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HPV Vaccination Among Daughters of Latina Immigrants

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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

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Healthy Diet Behavioral: HPV Vaccination Behavioral: Healthy Eating Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 634 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group randomized trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: HPV Vaccination Among Daughters of Latina Immigrants
Actual Study Start Date : June 15, 2012
Actual Primary Completion Date : August 10, 2016
Actual Study Completion Date : August 10, 2016

Arm Intervention/treatment
Active Comparator: HPV Vaccination
Mothers participated in educational/behavior change sessions to promote HPV vaccination among their 9-12 year old daughters
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

Active Comparator: Healthy Eating
Mothers and daughters participated in educational/behavior change sessions to promote healthy eating and appropriate nutrition label interpretation
Behavioral: Healthy Eating
Mothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women
Accepts Healthy Volunteers:   Yes
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:

-


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Responsible Party: Isabel Scarinci, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04154319     History of Changes
Other Study ID Numbers: IRB-120503007
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Isabel Scarinci, University of Alabama at Birmingham:
HPV vaccination
Healthy Eating
Latina immigrants
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vaccines
Immunologic Factors
Physiological Effects of Drugs