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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 50
Healthy Volunteers: t
View:

• 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.

Locations
United States
Rhode Island
Women and Infants Hospital
RECRUITING
Providence
Contact Information
Primary
Laurie Griffin, MD/PhD
LGRIFFIN@WIHRI.ORG
9785182135
Backup
Adam Lewkowitz, MD/MPHS
Alewkowitz@kentri.org
401-274-1122
Time Frame
Start Date: 2024-05-28
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 150
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Women and Infants Hospital of Rhode Island

This content was sourced from clinicaltrials.gov