P3+ Intervention Phase



Status:Active, not recruiting
Conditions:Vaccines
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 50
Updated:8/16/2018
Start Date:June 12, 2017
End Date:December 2019

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A Comprehensive Pre-Natal Intervention to Increase Vaccine Coverage (P3+): Practice, Provider, Patient Level Interventions

This study will address vaccine uptake both for pregnant women and for their children,
through 20 months of age, to test the hypothesis that exposure to the P3+ intervention
package will increase the likelihood a pregnant woman gets herself vaccinated against
influenza and pertussis before delivery and get her child vaccinated on time. This study
builds off of a prior intervention, developed by Emory, at the practice, provider, and
patient levels (P3) to develop, implement and evaluate an enhanced intervention (P3+) to
improve vaccination uptake among pregnant women, and later, their children.

This study will address vaccine uptake both for pregnant women and for their children,
through 20 months of age, to test the hypothesis that exposure to the P3+ intervention
package will increase the likelihood a pregnant woman gets herself vaccinated against
influenza and pertussis before delivery and get her child vaccinated on time.

This study uses a multi-level factorial design which randomizes at both the practice and the
patient level. Obstetric practices in Georgia and Colorado will be randomized to be either an
intervention practice or a control practice. The women recruited in the practices and
enrolled in the study will be randomly assigned to the intervention arm or the control arm.

Women randomized to the intervention arm will complete a computer-based questionnaire
(administered via iPad with a preloaded study app) which asks for their basic demographic and
contact information and asks questions about their vaccine knowledge, attitudes, and beliefs.
Immediately following the questionnaire, participants will receive the individual level
intervention (videos providing information on vaccines) on the same iPad. In order to best
answer their questions and not provide information beyond the scope of what the study
participants need or want, the videos provided to each participant will be selected based on
responses to the survey questions. There are 6 videos: one discusses the dangers of the
diseases prevented by vaccines, and the others address specific vaccine concerns (concerns
include vaccine ingredients, children receiving simultaneous vaccines (multiple vaccines at
one time), and the safety of receiving the tdap or flu vaccine during pregnancy). If the
participant does not have any concerns, they will only see the video about dangers of vaccine
preventable diseases. Participants expressing concerns in the survey will receive up to two
videos addressing those concerns, based on an order of priority determined by the study
researchers.

Women randomized to the control arm will also complete a computer-based questionnaire which
includes their personal information and vaccine knowledge, attitudes, and beliefs questions
but will then continue to receive usual prenatal care rather than view informational videos.

All enrolled women complete two follow-up surveys when their children are 30 days and 18
months of age.

Inclusion Criteria:

- Have not previously participated in this study

- Currently pregnant

- Up to 26 weeks gestational age

- Able to understand and communicate in English

Exclusion Criteria:

- Have received pertussis vaccine during the current pregnancy
We found this trial at
23
sites
3630 Savannah Place Drive
Duluth, Georgia 30096
Phone: 770-730-0451
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Duluth, GA
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3400 Old Milton Parkway
Alpharetta, Georgia 30005
Phone: 770-667-7440
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Alpharetta, GA
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11975 Morris Road
Alpharetta, Georgia 30005
Phone: 770-571-3600
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Alpharetta, GA
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Athens, Georgia 30606
Phone: 706-475-7000
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Athens, GA
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740 Prince Avenue
Athens, Georgia 30606
Phone: 706-548-4272
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Athens, GA
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355 Hawthorne Lane
Athens, Georgia 30606
Phone: 706-369-0019
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Athens, GA
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993 Johnson Ferry Road Northeast
Atlanta, Georgia 30342
Phone: 404-250-1350
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Atlanta, GA
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Atlanta, Georgia 30322
Phone: 404-778-8651
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Atlanta, GA
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1635 Aurora Court
Aurora, Colorado 80045
Phone: 720-985-7349
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Aurora, CO
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13123 East 16th Avenue
Aurora, Colorado 80045
Phone: 303-724-5733
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1635 Aurora Court
Aurora, Colorado 80045
Phone: 303-248-6283
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Aurora, CO
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4745 Arapahoe Avenue
Boulder, Colorado 80303
Phone: 303-441-0587
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Boulder, CO
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1800 Northside Forsyth Drive
Cumming, Georgia 30041
Phone: 770-888-0188
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Cumming, GA
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1960 North Ogden Street
Denver, Colorado 80218
Phone: 303-318-2626
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4500 East 9th Avenue
Denver, Colorado 80220
Phone: 303-399-3315
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Denver, CO
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Denver, Colorado 80220
Phone: 303-399-0055
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Denver, CO
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1829 Independence Square
Dunwoody, Georgia 30338
Phone: 770-551-9616
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Dunwoody, GA
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322 Beard Creek Road
Edwards, Colorado 81632
Phone: 970-569-6333
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Edwards, CO
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180 East Hampden Avenue
Englewood, Colorado 80113
Phone: 303-789-4968
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Englewood, CO
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2801 Youngfield Street
Golden, Colorado 80401
Phone: 303-940-1867
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Golden, CO
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449 Pleasant Hill Road
Lilburn, Georgia 30047
Phone: 770-923-5033
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Lilburn, GA
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9195 Grant Street
Thornton, Colorado 80229
Phone: 303-280-2229
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Thornton, CO
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190 Handley Road
Tyrone, Georgia 30290
Phone: 770-997-5714
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Tyrone, GA
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