RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-28
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06135636

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Partners of pregnant patients who are receiving their prenatal care at the OGCC
  2. 2. 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.
  3. 3. 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.
  4. 4. Fluency in English or Spanish: Consents, surveys, and Tdap and cocooning information will be available in both languages.
  1. 1. Latex allergy: Contraindication to the state supplied Tdap vaccine
  2. 2. Lethal fetal anomaly diagnosed prior to enrollment to prevent undue distress with follow-up postpartum

Contacts and Locations

Study Contact

Laurie Griffin, MD/PhD
CONTACT
9785182135
LGRIFFIN@WIHRI.ORG
Adam Lewkowitz, MD/MPHS
CONTACT
401-274-1122
Alewkowitz@kentri.org

Principal Investigator

Laurie Griffin, MD/PhD
PRINCIPAL_INVESTIGATOR
Women and Infants Hospital

Study Locations (Sites)

Women and Infants Hospital
Providence, Rhode Island, 02920
United States

Collaborators and Investigators

Sponsor: Women and Infants Hospital of Rhode Island

  • Laurie Griffin, MD/PhD, PRINCIPAL_INVESTIGATOR, Women and Infants Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-28
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-05-28
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Tdap
  • Vaccine
  • Vaccine access
  • Non-birthing partner
  • Pregnancy

Additional Relevant MeSH Terms

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