- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04017143
Multi-Level Communication Strategies for HPV Vaccination in Hmong Adolescents
April 13, 2022 updated by: University of Minnesota
The specific aims are: 1) to design a multilevel, theory-driven, highly interactive, culturally and cognitively tailored hAppy app intervention to facilitate HPV vaccination completion among Hmong adolescents and their parents using CBPAR; 2) establish a systematic health care provider protocol for identifying and engaging Hmong adolescents and their parents in the use of the hAppy app; and 3) examine participants' intent, knowledge and self-efficacy of HPV vaccinations, perceptions of the hAppy app and their patient-provider experiences.
This study will advance existing knowledge of mHealth's impact on populations at risk for cancer and contribute new, important information to cancer health disparities research.
If found to be effective, this intervention will have extensive implications for prevention of other types of cancer among different underserved populations, potentially reducing cancer-related disparities, morbidity, and mortality.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A quarter million Hmong Americans (Hmong) reside in the United States and 25% live in the Twin Cities metropolitan area.
With a median age of 20.4 years old, this young community has a poverty rate of 26% in Minnesota and 27.4% nationally.
Cervical cancer knowledge and prevention, such as awareness of HPV's effectiveness in reducing cancer risk, is low among Hmong women (19-50%) and men (38%), which may explain Hmong's high cervical cancer incidence rates (three times higher than other Asian Americans (AA) and four times higher than Non-Hispanic Whites).
This problem is further aggravated by the rise of cervical cancer incidence and mortality rates among Hmong women.
Clearly, multilevel strategies to increase HPV vaccination rates and reduce HPV-related cancers among Hmong are urgently needed.
Yet Hmong women face structural and cultural barriers that limit their access to preventive health care.
Language difficulties, poor health literacy, lack of time or transportation, visiting a doctor only when symptomatic or in pain and abstaining from gynecological visits due to embarrassment are some of these barriers.
These barriers and beliefs must be carefully integrated into the design of any effective multilevel strategy to promote HPV vaccination uptake and completion.
This study proposes to use a Community-Based Participatory Action Research (CBPAR) approach to develop and test the effectiveness of a theory-based culturally and cognitively appropriate mobile application (hAppy app) intervention that facilitate HPV vaccination completion among Hmong adolescents (11 to 17 years old) and their parents.
Mobile health (mHealth) technology is a promising tool allowing for effective person-centered customization.
The study's primary objective is to evaluate the effectiveness of hAppy app intervention in Hmong adolescents and their parents.
100 Hmong adolescents and their parents will be recruited and a single blind, two arm, randomized controlled trial will be conducted.
Participants will be randomized by a 1:1 ratio to receive the hAppy app intervention (N=50) or usual care (UC, N=50) for a 9-month period.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States
- University of Minnesota, Twin Cities
-
-
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
11 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Teen: (1) aged between 11-17, (2) not yet completed HPV vaccination, (3) living in Minnesota
- Parents: those who have teen child aged between 11-17
Exclusion Criteria:
- Teens who have completed HPV vaccination
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HPV App group
Participants will be assigned to receive an HPV app.
|
Participants assigned to this group will receive an HPV app that targets a dyad of parent and a teen boy or girl.
|
No Intervention: Usual Care
This is a usual care group that receives a brochure that is usually distributed by a clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of HPV vaccination (completion of recommended HPV vaccine)
Time Frame: 9-months
|
Number of teen participants who receive the complete series of recommended HPV vaccine
|
9-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
September 30, 2016
Primary Completion (Actual)
September 30, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
December 17, 2018
First Submitted That Met QC Criteria
July 10, 2019
First Posted (Actual)
July 12, 2019
Study Record Updates
Last Update Posted (Actual)
April 14, 2022
Last Update Submitted That Met QC Criteria
April 13, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00002064
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.
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