An interventional study of ADEPT in Vaccination Refusal, sponsored by Emory University. Suspended at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Emory University · Not applicable, Interventional, and Health services research
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.
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.
36 studies on the registry are indexed under Vaccination Hesitancy; 7 are open to participants now.
This study's planned enrollment of 770 is above the median of 300 across 33 interventional studies indexed under Vaccination Hesitancy.
Browse Vaccination Hesitancy studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria for Nested Sub-Study:
Exclusion Criteria:
Individuals receiving prenatal care at a practice that was randomized to deliver the ADEPT intervention.
Behavioral: ADEPT
Individuals receiving prenatal care at a practice that was randomized to deliver the standard of care.
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.
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.
Time frame: 2 months post birth
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.
Time frame: 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)
Plan to share: Yes — Datasets related to the primary outcome will be made available after deidentification.
Supporting information: Study protocol, Icf
This study is suspended, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Vaccination Refusal
Emory University