where pregnant individuals were vaccinated at half of the rate of non-pregnant individuals. General barriers and facilitators for antenatal vaccine uptake have been well studied and are centered on provider recommendation, women's knowledge and beliefs about the safety of the vaccine, and logistical barriers such as on site availability. However, a recent initiative to offer on-site COVID-19 vaccination at a high risk pregnancy clinic resulted in only a 3% uptake of the vaccine among eligible, high-risk obstetric patients, suggesting that vaccine hesitancy, not availability, is a critical driver of the low vaccination rates in this population. Therefore, novel and multiple interventions are needed to address patient motivation and hesitancy, in addition to vaccine availability, to optimize vaccine uptake in pregnancy.\n\nThe central hypothesis is that a multimodal approach is needed to enhance RSVpreF vaccine uptake in pregnancy rather than the current standard of care that relies solely on physician recommendations at routine prenatal visits and/or mass messaging to the public. The investigators propose a pilot sequential multiple assignment randomized trial (SMART) to evaluate the effectiveness of a bundle of evidence-based and sequential strategies and test the following aims:\n\nAim 1: Assess the effectiveness of early (28-30 week) and low-intensity interventions to increase prenatal RSV vaccination uptake The investigators will compare vaccination uptake rates among pregnant patients 28-30 weeks gestation who are randomized to receive one of two low-intensity and universally acceptable interventions: physician counseling at prenatal visits vs routine counseling + patient visual aid administration (Figure 1). The investigators hypothesize that the combination of a visual aid with routine counseling will increase vaccination uptake rates by 34 weeks gestation. The investigators will explore whether demographic, clinical, or psychosocial factors modify the effects of each intervention.\n\nAim 2: Assess the effectiveness of late (34-36 week) higher-intensity interventions to increase prenatal RSV vaccination uptake for those who remain unvaccinated at 34 weeks gestation. The investigators will compare vaccination uptake rates in patients who remain unvaccinated at 34 weeks between two higher-intensity interventions: targeted patient phone calls encouraging vaccination versus individual physician reminders on the day of patient appointment. The investigators hypothesize that targeted patient calls will result in the highest vaccination uptake rates due to prior literature supporting the efficacy of this intervention. The investigators will explore whether demographic, clinical, or psychosocial factors modify the effects of each intervention."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Confirmed intrauterine pregnancy (IUP) at 28-30 weeks.\n2. No contraindications to the RSV vaccine: history of severe allergic reaction to any vaccine component or active moderate/severe acute illness with or without fever or receipt of RSV vaccine during the pregnancy\n\nExclusion Criteria:\n\n* Those who do not have confirmed IUP at 28-30 weeks, or who have a contraindication to the RSV vaccine (history of severe allergic reaction to any vaccine component or active moderate/severe acute illness with or without fever or receipt of RSV vaccine during the pregnancy) will be excluded.'}, 'identificationModule': {'nctId': 'NCT06640868', 'acronym': 'PRIME', 'briefTitle': 'Promotion of RSV Immunization Through Multiple Efforts', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Pilot Sequential Multiple Assignment Randomized Trial for RSV Vaccine Uptake in Pregnancy', 'orgStudyIdInfo': {'id': '202408045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine counseling', 'description': 'Randomized to routine counseling at 28-30 weeks'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine counseling + MyChart nurse managing', 'description': 'Randomized to routine counseling at 28-30 weeks; not vaccinated by 34 weeks, and randomized to receive a MyChart message from the nurse encouraging vaccination at 34 weeks', 'interventionNames': ['Behavioral: MyChart nurse message']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine counseling + SMFM video', 'description': 'Randomized to routine counseling at 28-30 weeks; not vaccinated by 34 weeks, and randomized to watch the SMFM video on RSV vaccination at a prenatal visit at 34 weeks', 'interventionNames': ['Behavioral: SMFM video']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine counseling/visual aid', 'description': 'Randomized to routine counseling and receipt of a visual aid encouraging RSV vaccination at 28-30 weeks', 'interventionNames': ['Behavioral: Visual aid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine counseling/visual aid + MyChart nurse message', 'description': 'Randomized to routine counseling and receipt of a visual aid encouraging RSV vaccination at 28-30 weeks; not vaccinated by 34 weeks, and randomized to receive a MyChart message from the nurse encouraging vaccination at 34 weeks', 'interventionNames': ['Behavioral: MyChart nurse message', 'Behavioral: Visual aid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine counseling/visual aid + SMFM video', 'description': 'Randomized to routine counseling and receipt of a visual aid encouraging RSV vaccination at 28-30 weeks; not vaccinated by 34 weeks, and randomized to watch the SMFM video on RSV vaccination at a prenatal visit at 34 weeks', 'interventionNames': ['Behavioral: SMFM video', 'Behavioral: Visual aid']}], 'interventions': [{'name': 'MyChart nurse message', 'type': 'BEHAVIORAL', 'description': 'Receipt of a MyChart nurse message around 34 weeks encouraging RSV vaccination', 'armGroupLabels': ['Routine counseling + MyChart nurse managing', 'Routine counseling/visual aid + MyChart nurse message']}, {'name': 'SMFM video', 'type': 'BEHAVIORAL', 'description': 'Receipt of SMFM video around 34 weeks encouraging RSV vaccination', 'armGroupLabels': ['Routine counseling + SMFM video', 'Routine counseling/visual aid + SMFM video']}, {'name': 'Visual aid', 'type': 'BEHAVIORAL', 'description': 'Receipt of a visual aide encouraging RSV vaccination at 28-30 wks', 'armGroupLabels': ['Routine counseling/visual aid', 'Routine counseling/visual aid + MyChart nurse message', 'Routine counseling/visual aid + SMFM video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jeannie Kelly', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}