Recruiting

Tdap Acceptance

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT06135636

Conditions

Non-birthing Partner Vaccination in Pregnancy

Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination

Vaccine Exposure During Pregnancy

Eligibility Criteria

Sex: All

Age: 19 - 50

Healthy Volunteers: Accepted

Interventions

Education

Vaccine administration

Study Details

Brief 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.

Conditions

Non-birthing Partner Vaccination in Pregnancy

Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination

Vaccine Exposure During Pregnancy

Study ID

NCT06135636

Start date

May 28, 2024

Status verified date

Sep, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Partners of pregnant patients who are receiving their prenatal care at the OGCC
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. 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. Fluency in English or Spanish: Consents, surveys, and Tdap and cocooning information will be available in both languages.

Exclusion Criteria:

1. Latex allergy: Contraindication to the state supplied Tdap vaccine
2. Lethal fetal anomaly diagnosed prior to enrollment to prevent undue distress with follow-up postpartum

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

Education

Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery

Vaccine administration

Option to receive Tdap at their convenience at the WIH obstetric care clinic provided to participant

Primary outcome measure

  • Tdap vaccination rate for non-birthing partners [ Time Frame: During pregnancy though 1 week postpartum ]

Central Contacts and Locations

Central contacts

Laurie Griffin, MD/PhD

9785182135LGRIFFIN@WIHRI.ORG

Adam Lewkowitz, MD/MPHS

401-274-1122Alewkowitz@kentri.org

Locations

Women and Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02920

Contacts

Laurie B Griffin, Md/PhD

401-274-1122LGriffin@wihri.org

Adam Lewkowitz, MD/MPHS

401-274-1122ALewkowitz@KentRI.org

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

Sep 20, 2024

Last verified

Sep, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2024-09-20.