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Vaccine Acceptance in Pregnant Minority Women

Vaccine Acceptance in Pregnant Minority Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01740310
Enrollment
121
Registered
2012-12-04
Start date
2012-07-31
Completion date
2014-07-31
Last updated
2015-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

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

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.

Interventions

BEHAVIORALMaternal 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.

Sponsors

Kaiser Permanente
CollaboratorOTHER
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Influenza vaccination rates in pregnancyBaseline and one month after participant's expected date of deliveryData 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

MeasureTime frameDescription
Tdap vaccination rates in pregnancyBaseline and one month after participant's expected date of deliveryData 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 vaccinationBaseline and one month after the expected date of deliveryData 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026