An Adaptive Prenatal Intervention to Increase Childhood Vaccinations

NCT05795855 | Suspended

• 4 other identifiers: STUDY00005432STUDY00005431U01IP001149STUDY00005457
• Study Type: interventional
• Target: 770
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaccination Refusal

Keywords

Vaccine hesitancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Vaccine Hesitancy

  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)

Study Arms (2)

ADEPT

EXPERIMENTAL

Individuals receiving prenatal care at a practice that was randomized to deliver the ADEPT intervention.

Behavioral: ADEPT

Standard of Care

NO INTERVENTION

Individuals receiving prenatal care at a practice that was randomized to deliver the standard of care.

Interventions

ADEPT BEHAVIORAL

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.

ADEPT

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Duke Health System

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Vasudevan L, Porter RM, Campos I, Turner EL, Stinnett SS, Zullig LL, Walter EB, Swamy GK, Bednarczyk RA, Orenstein WA, Gray B. An ADaptivE PrenaTal (ADEPT) intervention to increase childhood vaccinations: Protocol for a cluster randomized trial and nested mixed methods evaluation. PLoS One. 2024 Nov 21;19(11):e0313742. doi: 10.1371/journal.pone.0313742. eCollection 2024.

  PMID: 39570957 DERIVED

MeSH Terms

Conditions

Vaccination Refusal; Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Lavanya Vasudevan, PhD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: April 27, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Dataset will be posted after publication of manuscript describing the primary outcome, with no end date.
• 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.

Locations

US (1)