HPV Vaccination Among Daughters of Latina Immigrants
November 4, 2019 updated by: Isabel Scarinci, University of Alabama at Birmingham
The overall goal of this study to promote HPV vaccine uptake among daughters of Latina immigrants between the ages of 9 and 12.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
634
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Mothers assigned to this arm participated in educational/behavior change sessions to promote HPV vaccination among their unvaccinated 9-12 year old daughters
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
|
Mothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
7 months
|
|
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
|
7 months
|
|
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
|
7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2012
Primary Completion (Actual)
August 10, 2016
Study Completion (Actual)
August 10, 2016
Study Registration Dates
First Submitted
November 4, 2019
First Submitted That Met QC Criteria
November 4, 2019
First Posted (Actual)
November 6, 2019
Study Record Updates
Last Update Posted (Actual)
November 6, 2019
Last Update Submitted That Met QC Criteria
November 4, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-120503007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.