Strategies for Increasing HPV Vaccination Rates

Recruiting in Palo Alto (17 mi)

Overseen by Stephanie Staras, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Florida

Disqualifiers: Out of age range, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

There are three main objectives of the protocol. First, we will evaluate the added clinical- and cost- effectiveness of parent-targeted motivational aids (reminder/recall and phone-based MI) alone and when combined with community-targeted healthcare access assistance beyond the effects of clinician-targeted training. Second, we will estimate the differential effectiveness of the implementation strategies by patient-level factors (age, race/ethnicity, sex, distance from home to clinic, social vulnerability). Third, we will measure moderation of implementation strategy effectiveness by clinic-level factors (HPV vaccination priority, resources, clinic visit types, scheduling practices, and implementation success). Within 11 rural North Central Florida counties, we will evaluate the layering of evidence-based implementation strategies that progressively addressing clinician, parent, and healthcare access barriers faced by rural communities on HPV vaccination rates among 9- to 12-year-olds. To best address our main question of whether layering complementary strategies continues to increase effects on HPV vaccination, we will test our hypotheses with a three-arm cluster randomized study design of nested strategies. The proposed nested study design optimizes evaluation, causal inference, and scientific rigor by putting the maximum number of clinics towards addressing the layering of strategies. Randomization will occur at the clinic level. All clinics will receive implementation strategy A: clinician-targeted recommendation training. A random 20 of 30 of clinics will also receive facilitation of parent-targeted motivational aids (B) for an implementation strategy package of A+B. Finally, a random half of the clinics who receive A+B will also receive community-targeted healthcare access (C) for a total implementation strategy package of A+B+C. This equates to a three-arm cluster randomized trial in which 10 clinics receive clinician- targeted recommendation training alone (A), 10 clinics receive clinician-targeted recommendation training and parent-targeted motivational aids (A+B), and 10 clinics receive clinician-targeted recommendation training, parent-targeted motivational aids, and community-targeted healthcare access (A+B+C).

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 Parent-targeted motivational aids for increasing HPV vaccination rates?

Research shows that parent reminders, such as text messages, can effectively increase HPV vaccination rates among adolescents. Additionally, personalized communication strategies have been shown to improve vaccination uptake, suggesting that motivational aids targeting parents could be beneficial. ^{1 2 3 4 5}

Is the HPV vaccine safe for humans?

The research articles primarily discuss concerns and perceptions about the safety of the HPV vaccine, but they do not provide specific safety data. Concerns about safety are common reasons for vaccine refusal, indicating a need for more education and information to address these worries. ^{2 6 7 8 9}

How does the parent-targeted motivational aids treatment for increasing HPV vaccination rates differ from other treatments?

The parent-targeted motivational aids treatment is unique because it combines reminders with phone-based motivational interviewing (a technique that helps people find their own motivation to change) to encourage parents to vaccinate their children against HPV. This approach is different from other methods like mailed letters or text messages, as it involves direct interaction and personalized motivation, which can be more effective in addressing parents' concerns and increasing vaccination rates. ^{1 2 10 11 12}

Research Team

Stephanie Staras, PhD

Principal Investigator

University of Florida

Eligibility Criteria

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

Providers unwilling to consent

I am not an adolescent.

Trial Timeline

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

Treatment Details

Interventions

• Parent-targeted motivational aids (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Stephen J. Motew

University of Florida

Chief Executive Officer since 2024

MD cum laude from the University of Illinois at Chicago School of Medicine, Master's in Healthcare Administration from the University of North Carolina at Chapel Hill

Dr. Timothy E. Morey

University of Florida

Chief Medical Officer since 2023

MD and Bachelor's from the University of Florida

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A feasibility trial of parent HPV vaccine reminders and phone-based motivational interviewing. [2021]

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

Effectiveness and feasibility of three types of parent reminders to increase adolescent human papillomavirus (HPV) vaccination. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Parent report of provider HPV vaccine communication strategies used during a randomized, controlled trial of a provider communication intervention. [2022]

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

A Learning Health System Approach to Increasing Human Papillomavirus Immunizations Among Young Adults. [2023]

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

A pilot intervention combining assessment and feedback with communication training and behavioral nudges to increase HPV vaccine uptake. [2022]

6. United States 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. [2022]

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

Delay and refusal of human papillomavirus vaccine for girls, national immunization survey-teen, 2010. [2022]

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

A national study of HPV vaccination of adolescent girls: rates, predictors, and reasons for non-vaccination. [2021]

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

Effects of Educational Interventions on Human Papillomavirus Vaccine Acceptability: A Randomized Controlled Trial. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Preventing Cervical Cancer in the United States: Barriers and Resolutions for HPV Vaccination. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccine: 2-1-1 helplines and minority parent decision-making. [2022]

12. Switzerland 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. [2023]