Vaccine Acceptance in Pregnant Minority Women

Pregnancy Clinical Trial

Official title:

Vaccine Acceptance in Pregnant Minority Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740310
• Other study ID #: IRB00057339
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: March 6, 2015
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Grady Health System	Atlanta	Georgia
United States	Dourron OB/Gyn Associates Clinic	Decatur	Georgia
United States	New Millenium Obstetrics & Gynecology	Riverdale	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Kaiser Permanente

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. Epub 2007 Oct 23. — View Citation

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. Epub 2005 Aug 26. — View Citation

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

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:S120-6. doi: 10.1542/peds.2010-1722R. Epub 2011 Apr 18. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Tdap 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	No
Secondary	Change in attitudes regarding vaccination	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.	Baseline and one month after the expected date of delivery	No