Completed

NCT Number: NCT04017143

Multi-Level Communication Strategies for HPV Vaccination in Hmong Adolescents

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.

Completed

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Key information

Conditions

HPV-associated Cancer

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Twin Cities

Minneapolis, Minnesota, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV app intervention

Behavioral

Participants assigned to this group will receive an HPV app that targets a dyad of parent and a teen boy or girl.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

Centers for Disease Control and Prevention

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Jul 12, 2019
Registry last updated: Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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