Clinical Trial

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

Study acronym: ITAPP
Recruiting Phase 4
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Record status
This record was last updated September 20, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-11-12.
Status change: Not Yet Recruiting → Recruiting 2024-09-18
Trial Details
NCT Number NCT06135636
Lead Sponsor Women and Infants Hospital of Rhode Island
Conditions Non-birthing Partner Vaccination in Pregnancy, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Vaccine Exposure During Pregnancy
Enrollment 150 participants
Start Date 2024-05-28
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-09-20