An Adaptive Prenatal Intervention to Increase Childhood Vaccinations (ADEPT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaccination Refusal
• Intervention / Treatment: Behavioral: ADEPT

Detailed Description

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 information on vaccines recommended during pregnancy and for children after birth. The core component of ADEPT includes prenatal provider trainings and a recommendation to pregnant individuals encouraging vaccinations during pregnancy and for children after birth. Those pregnant individuals who remain vaccine-hesitant despite the provider recommendation will receive adaptive intervention components, which include evidence-based educational materials on 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. Individuals receiving prenatal care at a clinic implementing ADEPT will be screened for vaccination intention 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. After the pregnant individuals in the intervention and control arms give birth, the researchers will assess their children's vaccination outcomes at birth, 2, 4, 6, and 12 months using data from the North Carolina Immunization Registry (NCIR). The primary study outcome is the difference in timely childhood vaccination at 2 months between the intervention and control arms. In addition, maternal vaccination data will be collected from NCIR for vaccines during pregnancy.

• Study Type: Interventional
• Enrollment (Estimated): 770
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lavanya Vasudevan, PhD, MPH; Phone Number: 404-727-8812; Email: lavanya.vasudevan@emory.edu
• Study Contact Backup: Name: Beverly Gray, MD; Phone Number: (919) 684-8111; Email: beverly.gray@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Health System
      • Contact: Beverly Gray, MD; Phone Number: 919-684-8111; Email: beverly.gray@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADEPT; Individuals receiving prenatal care at a practice that was randomized to deliver the ADEPT intervention.	Behavioral: ADEPT; Prenatal providers will participate in trainings that will lay the foundation for an effective vaccination recommendation. After the completion of training, prenatal care providers will begin making recommendations promoting the importance of maternal and childhood vaccinations to pregnant individuals, as part of routine prenatal care. The core component of ADEPT is prenatal provider training to enable a vaccination recommendation, encouraging pregnant individuals to receive vaccines during pregnancy and for 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 vaccinations and phone consultations with a vaccine navigator to discuss residual concerns.
No Intervention: Standard of Care; Individuals receiving prenatal care at a practice that was randomized to deliver the standard of care.

What is the study measuring?

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.	2 months post birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Lavanya Vasudevan, PhD, MPH, Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Vaccine hesitancy
• Other Study ID Numbers: STUDY00005432; STUDY00005431 (Other Identifier: Emory University); STUDY00005457 (Other Identifier: Emory University); U01IP001149 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Datasets related to the primary outcome will be made available after deidentification.
• IPD Sharing Time Frame: Dataset will be posted after publication of manuscript describing the primary outcome, with no end date.
• IPD Sharing Access Criteria: Individual participant data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims in the approved proposal. Proposals should be directed to lavanya.vasudevan@emory.edu. To gain access, data requesters will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No