NCT06135636 · Women and Infants Hospital of Rhode Island
Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy
(ITAPP)
What this study is about
The goal of this randomly assigned 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.
View original scientific 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.
Interventions
BEHAVIORAL
Education
Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery
BIOLOGICAL
Vaccine administration
Option to receive Tdap at their convenience at the WIH obstetric care clinic provided to participant
Primary outcome measures
Tdap vaccination rate for non-birthing partners
Time frame: During pregnancy though 1 week postpartum
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Latex allergy: Contraindication to the state supplied Tdap vaccine
- Lethal fetal anomaly diagnosed prior to enrollment to prevent undue distress with follow-up postpartum
Where
- Providence, Rhode Island
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 20, 2024 · Source of record for eligibility and locations