Vaccine Acceptance in Pregnant Minority Women

Study Overview
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Brief Summary
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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.

Official Title
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Vaccine Acceptance in Pregnant Minority Women

Conditions
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Pregnancy

Intervention / Treatment
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* Behavioral: Maternal Vaccine Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Elaboration Video Arm<br>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<br>* 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.<br>|
| Experimental: High Elaboration Interactive Tutorial Arm<br>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<br>* 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.<br>|
| Placebo Comparator: Low Elaboration / Control Arm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy,, vaccine acceptance,, vaccination,, influenza,, pertussis,, Tdap,, minority,, African-American