NCT03856437

Brief Summary

The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Participants are randomized into gain and loss conditions in which they view either gain-framed or loss-framed HPV vaccination messages. Key outcome variables include parents' attitudes and intentions toward vaccinating their children against HPV.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 22, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 15, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

December 17, 2018

Results QC Date

June 28, 2023

Last Update Submit

March 12, 2024

Conditions

Cervical CancerAnal CancerPenile Cancer

Outcome Measures

Primary Outcomes (2)

  • Attitudes

    Attitudes toward HPV vaccination for children Scale range: 1-7 (higher score indicates more positive attitude) Subscales were averaged.

    baseline posttest (test was approximately 5 minutes to complete)

  • Intention to Vaccinate Free of Cost

    Intention to have children vaccinated against HPV free of cost Scale range: 1-6 (higher score indicates stronger intention) Subscales were averaged.

    baseline posttest (test was approximately 5 minutes to complete)

Secondary Outcomes (1)

  • Intention to Vaccinate With Cost

    baseline posttest (test was approximately 5 minutes to complete)

Study Arms (3)

Gain-framed messages

EXPERIMENTAL

Participants in this arm receive gain-framed HPV vaccination messages.

Behavioral: HPV vaccination messages

Loss-framed messages

EXPERIMENTAL

Participants in this arm receive loss-framed HPV vaccination messages.

Behavioral: HPV vaccination messages

Control messages

ACTIVE COMPARATOR

Participants in this arm receive non-framed HPV vaccination messages.

Behavioral: HPV vaccination messages

Interventions

HPV vaccination messagesBEHAVIORAL

Digital multimedia messages consisting of text and imagery conveying the benefits of being vaccinated against HPV, the costs of not being vaccinated against HPV, or neither benefits or costs but simply a call for action.

Control messagesGain-framed messagesLoss-framed messages

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Self-identify as African American
  • Custodial parent or caretaker of at least one child under the age of 18 who has not been fully vaccinated against HPV.
  • Has access to Internet to complete the study

You may not qualify if:

  • Younger than 18 years
  • Does not self-identify as African American
  • Not a custodial parent or caretaker of at least one child under the age of 18 who has not been fully vaccinated against HPV.
  • Has no access to Internet to complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

College Park, Maryland, 20742, United States

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsAnus NeoplasmsPenile Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesRectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesGenital Neoplasms, MaleGenital Diseases, MalePenile DiseasesMale Urogenital Diseases

Limitations and Caveats

The online survey-experiment may not fully reflect how individuals typically encounter health messages in the real world. There is concern about ecology validity. Also the long-term effects of message exposure were not determined.

Results Point of Contact

Title
Xiaoli Nan
Organization
University of Maryland, College Park
nan@umd.edu
301-405-0640

Study Officials

  • Xiaoli Nan

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2018

First Posted

February 27, 2019

Study Start

January 22, 2021

Primary Completion

March 25, 2021

Study Completion

April 15, 2022

Last Updated

March 15, 2024

Results First Posted

March 15, 2024

Record last verified: 2024-03

Locations

US(1)