An intervention to improve childhood vaccinations through prenatal education
An Adaptive Prenatal Intervention to Increase Childhood Vaccinations
This study is testing a new way to help expectant parents feel more confident about vaccinations by providing them with helpful information during pregnancy to ensure their children get vaccinated on time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 770 (estimated) |
| Sex | Female |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05795855 on ClinicalTrials.gov |
What this trial studies
This study aims to address vaccine hesitancy by proactively connecting expectant parents with factual vaccination information during pregnancy. The ADEPT intervention will be implemented in diverse prenatal care practices in North Carolina, where prenatal providers will receive training and encourage vaccinations for both the mother and child. For those who remain hesitant, additional support will be provided through educational materials and consultations with a vaccine navigator. The goal is to build confidence in vaccinations and ensure timely vaccinations for children after birth.
Who should consider this trial
Good fit: Ideal candidates for this study are nulliparous individuals in their late second trimester of a singleton pregnancy who receive prenatal care at participating practices in North Carolina.
Not a fit: Patients who are not vaccine-hesitant or those who do not meet the inclusion criteria, such as having prior live births or multiple pregnancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly increase childhood vaccination rates and reduce outbreaks of vaccine-preventable diseases.
How similar studies have performed: Other studies have shown success in using educational interventions to reduce vaccine hesitancy, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Nulliparous individuals (no prior live birth) * Singleton pregnancy (excludes twins, triplets, etc.) * No known fetal congenital malformations or genetic abnormalities * Not at known risk for preterm birth * In late second trimester during study recruitment period * Receive prenatal care at one of the study practices Inclusion Criteria for Nested Sub-Study: * Eligible to receive adaptive components of ADEPT (vaccine-hesitant after provider recommendation) * At least 18 years of age * Provide informed consent * Agree to participate in surveys and in-depth interview * Agree for child's vaccination outcomes to be extracted from the North Carolina Immunization Registry (NCIR) * Plan to stay in North Carolina for at least 3 months after delivery Exclusion Criteria: * none
Where this trial is running
Durham, North Carolina
- Duke Health System — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Lavanya Vasudevan, PhD, MPH — Emory University
- Study coordinator: Lavanya Vasudevan, PhD, MPH
- Email: lavanya.vasudevan@emory.edu
- Phone: 404-727-8812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.