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Clinical Trials/NCT04154319
NCT04154319CompletedNot Applicable

HPV Vaccination Among Daughters of Latina Immigrants

University of Alabama at Birmingham0 sites634 target enrollmentStarted: June 15, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
634
Primary Endpoint
Appropriate nutrition label interpretation among Latina immigrants mothers and 9-'12yo daughters

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

  • Not provided

Arms & Interventions

HPV Vaccination

Active Comparator

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

Intervention: HPV Vaccination (Behavioral)

HPV Vaccination

Active Comparator

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

Intervention: Healthy Eating (Behavioral)

Healthy Eating

Active Comparator

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

Intervention: Healthy Eating (Behavioral)

Outcomes

Primary Outcomes

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

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Isabel Scarinci

Professor

University of Alabama at Birmingham

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