Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05204030
Other study ID # 2108351667
Secondary ID 7R01CA229324-04
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 13, 2021
Est. completion date August 30, 2023

Study information

Verified date January 2023
Source University of Arkansas, Fayetteville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Parents use social media as an important parenting tool and source for health information. Using social media data to examine public opinion has had an early impact in public health and in cancer control and prevention efforts, including about the human papillomavirus (HPV) vaccine. A next step in this area of research is to develop and share messages on social media with parents to help inform and educate them about the HPV vaccine - ultimately assisting them with their decision to vaccinate their child. This study will evaluate the efficacy of social media messages through Twitter, using a randomized controlled trial to determine what types of messages resonate with parents. The investigators will examine differences between two types of messages - narrative messages (i.e., stories) and non-narrative messages (i.e., numbers and facts).


Description:

Approximately 80 million people in the United States - or about one in four - are infected with human papillomavirus (HPV). HPV can cause cancer and there are vaccines that protect against cancer-related strains. Evidence supporting vaccine efficacy and safety is robust, and vaccine availability is widespread; however coverage rates continue to fall short of the national goal of 80% (48.6% in 2017). Understanding the barriers to vaccine acceptance, particularly related to parent resistance and their informational needs, is key to strengthening vaccine uptake among adolescents. Communicating evidence to parents and engaging them through narrative strategies may address some of the barriers during the decision-making process. Parents use social media as an important parenting tool and useful source for health information. In 2015, 75% of all parents used social media, and of these 1 in 4 used Twitter - equating to millions of parent users. The investigators know that using social media data for surveillance has had early impact in public health. However, what is not known is the effectiveness of using large-scale social media data to inform a targeted social media intervention to support HPV vaccine uptake. This study will advance the growing field by evaluating the efficacy of an innovative narrative-focused intervention designed to communicate evidence and information about the HPV vaccine for parents who use social media as a health information source. The approach is informed by narrative engagement theory that posits narratives strengthen knowledge and promote engagement through storytelling by tapping into feelings of empathy, identification, and transportation. The investigators will evaluate the efficacy of our Twitter-based pilot intervention in a randomized controlled trial that will enroll 600 parents/caregivers of children ages 9-14, whose child(ren) has not started the vaccine series. Our central hypothesis is that exposure to narrative-focused exemplar messages will lead to greater intention to vaccinate, and subsequently increased rates of vaccination in the intervention group compared to parents in the comparison group, who receive non-narrative HPV vaccine information (i.e., existing HPV vaccine information developed for Twitter). The investigators will use a Twitter-based Community Advisory Board, virtual focus groups, and existing Twitter messages developed by the HPV Roundtable to inform narrative-focused message development. The proposed study will address three specific aims: 1) Develop narrative-focused scientific exemplars for HPV vaccine communication utilizing existing online messages and community engagement on Twitter; 2) Quantify differences in engagement, intention to vaccinate, and self-reported vaccination between parents exposed to the narrative-focused scientific exemplars and parents exposed to non-narrative scientific messages; 3) Collect and analyze longitudinal participant metadata to measure Twitter activity during the study period. This study will impact the field of cancer prevention generally and HPV vaccination specifically by establishing the efficacy of narrative-focused health messaging campaign on social media, using a Twitter-based parent-engagement strategy.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: The study population includes parents who have children ages 9-14. All participants will be 18 years of age or older, and we will specifically target parents ages 25 and older. Eligibility for enrollment in the study will be limited to the following criteria: 1. Adults 18 years of age and older; 2. Utilizes Twitter, a social media platform; 3. Has a child aged 9-14; 4. Child has not started the 2-dose HPV vaccination series; 5. Has no child who has completed any dose HPV vaccination series; 6. Has a well-care visit scheduled for their child before December, 2022. Exclusion Criteria: 1. Any adult who does not have a child 9-14 years of age; 2. Any adult who does not indicate some level of participation in Twitter; 3. Any adults who indicates a high level of anti-vaccine sentiment (assessed by vaccine hesitancy questions asked in the screener).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
HPV Twitter Education Program - Narrative
This study will evaluate the efficacy of social media messages through Twitter, using a randomized controlled trial to determine what types of messages resonate with parents. The investigators will examine narrative messages (i.e., stories). The central hypothesis is that parents who read narrative-focused messages will be more likely to report narrative engagement, intention to vaccinate their child, and self-reported vaccination compared to parents who read non-narrative messages.
HPV Twitter Education Program - Non-Narrative
This study will evaluate the efficacy of social media messages through Twitter, using a randomized controlled trial to determine what types of messages resonate with parents. The investigators will examine non-narrative messages (i.e., scientific information - numbers and facts). The central hypothesis is that parents who read narrative-focused messages will be more likely to report narrative engagement, intention to vaccinate their child, and self-reported vaccination compared to parents who read non-narrative messages.

Locations

Country Name City State
United States University of Arkansas Fayetteville Arkansas

Sponsors (5)

Lead Sponsor Collaborator
University of Arkansas, Fayetteville National Cancer Institute (NCI), Thomas Jefferson University, University at Albany, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (3)

Massey PM, Chiang SC, Rose M, Murray RM, Rockett M, Togo E, Klassen AC, Manganello JA, Leader AE. Development of Personas to Communicate Narrative-Based Information About the HPV Vaccine on Twitter. Front Digit Health. 2021 Aug 4;3:682639. doi: 10.3389/fdgth.2021.682639. eCollection 2021. — View Citation

Massey PM, Kearney MD, Hauer MK, Selvan P, Koku E, Leader AE. Dimensions of Misinformation About the HPV Vaccine on Instagram: Content and Network Analysis of Social Media Characteristics. J Med Internet Res. 2020 Dec 3;22(12):e21451. doi: 10.2196/21451. — View Citation

Massey PM, Togo E, Chiang SC, Klassen AC, Rose M, Manganello JA, Leader AE. Identifying HPV vaccine narrative communication needs among parents on social media. Prev Med Rep. 2021 Jul 7;23:101488. doi: 10.1016/j.pmedr.2021.101488. eCollection 2021 Sep. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in caregiver self-reported HPV vaccination status of child questionnaire dependent variable; measure collects date of vaccination and number of vaccine doses to date Change in caregiver self-reported HPV vaccination of child at 1-month follow-up from baseline
Primary Change in caregiver self-reported HPV vaccination status of child questionnaire dependent variable; measure collects date of vaccination and number of vaccine doses to date Change in caregiver self-reported HPV vaccination of child at 1-year follow-up from 1-month follow-up
Secondary Caregiver self-reported empathy subscale adapted from Busselle & Bilandzic (2009) and Murphy, Frank, Chatterjee, Baezconde-Garbanati (2013). mediating/moderating variable only at 1-month post intervention
Secondary Caregiver self-reported transportation subscale adapted from Murphy, Frank, Chatterjee, Baezconde-Garbanati (2013). Narrative versus Non-narrative: The Role of Identification, Transportation and Emotion in Reducing Health Disparities. mediating/moderating variable only at 1-month post intervention
Secondary Caregiver self-reported identification subscale adapted from Murphy, Frank, Chatterjee, Baezconde-Garbanati (2013). Narrative versus Non-narrative: The Role of Identification, Transportation and Emotion in Reducing Health Disparities. mediating/moderating variable only at 1-month post intervention
Secondary Change in caregiver self-reported intention to vaccinate their child questionnaire dependent variable; measures readiness and likeliness to receive HPV vaccination Change in caregiver self-reported intention to vaccinate their child at 1-month follow-up from baseline
Secondary Change in caregiver self-reported intention to vaccinate their child questionnaire dependent variable; measures readiness and likeliness to receive HPV vaccination Change in caregiver self-reported intention to vaccinate their child at 1-year follow-up from 1-month follow-up
See also
  Status Clinical Trial Phase
Recruiting NCT05329961 - Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study Early Phase 1
Completed NCT05862844 - Promise Women Project N/A
Active, not recruiting NCT04199078 - Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions. N/A
Recruiting NCT05566106 - Anal Follow-up of Patients With a Gynecological History of High-grade Lesion and More Induced HPV
Not yet recruiting NCT06229353 - Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department
Completed NCT01757392 - Candin Safety & Efficacy Study for the Treatment of Warts Phase 2
Active, not recruiting NCT04716127 - A Proximity-incentive Strategy for Cervical Cancer Screening N/A
Recruiting NCT05210348 - Clinical Evaluation of Detection of High Risk HPV in Urine
Recruiting NCT05835947 - Anal Cancer Risk In Women
Not yet recruiting NCT03947775 - HPV-SAVE_Merck_Sub-Study for Preventing Recurrence of HSIL Phase 2
Terminated NCT03404310 - Zinc Sulfate for Human Papillomavirus (HPV) N/A
Recruiting NCT03302858 - A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRXâ„¢ Anorectal Wand Phase 2
Completed NCT03082950 - HPV Infections, Cancer of the Vulva and Therapeutical Success
Recruiting NCT04950101 - Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis N/A
Recruiting NCT05146895 - A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts N/A
Completed NCT04002154 - Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV N/A
Recruiting NCT04232917 - Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections. Phase 4
Active, not recruiting NCT03729518 - TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck N/A
Recruiting NCT05640700 - Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Recruiting NCT05362669 - SMS Messaging for Invitation in the Cervical Cancer Screening Programme N/A