This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative Research, is properly cited. The complete bibliographic information, a link to the original publication on https://formative.jmir.org, as well as this copyright and license information must be included.
Human papillomavirus (HPV) vaccine hesitancy is on the rise, and provider communication is a first-line strategy to address parental concerns. The use of the presumptive approach and motivational interviewing by providers may not be enough to influence parental decision-making owing to the providers’ limited time, self-efficacy, and skills to implement these strategies. Interventions to enhance provider communication and build parental HPV vaccine confidence have been undertested. Delivering tailored patient education to parents via mobile phones before they visit the health care provider may address time constraints during clinic visits and positively affect vaccine uptake.
This study aimed to describe the development and evaluate the acceptability of a mobile phone–based, family-focused intervention guided by theory to address concerns of HPV vaccine–hesitant parents before the clinic visit, as well as explore intervention use to facilitate parent-child communication.
The health belief model and theory of reasoned action guided intervention content development. A multilevel stakeholder engagement process was used to iteratively develop the
The qualitative interviews yielded 4 themes: overall views toward mobile device use for health information, acceptability of
The multilevel stakeholder-engaged process used to iteratively develop this novel intervention for HPV vaccine–hesitant families can be used as a model to develop future mobile health interventions. This intervention is currently being pilot-tested in preparation for a randomized controlled trial aiming to increase HPV vaccination among adolescent children of vaccine-hesitant parents in a clinic setting. Future research can adapt
Improving human papillomavirus (HPV) vaccination rates among adolescents is a public health priority [
A strong recommendation and effective communication from a provider are critical to address parental vaccine hesitancy and increase uptake [
Communication can come in several forms from providers. Nevertheless, few research studies explore modalities used by providers or parent and patient preference of these modalities [
Offering previsit patient education could be an effective complement to provider communication strategies offered during a clinic visit to promote uptake among HPV vaccine–hesitant parents [
Our primary goal was to develop an individually tailored educational intervention for HPV vaccine–hesitant parents that providers could deliver before clinic visits to increase HPV vaccine confidence and uptake. The secondary goals were for this intervention to facilitate parent-child communication, reduce parent-child anxiety, and minimize provider time burden during clinic visits. We explored (1) intervention acceptability from HPV vaccine–hesitant parents undecided about the HPV vaccine and health care providers serving adolescents and (2) potential use of this intervention to facilitate parent-child communication.
We conducted a formative research study, applying community-engaged research principles to develop
Mobile phone–based intervention HPVVaxFacts development process. CAB: community advisory board; CEHC: Center for Effective Health Communication; MVTCP: Meharry-Vanderbilt–Tennessee State University Cancer Partnership; RLA: reading-level assessment.
This research was approved by the institutional review board of Meharry Medical College (18-12-890). Written consent was obtained from parents and providers before their interviews. Interview transcriptions were deidentified and assigned a code before data analysis to protect the participants’ confidentiality. Providers were compensated with a US $50 gift card, and parents were compensated with a US $40 gift card.
Our research team developed the initial intervention plan, content, and prototype for the mobile phone–based intervention,
The theory of reasoned action (TRA) [
Each parental concern also has an optional button called
Upon completion, the parent is prompted to save the information about their top concerns and send it to themselves via SMS text message or email or print it out for future reference and to discuss the concerns with their provider at the upcoming visit. A
Established in 2011, the Meharry-Vanderbilt–Tennessee State University Cancer Partnership (MVTCP) Cancer Outreach Core community advisory board (CAB) is an academic-community partnership that provides consultation on numerous MVTCP research projects and supports implementation of clinical trials. The CAB meets quarterly and includes >20 community members from diverse racial and ethnic backgrounds who are cancer survivors, caregivers, representatives of cancer-related organizations, and other community members with an interest in cancer prevention and control [
We also created an advisory panel of 5 African American mothers who were hesitant to get their child the HPV vaccine. They were invited from an existing database of past research participants who agreed to be contacted for future studies. We presented the mobile phone–based intervention and message content to the mothers, and they provided feedback on the extensiveness, comprehension, and cultural appropriateness of the design and content. The research team discussed the feedback and revised the intervention accordingly. This one-time review occurred via a 90-minute Zoom (Zoom Video Communications, Inc) session, with US $20 paid as compensation to the mothers.
The Center for Effective Health Communication (CEHC) located at Vanderbilt University promotes improved health care quality and outcomes via effective health information exchange. For our study, the CEHC consultants included a behavioral scientist, a physician, and a medical sociologist. They reviewed the content to ensure that it would be comprehensible to parents and their adolescent children with varying literacy skills and diverse cultures. Specifically, they proposed content changes to reflect best practices for effective communication (eg, communicating 1 thought per sentence, simplifying sentence structure, and removing or clearly defining medical jargon) along with pre-post information on readability (ie, Flesch-Kincaid Grade Level, Flesch Reading Ease, and words per sentence) [
We used a qualitative, descriptive study design to understand decision-making on the HPV vaccine and gather feedback on the intervention among parents who self-identified as vaccine hesitant and among providers who served adolescent children of vaccine-hesitant parents. We conducted semistructured interviews and then iteratively revised the intervention design and content (ie, quiz items, draft messages, images or graphics, and layout) using interview data to guide optimization.
Parents were recruited from the southeastern region of the United States. We recruited a purposeful criterion sample, which is a selection of individuals who are especially knowledgeable about, or have experience regarding, a phenomenon of interest [
We drafted an open-ended interview protocol for parents and another one for providers to elicit (1) attitudes about the HPV vaccine and actual or perceived facilitators and barriers to HPV vaccination and (2) feedback on the wording, aesthetics, and format of draft intervention content and delivery to inform revisions. Data collection for parents occurred from February 2021 to May 2021 and for providers from May 2021 to March 2022. Before the interview, parents were sent a link via email for the informed consent document and an adapted 10-item survey to be used in the intervention. The survey assessed parental concerns about the HPV vaccine from the parent and provider perspectives. These data were collected via REDCap (Research Electronic Data Capture; Vanderbilt University), a secure web-based data collection application [
SPSS software (version 28.0; IBM Corp) was used to analyze survey data. Descriptive analyses (eg, means and frequencies) were used to describe patterns in the data from the surveys of parents and providers. Qualitative data analysis was conducted by the lead author (JC-E) and a graduate student (MD), both trained in qualitative research methods. An a priori hierarchical coding system was developed based on the interview protocol and a preliminary review of the transcripts. Reliability was established in the coding system, followed by independent reviews of each transcript. Next, codes were compared and discrepancies resolved. Using an iterative inductive-deductive approach, codes were merged to form higher-order themes. Strategies to ensure rigor included triangulation, thick descriptions, and peer debriefing [
Two experts conducted a final review of the message library content for accuracy. The content reviewers were an expert in vaccinology (including clinical trials, vaccines, and infectious diseases such as HPV; KE) and an expert in pediatrics and immunization delivery (including HPV vaccination; AFD). Content was deemed evidential if the experts did not find inaccurate or obsolete information using existing peer-reviewed literature. Corrections were completed if identified by the experts.
The research team made a final round of modifications to the intervention to ensure incorporation of all the key interview findings of parents and providers and the feedback from the CAB members, parental advisory panel, and vaccine experts. Areas of refinement included the individually tailored message concepts, images, and design of the intervention. The review by HPV vaccine experts and CEHC consultants ensured that the content in the messaging library was accurate and comprehensible. Finally, we confirmed that the tailoring variables were matched to specific educational messages identified by parents.
Overall, the MVTCP CAB members acknowledged that addressing HPV vaccination among adolescents was an important strategy to reduce cancer disparities. They perceived that the intervention was necessary, “eye-catchy,” and user-friendly and addressed specific parental concerns. However, they stated that more diversity in sexual orientation as well as race and ethnicity was needed in the pictures presented on the home page to promote inclusiveness. In addition, they suggested that the intervention should include more visuals to reflect HPV vaccination for male patients. Finally, participants suggested lowering the literacy level because the terms seemed to be “too scientific” or “high grade level.”
The top concern among the parents on the advisory panel was the short- and long-term side effects of the vaccine. They also questioned whether and why the vaccine was needed at the recommended age, which they perceived to be young. The parents demonstrated overall enthusiasm with the mobile phone–based intervention and perceived that it increased their knowledge of HPV and the vaccine. They particularly liked the colors and the “clean look” achieved via the use of white space throughout the intervention. The question-and-answer choices were approved, and a suggestion was made to add the option for parents to modify the ranking of top concerns that was generated based on their survey responses. The format to provide content was deemed acceptable. However, the parents did not perceive that the home page depicted enough diversity. They suggested adding an African American family, particularly a man and son, with the other parents. Another suggestion was to add pictures, including those of (1) men throughout the intervention because it appeared too female oriented and (2) medical doctors who reflect “all races in white coats.” The parents preferred a brief video for each vaccine with comprehensible and accurate content. The final suggestion was to be “kid friendly.” The parents requested the addition of an
The Flesch-Kincaid Grade Level was 8.0 before the CEHC review compared with 7.2 after the CEHC review. The Flesch Reading Ease score was 65.6 before the CEHC review and 68.2 after the CEHC review. Finally, there were 16 words per sentence before the CEHC review and 14 words per sentence after the CEHC review. This was better than the recommended range of 15 to 20 words per sentence. Additional recommendations were related to grammar (eg, reordering or removal of information and removing potentially manipulative or contradictory language).
Of the 31 parents, 18 (58%) were White, 25 (81%) were women, and 19 (61%) had a bachelor’s degree or higher. Although there was a wide range in terms of income, 55% (16/29) had an annual household income of <US $80,000. Of the 15 providers, 10 (67%) were White, 11 (74%) were women, 13 (87%) were pediatricians, and 10 (67%) practiced in an urban area (
Sociodemographics of parents (n=31) and providers (n=15).
Characteristics | Values | |||||||
|
||||||||
|
|
|||||||
|
|
African American | 12 (39) | |||||
|
|
White | 18 (58) | |||||
|
|
Latinx | 1 (3) | |||||
|
|
|||||||
|
|
Male | 6 (19) | |||||
|
|
Female | 25 (81) | |||||
|
|
|||||||
|
|
GEDa or high school diploma | 2 (7) | |||||
|
|
Associate degree | 5 (16) | |||||
|
|
Some college | 5 (16) | |||||
|
|
Bachelor’s degree | 10 (32) | |||||
|
|
Postgraduate degree | 9 (29) | |||||
|
|
|||||||
|
|
<20,000 | 3 (10) | |||||
|
|
20,001 to 40,000 | 4 (13) | |||||
|
|
40,001 to 60,000 | 5 (16) | |||||
|
|
60,001 to 80,000 | 4 (13) | |||||
|
|
>80,000 | 13 (42) | |||||
|
|
Did not want to answer | 2 (7) | |||||
|
||||||||
|
|
|||||||
|
|
African American | 2 (13) | |||||
|
|
White | 10 (67) | |||||
|
|
Other | 3 (20) | |||||
|
|
|||||||
|
|
Male | 4 (27) | |||||
|
|
Female | 11 (73) | |||||
|
|
|||||||
|
|
Pediatrics | 13 (87) | |||||
|
|
Family medicine | 1 (7) | |||||
|
|
Adolescent medicine | 1 (7) | |||||
|
|
|||||||
|
|
Urban | 10 (67) | |||||
|
|
Suburban | 4 (27) | |||||
|
|
Rural or mostly mural | 1 (7) | |||||
|
Years in practice, mean (SD) | 14.3 (8.6) | ||||||
|
Residency year training (range) | 1982-2021 |
aGED: General Educational Development Test.
We identified 5 themes, and each is outlined in the following sections.
Almost all parents and providers stated that mobile devices were acceptable for receiving health information related to their children. They preferred that the medical home deliver the health information to the parents’ mobile device to ensure accuracy and increase the likelihood of trusting the information for use in decision-making. Each unique perspective on overall mobile device use for health information has been provided in the paragraphs that follow.
Nearly all parents reported that they knew how to find health information on apps. The use of mobile web pages was common, easy, and convenient. The types of health information previously accessed via mobile device included laboratory reports after a health care visit and Google to access health information sites.
Most of the providers stated that there is an increasing trend in mobile device use to access health information, and nearly all perceived that this was due to societal norms. The use of mobile devices was also perceived to be driven by medical homes using telemedicine and web-based health portals to engage patients. As a result, most of the providers believed that accessing a mobile phone–based intervention would be easy and convenient for most parents.
All participants found the intervention acceptable. The layout, including the survey (
Both parents and providers stated that intervention delivery via mobile phone would be easy and convenient based on prior experiences. This allows time to review messages before the clinic visit. However, they differed in the timing of intervention delivery. All parents wanted information from 2 weeks to a month before the clinic visit. This would allow them to process the information and have conversations with their family. The providers recognized clinic-specific time constraints and how this intervention would be beneficial before the clinic visit. However, a small number of providers perceived that providing information weeks to months in advance would be too far ahead, and, instead, they thought that delivery in the waiting room immediately before the clinic visit would be ideal. Each unique perspective on facilitators of
Overall, parents reported that they would use the mobile phone–based intervention before a clinic visit. They perceived that the previsit timing gives the parent control and empowerment in the decision-making process. It prevents the parent from feeling “pressured” to make a quick decision in the physician’s office. In addition, many parents stated that the previsit information would allow them time to think about and discuss the vaccine with their family, spouse, and children. Most of the parents liked the fact that
Most of the providers believed that the
Parents and providers identified potential barriers to using
A commonly cited barrier was concern about a breach of privacy and confidentiality. A parent feared being exposed to a security breach because data would be stored in the “cloud.” Therefore, this parent stated that they were more likely to use the intervention through a health portal than through a mobile app. A parent wanted additional guidance on intervention navigation. Some of the parents cited a possible lack of accessibility for other parents who do not have a computer or lack access to a mobile phone. Suggestions to increase access included creating an additional physical document that could be retrieved at the library, clinic, or health department if there was an issue with computer or mobile phone access. Other parents described issues related to reading words and visuals on the small mobile screens. Parents recommended increasing font size and white space and creating a complementary paper document to be handed over along with
A few of the providers noted potential disruption of clinic workflow from intervention implementation. In addition, delivering the intervention before the clinic visit could cause a parent to delay or cancel an upcoming wellness or sick visit. It could also create new concerns about the HPV vaccine or about vaccines in general. Another concern was that many parents do not schedule appointments far in advance. Therefore, some parents may not receive the information until shortly before or during the visit. As a result, clinics should map out to whom and how this intervention should be delivered. Language is another barrier for parents who do not speak English or for those for whom English is a second language. The providers also stated that a mobile-based web page limits accessibility
Two HPV vaccine experts perceived that the messaging was authoritative. Text was added, rearranged, or removed to increase clarity of a message or if it was considered not essential by the experts; for example, text was removed and added to increase understanding of the importance of vaccine-induced immunity compared with natural immunity. In addition, it was suggested to consistently use either
We iteratively adapted the tailored health communication intervention
Summary of suggestions and changes at each phase of HPVVaxFacts development.
Phase | Title | Suggestions | Changes |
2 | MVTCPa CABb Review |
Modify literacy level Make language understandable to lay persons Diversity in images regarding sexual orientation, sex, and race |
Lowered literacy level to grade 7 using simple terms Substituted scientific words or added definitions Updated images to be more racially diverse and more male oriented |
3 | Parental Advisory Panel Review |
Need diversity in images (ie, in terms of race, age, and sex) Add images of physicians reflective of all races in white coats Add videos to complement content Add adolescents’ corner (images, messages, and testimonials for adolescents) |
Updated more images to reflect diversity in age, race, and sex for children, parents, and physicians Developed videos from providers belonging to different racial groups Added videos that reinforced content of each concern Adolescents’ corner added with images and messages |
4 | CEHCc Content Review |
Reorder or remove information Remove manipulative or contradictory language |
Removed problematic language (eg, “as a good parent”) Revised misleading statements (eg, how HPVd is spread) Reordered and revised content |
|
|||
|
Semistructured Interviews With Parents |
Modify content to increase clarity Add images for diversity Add sources for content Add more research-based studies Tailor content to adolescents’ medical condition Introduce research team Increase font size and white space Add guidance on navigation |
Updated 3 infographics to increase clarity on content (eg, impact of HPV vaccine on cancer rates) Updated links to go to visuals (eg, genital warts) Updated 2 images to reflect sex and diversity Substituted, added, or removed content from each concern (eg, edited language on rationale for age recommendation) Identified and added sources for content to increase credibility Added About Us tab of research team members with pictures and bio Shortened sentences, added white space, and increased font size Updated instructions on web page |
|
Semistructured Interviews With Providers |
Give providers information on content to prepare for discussion with parents |
Developed 1-page summary for providers on vaccine concerns Offered demonstration for providers |
6 | Expert Review |
Edit content to improve accuracy and clarity Change 1 image to be more content appropriate |
Edited content for all concerns (eg, updated explanation of natural immunity vs vaccine immunity) We did not change the picture for genital wart content because parents wanted the option to click a link that would lead to a picture of genital warts |
aMVTCP: Meharry-Vanderbilt–Tennessee State University Cancer Partnership.
bCAB: community advisory board.
cCEHC: Center for Effective Health Communication.
dHPV: human papillomavirus.
The final message library addressed 9 concerns related to the HPV vaccine: safety, recommended age, effectiveness to prevent genital warts and cancers, too many vaccines for adolescents, preference for natural immunity over vaccine immunity, need to prevent cancer, need to prevent genital warts, and the perceptions that vaccine receipt will encourage sexual activity and cause serious health problems to the child. Refer to
Tailoring variable: natural immunity vs vaccine immunity
Quiz item: I wonder if natural immunity against HPV is better than getting the HPV vaccine
Initial message before the development process
Like you, some parents question whether natural immunity is better than HPV vaccination to protect their child’s health.
Although natural immunity from HPV provides immunity like the HPV vaccine does, the risk with HPV infection is much higher. With natural infections, a child might develop complications such as genital warts and cancer. On the other hand, if your child is exposed to a disease like HPV after being vaccinated, he or she would already be armed and able to fight it off.
This means your child does not have to get sick from HPV first to develop protective antibodies.
All children need their HPV shots to prevent cancer and genital warts.
HPV is a very common virus with 14 million affected yearly including teens.
Almost all people (4 out of 5) will be affected at some point in their lifetime.
1 person gets HPV every 20 minutes of every day.
Over 45,000 cases of HPV cancers a year could be prevented with HPV vaccination.
HPV infections can cause:
cancers of the cervix, vagina, and vulva in women
cancers of the penis in men; and
cancers of the anus and back of the throat, including the base of the tongue and tonsils in both men and women
genital warts in both men and women.
HPV-linked throat cancers are highest in men with a 225% increase in cases.
Final message after the development process
Natural immunity happens when your child gets the HPV infection and makes antibodies to fight the infection. The problem with this type of immunity is the danger that getting the infection can lead to genital warts and/or cancer later in life.
Immunity through vaccination is when the HPV vaccine causes the body to develop protective antibodies before coming into contact with the virus. This means your child’s body will be armed with protective antibodies that stop the most common types of HPV from infecting them and causing cancer and/or genital warts.
Vaccination is much safer than natural immunity. For natural immunity, your child will catch HPV infection which will place them at risk of genital warts and cancer later in life while vaccination will protect your child from infection with the most common HPV types.
Vaccination produces antibodies and infection fighting cells called T cells that provide stronger and longer protection against HPV compared to natural infection. There is no evidence of protection decreasing from the vaccine over time.
It is important to remember that there are many different types of HPV. Infection provides immunity against one specific type of HPV, while the HPV vaccine provides protection against many different HPV types that cause cancer and genital warts.
The images on the web page were edited throughout to increase diversity while promoting inclusion. An
Screenshots of the HPVVaxFacts intervention.
The intervention was programmed as a web-based application that can be viewed on mobile phones as well as PCs. In addition, programming was adapted to ensure that this intervention could be viewed on different web browsers, including Safari, Google Chrome, and Mozilla Firefox.
We provided a detailed description and key findings from the multiphase stakeholder-engaged process used to develop a tailored health communication intervention,
This study contributes critical information to the small but growing body of research conducted on mHealth interventions for HPV vaccination [
The acceptability of mHealth intervention use in clinic settings by both parents and providers is critical to increase the likelihood of use and effectiveness. Both parents and providers indicated that the medical home was the preferred setting for intervention delivery, which concurs with previous research findings that the provider is considered a trusted information source [
Early during the COVID-19 pandemic, clinics did not have the capacity to conduct research activities. Therefore, we had to switch to recruiting parents from ResearchMatch, a voluntary research registry, which could be biased toward people who have an interest in research participation. Another potential limitation is the pushback against COVID-19 vaccination and increased general vaccine hesitancy during the pandemic, which may have caused and increased hesitancy among these parents [
Parents were recruited from only the southeastern region of the United States. Therefore, it is possible that this region’s local context of vaccine hesitancy may differ from that of other regions. However, the southern region is an important area to focus on because the states in this region generally have lower rates of HPV vaccination and higher levels of vaccine hesitancy than other regions in the United States [
We are completing pretesting to optimize the intervention study protocol and implementation procedures (eg, the timing of intervention delivery before the clinic visit and adoption into the clinic setting). Next, we will conduct a pilot randomized controlled trial to establish the feasibility of the intervention protocol and obtain preliminary data for a full-scale randomized controlled trial.
Strategies are needed to promote HPV vaccination because parental hesitancy continues to rise and threaten adolescent prevention against HPV-related cancers. We developed a theory-driven tailored health communication intervention using community-engaged research processes. The iterative development of our intervention with the input of the primary target audience, vaccine-hesitant parents, was critical and necessary, given the unique needs of this population, which made it more challenging in terms of changing attitudes and behavior. The input of providers and vaccine experts provided added value and enhanced acceptability. Our findings and the resulting intervention contribute to advancing the science around addressing parental vaccine hesitancy for HPV vaccine or other vaccines. Future research could adapt this intervention for use in other settings such as schools, health departments, and pharmacies. In addition, the systematic stakeholder-engaged development process documented here may be replicated in future research to design other mHealth interventions.
community advisory board
Center for Effective Health Communication
health belief model
human papillomavirus
mobile health
Meharry-Vanderbilt–Tennessee State University Cancer Partnership
Research Electronic Data Capture
theory of reasoned action
The authors would like to thank the parents and pediatric providers for their valuable insights into the needs of parents who are undecided about human papillomavirus vaccination and strategies to increase acceptance. The authors also thank the parental advisory panel and community advisory board guiding this study. This work was supported by the National Cancer Institute of the National Institutes of Health (1K01CA237748, U54CA163072, U54CA163066, and U54CA163069). This work was also supported by the National Center for Advancing Translational Science of the National Institutes of Health (UL1 RR024975 and UL1 TR000445). The funders were not involved in any aspects of this research study.
The supporting data cannot be made openly available because of the confidentiality agreements.
AFD is currently an employee of Merck; her involvement in this study occurred before this, when she was a faculty member at the University of Colorado. JE is an education consultant for Merck; she became a consultant after this study was completed. KE receives grant funding from the National Institutes of Health (NIH) and is a consultant to Bionet. KE is also a member of the IBM Data Safety and Monitoring Board for Sanofi, X-4 Pharma, Seqirus, Moderna, Pfizer, Merck, and Roche. PCH has received funding from the Merck Foundation for research (unrelated to human papillomavirus vaccination) focused on patient navigation for patients with cancer.