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HPV Vaccination Among Daughters of Latina Immigrants

Primary Purpose

Cervical Cancer, Healthy Diet

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HPV Vaccination
Healthy Eating
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring HPV vaccination, Healthy Eating, Latina immigrants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    HPV Vaccination

    Healthy Eating

    Arm Description

    Mothers participated in educational/behavior change sessions to promote HPV vaccination among their 9-12 year old daughters

    Mothers and daughters participated in educational/behavior change sessions to promote healthy eating and appropriate nutrition label interpretation

    Outcomes

    Primary Outcome Measures

    HPV vaccination among 9-12yo daughters of Latina immigrants
    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
    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 4, 2019
    Last Updated
    November 4, 2019
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04154319
    Brief Title
    HPV Vaccination Among Daughters of Latina Immigrants
    Official Title
    HPV Vaccination Among Daughters of Latina Immigrants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 15, 2012 (Actual)
    Primary Completion Date
    August 10, 2016 (Actual)
    Study Completion Date
    August 10, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Healthy Diet
    Keywords
    HPV vaccination, Healthy Eating, Latina immigrants

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group randomized trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    634 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HPV Vaccination
    Arm Type
    Active Comparator
    Arm Description
    Mothers participated in educational/behavior change sessions to promote HPV vaccination among their 9-12 year old daughters
    Arm Title
    Healthy Eating
    Arm Type
    Active Comparator
    Arm Description
    Mothers and daughters participated in educational/behavior change sessions to promote healthy eating and appropriate nutrition label interpretation
    Intervention Type
    Behavioral
    Intervention Name(s)
    HPV Vaccination
    Intervention Description
    Mothers assigned to this arm participated in educational/behavior change sessions to promote HPV vaccination among their unvaccinated 9-12 year old daughters
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Eating
    Intervention Description
    Mothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels
    Primary Outcome Measure Information:
    Title
    HPV vaccination among 9-12yo daughters of Latina immigrants
    Description
    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.
    Time Frame
    7 months
    Title
    Healthy eating among Latina immigrants and their 9-12 yo daughters
    Description
    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
    Time Frame
    7 months
    Title
    Appropriate nutrition label interpretation among Latina immigrants mothers and 9-'12yo daughters
    Description
    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
    Time Frame
    7 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    women
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: -

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32671515
    Citation
    Scarinci IC, Hansen B, Kim YI. A Cluster-Randomized Controlled Trial to Evaluate a Community-Based Healthy Eating and Nutrition Label Interpretation Intervention Among Latinx Immigrant Mothers and Their Daughters. J Community Health. 2021 Apr;46(2):313-323. doi: 10.1007/s10900-020-00885-x.
    Results Reference
    derived

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    HPV Vaccination Among Daughters of Latina Immigrants

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