Clinical trial NCT01740310: Vaccine Acceptance in Pregnant Minority Women
Official title: Vaccine Acceptance in Pregnant Minority Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: pregnancy,
vaccine acceptance,
vaccination,
influenza,
pertussis,
Tdap,
minority,
African-American
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
First posted: 2012-12-04
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.


Eligibility 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

Primary outcomes:
measure: Influenza vaccination rates in pregnancy
timeFrame: Baseline and one month after participant's expected date of delivery
Secondary outcomes:
measure: Tdap vaccination rates in pregnancy
timeFrame: Baseline and one month after participant's expected date of delivery
measure: Change in attitudes regarding vaccination
timeFrame: Baseline and one month after the expected date of delivery
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Decatur
country: United States
facility: Dourron OB/Gyn Associates Clinic
state: Georgia
city: Riverdale
country: United States
facility: New Millenium Obstetrics & Gynecology
state: Georgia
Study officials:
affiliation: Emory University
name: Saad B Omer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.5993/ajhb.29.1.7.
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. doi: 10.1093/her/cym065. Epub 2007 Oct 23.
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. doi: 10.1016/j.vaccine.2005.08.053. Epub 2005 Aug 26.
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. doi: 10.1016/j.jneb.2006.09.001.
citation: 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.
citation: Petty R, Cacioppo J. Communication and Persuasion: Central and Peripheral Routes to Attitude Change. New York, NY: Springer-Verlag; 1986.
citation: 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.
citation: 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.