Tailoring of Vaccine-Focused Messages: Disease Salience

NCT03002324 | Completed

• 1 other identifier: IRB00087211a
• Study Type: interventional
• Target: 1,320
• Locations: 1 country
• Sites: 1

Brief Summary

This study is the second phase of a trial examining decision making about vaccines. For this phase of this study, the researchers will conduct a 3-arm randomized trial to compare the current Centers for Disease Control and Prevention (CDC) human papillomavirus (HPV) message, a new cervical cancer focused message developed by the study team, and a non-vaccine related control passage among parents of adolescent females. The goal of the trial will be to determine if the new cervical cancer framed message has an increased impact on intent to have daughters receive the HPV vaccine over the trial period as compared to the current CDC message used in the field. Additionally, the researchers will examine the impact both the CDC message and the new message individually have on intent to vaccinate when compared to the non-vaccine related control message. The participant's vaccine beliefs and intent to vaccinate will be assessed through an online survey at baseline. Two weeks later, participants will be randomized to view one of the three messages: the current CDC message, the cervical cancer framed message, or a non-vaccine related control message. Immediately afterwards, vaccine beliefs and intent to vaccinate will be assessed to determine the impact of the message.

Conditions

Human Papillomavirus

Keywords

Vaccines; Childhood Vaccination; Decision Making; Health Belief Model

Outcome Measures

Primary Outcomes (2)

• Overall change in attitude towards the human papilloma virus (HPV) vaccine

  Number of caregivers experiencing a change in attitude towards the HPV vaccine

  Week 2

• Intent to have their child vaccinated against HPV

  Number of caregivers intending to have their daughter(s) receive the HPV vaccine

  Week 2

Study Arms (3)

Current CDC Message Arm

ACTIVE COMPARATOR

Participants randomized to this arm will receive a message developed to directly follow the current message on the CDC's website.

Behavioral: Baseline Survey; Behavioral: Current CDC Message; Behavioral: Post-Intervention Survey

Cervical Cancer Message Arm

EXPERIMENTAL

Participants randomized to this arm will receive a message focused on cervical cancer risks and prevention and framed to highlight perceived susceptibility, perceived benefit, and self-efficacy.

Behavioral: Baseline Survey; Behavioral: Cervical Cancer Message; Behavioral: Post-Intervention Survey

Control Message

SHAM COMPARATOR

Participants randomized to the control arm will be provided with a short message about the costs and benefits of bird feeding.

Behavioral: Baseline Survey; Behavioral: Control Message; Behavioral: Post-Intervention Survey

Interventions

Baseline Survey BEHAVIORAL

The baseline survey is a combination of the Vaccine Confidence Scale, and a short form of the Parents' Attitudes about Childhood Vaccines (PACV) Scale. Participants will be asked an additional 10 questions developed as a part of a behavioral phenotyping questionnaire to assess behavioral biases at baseline within the study population. Demographic information and intent to vaccinate will also be collected.

Cervical Cancer Message Arm; Control Message; Current CDC Message Arm

Current CDC Message BEHAVIORAL

Participants randomized to the current CDC message arm will read a message taken almost directly from the CDC Vaccine Information Sheet (VIS) on HPV. This message was minimally altered for length and clarity.

Current CDC Message Arm

Cervical Cancer Message BEHAVIORAL

Participants randomized to the cervical cancer messaging arm will receive a message developed by the study team to appeal tenants of the Health Belief Model (self-efficacy, perceived benefit) and on the purity tenant of the moral foundations theory.

Cervical Cancer Message Arm

Control Message BEHAVIORAL

Participants randomized to the non-vaccine related control arm will read a bird-feeding passage.

Control Message

Post-Intervention Survey BEHAVIORAL

The immediate post-intervention survey will include questions from the Vaccine Confidence Scale and the PACV short scale. Intent to vaccinate will be assessed.

Cervical Cancer Message Arm; Control Message; Current CDC Message Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have at least one daughter between 9 and 17 years of age (inclusive)
• Reside in the United States

You may not qualify if:

• Have previously participated in the disease salience phase of this study

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Porter RM, Amin AB, Bednarczyk RA, Omer SB. Cancer-salient messaging for Human Papillomavirus vaccine uptake: A randomized controlled trial. Vaccine. 2018 Apr 25;36(18):2494-2500. doi: 10.1016/j.vaccine.2018.01.040. Epub 2018 Mar 26.

  PMID: 29599089 DERIVED

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Saad B Omer, BBS, MPH, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 23, 2016
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)