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
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

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.

Sponsor

University of Alabama at Birmingham

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.

General Publications

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

Keywords

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.

Clinical Trials on Cervical Cancer

Clinical Trials on HPV Vaccination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe