Strategies for Increasing RSV Vaccination During Pregnancy
(PRIME Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for pregnant individuals between 28-36 weeks gestation. It's designed to test if multiple strategies can increase RSV vaccination rates during pregnancy compared to standard care.

Inclusion Criteria

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

I am confirmed to be 28-30 weeks pregnant.

Exclusion Criteria

Those who do not have confirmed IUP at 28-30 weeks

Those with 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

Treatment Details

Interventions

MyChart nurse message (Behavioral Intervention)
SMFM video (Behavioral Intervention)
Visual aid (Behavioral Intervention)

Trial OverviewThe study tests a bundle of strategies including MyChart nurse messages, an SMFM video, and visual aids at two different stages of pregnancy (early: 28-30 weeks, late: 34-36 weeks) to see which increases RSV vaccine uptake.

Participant Groups

6Treatment groups

Active Control

Group I: Routine counselingActive Control1 Intervention

Randomized to routine counseling at 28-30 weeks

Group II: Routine counseling + MyChart nurse managingActive Control1 Intervention

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

Group III: Routine counseling + SMFM videoActive Control1 Intervention

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

Group IV: Routine counseling/visual aid + SMFM videoActive Control2 Interventions

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

Group V: Routine counseling/visual aidActive Control1 Intervention

Randomized to routine counseling and receipt of a visual aid encouraging RSV vaccination at 28-30 weeks

Group VI: Routine counseling/visual aid + MyChart nurse messageActive Control2 Interventions

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