Strategies for Increasing HPV Vaccination Rates

Overseen By Stephanie Staras, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Out of age range, others

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

Compensation: Varies

Number of Visits: Unknown

4630 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to increase HPV vaccination rates among children aged 9 to 12 in rural North Central Florida. Researchers are testing various strategies, such as training doctors to recommend the vaccine, sending reminders and motivational messages to parents (parent-targeted motivational aids), and improving access to healthcare. The trial compares these strategies across three groups of clinics to determine which combination works best. Children between 9 and 12 years old who haven't received both doses of the HPV vaccine may be suitable for this study. As an unphased trial, this study provides a unique opportunity to enhance public health strategies for increasing vaccination rates.

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 prior data suggests that these strategies are safe for increasing HPV vaccination rates?

Research has shown that tools designed to motivate parents, such as reminders and phone calls, are generally well-received. One study examined the use of these tools for the HPV vaccine and found them practical and acceptable for parents. Another study discovered that mobile health (mHealth) tools, which include these aids, increased parents' knowledge and intentions regarding HPV vaccination. Parents responded well to these motivational tools without major side effects. Overall, evidence suggests these tools safely increase HPV vaccination rates. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these strategies to boost HPV vaccination rates because they focus on both healthcare providers and parents, aiming for a comprehensive approach. Unlike traditional methods that primarily rely on clinicians to recommend the vaccine, these strategies include clinician-targeted training to improve communication and engagement, as well as parent-targeted motivational aids, like reminder messages and phone-based interviews, to directly encourage parents. Additionally, some strategies incorporate healthcare access assistance, which can help overcome barriers to getting vaccinated. This three-pronged approach could significantly increase vaccination rates by addressing multiple aspects of the decision-making process.

What evidence suggests that this trial's strategies could be effective for increasing HPV vaccination rates?

This trial will evaluate different strategies to increase HPV vaccination rates. One strategy involves parent-targeted motivational aids, such as reminder messages and phone calls. Studies have shown that these tools can increase HPV vaccination rates, with 57.89% of such efforts leading to more vaccinations. Specifically, one study found that 82% of parents reacted positively to vaccine reminders, indicating that reminders and motivational talks can encourage more parents to vaccinate their children. Additionally, mobile health tools have made parents more likely to vaccinate. Overall, these strategies help more teens start and complete their HPV vaccine series. ^{2 3 4 6 7}

Who Is on the Research Team?

Stephanie Staras, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adolescents aged 8 to 12 who have visited a participating clinic in the past year or during the study and haven't received both HPV vaccine doses. It also includes providers who give primary care to patients aged 9 to 12 at a participating clinic.

Inclusion Criteria

I am between 8 to 12 years old and have not received both HPV vaccine doses.

I provide primary care to children aged 9-12 at a participating clinic.

Exclusion Criteria

I am not an adolescent.

Providers unwilling to consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinics receive clinician-targeted recommendation training, parent-targeted motivational aids, and community-targeted healthcare access

24 months

Multiple visits as per clinic schedule

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Parent-targeted motivational aids

Trial Overview The ReMARK trial tests if adding parent-targeted motivational aids and community healthcare access improves HPV vaccination rates in rural areas, beyond clinician training alone. Clinics are randomly assigned to three groups with varying combinations of these strategies.

How Is the Trial Designed?

Group I: Clinician-targeted training, Parent-targeted motivational aids, and Healthcare Access Experimental Treatment 3 Interventions

All clinicians and nurses will be assigned to participate in a training on how to recommend or discuss the HPV vaccine. Also, clinics will send reminder/recall messages to parents about the HPV vaccine and offer phone-based motivational interviews. Plus, clinics will have access to healthcare access assistance.

Group II: Clinician-targeted training and Parent-targeted motivational aids Experimental Treatment 2 Interventions

All clinicians and nurses will be assigned to participate in a training on how to recommend or discuss the HPV vaccine. Also, clinics will send reminder/recall messages to parents about the HPV vaccine and offer phone-based motivational interviews.

Group III: Clinician-targeted training Experimental Treatment 1 Intervention

All clinicians and nurses will be assigned to participate in a training on how to recommend or discuss the HPV vaccine.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The study involved 286 parents of 11- to 12-year-old children and tested different reminder methods for the HPV vaccine, finding that nearly all messages were deliverable and 82% of parents found the reminders acceptable.

Phone-based Motivational Interviewing (MI) was well-received, with a high adherence rate to MI techniques, indicating that this approach could effectively engage parents in discussions about HPV vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility trial of parent HPV vaccine reminders and phone-based motivational interviewing. Staras, SAS., Richardson, E., Merlo, LJ., et al.[2021]

In a study involving 877 adolescents due for an HPV vaccine, text message reminders significantly increased vaccination rates to 23% compared to 12% in the control group, demonstrating their effectiveness in promoting HPV vaccination.

Text message reminders were found to be the most feasible and effective method for increasing HPV vaccination rates, especially among boys, while robocalls were the least effective reminder type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and feasibility of three types of parent reminders to increase adolescent human papillomavirus (HPV) vaccination. Glenn, BA., Crespi, CM., Herrmann, AK., et al.[2023]

Only 29% of daughters from low-income minority families who called the 2-1-1 Helpline received the HPV vaccine, which is significantly lower than national and Texas vaccination rates.

Key factors that increased the likelihood of HPV vaccination included being offered the vaccine by a healthcare provider, believing in its effectiveness against cervical cancer, and identifying as Hispanic, highlighting the need for targeted interventions in these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccine: 2-1-1 helplines and minority parent decision-making. Savas, LS., Fernández, ME., Jobe, D., et al.[2022]

HPV vaccination rates among preadolescent and adolescent girls in the U.S. are significantly lower than in other developed countries, influenced by factors such as region, socioeconomic status, and insurance coverage.

Educational campaigns targeting both parents and physicians, along with school-based vaccine clinics, are proposed as effective strategies to improve awareness and increase HPV vaccination rates, aiming to meet the Healthy People 2020 goal of over 80% coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Cervical Cancer in the United States: Barriers and Resolutions for HPV Vaccination. Beavis, AL., Levinson, KL.[2022]

The Adolescent Vaccination Program Implementation Tool (AVP-IT) was developed to enhance HPV vaccination rates in pediatric clinics by providing tailored guidance on six evidence-based strategies, and it was positively received by healthcare providers in usability testing.

Healthcare providers found the AVP-IT to be easier and more effective for implementing vaccination strategies compared to usual practices, indicating its potential as a scalable tool to improve HPV vaccination rates in community clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation and Formative Evaluation of Online Decision Support to Implement Evidence-Based Strategies to Increase HPV Vaccination Rates in Pediatric Clinics. Shegog, R., Savas, LS., Frost, EL., et al.[2023]

Among 4103 parents of girls aged 13 to 17, 69% did not delay or refuse the HPV vaccine, but 28% either delayed or refused it, indicating a significant portion of parents are hesitant about vaccination.

Common reasons for delaying or refusing the HPV vaccine included concerns about potential long-term health issues, doubts about its effectiveness, and the belief that the vaccine is unnecessary, with higher refusal rates among non-Hispanic white families and those with higher income and education levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delay and refusal of human papillomavirus vaccine for girls, national immunization survey-teen, 2010. Dorell, C., Yankey, D., Jeyarajah, J., et al.[2022]

In a study involving 777 parents of adolescents, strong recommendations from healthcare providers for the HPV vaccine were linked to improved parental attitudes and acceptance towards vaccination, indicating that communication strategies can significantly influence vaccination decisions.

The study found that these strong recommendations did not negatively affect parents' experiences or trust in their providers, even among those who were initially hesitant about vaccines, suggesting that assertive communication can be a safe and effective approach to increase HPV vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent report of provider HPV vaccine communication strategies used during a randomized, controlled trial of a provider communication intervention. Dempsey, AF., Pyrzanowski, J., Campagna, EJ., et al.[2022]

A clinical trial involving 7,718 young adults aged 18-26 tested different outreach methods to encourage HPV vaccination, revealing that personalized messages and mailed letters increased vaccination rates compared to no additional outreach.

Despite the increase in vaccination rates (from 3.5% with no outreach to 5.1% with mailed letters), the overall gains were not clinically significant, indicating a need for more effective strategies to improve HPV vaccination among young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Learning Health System Approach to Increasing Human Papillomavirus Immunizations Among Young Adults. Khan, AA., Tran, HN., Lai, JA., et al.[2023]

An intervention combining behavioral nudges and provider communication training led to increased HPV vaccination rates in some pediatric practices, with 72% of parents reporting their child received the vaccine during the study visit.

Despite the overall increase in vaccination rates, concerns about vaccine safety and necessity persisted among some parents, highlighting the need for continued education and communication about HPV vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot intervention combining assessment and feedback with communication training and behavioral nudges to increase HPV vaccine uptake. Bradley-Ewing, A., Lee, BR., Doctor, JN., et al.[2022]

The study found that intentions to refuse HPV vaccination due to safety concerns increased among all parent-child gender pairings from 2010 to 2019, with the highest refusal rates reported by mothers regarding their unvaccinated daughters.

Fathers were nearly twice as likely to refuse HPV vaccination for their daughters compared to sons, while mothers showed even higher refusal rates, indicating a significant gender disparity that could affect HPV vaccination uptake and potentially lead to increased HPV-associated cancer risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of parent-child gender on intentions to refuse HPV vaccination due to safety concerns/side effects, National Immunization Survey - Teen, 2010-2019. Chido-Amajuoyi, OG., Talluri, R., Jackson, I., et al.[2022]

A randomized controlled trial involving 256 young women showed that an educational video significantly increased HPV vaccine acceptability to 51.7%, compared to 33.3% for an educational handout and 28.2% for a control group (P<.01).

Both educational interventions improved HPV vaccine knowledge, with participants in the video arm scoring higher on knowledge assessments and reporting the video as more helpful in making vaccination decisions (86.2% vs 70.2%, P<.01).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Educational Interventions on Human Papillomavirus Vaccine Acceptability: A Randomized Controlled Trial. Cory, L., Cha, B., Ellenberg, S., et al.[2021]

In a national survey of 501 mothers of adolescent girls, only 51.1% reported that their daughters received the HPV vaccine, and only 38.3% completed all three doses, highlighting a significant public health issue.

Common reasons for not vaccinating included concerns about vaccine safety and lack of recommendation from healthcare providers, indicating that addressing these fears and improving provider communication could enhance vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national study of HPV vaccination of adolescent girls: rates, predictors, and reasons for non-vaccination. Kester, LM., Zimet, GD., Fortenberry, JD., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06535139

ReMARK: Addressing Disparities in Rural HPV-related ... First, we will evaluate the added clinical- and cost- effectiveness of parent-targeted motivational aids (reminder/recall and phone-based MI) alone and when ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11433691/

The Effectiveness of Interventions Targeting Adolescents in ... A total of 19 studies reported vaccination rates (initiation and/or completion) after the intervention. A total of 11 of them (57.89%) outlined ...

3. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-10132-6

A feasibility trial of parent HPV vaccine reminders and phone ... The acceptability survey response rate was 37% (38/102). Respondents were favorable toward vaccine reminders for all parents (82%). Among 20 ...

4. pediatrics.jmir.org pediatrics.jmir.org/2023/1/e47334/

The Effectiveness of mHealth Interventions Targeting Parents ... This study aims to conduct a systematic review to assess the effectiveness of mHealth interventions on parental intent to vaccinate youth against HPV and youth ...

5. thelancet.com thelancet.com/journals/lanam/article/PIIS2667-193X(24)00021-8/fulltext

Factors associated with parental human papillomavirus ... We examined and compared the factors associated with parental HPV vaccination intentions between socioeconomically divergent groups.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7797089/

A feasibility trial of parent HPV vaccine reminders and ... We assessed the feasibility and acceptability of a sequential approach of parent-targeted HPV vaccine reminders and phone-based Motivation Interviewing (MI).

7. sciencedirect.com sciencedirect.com/science/article/pii/S0882596323000623

Awareness of HPV and HPV vaccines, acceptance to ... Parents willing to vaccinate themselves and their children against HPV were 84.9% and 87.6%, respectively. Parents were more likely to vaccinate their daughters ...