Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy
Recruiting now · Phase 4
Conditions studied: Non-birthing Partner Vaccination in Pregnancy, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Vaccine Exposure During Pregnancy
In brief
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 facts
- Study ID
- NCT06135636
- Run by
- Women and Infants Hospital of Rhode Island
- People needed
- 150
- Starts
- 2024-05-28
- Expected to finish
- 2025-06-30
- Last updated by the study team
- 2024-09-20
Who can join
Age: 19 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Partners of pregnant patients who are receiving their prenatal care at the OGCC
- 19-50 years old: This age range was selected as 19 years is both the age at which adult Tdap vaccination is recommended by the CDC as well as the age for the State supplied adult Tdap and Influenza Vaccines. Fifty years old is the upper limit of "reproductively aged individuals, the target population for this study.
- Have not or are unsure if they have received the adult Tdap vaccine or booster in the last 10 years: In addition to the CDC recommendation for adult Tdap vaccination and Td or Tdap booster every 10 years, the CDC recommends vaccination for any adult who is unsure of their vaccination status to ensure they are vaccinated as repeat vaccination does not cause additional harm.
- Fluency in English or Spanish: Consents, surveys, and Tdap and cocooning information will be available in both languages.
You may not qualify if…
- Latex allergy: Contraindication to the state supplied Tdap vaccine
- Lethal fetal anomaly diagnosed prior to enrollment to prevent undue distress with follow-up postpartum
Where it is running
- Women and Infants Hospital — Providence, Rhode Island, United States (enrolling)
Full record on ClinicalTrials.gov
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