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

Study acronym: ITAPP
StatusUnknown
PhasePhase 4
Started
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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.

Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Notable Phase: Not applicable to Phase 4v2 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 1, 2024 to Jun 30, 2025
    • Start date changed from estimate of Dec 1, 2023 to May 28, 2024
    • Study sites: 0 to 1
    • Study description revised
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06135636
Lead Sponsor Women and Infants Hospital of Rhode Island
Conditions
(from sponsor)
Non-birthing Partner Vaccination in Pregnancy, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Vaccine Exposure During Pregnancy
Related terms Diphtheria
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov