HPV Vaccination Among Daughters of Latina Immigrants

Cervical Cancer Clinical Trial

Official title:

HPV Vaccination Among Daughters of Latina Immigrants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04154319
• Other study ID #: IRB-120503007
• Status: Completed
• Phase: N/A
• Start date: June 15, 2012
• Est. completion date: August 10, 2016

Study information

• Verified date: November 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal of this study to promote HPV vaccine uptake among daughters of Latina immigrants between the ages of 9 and 12.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: August 10, 2016
• Est. primary completion date: August 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Cervical Cancer
• Healthy Diet
• Uterine Cervical Neoplasms

Intervention

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
• Healthy Eating
Mothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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