Skip to main content
OpenTrials
Completed

NCT Number: NCT01740310

Vaccine Acceptance in Pregnant Minority Women

The purpose of study will be to test two vaccine education strategies to learn how they impact flu and pertussis (Tdap) vaccination rates and attitudes regarding vaccination during pregnancy after participating in the intervention. The education strategies will be based on the elaboration likelihood model (ELM). This model is based on experimental psychology and has been previously used to increase breast cancer screening rates. These education strategies will be delivered through routine prenatal care visits to black/African-American women in Atlanta.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Gram-Negative Bacterial Infections Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Whooping Cough

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital Midtown, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant, expecting delivery between August 31, 2012 and June 30, 2013
  • Between the ages of 18-50 years old
  • Black/African American

Exclusion criteria

  • Have received the influenza or Tdap vaccine during the current pregnancy
  • Already enrolled in the study

Treatment and study plan

Maternal Vaccine Education

Behavioral

It is assumed that the women will also receive vaccine education materials from the OB/GYN practices as part of routine care. The intervention for all three arms will be conducted during routine prenatal office visits. Participants will complete a baseline questionnaire to assess attitudes regarding vaccination and will then be randomized to one of three enrollment arms and will be exposed to an intervention designed to take no longer than 20 minutes, so that patients can complete it during the time they are waiting to be seen. While participants are completing the handheld/electronic tablet device-based intervention, the study recruiter will observe them and document dose exposure to the messages being presented. The enrolled women will be contacted a month after the expected date of delivery and a follow up interview will be conducted to ascertain their vaccination status for receipt of influenza vaccine in pregnancy and Tdap during pregnancy or immediately post-partum.

Primary outcomes

  1. Influenza vaccination rates in pregnancy

    Time frame: Baseline and one month after participant's expected date of delivery

    Data on vaccination status will be collected from participants enrolled in the main phase of the study during follow up starting one month after the expected date of delivery. We will contact healthcare providers to obtain vaccination records for those who provide written consent to release their immunization records.

Secondary outcomes

  1. Tdap vaccination rates in pregnancy

    Time frame: Baseline and one month after participant's expected date of delivery

    Data on vaccination status will be collected from participants enrolled in the main phase of the study during follow up starting one month after the expected date of delivery. We will contact healthcare providers to obtain vaccination records for those who provide written consent to release their immunization records.

  2. Change in attitudes regarding vaccination

    Time frame: Baseline and one month after the expected date of delivery

    Data on attitudes regarding vaccination status will be collected from participants enrolled in the main phase of the study during follow up starting one month after the expected date of delivery.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Kaiser Permanente

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2012
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.