Promotion of RSV Immunization Through Multiple Efforts
PRIME
Pilot Sequential Multiple Assignment Randomized Trial for RSV Vaccine Uptake in Pregnancy
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pregnancy
Started Nov 2024
Shorter than P25 for phase_3 pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedStudy Start
First participant enrolled
November 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2025
CompletedDecember 8, 2025
November 1, 2025
4 months
September 30, 2024
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Vaccinated for RSV by delivery
Vaccinated for RSV by delivery
Between 32 weeks and delivery, usually around 40 weeks gestation
Feasibility Outcomes
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
From time of randomization through delivery; at most will be 15 weeks
Secondary Outcomes (4)
Vaccinated for RSV by 34 weeks
Pregnancy by 34 weeks
Receipt of Tdap during pregnancy
Between 27 weeks and delivery, usually around 40 weeks gestation
Receipt of Flu vaccine during pregnancy
During pregnancy, usually 40 weeks long
Receipt of COVID vaccine during pregnancy
During pregnancy, usually 40 weeks long
Study Arms (6)
Routine counseling
NO INTERVENTIONRandomized to routine counseling at 28-30 weeks
Routine counseling + MyChart nurse managing
ACTIVE COMPARATORRandomized 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
Routine counseling + SMFM video
ACTIVE COMPARATORRandomized 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
Routine counseling/visual aid
ACTIVE COMPARATORRandomized to routine counseling and receipt of a visual aid encouraging RSV vaccination at 28-30 weeks
Routine counseling/visual aid + MyChart nurse message
ACTIVE COMPARATORRandomized 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
Routine counseling/visual aid + SMFM video
ACTIVE COMPARATORRandomized 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
Interventions
Receipt of a MyChart nurse message around 34 weeks encouraging RSV vaccination
Receipt of SMFM video around 34 weeks encouraging RSV vaccination
Receipt of a visual aide encouraging RSV vaccination at 28-30 wks
Eligibility Criteria
You may qualify if:
- Confirmed intrauterine pregnancy (IUP) at 28-30 weeks.
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University in St. Louis
St Louis, Missouri, 63110, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 30, 2024
First Posted
October 15, 2024
Study Start
November 4, 2024
Primary Completion
February 20, 2025
Study Completion
February 20, 2025
Last Updated
December 8, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share