Vaccine Acceptance in Pregnant Minority Women

Sponsor

Emory University (Other)

Overall Status

Completed

CT.gov ID

NCT01740310

Collaborator

Kaiser Permanente (Other)

121

Enrollment

Locations

Arms

Duration (Months)

30.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Behavioral: Maternal Vaccine Education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

121 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Official Title:

Vaccine Acceptance in Pregnant Minority Women

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	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.
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.	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.

Arm

Intervention/Treatment

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.

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.

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.

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.

Behavioral: Maternal Vaccine Education

Outcome Measures

Primary Outcome Measures

Influenza vaccination rates in pregnancy [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.

Secondary Outcome Measures

Tdap vaccination rates in pregnancy [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grady Health System	Atlanta	Georgia	United States	30303
2	Emory University Hospital Midtown	Atlanta	Georgia	United States	30308
3	Dourron OB/Gyn Associates Clinic	Decatur	Georgia	United States	30033
4	New Millenium Obstetrics & Gynecology	Riverdale	Georgia	United States	30274