NCT05206669

Brief Summary

Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. Hispanic women have the highest rates of HPV-related cervical cancer compared to all other groups in the U.S. Previous research has delineated several unique barriers to HPV vaccination among Hispanic women, suggesting that interventions that focus on addressing these barriers may improve HPV vaccination compliance in this population. To address some of these unique barriers, an online tailored messaging intervention was developed and tested. Initial analyses demonstrate that participants exposed to an online intervention demonstrated higher intentions to vaccinate for HPV after viewing the informational materials. The next phase of the project will be comprised of promoting use of the online intervention to the general public through the use of theory-based, pretested messages delivered via advertisements on Facebook and Twitter. Specifically, messages will be targeted based on differences between Hispanic parents of adolescents and Hispanic young adults. Previous research has explored the use of the Extended Parallel Processing Model as a theory to guide messages designed to promote health behaviors. The current study extends this work in the area of HPV prevention. Specifically, it seeks to examine the use of this theory as a means to stimulate information seeking behavior in the form of use of the previously developed online intervention that provides information about HPV. We also hope to make a significant contribution to research demonstrating the importance of targeting messages based on differences in population characteristics. Additionally, this study seeks to build on research examining the use of social media sites as a means for implementing health interventions and promoting positive health outcomes. Ultimately, the current study seeks to improve both the HPV vaccination decision-making process and HPV vaccination rates. If this was achieved among the Hispanic population it could substantially decrease disparities in cervical cancer and other HPV-related diseases.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
784

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2017

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

December 17, 2021

Last Update Submit

January 24, 2022

Conditions

Keywords

HPV vaccineVaccine intention

Outcome Measures

Primary Outcomes (2)

  • Intention to Seek Information - 1

    Hyperlinks were embedded in intervention messages where participants were told they could find more information about HPV. A click on the link was considered intention to seek information. Not clicking on the link was considered no intention to seek information.

    1 day (one time while participants viewed the brief intervention.)

  • Intention to Seek Information - 2

    Intention to Seek Information survey items measure participants likelihood to seek information about HPV. Survey items included a Yes-No response to the statement "I intend to look for more information about the HPV vaccination within the next 30 days." Those who answer "Yes" were then shown a series of questions prompting them to indicate their likelihood of seeking more information about the HPV vaccination from their "doctor or healthcare provider," "a friend of family member," "the Internet," and "other sources." Responses were measured on a 7-point Likert-type scale that ranged from Very Likely to Very Unlikely. Those who answered "No" were shown the question "Which of the following best represents your reason for not seeking information about the HPV vaccine?". Responses included 1) low interest in the topic, 2) already well informed on the topic, 3) topic is not relevant to me, and 4) information on this topic is upsetting to me.

    Outcome was measured one time immediately post-intervention via the post-survey items described to assess their degree of intention.

Secondary Outcomes (1)

  • Intention to Vaccinate for HPV

    Outcome was measured one time immediately post-intervention via the post-survey items described to assess their degree of intention

Study Arms (6)

Cancer Messages - Young Adults

EXPERIMENTAL

Messages providing information about the use of HPV vaccines to prevent cancer.

Behavioral: Health Messages

Cancer Messages - Parents of Adolescents

EXPERIMENTAL

Messages providing information about the use of HPV vaccines for their adolescent children to prevent cancer.

Behavioral: Health Messages

Genital Wart Messages - Young Adults

EXPERIMENTAL

Messages providing information about the use of HPV vaccines to prevent genital warts.

Behavioral: Health Messages

Genital Wart Messages - Parents of Adolescents

EXPERIMENTAL

Messages providing information about the use of HPV vaccines or their adolescent children to prevent genital warts.

Behavioral: Health Messages

Control Messages - Young Adults

ACTIVE COMPARATOR

Messages providing information about HPV vaccines that did not mention prevention of other diseases or conditions.

Behavioral: Health Messages

Control Messages - Parents of Adolescents

ACTIVE COMPARATOR

Messages providing information about HPV vaccines for their adolescent children that did not mention prevention of other diseases or conditions.

Behavioral: Health Messages

Interventions

Health MessagesBEHAVIORAL

Brief messages providing information about the effectiveness of HPV vaccines. Messages included embedded links where participants could find more information.

Cancer Messages - Parents of AdolescentsCancer Messages - Young AdultsControl Messages - Parents of AdolescentsControl Messages - Young AdultsGenital Wart Messages - Parents of AdolescentsGenital Wart Messages - Young Adults

Eligibility Criteria

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

You may qualify if:

  • For parents eligibility criteria were being: 1) of Hispanic or Latino origin, 2) 18 years or older, 3) a parent or guardian of a child ages 11-17 who had not been vaccinated for HPV.
  • For young adults eligibility were being: 1) of Hispanic or Latino origin, 2) 18-26 years of age (vaccine eligibility at the time of data collection, and 3) having not been vaccinated for HPV.

You may not qualify if:

  • Being under 18 years of age
  • Not identifying as Hispanic or Latino
  • For parents, having no children ages 11-17 or having only children already vaccinated for HPV
  • For young adults, having already been vaccinated for HPV or no longer being eligible due to age (\>26)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Reno JE, Dempsey AF. Promoting HPV vaccination among Latinx: an application of the extended parallel processing model. J Behav Med. 2023 Apr;46(1-2):324-334. doi: 10.1007/s10865-022-00293-7. Epub 2022 Feb 18.

MeSH Terms

Conditions

Information Seeking BehaviorVaccination Hesitancy

Condition Hierarchy (Ancestors)

CommunicationBehaviorVaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were not informed of the study design and were unaware of the other message conditions.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: The current study employed a 2 x 3 mixed factorial design. Participants consisted of two groups: 1) Hispanic or Latino parents of adolescents (age 11-17), and 2) Hispanic or Latino young adults (age 18-26). Participants were randomly assigned to one of three message conditions: cancer, genital warts, or control messages.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2021

First Posted

January 25, 2022

Study Start

November 18, 2016

Primary Completion

March 5, 2017

Study Completion

March 5, 2017

Last Updated

January 25, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share