A mobile, web-based storytelling HPV intervention to promote HPV vaccine uptake among Korean college women

ISRCTN ISRCTN12175285
DOI https://doi.org/10.1186/ISRCTN12175285
Secondary identifying numbers 2016146
Submission date
18/12/2019
Registration date
31/12/2019
Last edited
06/02/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Cervical cancer is related to infection by the human papillomavirus (HPV). Though cervical cancer has decreased in the last 40 years as a result of HPV vaccination and Pap smear screening, it is still high among ethnic minority and foreign-born women in the US. Despite the availability of HPV vaccinations to prevent HPV infection, only about a third of female college students have received a vaccination, which falls far short of the Healthy People 2020 HPV vaccination rate goal of 80%. Furthermore, HPV vaccination and Pap smear rates have been low among Asian American women, especially among Koreans in the U.S. Thus, it is vital to develop prevention strategies for this group. Reducing racial/ethnic differences in immunization rates is an important public health goal.
Storytelling can be a powerful way to raise awareness and reduce health inequalities, since it can expand the listener or viewer's understanding of a subject within their social and cultural context by presenting 'real stories' and 'own voices' in similar life settings in which health decisions are made.
This study aimed to investigate whether culturally-grounded storytelling could increase HPV vaccination uptake by providing health information about this disease and its prevention.

Who can participate?
University undergraduate or graduate female students in the Northeast region of the USA who identify themselves as Korean or Korean American, are between the ages of 18 and 26 years, who can speak or read English, and have not yet been vaccinated.

What does the study involve?
The participants were randomly allocated to one of two groups. One group watched a story-telling video of about 17 min. The other group was given written information about HPV and vaccination. Both groups completed surveys before they received the video or written information, after they had received it and 2 months afterwards.

What are the possible benefits and risks of participating?
There were no direct risks to participants. The information learned from this study could help to increase the health and quality of life of the participants.

Where is the study run from?
University of Massachusetts Boston

When is the study starting and how long is it expected to run for?
September 2016 to December 2016

Who is funding the study?
American Cancer Society (USA)

Who is the main contact?
MinJin Kim, MinJin.Kim001@umb.edu

Contact information

Dr Minjin Kim
Scientific

285 Plantation St. 7-716
Worcester
01604
United States of America

ORCiD logoORCID ID 0000-0002-9164-8149
Phone +1 720-209-5559
Email minjin.kim001@umb.edu

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typeOther
Participant information sheet No participant information sheet available.
Scientific titleAcceptability, feasibility, and preliminary effectiveness of a mobile, web-based storytelling HPV intervention to promote HPV vaccine uptakes among Korean college women
Study objectives1. Women receiving the STN intervention will have greater knowledge and more positive perceptions (cognitive) and feelings (affective) toward the HPV vaccine compared to the control group at post-intervention.
2. Women receiving the STN intervention will demonstrate a higher intention to receive the HPV vaccine (conative) compared to the control group at post-intervention and at the 2-month follow-up.
3. Women receiving the STN intervention will demonstrate higher HPV vaccine uptake compared to the control group at the 2-month follow-up.
Ethics approval(s)Approved 12/09/2016, University of Massachusetts Boston Institutional Review Board (Office of Research and Sponsored Programs, University of Massachusetts Boston, 100 Morrissey Boulevard, Boston, MA 02125, USA; +1 617-287-5374; sharon.wang@umb.edu), ref: #2016146
Health condition(s) or problem(s) studiedKnowledge and attitudes toward HPV vaccination
InterventionAt the end of the baseline survey, participants were randomly assigned to either the experimental group (a storytelling video intervention) or comparison group (a non-narrative, written statement about HPV and HPV vaccine) by Qualtrics software until each group contained 60 participants.

The experimental group received a theory-led, evidence-based, culturally appropriate storytelling video intervention about HPV and cervical cancer prevention. The video includes three pairs of Korean American college women’s shared thoughts, memories, and ideas about HPV, HPV vaccine and cervical cancer. Additionally, a Korean American physician provides supportive material to fill in gaps not covered by the stories and provide scientific, evidence-based information on HPV, HPV vaccine, and cervical cancer. The video is about 17 minutes in length. The comparison group received written, non-narrative education materials that include a Fact Sheet about HPV infection from the CDC and a HPV vaccine information from the American Cancer Society. Surveys were conducted via an online laboratory at baseline, at post-intervention, and at 2-month follow-up after the intervention.
Intervention typeBehavioural
Primary outcome measureInitiation of HPV vaccine uptake assessed using a self-report of HPV vaccination initiation at the 2-month follow-up after the intervention.
Secondary outcome measures1. Knowledge about HPV vaccination
2. Attitudes toward HPV vaccination
3. Intention to receive the HPV vaccine

Surveys were conducted via an online laboratory at baseline, at post-intervention, and at 2-month follow-up after the intervention.
Overall study start date12/09/2016
Completion date31/12/2016

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
Upper age limit26 Years
SexFemale
Target number of participants100
Total final enrolment104
Key inclusion criteria1. Current university undergraduate or graduate female students
2. Identified themselves as Korean or Korean American
3. Resident in the northeast region of the U.S.
4. Aged 18-26 years
5. Able to speak or read English
6. Not yet vaccinated against HPV
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment12/09/2016
Date of final enrolment31/10/2016

Locations

Countries of recruitment

  • United States of America

Study participating centre

University of Massachusetts Boston
100 Morrissey Blvd
Boston
02125
United States of America

Sponsor information

University of Massachusetts Boston
University/education

100 Morrissey Blvd
Boston
02125
United States of America

Phone +1 6172875000
Email sharon.wang@umb.edu
Website https://www.umb.edu/
ROR logo "ROR" https://ror.org/04ydmy275

Funders

Funder type

Charity

American Cancer Society
Government organisation / Associations and societies (private and public)
Alternative name(s)
American Cancer Society, Inc., Sociedad Americana Contra El Cáncer, ACS
Location
United States of America

Results and Publications

Intention to publish date30/06/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planResults have been published. Several other articles are in press as of December 2019.
IPD sharing planThe datasets generated and/or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications baseline characteristics 01/08/2019 23/12/2019 Yes No
Results article acceptability results 01/10/2019 23/12/2019 Yes No
Results article results 29/01/2020 06/02/2020 Yes No

Editorial Notes

06/02/2020: Publication reference added.
23/12/2019: Trial's existence confirmed by University of Massachusetts Boston.