Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi-Level Communication Strategies for HPV Vaccination in Hmong Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04017143
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HPV-associated Cancer Behavioral: HPV app intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-Arm Randomized Clinical Trial
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Multi-Level Communication Strategies for HPV Vaccination in Hmong Adolescents
Actual Study Start Date : September 30, 2016
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: HPV App group
Participants will be assigned to receive an HPV app.
Behavioral: HPV app intervention
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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017143


Contacts
Layout table for location contacts
Contact: Joeseph Koopmeiners, PhD 612-624-7486 koopm007@umn.edu

Locations
Layout table for location information
United States, Minnesota
University of Minnesota, Twin Cities Recruiting
Minneapolis, Minnesota, United States
Contact: Joseph Koopmeiners, PhD    612-624-7486    koopm007@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Centers for Disease Control and Prevention

Layout table for additonal information
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT04017143     History of Changes
Other Study ID Numbers: STUDY00002064
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No