HPV Vaccination Among Daughters of Latina Immigrants

Not Applicable

Completed

• Conditions: Cervical Cancer; Healthy Diet
• Interventions: Behavioral: HPV Vaccination; Behavioral: Healthy Eating

• Registration Number: NCT04154319
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-06-15
• Primary Completion: 2016-08-10
• Study Completion: 2016-08-10
• Status Verified: 2019-11
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-04
• Last Update Submitted: 2019-11-04
• Study First Posted: 2019-11-06
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 634

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPV Vaccination	Healthy Eating	Mothers participated in educational/behavior change sessions to promote HPV vaccination among their 9-12 year old daughters
Healthy Eating	Healthy Eating	Mothers and daughters participated in educational/behavior change sessions to promote healthy eating and appropriate nutrition label interpretation
HPV Vaccination	HPV Vaccination	Mothers participated in educational/behavior change sessions to promote HPV vaccination among their 9-12 year old daughters

Primary Outcome Measures

Name	Time	Method
Appropriate nutrition label interpretation among Latina immigrants mothers and 9-'12yo daughters	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	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	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.