Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05795855
Study type Interventional
Source Emory University
Contact Lavanya Vasudevan, PhD, MPH
Phone 404-727-8812
Email lavanya.vasudevan@emory.edu
Status Not yet recruiting
Phase N/A
Start date July 20, 2024
Completion date March 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05057208 - Does the COVID-19 Vaccination Rate Change According to the Education, Income, Culture Level, Prosociality ?
Completed NCT05764174 - Digital Applications to Monitor Novel Coronavirus Disease and Response in Colombia - Syndromic and Vaccination Surveillance N/A
Completed NCT05529030 - COVID-19 Booster Readiness Survey N/A
Active, not recruiting NCT05479383 - Tobacco Use and Uptake of COVID-19 Vaccinations
Active, not recruiting NCT04779827 - Improving Health Equity for COVID-19 Vaccination for At-risk Populations Using Online Social Networks N/A
Completed NCT04871243 - Children Vaccination From 11 to 14 Years Old
Completed NCT05252936 - Effectiveness of a Mayan Language Social Media Campaign on COVID-19 Vaccine Beliefs in Guatemala N/A
Completed NCT05923320 - The Effect of Education Given to Postpartum Women on Their Attitudes Towards Childhood Vaccinations and Breastfeeding N/A
Recruiting NCT05772117 - A RCT Evaluating an Online Intervention in Increasing Pneumococcal Vaccination Among Older Adults N/A
Withdrawn NCT05442762 - Social Media-based Vaccine Confidence and Hesitancy Monitoring
Completed NCT05390697 - Educational Videos to Address Vaccine Hesitancy in Childhood Immunization N/A
Active, not recruiting NCT05419232 - COVID-19 Vaccine Uptake Trial N/A
Completed NCT05225064 - Increasing COVID-19 Vaccine Uptake in Developing Countries (Bihar) N/A
Completed NCT04728594 - Emails Promoting COVID-19 Vaccination Among Healthcare Workers N/A
Recruiting NCT05866237 - COVID-19 Vaccine Uptake Amongst Underserved Populations in East London N/A
Completed NCT05043155 - Strategies to Continue Gynae-oncology Services in the Era of COVID-19 Outbreak: Concerns and Challenges in a Referral Centre in Malaysia
Completed NCT05182554 - COVID-19 Messaging for Vaccination N/A
Completed NCT05155241 - A Randomized Controlled Trial Evaluating an Online Intervention in Increasing Seasonal Influenza Vaccination Among Community Dwelling People Aged ≥65 Years N/A
Active, not recruiting NCT05891626 - Group Intervention on Vaccine Confidence N/A
Completed NCT04203277 - Improving Vaccinations for Young Children (IVY) N/A