Vaccine Acceptance in Pregnant Minority Women

NCT01740310 | Completed

• 1 other identifier: IRB00057339
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 4

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.

Conditions

Pregnancy

Keywords

pregnancy,; vaccine acceptance,; vaccination,; influenza,; pertussis,; Tdap,; minority,; African-American

Outcome Measures

Primary Outcomes (1)

• Influenza vaccination rates in pregnancy

  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.

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

Secondary Outcomes (2)

• Tdap vaccination rates in pregnancy

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

• Change in attitudes regarding vaccination

  Baseline and one month after the expected date of delivery

Study Arms (3)

High Elaboration Video Arm

EXPERIMENTAL

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

High Elaboration Interactive Tutorial Arm

EXPERIMENTAL

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

Low Elaboration / Control Arm

PLACEBO COMPARATOR

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

Interventions

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.

High Elaboration Interactive Tutorial Arm; High Elaboration Video Arm; Low Elaboration / Control Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• Kaiser Permanente: collaborator

Study Sites (4)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Dourron OB/Gyn Associates Clinic

Decatur, Georgia, 30033, United States

Location

New Millenium Obstetrics & Gynecology

Riverdale, Georgia, 30274, United States

Location

Related Publications (8)

• Gust D, Brown C, Sheedy K, Hibbs B, Weaver D, Nowak G. Immunization attitudes and beliefs among parents: beyond a dichotomous perspective. Am J Health Behav. 2005 Jan-Feb;29(1):81-92. doi: 10.5993/ajhb.29.1.7.

  PMID: 15604052 BACKGROUND

• Gust DA, Kennedy A, Wolfe S, Sheedy K, Nguyen C, Campbell S. Developing tailored immunization materials for concerned mothers. Health Educ Res. 2008 Jun;23(3):499-511. doi: 10.1093/her/cym065. Epub 2007 Oct 23.

  PMID: 17959583 BACKGROUND

• Paulussen TG, Hoekstra F, Lanting CI, Buijs GB, Hirasing RA. Determinants of Dutch parents' decisions to vaccinate their child. Vaccine. 2006 Jan 30;24(5):644-51. doi: 10.1016/j.vaccine.2005.08.053. Epub 2005 Aug 26.

  PMID: 16157423 BACKGROUND

• Wilson BJ. Designing media messages about health and nutrition: what strategies are most effective? J Nutr Educ Behav. 2007 Mar-Apr;39(2 Suppl):S13-9. doi: 10.1016/j.jneb.2006.09.001.

  PMID: 17336800 BACKGROUND

• Baxter CE, Barata PC. The paradox of HPV vaccines: how to reach sexually inexperienced women for protection against a sexually transmitted infection. Womens Health Issues. 2011 May-Jun;21(3):239-45. doi: 10.1016/j.whi.2010.11.007. Epub 2011 Feb 18.

  PMID: 21330153 BACKGROUND

• Petty R, Cacioppo J. Communication and Persuasion: Central and Peripheral Routes to Attitude Change. New York, NY: Springer-Verlag; 1986.

  BACKGROUND

• Vannice KS, Salmon DA, Shui I, Omer SB, Kissner J, Edwards KM, Sparks R, Dekker CL, Klein NP, Gust DA. Attitudes and beliefs of parents concerned about vaccines: impact of timing of immunization information. Pediatrics. 2011 May;127 Suppl 1(Suppl 1):S120-6. doi: 10.1542/peds.2010-1722R. Epub 2011 Apr 18.

  PMID: 21502250 BACKGROUND

• Kriss JL, Frew PM, Cortes M, Malik FA, Chamberlain AT, Seib K, Flowers L, Ault KA, Howards PP, Orenstein WA, Omer SB. Evaluation of two vaccine education interventions to improve pertussis vaccination among pregnant African American women: A randomized controlled trial. Vaccine. 2017 Mar 13;35(11):1551-1558. doi: 10.1016/j.vaccine.2017.01.037. Epub 2017 Feb 16.

  PMID: 28216190 DERIVED

MeSH Terms

Conditions

Influenza, Human; Whooping Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Saad B Omer, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

US (4)