Communication Campaign for HPV Vaccination

Overseen By Isabel C Scarinci, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

29 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Multi-Channel Communication Campaign for HPV Vaccination?

Research shows that strong communication strategies, like persuasive messaging and educational reminders, can increase HPV vaccine acceptance and uptake. Studies highlight that healthcare providers' recommendations and communication approaches significantly influence parents' decisions to vaccinate their children against HPV. ^{1 2 3 4 5}

Is the HPV vaccine generally safe for humans?

Research shows that the HPV vaccine is generally safe, with most reported side effects being mild, such as reactions at the injection site, headaches, and dizziness. No deaths have been reported, and the rate of adverse events has decreased over time. ^{6 7 8 9 10}

How does the Multi-Channel Communication Campaign treatment for HPV vaccination differ from other treatments?

The Multi-Channel Communication Campaign is unique because it uses various social media platforms to spread awareness and correct misinformation about the HPV vaccine, aiming to increase vaccination rates by engaging with parents and youth directly online. This approach differs from traditional methods by leveraging the widespread reach and interactive nature of social media to influence public perception and behavior. ^{3 11 12 13 14}

What is the purpose of this trial?

The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination for all children and adults ages 9 to 26 in the U.S. However, HPV vaccination rates nationally and in Alabama lag far behind the Healthy People 2020 goal of 80% coverage. Despite multiple efforts, Alabama still ranks third in cervical cancer mortality and incidence nationally with great disparities within the state, particularly between urban and rural counties. In order to address this public health challenge, organizations have come together to develop, implement, and evaluate a statewide action plan to eliminate cervical cancer as a public health problem in Alabama by 2033. This plan was officially launched by the State Health Officer in May 2023 as a partnership between government, academia, civic organizations, and non-profit organizations and is known as OPERATION WIPE OUT. The overall goal of this Supplement is to develop, implement, and examine the feasibility and scalability of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake that is designed and delivered by high school students with the support of OPERATION WIPE OUT partners and linked to school-based vaccination in a rural county that has the highest cervical cancer incidence in the state (Chambers County). The specific aims are: (1) To develop and examine the feasibility of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake with high school students being agents of change and provision of school-based vaccination; and (2) To examine specific features of the multi-channel communication campaign regarding scalability, sustainability, and potentially a future full-scale implementation science trial. The primary outcome will be HPV vaccination uptake at the county level obtained Alabama Department of Public Health Vaccination Registry (ImmPRINT). Additionally, treatment fidelity and scalability assessments will be conducted to inform sustainability efforts.

Research Team

Isabel Scarinci, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for the community of Chambers County, Alabama. It aims to increase HPV vaccination rates among children and adults aged 9 to 26. The focus is on a participatory campaign led by high school students with support from various organizations.

Inclusion Criteria

High school students enrolled in the Health Science Program at the Chambers County School District, Alabama

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Implementation

Development and implementation of a multi-channel communication campaign by high school students to promote HPV vaccination

6 months

Ongoing engagement with students, parents, and school staff

School-based Vaccination

Provision of school-based HPV vaccination linked to the communication campaign

6 months

Follow-up

Participants are monitored for HPV vaccination uptake at the county level

1 year

Treatment Details

Interventions

• Multi-Channel Communication Campaign

Trial Overview A multi-channel communication campaign called OPERATION WIPE OUT is being tested to boost HPV vaccine uptake in rural areas with high cervical cancer rates. High school students will lead the effort, linked to school-based vaccinations.

Participant Groups

Group I: HPV vaccination Experimental Treatment 1 Intervention

Multi-channel campaign to promote HPV vaccination

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

An evidence-based educational brochure and reminder system significantly increased HPV vaccine uptake among parents of preteen girls, with a 9.4 times higher likelihood of vaccination compared to a historical control group.

The intervention also led to a remarkable 22.5 times increase in dose completion rates, highlighting the effectiveness of structured educational and reminder strategies in improving vaccination outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quality improvement initiative to increase HPV vaccine rates using an educational and reminder strategy with parents of preteen girls. Cassidy, B., Braxter, B., Charron-Prochownik, D., et al.[2015]

A 12-month randomized controlled trial showed that healthcare providers who used a combination of communication strategies, including the presumptive approach and motivational interviewing, reported higher levels of parental acceptance of the HPV vaccine.

The intervention also led to increased vaccination rates among adolescents, highlighting the importance of effective communication in improving HPV vaccination uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining strategies for improving healthcare providers' communication about adolescent HPV vaccination: evaluation of secondary outcomes in a randomized controlled trial. Reno, JE., Thomas, J., Pyrzanowski, J., et al.[2020]

A review of 14 public awareness campaigns about HPV vaccination revealed that while many campaigns exist, they primarily emphasize the cancer prevention benefits of the vaccine, with few addressing barriers to vaccination.

Only 4 out of the 14 campaigns had data on their effectiveness, and just 2 evaluated actual vaccination outcomes, indicating a lack of evidence on how these campaigns impact vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV Vaccine Public Awareness Campaigns: An Environmental Scan. Blasi, PR., King, D., Henrikson, NB.[2015]

Mothers are the primary decision-makers for HPV vaccination, with a strong emphasis on prevention messages about cervical cancer being the most effective way to motivate parents across five countries.

Television is the preferred source of information about HPV vaccination in most countries surveyed, highlighting the importance of effective communication strategies by providers to enhance vaccination uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persuasive messaging for human papillomavirus vaccination by adolescent providers in a five-country multi-site study. Rwamwejo, J., Ramos, S., Morgan, K., et al.[2020]

Gardasil-9, the only HPV vaccine available in the U.S., is nearly 100% effective at preventing precancers caused by oncogenic HPV types, yet only about half of adolescents are fully vaccinated.

Strong and presumptive recommendations from healthcare clinicians significantly improve HPV vaccine uptake, highlighting the importance of effective communication strategies in increasing vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician communication strategies associated with increased uptake of the human papillomavirus (HPV) vaccine: A systematic review. Constable, C., Ferguson, K., Nicholson, J., et al.[2022]

The reporting rate of adverse events following immunization (AEFI) for the HPV vaccine in the Valencian Community significantly decreased from 2008 to 2018, particularly showing a sharp decline of 54.9% from 2009 to 2011, indicating improved perceptions of vaccine safety over time.

Most reported AEFIs were nonserious, such as local reactions, headaches, and dizziness, with no deaths reported, suggesting that the HPV vaccine is generally safe for the population, especially among girls aged 14-15 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends of Adverse Events Following Immunization (AEFI) Reports of Human Papillomavirus Vaccine in the Valencian Community-Spain (2008-2018). Egoavil, CM., Tuells, J., Carreras, JJ., et al.[2020]

The study estimated background rates of potential adverse events following immunization (AEFI) in adolescent boys, finding rates of 252.9 neurological events and 175.2 allergic events per 100,000 person-years, which helps establish a baseline for safety monitoring after the quadrivalent HPV vaccination.

After vaccinating approximately 1.44 million boys, the study predicts about 2.4 cases of Guillain-Barré syndrome, 3.9 seizures, and 0.3 anaphylaxis episodes in the first 6 weeks, indicating that while some adverse events may occur, they are expected at low rates relative to the number of vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccine in boys: background rates of potential adverse events. Clothier, HJ., Lee, KJ., Sundararajan, V., et al.[2019]

Out of 1577 patients referred to the One Access centers for suspected adverse events following HPV vaccination, only 404 (26%) were reported to the Danish Medicines Agency, highlighting significant gaps in AEFI reporting.

The study identified regional differences in reporting completeness and factors influencing physicians' reporting behavior, suggesting that these inconsistencies could affect the reliability of AEFI data used for research and policy decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the contextual nature of vaccine safety monitoring: Adverse events reporting after HPV-vaccination in Denmark, 2015. Schartau, S., Heering Holt, D., Lützen, T., et al.[2020]

The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.

The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

A study involving 418,289 Danish girls aged 12-15 years established baseline incidence rates of immune-mediated disorders before the introduction of the HPV vaccination, which is crucial for assessing vaccine safety.

The research provides a systematic framework for evaluating potential adverse events related to HPV vaccination by comparing actual cases of immune-mediated disorders to expected cases that could occur by chance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus immunisation of adolescent girls and anticipated reporting of immune-mediated adverse events. Callréus, T., Svanström, H., Nielsen, NM., et al.[2009]

The HPV vaccine, introduced in 2006, has significantly reduced the incidence of HPV-related cancers, yet over 47,000 new cases still occur annually in the U.S., particularly in rural areas with lower vaccination rates.

The article proposes a comprehensive, evidence-based strategy to promote HPV vaccination in rural northern New England, utilizing community partnerships, storytelling, and media outreach to address health disparities and improve vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Raising the HPV Vaccination Rate in Rural Northern New England Using Local Opinion Leaders. Dugan, M., Stein, GS., Khan, S., et al.[2023]

The HPV Vaccination NOW campaign in South Carolina successfully raised awareness and confidence in HPV vaccination, reaching over 33,000 individuals and generating more than 370,000 impressions in just ten weeks.

Engagement through personal stories on social media helped counter misinformation about the HPV vaccine, demonstrating the effectiveness of peer-to-peer dialogue in promoting accurate information and encouraging vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correcting HPV Vaccination Misinformation Online: Evaluating the HPV Vaccination NOW Social Media Campaign. Sundstrom, B., Cartmell, KB., White, AA., et al.[2023]

A one-month Twitter campaign aimed at promoting HPV vaccine knowledge among 35 low-income women aged 18-26 in public housing was found to be feasible and acceptable, with participants remaining engaged throughout the intervention.

Despite the campaign's acceptability, there were no significant changes in HPV knowledge, attitudes, or vaccine intentions, although participants reported a decreased perceived risk for cervical cancer, indicating the need for further research to effectively increase vaccine uptake in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a twitter campaign to promote HPV vaccine uptake among racially/ethnically diverse young adult women living in public housing. Allen, JD., Hollander, J., Gualtieri, L., et al.[2023]

A study adapted a National Cancer Institute HPV vaccine program for social media, using strategies that significantly increased reach and engagement, particularly on Instagram and TikTok, over a 4-month period.

The research identified effective strategies for disseminating vaccine messages, such as using videos and hashtags, which helped improve visibility and follower engagement, especially on Instagram.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation and Dissemination of a National Cancer Institute HPV Vaccine Evidence-Based Cancer Control Program to the Social Media Messaging Environment. Hopfer, S., Phillips, KK., Weinzierl, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A quality improvement initiative to increase HPV vaccine rates using an educational and reminder strategy with parents of preteen girls. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Examining strategies for improving healthcare providers' communication about adolescent HPV vaccination: evaluation of secondary outcomes in a randomized controlled trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

HPV Vaccine Public Awareness Campaigns: An Environmental Scan. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Persuasive messaging for human papillomavirus vaccination by adolescent providers in a five-country multi-site study. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Clinician communication strategies associated with increased uptake of the human papillomavirus (HPV) vaccine: A systematic review. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Trends of Adverse Events Following Immunization (AEFI) Reports of Human Papillomavirus Vaccine in the Valencian Community-Spain (2008-2018). [2020]

7. Australia pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccine in boys: background rates of potential adverse events. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

On the contextual nature of vaccine safety monitoring: Adverse events reporting after HPV-vaccination in Denmark, 2015. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. [2015]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Human papillomavirus immunisation of adolescent girls and anticipated reporting of immune-mediated adverse events. [2009]

11. United States pubmed.ncbi.nlm.nih.gov

Raising the HPV Vaccination Rate in Rural Northern New England Using Local Opinion Leaders. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Correcting HPV Vaccination Misinformation Online: Evaluating the HPV Vaccination NOW Social Media Campaign. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Feasibility of a twitter campaign to promote HPV vaccine uptake among racially/ethnically diverse young adult women living in public housing. [2023]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Adaptation and Dissemination of a National Cancer Institute HPV Vaccine Evidence-Based Cancer Control Program to the Social Media Messaging Environment. [2022]