HPV Vaccination Among Daughters of Latina Immigrants

Study Overview
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Brief Summary
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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
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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.

Official Title
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HPV Vaccination Among Daughters of Latina Immigrants

Conditions
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Cervical Cancer, Healthy Diet

Intervention / Treatment
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* Behavioral: HPV Vaccination
* Behavioral: Healthy Eating


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HPV Vaccination<br>Mothers participated in educational/behavior change sessions to promote HPV vaccination among their 9-12 year old daughters | Behavioral: HPV Vaccination<br>* Mothers assigned to this arm participated in educational/behavior change sessions to promote HPV vaccination among their unvaccinated 9-12 year old daughters<br>Behavioral: Healthy Eating<br>* Mothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels<br>|
| Active Comparator: Healthy Eating<br>Mothers and daughters participated in educational/behavior change sessions to promote healthy eating and appropriate nutrition label interpretation | Behavioral: Healthy Eating<br>* Mothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 months | 
| 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 | 7 months | 
| 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 | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV vaccination, Healthy Eating, Latina immigrants