Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy

Conditions

• Non-birthing Partner Vaccination in Pregnancy
• Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
• Vaccine Exposure During Pregnancy

Eligibility Criteria

Sex

ALL

Age

19 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Education — BEHAVIORAL
  Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery
• Vaccine administration — BIOLOGICAL
  Option to receive Tdap at their convenience at the WIH obstetric care clinic provided to participant

Study Details

The goal of this randomized control trial is to assess if prenatal vaccine education and in-office vaccination administration for non-birthing partners of pregnant patients increases Tdap vaccination rates compared to usual care. The main question\[s\] it aims to answer are: * To assess whether compared to standard prenatal care, targeted prenatal education regarding Tdap vaccination recommendations with and without in office vaccination opportunities improves Tdap uptake among non-birthing partners of pregnant patients. * To assess whether non-birthing partners presenting for Tdap vaccination are willing to accept dual vaccination with Tdap and influenza. Participants will receive direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery with or without the option to receive Tdap at their convenience at the WIH obstetric care clinic. If there is a comparison group: Researchers will compare "Upfront Education" and "Upfront Education and Vaccination Administration" to "Usual care" to see if education and/or the offer for vaccination in the office increases Tdap vaccine acceptance for non-birthing partners.

Key Dates

Start date

May 28, 2024

Status verified

Sep 2024

Primary completion

Jun 30, 2025

Completion

Jun 30, 2025

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• No Intervention: Usual Care
  No up-front education, routine counseling as per their primary provider's standard practice, and written education on cocooning and recommendation for partner Tdap vaccination provided upon completion of the postpartum survey
• Experimental: Upfront Education Only
  Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery
• Experimental: Upfront Education and Vaccination Administration:
  Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery plus the option to receive Tdap at their convenience at the WIH obstetric care clinic.

Primary Outcome Measure

Tdap vaccination rate for non-birthing partners [ Time Frame: During pregnancy though 1 week postpartum ]

Central Contacts

• Laurie Griffin, MD/PhD
  9785182135
  [email protected]
• Adam Lewkowitz, MD/MPHS
  401-274-1122
  [email protected]

Locations (1)

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