Vaccine Acceptance in Pregnant Minority Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Saad B. Omer, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT01740310
First received: November 30, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Pregnancy
Behavioral: Maternal Vaccine Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Vaccine Acceptance in Pregnant Minority Women

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Influenza vaccination rates in pregnancy [ Time Frame: Baseline and one month after participant's expected date of delivery ] [ Designated as safety issue: No ]
    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:
  • Tdap vaccination rates in pregnancy [ Time Frame: Baseline and one month after participant's expected date of delivery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and one month after the expected date of delivery ] [ Designated as safety issue: No ]
    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.


Enrollment: 121
Study Start Date: July 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Elaboration Video Arm
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.
Behavioral: Maternal Vaccine Education
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.
Experimental: High Elaboration Interactive Tutorial Arm
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.
Behavioral: Maternal Vaccine Education
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.
Placebo Comparator: Low Elaboration / Control Arm
Women randomized to the control arm will be provided standard CDC vaccine information statements that will likely lead to low elaboration information processing.
Behavioral: Maternal Vaccine Education
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01740310

Locations
United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Dourron OB/Gyn Associates Clinic
Decatur, Georgia, United States, 30033
New Millenium Obstetrics & Gynecology
Riverdale, Georgia, United States, 30274
Sponsors and Collaborators
Emory University
Kaiser Permanente
Investigators
Principal Investigator: Saad B Omer, PhD Emory University
  More Information

Publications:
Responsible Party: Saad B. Omer, PhD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT01740310     History of Changes
Other Study ID Numbers: IRB00057339
Study First Received: November 30, 2012
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
pregnancy,
vaccine acceptance,
vaccination,
influenza,
pertussis,
Tdap,
minority,
African-American

ClinicalTrials.gov processed this record on August 27, 2014