Vaccination Refusal Clinical Trial
— ADEPTOfficial title:
An Adaptive Prenatal Intervention to Increase Childhood Vaccinations
This study will test whether proactively connecting expectant parents with factual vaccination information during pregnancy can build confidence in vaccinations and lead to timely vaccinations during pregnancy and once their child is born.
Status | Not yet recruiting |
Enrollment | 770 |
Est. completion date | March 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke Health System | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of children receiving timely vaccinations | The proportion of children who receive vaccinations per the Advisory Committee on Immunization Practices (ACIP) recommended schedule at 2 months-post birth, by study arm. | 2 months post birth | |
Secondary | Change in Vaccine Hesitancy | In the intervention arm only, vaccine hesitancy will be examined among pregnant individuals in the intervention prenatal practices. When asked about vaccination intention, lack of intention to get vaccinations during pregnancy or for their child after birth will determine if they will receive the adaptive portion of ADEPT. The question will be asked again following completion of the ADEPT adaptive components. | 28-32 weeks gestation (after receiving the core ADEPT intervention), following completion of the adaptive portion of ADEPT (prior to birth, typically 40 weeks gestation) |
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