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PregnancyNCT01740310

Vaccine Acceptance in Pregnant Minority Women

A study testing Maternal Vaccine Education in people with Pregnancy, run by Emory University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Maternal Vaccine Education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
4 sitesUnited States
Study dates
Jul 2012to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Pregnant, expecting delivery between August 31, 2012 and June 30, 2013
  • Between the ages of 18-50 years old
  • Black/African American

Who cannot join

  • Have received the influenza or Tdap vaccine during the current pregnancy
  • Already enrolled in the study

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Dourron OB/Gyn Associates Clinic

    Decatur, Georgia, 30033

  • New Millenium Obstetrics & Gynecology

    Riverdale, Georgia, 30274

Other trials in United States

About this study

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.

Conditions
Pregnancy
Being tested
Maternal Vaccine Education
Keywords
pregnancy,, vaccine acceptance,, vaccination,, influenza,, pertussis,, Tdap,, minority,, African-American
Medical subject headings
Influenza, Human, Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maternal Vaccine EducationBehavioural

    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.

Study groups in NCT01740310
Study groupRoleWhat they receive
High Elaboration Video ArmExperimentalWomen 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.
Receives: Behavioral: Maternal Vaccine Education
High Elaboration Interactive Tutorial ArmExperimentalWomen 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.
Receives: Behavioral: Maternal Vaccine Education
Low Elaboration / Control ArmPlacebo comparatorWomen randomized to the control arm will be provided standard CDC vaccine information statements that will likely lead to low elaboration information processing.
Receives: Behavioral: Maternal Vaccine Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and one month after participant's expected date of delivery

Secondary outcomes (2)

  1. 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.

    Measured: Baseline and one month after participant's expected date of delivery

  2. 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.

    Measured: Baseline and one month after the expected date of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01740310
Sponsor's protocol ID
IRB00057339
Status last verified
Mar 2015
First submitted
30 Nov 2012
Last updated
9 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15604052

  • 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.

    PubMed 17959583

  • 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.

    PubMed 16157423

  • 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.

    PubMed 17336800

  • 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.

    PubMed 21330153

  • Petty R, Cacioppo J. Communication and Persuasion: Central and Peripheral Routes to Attitude Change. New York, NY: Springer-Verlag; 1986.

  • 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.

    PubMed 21502250

  • 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.

    PubMed 28216190

Questions about this trial

What is this clinical trial studying?

A study testing Maternal Vaccine Education in people with Pregnancy, run by Emory University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Influenza vaccination rates in pregnancy (time frame: Baseline and one month after participant's expected date of delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01740310, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.

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