Strategies for Increasing RSV Vaccination During Pregnancy

(PRIME Trial)

Overseen By Jeannie C Kelly

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Washington University School of Medicine

Disqualifiers: No confirmed IUP, Severe allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

50 Participants Needed

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Intervention

Participants receive low-intensity interventions such as physician counseling and visual aids at 28-30 weeks gestation to increase RSV vaccination uptake.

2 weeks

1 visit (in-person)

Late Intervention

Participants who remain unvaccinated at 34 weeks receive higher-intensity interventions such as targeted phone calls or physician reminders to increase RSV vaccination uptake.

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for vaccination status and safety until delivery.

6 weeks

Treatment Details

Interventions

• MyChart nurse message
• SMFM video
• Visual aid

Trial Overview The 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

Group I: Routine counseling Active Control 1 Intervention

Randomized to routine counseling at 28-30 weeks

Group II: Routine counseling + MyChart nurse managing Active Control 1 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 video Active Control 1 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 video Active Control 2 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 aid Active Control 1 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 message Active Control 2 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

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+