Increasing Tdap Vaccination for Partners of Pregnant Patients

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

This study is testing if giving extra information and the chance to get vaccinated for whooping cough and flu during prenatal visits can help partners of pregnant women get vaccinated more often.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 19 Years to 50 Years
• Sex: All
• Sponsor: Women and Infants Hospital of Rhode Island (other)
• Locations: 1 site (Providence, Rhode Island)
• Trial ID: NCT06135636 on ClinicalTrials.gov

What this trial studies

This randomized control trial aims to evaluate whether providing targeted prenatal education and the option for in-office Tdap vaccination increases vaccination rates among non-birthing partners of pregnant patients compared to standard care. Participants will receive both verbal and written information about the importance of Tdap vaccination and the concept of 'cocooning' to protect newborns from vaccine-preventable diseases. The study will also assess the willingness of non-birthing partners to receive dual vaccinations for Tdap and influenza during their visit. The trial is conducted at the Women and Infants Hospital in Rhode Island.

Who should consider this trial

Good fit: Ideal candidates for this study are partners of pregnant patients aged 19-50 who are unsure of their Tdap vaccination status.

Not a fit: Patients who have received a Tdap vaccine or booster in the last 10 years or have a latex allergy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly increase Tdap vaccination rates among non-birthing partners, thereby enhancing neonatal immunity and reducing the risk of disease transmission.

How similar studies have performed: Previous studies have shown that targeted educational interventions can improve vaccination rates, suggesting potential success for this approach.

Eligibility criteria

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

Where this trial is running

Providence, Rhode Island

• Women and Infants Hospital — Providence, Rhode Island, United States (RECRUITING)

Study contacts

• Principal investigator: Laurie Griffin, MD/PhD — Women and Infants Hospital
• Study coordinator: Laurie Griffin, MD/PhD

Conditions: Non-birthing Partner Vaccination in Pregnancy, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Vaccine Exposure During Pregnancy, Tdap, Vaccine, Vaccine access, Non-birthing partner, Pregnancy