An Adaptive Prenatal Intervention to Increase Childhood Vaccinations

Study Overview
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Brief Summary
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This study will test whether proactively connecting expectant parents with factual vaccination information during pregnancy can build parental confidence in childhood vaccinations and lead to timely vaccinations once their child is born.

Detailed Description
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In the United States (US), parents' decision to delay or refuse vaccines for their children has resulted in pockets of under-vaccination as well as recurring outbreaks of vaccine-preventable diseases. To increase childhood vaccinations and stem recurring outbreaks, there is a need for effective interventions that build parents' confidence in vaccines and reduce their vaccine hesitancy. The first recommended routine vaccination for children is due at birth. Yet, many parents lack timely or evidence-based information on childhood vaccinations prior to their child's birth. Hence, the researchers of this study propose to evaluate ADEPT - an adaptive intervention that is implemented in prenatal care settings to proactively connect expectant parents with evidence-based childhood vaccination information before their child's birth. The core component of ADEPT includes prenatal provider trainings and a recommendation to pregnant individuals in their early third trimester (28-32 weeks gestation) encouraging childhood vaccinations after the child is born. Those pregnant individuals who remain vaccine-hesitant despite the provider recommendation will receive adaptive intervention components, which include evidence-based educational materials on childhood vaccinations and phone consultations with a vaccine navigator to discuss any residual concerns. In the proposed study, ADEPT will be implemented and evaluated in diverse prenatal care practices in North Carolina. Study prenatal care practices will be randomized to the ADEPT intervention or standard of care to pregnant individuals. The timeliness of childhood vaccinations will be compared between study arms. Individuals receiving prenatal care at a clinic implementing ADEPT will be screened for vaccine-hesitancy following the provider recommendation. Vaccine-hesitant pregnant individuals will be offered enrollment into a nested sub-study designed to assess the implementation of the ADEPT intervention.

Official Title
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An Adaptive Prenatal Intervention to Increase Childhood Vaccinations

Conditions
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Vaccination Refusal

Intervention / Treatment
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* Behavioral: ADEPT


Participation Criteria
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Eligibility Criteria
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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 early third 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADEPT<br>Individuals in their third trimester of pregnancy receiving prenatal care at a practice that was randomized to deliver the ADEPT intervention. | Behavioral: ADEPT<br>* Prenatal providers will participate in trainings that will lay the foundation for an effective childhood vaccination recommendation. After the completion of training, prenatal care providers will begin making recommendations promoting the importance of childhood vaccinations to pregnant individuals who are in the early third trimester, as part of routine prenatal care. The core component of ADEPT is prenatal provider training to enable a recommendation in the early third trimester, encouraging pregnant individuals to vaccinate their child after birth. Pregnant individuals who remain vaccine hesitant despite the provider recommendation, will be eligible to receive the adaptive components of ADEPT in the form of evidence-based educational materials on childhood vaccinations and phone consultations with a vaccine navigator to discuss residual concerns.<br>|
| No Intervention: Standard of Care<br>Individuals in their third trimester of pregnancy receiving prenatal care at a practice that was randomized to deliver the standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months post birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vaccine Hesitancy | Vaccine hesitancy will be examined among pregnant individuals in the intervention prenatal practices. When asked how they feel about getting their child vaccinated, pregnant individuals will respond with one of four options which 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine hesitancy