Vaccine Acceptance in Pregnant Minority Women

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Behavioral: Maternal Vaccine Education

• Registration Number: NCT01740310
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
High Elaboration Interactive Tutorial Arm	Maternal Vaccine Education	Women will be exposed to a handheld/electronic tablet device-based intervention designed to invoke a high level of attention to the message and thought (elaboration) while processing information through an interactive question/answer format.
Low Elaboration / Control Arm	Maternal Vaccine Education	Women randomized to the control arm will be provided standard CDC vaccine information statements that will likely lead to low elaboration information processing.
High Elaboration Video Arm	Maternal Vaccine Education	Women randomized to this arm will be exposed to a handheld/electronic tablet device-based video with detailed vaccine-related information designed to invoke a high level of attention to the message and thought (elaboration) while processing information.

Primary Outcome Measures

Name	Time	Method
Influenza vaccination rates in pregnancy	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 Outcome Measures

Name	Time	Method
Tdap vaccination rates in pregnancy	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.
Change in attitudes regarding vaccination	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.

Trial Locations

Locations (4)

Grady Health System; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Dourron OB/Gyn Associates Clinic; 🇺🇸 Decatur, Georgia, United States

New Millenium Obstetrics & Gynecology; 🇺🇸 Riverdale, Georgia, United States