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Multi-Level Communication Strategies for HPV Vaccination in Hmong Adolescents

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ClinicalTrials.gov Identifier: NCT04017143
Recruitment Status : Completed
First Posted : July 12, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE December 17, 2018
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE September 30, 2016
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04017143 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-Level Communication Strategies for HPV Vaccination in Hmong Adolescents
Official Title  ICMJE Multi-Level Communication Strategies for HPV Vaccination in Hmong Adolescents
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two-Arm Randomized Clinical Trial
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE HPV-associated Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: HPV App group
    Participants will be assigned to receive an HPV app.
    Intervention: Behavioral: HPV app intervention
  • No Intervention: Usual Care
    This is a usual care group that receives a brochure that is usually distributed by a clinic.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2019)
10
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2019)
1
Actual Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04017143
Other Study ID Numbers  ICMJE STUDY00002064
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE Not Provided
PRS Account University of Minnesota
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP