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HPV Vaccination Among Daughters of Latina Immigrants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154319
Recruitment Status : Completed
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Isabel Scarinci, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE November 4, 2019
First Posted Date  ICMJE November 6, 2019
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE June 15, 2012
Actual Primary Completion Date August 10, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2019)
  • HPV vaccination among 9-12yo daughters of Latina immigrants [ Time Frame: 7 months ]
    Daughters of mothers assigned to the HPV vaccination arm will more likely to complete the recommended HPV doses at 7-month follow-up than daughters of mothers assigned to the healthy eating arm.
  • Healthy eating among Latina immigrants and their 9-12 yo daughters [ Time Frame: 7 months ]
    Mothers and daughters assigned to the healthy eating arm will be more likely to eat fried food less than once per week, consume at least three portions of fruit/vegetables per day and have less than one sweetened beverage per day at 7-months than mothers and daughters assigned to the HPV vaccination arm
  • Appropriate nutrition label interpretation among Latina immigrants mothers and 9-`12yo daughters [ Time Frame: 7 months ]
    Mothers and daughters assigned to the healthy eating arm will be more likely to read nutrition labels sometimes/always and correctly interpret nutrition labels than mothers and daughters assigned to the HPV vaccination arm
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HPV Vaccination Among Daughters of Latina Immigrants
Official Title  ICMJE HPV Vaccination Among Daughters of Latina Immigrants
Brief Summary The overall goal of this study to promote HPV vaccine uptake among daughters of Latina immigrants between the ages of 9 and 12.
Detailed Description

Objective: Implementation and examination of the efficacy of a culturally relevant, community-based HPV vaccination intervention among daughters of Latina immigrants 9-12 years of age in Alabama.

Methods: Group-randomized controlled trial evaluating two interventions: 1) promotion of HPV vaccination and 2) promotion of healthy eating using "place of residence" as the unit of randomization. Between May 2013 and October 2017, forty locations with 317 mother-daughter dyads were enrolled.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Group randomized trial
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cervical Cancer
  • Healthy Diet
Intervention  ICMJE
  • Behavioral: HPV Vaccination
    Mothers assigned to this arm participated in educational/behavior change sessions to promote HPV vaccination among their unvaccinated 9-12 year old daughters
  • Behavioral: Healthy Eating
    Mothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels
Study Arms  ICMJE
  • Active Comparator: HPV Vaccination
    Mothers participated in educational/behavior change sessions to promote HPV vaccination among their 9-12 year old daughters
    Interventions:
    • Behavioral: HPV Vaccination
    • Behavioral: Healthy Eating
  • Active Comparator: Healthy Eating
    Mothers and daughters participated in educational/behavior change sessions to promote healthy eating and appropriate nutrition label interpretation
    Intervention: Behavioral: Healthy Eating
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2019)
634
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 10, 2016
Actual Primary Completion Date August 10, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Latina immigrant
  • Resident of selected randomization unit (place of residence)
  • 18 years of age and older
  • At least one HPV unvaccinated daughter between the ages of 9 and 12

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: women
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04154319
Other Study ID Numbers  ICMJE IRB-120503007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Isabel Scarinci, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alabama at Birmingham
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP