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

NCT06135636 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2095986
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Tdap vaccination rate for non-birthing partners

  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.

  During pregnancy though 1 week postpartum

Secondary Outcomes (1)

• Dual vaccination rates for non-birthing partners

  During pregnancy though 1 week postpartum

Study Arms (3)

Usual Care

NO INTERVENTION

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

Upfront Education Only

EXPERIMENTAL

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

Behavioral: Education

Upfront Education and Vaccination Administration:

EXPERIMENTAL

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.

Behavioral: Education; Biological: Vaccine administration

Interventions

Education BEHAVIORAL

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

Upfront Education Only; Upfront Education and Vaccination Administration:

Vaccine administration BIOLOGICAL

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

Upfront Education and Vaccination Administration:

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Partners of pregnant patients who are receiving their prenatal care at the OGCC
• 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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants Hospital

Providence, Rhode Island, 02920, United States

RECRUITING

MeSH Terms

Conditions

Diphtheria

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Laurie Griffin, MD/PhD

  Women and Infants Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie Griffin, MD/PhD

CONTACT

9785182135; LGRIFFIN@WIHRI.ORG

Adam Lewkowitz, MD/MPHS

CONTACT

401-274-1122; Alewkowitz@kentri.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: May 28, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)