Non-birthing Partner Vaccination in PregnancyPhase 4ITAPPNCT06135636
Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy
A Phase 4 study testing Education and Vaccine administration in people with Non-birthing Partner Vaccination in Pregnancy and Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-birthing Partner Vaccination in Pregnancy, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Vaccine Exposure During Pregnancy
- What is being tested?
- Education and Vaccine administration
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Latex allergy: Contraindication to the state supplied Tdap vaccine
- Lethal fetal anomaly diagnosed prior to enrollment to prevent undue distress with follow-up postpartum
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Women and Infants Hospital
Providence, Rhode Island, 02920
Laurie B Griffin, Md/PhD, 401-274-1122, LGriffin@wihri.org
Adam Lewkowitz, MD/MPHS, 401-274-1122, ALewkowitz@KentRI.org
About this study
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:
Read more
- 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.
Read the detailed description
Vaccination plays a critical role in decreasing the morbidity and mortality of vaccine-preventable diseases. During pregnancy, maternal vaccination increases neonatal immunity via passive immunity through antibody transmission across the placenta. However, when compared to relying on maternal vaccination alone, "cocooning"-the term for vaccinating all caregivers of newborns- is more effective in reducing neonatal morbidity and mortality from vaccine-related illnesses. Accordingly, the American College of Obstetrician and Gynecologist (ACOG) and Centers for Disease Control (CDC) both recommend that all caregivers be up-to-date on Tdap (Tetanus, Diphtheria and Pertussis), COVID-19, and influenza vaccinations to minimize risk of exposure of vaccine preventable diseases for postpartum individuals and neonates. Unfortunately, the majority of reproductive-aged individuals are not up to date on their routine vaccinations. For example, it is recommended that all adults ≥ 19 years old receive Tdap at least once in their lifetime with Td or Tdap boosters every 10 years; however, only 32.5% of reproductively aged individuals in the United States are vaccinated to TDAP.
The CDC has made calls for unique programs to minimize "missed opportunities," or when an eligible individual is at a health care encounter but fails to be vaccinated completely. Prenatal care is a time in which pregnant and non-pregnant reproductively aged individuals frequently participate in health care. Women who reported that a prenatal care provider offered vaccination in office or via referral were the most likely to receive a vaccination to influenza and Tdap compared to those who only received a vaccine recommendation or those who received no recommendation. This indicates that reducing barriers to vaccination (i.e. immediate in office vaccination), not just recommending vaccination, maximizes vaccine uptake. Prior small studies have demonstrated that the majority of parents of infants admitted to the Neonatal Intensive Care Unit and, in one small, non-randomized acceptability study, nearly two thirds of non-birthing partners accepted Tdap vaccination when offered during prenatal care. However, the majority of prenatal care providers do not offer vaccination to non-birthing partners due to administrative burden, a clear "missed opportunity" for vaccination. Programs expanding vaccine education and administration to non-birthing partners during routine prenatal care has yet to be explored, but such programs have the potential to improve perinatal and neonatal outcomes, thereby improving the health of multiple generations.
Investigators propose to implement a study of vaccine education and administration targeted specifically at Tdap vaccination for non-birthing partners of pregnant patients. The project will assess targeted educational tools for the counseling of non-birthing partners on Tdap recommendations and cocooning, as well as the impact of in-office vaccination opportunities on vaccine uptake for non-birthing partners during prenatal care.
- Conditions
- Non-birthing Partner Vaccination in Pregnancy, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Vaccine Exposure During Pregnancy
- Being tested
- Education, Vaccine administration
- Keywords
- Tdap, Vaccine, Vaccine access, Non-birthing partner, Pregnancy
- Medical subject headings
- Diphtheria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery
Vaccine administrationBiological
Option to receive Tdap at their convenience at the WIH obstetric care clinic provided to participant
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Education; Biological: Vaccine administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During pregnancy though 1 week postpartum
Secondary outcomes (1)
Dual vaccination rates for non-birthing partners
To assess whether non-birthing partners presenting for Tdap vaccination are willing to accept dual vaccination with Tdap and influenza.
Measured: During pregnancy though 1 week postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start28 May 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-birthing Partner Vaccination in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurie Griffin, Women and Infants Hospital of Rhode Island
- Investigators
- Laurie Griffin, MD/PhD, Principal investigator, Women and Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135636
- Sponsor's protocol ID
- 2095986
- Acronym
- ITAPP
- Status last verified
- Sep 2024
- First submitted
- 12 Nov 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected in this study will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy
- ClinicalTrials.gov ID
- NCT06135636
- Acronym / sponsor ID
- ITAPP / 2095986
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vaccination plays a critical role in decreasing the morbidity and mortality of vaccine-preventable diseases. During pregnancy, maternal vaccination increases neonatal immunity via passive immunity through antibody transmission across the placenta. However, when compared to relying on maternal vaccination alone, "cocooning"-the term for vaccinating all caregivers of newborns- is more effective in reducing neonatal morbidity and mortality from vaccine-related illnesses. Accordingly, the American College of Obstetrician and Gynecologist (ACOG) and Centers for Disease Control (CDC) both recommend that all caregivers be up-to-date on Tdap (Tetanus, Diphtheria and Pertussis), COVID-19, and influenza vaccinations to minimize risk of exposure of vaccine preventable diseases for postpartum individuals and neonates. Unfortunately, the majority of reproductive-aged individuals are not up to date on their routine vaccinations. For example, it is recommended that all adults ≥ 19 years old receive Tdap at least once in their lifetime with Td or Tdap boosters every 10 years; however, only 32.5% of reproductively aged individuals in the United States are vaccinated to TDAP.
The CDC has made calls for unique programs to minimize "missed opportunities," or when an eligible individual is at a health care encounter but fails to be vaccinated completely. Prenatal care is a time in which pregnant and non-pregnant reproductively aged individuals frequently participate in health care. Women who reported that a prenatal care provider offered vaccination in office or via referral were the most likely to receive a vaccination to influenza and Tdap compared to those who only received a vaccine recommendation or those who received no recommendation. This indicates that reducing barriers to vaccination (i.e. immediate in office vaccination), not just recommending vaccination, maximizes vaccine uptake. Prior small studies have demonstrated that the majority of parents of infants admitted to the Neonatal Intensive Care Unit and, in one small, non-randomized acceptability study, nearly two thirds of non-birthing partners accepted Tdap vaccination when offered during prenatal care. However, the majority of prenatal care providers do not offer vaccination to non-birthing partners due to administrative burden, a clear "missed opportunity" for vaccination. Programs expanding vaccine education and administration to non-birthing partners during routine prenatal care has yet to be explored, but such programs have the potential to improve perinatal and neonatal outcomes, thereby improving the health of multiple generations.
Investigators propose to implement a study of vaccine education and administration targeted specifically at Tdap vaccination for non-birthing partners of pregnant patients. The project will assess targeted educational tools for the counseling of non-birthing partners on Tdap recommendations and cocooning, as well as the impact of in-office vaccination opportunities on vaccine uptake for non-birthing partners during prenatal care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: EducationDirect verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery |
| Upfront Education and Vaccination Administration: | Experimental | Behavioral: Education, Biological: Vaccine administrationDirect 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. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Latex allergy: Contraindication to the state supplied Tdap vaccine
- Lethal fetal anomaly diagnosed prior to enrollment to prevent undue distress with follow-up postpartum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationDirect verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery | Behavioural | Upfront Education Only, Upfront Education and Vaccination Administration: |
| Vaccine administrationOption to receive Tdap at their convenience at the WIH obstetric care clinic provided to participant | Biological | Upfront Education and Vaccination Administration: |
Primary outcome
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.
1 secondary outcome
Dual vaccination rates for non-birthing partners
Time frame: During pregnancy though 1 week postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No. Data collected in this study will not be shared with other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Griffin, MD/PhD principal investigator
Women and Infants Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Education and Vaccine administration in people with Non-birthing Partner Vaccination in Pregnancy and Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurie Griffin, MD/PhD (9785182135, LGRIFFIN@WIHRI.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tdap vaccination rate for non-birthing partners (time frame: During pregnancy though 1 week postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.