Vaccine Acceptance in Pregnant Minority Women
6 mars 2015 uppdaterad av: Saad B. Omer, PhD, Emory University
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
121
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30308
- Emory University Hospital Midtown
-
Atlanta, Georgia, Förenta staterna, 30303
- Grady Health System
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Decatur, Georgia, Förenta staterna, 30033
- Dourron OB/Gyn Associates Clinic
-
Riverdale, Georgia, Förenta staterna, 30274
- New Millenium Obstetrics & Gynecology
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Experimentell: 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.
|
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-jämförare: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Influenza vaccination rates in pregnancy
Tidsram: 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.
|
Baseline and one month after participant's expected date of delivery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tdap vaccination rates in pregnancy
Tidsram: 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.
|
Baseline and one month after participant's expected date of delivery
|
|
Change in attitudes regarding vaccination
Tidsram: 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.
|
Baseline and one month after the expected date of delivery
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Saad B Omer, PhD, Emory University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2012
Primärt slutförande (Faktisk)
1 juli 2014
Avslutad studie (Faktisk)
1 juli 2014
Studieregistreringsdatum
Först inskickad
30 november 2012
Först inskickad som uppfyllde QC-kriterierna
30 november 2012
Första postat (Uppskatta)
4 december 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
9 mars 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 mars 2015
Senast verifierad
1 mars 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- IRB00057339
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .