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Vaccine Acceptance in Pregnant Minority Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740310
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : March 9, 2015
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Saad B. Omer, PhD, Emory University

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date March 9, 2015
Study Start Date  ICMJE July 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Influenza vaccination rates in pregnancy [ Time Frame: 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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • Tdap vaccination rates in pregnancy [ Time Frame: 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 [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Acceptance in Pregnant Minority Women
Official Title  ICMJE Vaccine Acceptance in Pregnant Minority Women
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Condition  ICMJE Pregnancy
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Maternal Vaccine Education
  • 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.
    Intervention: Behavioral: Maternal Vaccine Education
  • 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.
    Intervention: Behavioral: Maternal Vaccine Education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2013)
121
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
174
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740310
Other Study ID Numbers  ICMJE IRB00057339
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Saad B. Omer, PhD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Kaiser Permanente
Investigators  ICMJE
Principal Investigator: Saad B Omer, PhD Emory University
PRS Account Emory University
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP