Clinical trial NCT03002324: Tailoring of Vaccine-Focused Messages: Disease Salience
Official title: Tailoring of Vaccine-Focused Messages: Moral Foundations and Disease Salience - Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus
Keywords: Vaccines
Childhood Vaccination
Decision Making
Health Belief Model
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 1320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Genital human papillomavirus (HPV) is the most common sexually transmitted infection in the United States. Most HPV infections are asymptomatic and clear on their own within 2 years but persistent infections can lead to diseases, including several cancers. Cervical cancer is the most common cancer caused by HPV infection, and virtually all cervical cancers can be attributed to HPV infection. There is no cure for HPV, but HPV can be prevented through vaccination. Current recommendations from the Advisory Committee on Immunization Practices (ACIP) state that the HPV vaccine may be given starting at 11-12 years of age for boys and girls, through age 26. Despite the safety and efficacy of this vaccine, the coverage among adolescents aged 11-17 years old remains low. Attaining high vaccination rates among adolescents is essential to decreasing the burden of disease due to cervical cancer, and other cancers caused by HPV.

Parental decision to vaccinate their children, specifically with the HPV vaccine, can be tied to multiple constructs of the Health Belief Model. These include perceived susceptibility of HPV infection (is my child at risk of infection), perceived benefit, and perceived severity (of disease, and of vaccine related adverse events). This would suggest that messaging surrounding the HPV vaccination should be highly salient within these constructs. The current message tied to the HPV vaccine presented by the Centers for Disease Control (CDC) has a focus on HPV as an infection and is clinical in nature. In a randomized trial, parents given information about HPV were no more likely to be accepting of an HPV vaccine and no more likely to get their child vaccinated. Based on this literature, the researchers hypothesize that reframing the message to promote HPV vaccination as a means of protection against cervical cancer will impact intent to vaccinate among parents of adolescent females (aged 11-17 years old).

In the first phase of this study the researchers assessed how appealing to different moral foundations impacted attitudes towards vaccination and intent to vaccinate. For this phase of this study, the researchers will conduct a 3-arm randomized trial to compare the current CDC HPV, a 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. Additionally, the researchers will examine the impact both the CDC message and the new message 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Overall change in attitude towards the human papilloma virus (HPV) vaccine
timeFrame: Week 2
measure: Intent to have their child vaccinated against HPV
timeFrame: Week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Saad B Omer, BBS, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.