Condition category
Infections and Infestations
Date applied
18/12/2019
Date assigned
31/12/2019
Last edited
06/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Minjin Kim

ORCID ID

http://orcid.org/0000-0002-9164-8149

Contact details

285 Plantation St. 7-716
Worcester
01604
United States of America
+1 720-209-5559
minjin.kim001@umb.edu

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2016146

Study information

Scientific title

Acceptability, feasibility, and preliminary effectiveness of a mobile, web-based storytelling HPV intervention to promote HPV vaccine uptakes among Korean college women

Acronym

Study hypothesis

1. 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

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

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Other

Patient information sheet

No participant information sheet available.

Condition

Knowledge and attitudes toward HPV vaccination

Intervention

At 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 type

Behavioural

Phase

Drug names

Primary outcome measure

Initiation of HPV vaccine uptake assessed using a self-report of HPV vaccination initiation at the 2-month follow-up after the intervention.

Secondary outcome measures

1. 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 trial start date

12/09/2016

Overall trial end date

31/12/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 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

Participant type

Mixed

Age group

Adult

Gender

Female

Target number of participants

100

Total final enrolment

104

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

12/09/2016

Recruitment end date

31/10/2016

Locations

Countries of recruitment

United States of America

Trial participating centre

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

Sponsor information

Organisation

University of Massachusetts Boston

Sponsor details

100 Morrissey Blvd
Boston
02125
United States of America
+1 6172875000
sharon.wang@umb.edu

Sponsor type

University/education

Website

https://www.umb.edu/

Funders

Funder type

Charity

Funder name

American Cancer Society

Alternative name(s)

American Cancer Society, Inc., ACS, INC., ACS

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

United States of America

Results and Publications

Publication and dissemination plan

Results have been published. Several other articles are in press as of December 2019.

IPD sharing statement
The datasets generated and/or analysed during this study will be included in the subsequent results publication.

Intention to publish date

30/06/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2019 acceptability results in https://www.ncbi.nlm.nih.gov/pubmed/31298268 (added 23/12/2019)
2019 baseline characteristics in https://www.ncbi.nlm.nih.gov/pubmed/30863974 (added 23/12/2019)
2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32012036 (added 06/02/2020)

Publication citations

Additional files

Editorial Notes

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