HPV VaccinationPREVENTNCT06290206
PREVENT HPV-Related Cancers - BootCamp Translation
A study testing PREVENT - BCT in people with HPV Vaccination and Vaccine; Uptake, run by University of Utah at 1 site in United States.
Trial summary
This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccination, Vaccine; Uptake, Vaccination; Series Completion
- What is being tested?
- PREVENT - BCT
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents/Caregivers (P/C) of children/adolescents (C/A) ages 9-17 years of age (i.e., age-eligible for HPV vaccination);
- P/C with active clinic patients (i.e., have been seen in the clinic in the last 12 months); and
- P/C who speak either English or Spanish.
Who cannot join
- P/C of C/A with previous excluding HPV vaccination history (e.g., completed vaccination, or not due);
- P/C of C/A with clinical conditions that influence the CDC HPV vaccination recommendations (e.g., pregnancy);
- P/C of C/A with other factors that would influence CDC HPV recommendations; and
- P/C that does not speak Spanish or English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sea Mar Community Health Centers
Seattle, Washington, 98108
About this study
Official title: PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - BootCamp Translation
This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Once implemented into practice, this intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States.
The proposed study will determine the components of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington. This study is a boot camp translation to tailor messaging based on patient and provider input.
This study will refine intervention components and messages to increase HPV vaccination among rural children and adolescents (C/A). The research team will use a validated patient-engaged approach for parents/caregivers (P/Cs), Bootcamp Translation (BCT), with separate sessions conducted in English and Spanish.
Read the detailed description
The PREVENT BootCamp Translation (BCT) study will determine the components and messages of reminders to encourage parents to obtain an HPV vaccine for their age-eligible children and adolescents (C/A)
This study will design format and content of an intervention to promote adolescent HPV vaccine coverage that will consider unique information needs of diverse rural parents/caregivers. The study team will use BCT to develop locally relevant intervention materials (e.g., reminder phone scripts for automated calls, text messages, and patient portal messages for P/C). Targeted promotional materials for HPV vaccination are available in Spanish and could be translated into other languages, as needed. Newly designed messages and materials will seek to counter anti-vaccination sentiment by leveraging cancer prevention, vaccine effectiveness, and vaccine safety messages. BCT methods will provide the framework to tailor HPV vaccination messages for rural and Hispanic IMW P/C.
Bootcamp Translation (BCT), a method for engaging diverse stakeholders in a consensus-building process, has been used by this research team to actively develop and adapt study interventions. It uses an iterative, flexible schedule of face-to-face meetings combined with short, focused teleconferences in a process that addresses 2 questions: "What do we need to say in our message to the community (newly HPV vaccine-eligible adolescents and adolescents who have not completed the HPV vaccination series)?" and "How do we deliver that message to our community?" BCT emphasizes no wrong answers and no hierarchy of expertise. The process requires up to nine (9) hours of participant time over 3-6 months. Participants will be surveyed before and after the in-person session to assess learning outcomes and capture basic sociodemographic information.
With Sea Mar's project manager and/or Sea Mar's designated team member(s), this study will recruit P/C (i.e., participants) for BCT sessions by generating a list of potential P/C of patients across 4 clinics. This study will recruit 6 participants from each clinic (24 total): 12 whose preferred language is English and 12 whose preferred language is Spanish. About two Sea Mar staff members will participate in BCT.
Two parallel sessions will be conducted, one in English and one in Spanish, with approximately 12 study participants per session. The in-person or live Zoom presentation will consist of an expert presentation, and/or subject matter experts. They will share research on the safety and effectiveness of the HPV vaccine and social norms about vaccination. They will educate participants about the six different types of cancers that are prevented by the HPV vaccine among women and men in the United States. The study Investigators and/or subject matter experts to whom they delegate this responsibility will also present up-to-date evidence on effective messaging by clinicians (e.g., using presumptive statements, bundling HPV vaccine recommendations with recommendations for other vaccines) as well as novel formats for educational messages (e.g., digital videos, narratives).
Participants will be assigned to a Spanish-language or English-language text message group, as appropriate, to provide iterative feedback to the research team on HPV vaccination messages over a 3-month period. Clinical partners in rural communities emphasized the high prevalence of mobile phone use among the parents/caregivers in their communities for seeking and sharing health information, and nationally 95% of adults ages 18-49 have a smartphone, including the majority of Hispanics (85%) and rural residents (80%). Further, obtaining feedback from P/C about the suitability of HPV vaccine messages through text messaging will facilitate more specific and tailored feedback from participants, increase accessibility for individuals who may have limited access to meet in person, and provide an opportunity where individuals may feel more comfortable sharing their opinions and perceptions than they would during a face-to-face or synchronous online experience. Text messages will emphasize individual involvement and personal meaning to enhance retention and promote engagement. Text messages between study staff and BCT participants will occur through the text messaging Twillio, which the research team has previously used to pilot HPV vaccine reminders. Text messages will be designed to elicit feedback on the HPV vaccination messages (which are suitable for girls vs. boys, English vs. Spanish speaking parents/caregivers) that are developed during the Bootcamp sessions, on reminder scripts (i.e., automated call scripts, text messages, patient portal messages), and on key intervention components (e.g., reminder type, number, sequence). The text messages will occur two times per week. This process can be automated using the text-messaging tool Twillio. Each text will ask participants to provide their feedback via text response. Messages will be pilot tested.
Because the BCT process is interactive and iterative, recording and transcribing sessions is often impractical. Instead, field notes will be taken by the study team in English and/or Spanish during each session and shared during weekly meetings of the project team. Reminder materials tailored through BCT and proposed protocols for the intervention will be reviewed by members of the IMW HPV Vaccination Coalition and tested in a later study. Following BCT, the research team will finalize the trial protocol, including procedures for the Auto and the Auto-Plus arms of the intervention, and the study team will finalize methods for data coordination, management, and ongoing monitoring. Because the goal of this study is to craft materials and messages that are motivating for English- and Spanish-speakers, this study does not anticipate directly translating materials from English to Spanish. Instead, the research team will rely on BCT and native speakers to craft messages from the ground up; this approach was successful in prior research. This study aims for a broad scale-up, all English and Spanish materials will be reviewed by the Sea Mar marketing and communications office for appropriateness and equivalency.
- Being tested
- PREVENT - BCT
- Keywords
- Humans, Adolescent, Child, Male, Female, Caregivers, Parents, Hispanic or Latino, Rural Population, Health Personnel, United States, Vaccination, Papillomavirus Vaccines, Papillomavirus Vaccines / administration & dosage, Human Papillomavirus Viruses, Papillomavirus Infections, Papillomavirus Infections / prevention & control, Cancer / prevention & control, Incidence, Text Messaging
- Medical subject headings
- Papillomavirus Infections, Neoplasms, Vaccination Refusal, Behavior, Communication, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVENT - BCTBehavioural
Bootcamp Translation (BCT), a method for engaging diverse stakeholders in a consensus-building process, has been used by this research team to actively develop and adapt study interventions. It uses an iterative, flexible schedule of face-to-face meetings combined with short, focused teleconferences. BCT emphasizes no wrong answers and no hierarchy of expertise. The process requires up to nine (9) hours of participant time over 3-6 months. Participants will be surveyed before and after the in-person session to assess learning outcomes and capture basic sociodemographic information.
The BCT process will define the format (mode and frequency) and content of messages to promote vaccine series completion. Auto and Auto-Plus intervention arms may use some of the same components (automated calls, live calls, text messages, emails, and mailings).
| Study group | Role | What they receive |
|---|---|---|
| English Language Session and Messaging | Experimental | The in-person or live Zoom presentation in English will consist of an expert presentation about the research on the safety and effectiveness of the HPV vaccine and social norms about vaccination. In this session, participants will receive up-to-date evidence on effective messaging by clinicians (e.g., using presumptive statements, bundling HPV vaccine recommendations with recommendations for other vaccines) in addition to novel formats for educational messages (e.g., digital videos, narratives).
Participants in the English-language text message group will provide iterative feedback to the research team on HPV vaccination messages over a 3-month period. Receives: Behavioral: PREVENT - BCT |
| Spanish Language Session and Messaging | Experimental | The in-person or live Zoom presentation in Spanish will consist of an expert presentation about the research on the safety and effectiveness of the HPV vaccine and social norms about vaccination. In this session, participants will receive up-to-date evidence on effective messaging by clinicians (e.g., using presumptive statements, bundling HPV vaccine recommendations with recommendations for other vaccines) in addition to novel formats for educational messages (e.g., digital videos, narratives).
Participants in the Spanish-language text message group will provide iterative feedback to the research team on HPV vaccination messages over a 3-month period. Receives: Behavioral: PREVENT - BCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Parents Participating in BCT
This outcome measure will report the number of participants who participant in the BCT English sessions and number of participants who participant in the BCT Spanish sessions.
BCT is a community-based research approach to develop and evaluate messaging for health related issues. This study will employ BCT to determine the frequency and content of HPV messaging for future research.
Measured: 1 day after study enrollment
Secondary outcomes (2)
Likelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This Year
Participants will be surveyed before and after the in-person session to assess learning outcomes.
This outcome measure is a single-item self-report of the intention of parents to get the HPV vaccination for their children this year. A low score (Minimum: 1 Extremely Unlikely) is an unfavorable outcome and a high score (Maximum: 5 Extremely Likely) is a favorable outcome. This outcome measure will report the number of patients per response for the BCT English sessions and the BCT Spanish sessions.
Measured: After the in-person session (1 day)
Satisfaction With BCT Session
Participants will be surveyed before and after the in-person session to assess learning outcomes.
This outcome measure is a single-item self-report of the participants satisfaction with the BCT session. A low score (Minimum: 1 Not at all satisfied) is an unfavorable outcome and a high score (Maximum: 10 Extremely satisfied) is a favorable outcome. This outcome measure will report the mean score of participants for the BCT English sessions and the BCT Spanish sessions.
Measured: After the in-person session (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start2 Feb 2024
- Primary completion1 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (119)Papers the sponsor has linked to this study.
- Other trials for HPV VaccinationStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, University of Arizona, Sea Mar Community Health Centers, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Deanna Kepka, PhD, MPH, Principal investigator, Huntsman Cancer InstituteMedical Director, MD, Study chair, Sea Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290206
- Sponsor's protocol ID
- HCI161649-1
- Other IDs
- 1R01CA279973-01, DSS_10065815
- Acronym
- PREVENT
- Status last verified
- May 2025
- First submitted
- 4 Feb 2024
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A plan for sharing IDP that maintains participant anonymity has not yet been developed.
Publications
Saslow D, Andrews KS, Manassaram-Baptiste D, Loomer L, Lam KE, Fisher-Borne M, Smith RA, Fontham ET; American Cancer Society Guideline Development Group. Human papillomavirus vaccination guideline update: American Cancer Society guideline endorsement. CA Cancer J Clin. 2016 Sep;66(5):375-85. doi: 10.3322/caac.21355. Epub 2016 Jul 19.
PubMed 27434803Tabak RG, Duggan K, Smith C, Aisaka K, Moreland-Russell S, Brownson RC. Assessing Capacity for Sustainability of Effective Programs and Policies in Local Health Departments. J Public Health Manag Pract. 2016 Mar-Apr;22(2):129-37. doi: 10.1097/PHH.0000000000000254.
PubMed 25946700Brownson RC, Reis RS, Allen P, Duggan K, Fields R, Stamatakis KA, Erwin PC. Understanding administrative evidence-based practices: findings from a survey of local health department leaders. Am J Prev Med. 2014 Jan;46(1):49-57. doi: 10.1016/j.amepre.2013.08.013.
PubMed 24355671Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014 Jan 10;9:7. doi: 10.1186/1748-5908-9-7.
PubMed 24410955Wutich A, Bernard HR. Sharing qualitative data & analysis. With whom and how widely?: A response to 'Promises and pitfalls of data sharing in qualitative research'. Soc Sci Med. 2016 Nov;169:199-200. doi: 10.1016/j.socscimed.2016.09.041. Epub 2016 Sep 30. No abstract available.
PubMed 27720554Patton MQ. Qualitative research and evaluation methods. Thousand Oaks, CA: Sage Publications, Inc.; 2002
Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies: Guided by Information Power. Qual Health Res. 2016 Nov;26(13):1753-1760. doi: 10.1177/1049732315617444. Epub 2016 Jul 10.
PubMed 26613970Silverman D. Qualitative Research: A practical handbook. Thousand Oaks, CA: Sage Publications, Inc.; 2010.
Nonzee NJ, Baldwin SB, Cui Y, Singhal R. Disparities in parental human papillomavirus (HPV) vaccine awareness and uptake among adolescents. Vaccine. 2018 Feb 28;36(10):1243-1247. doi: 10.1016/j.vaccine.2017.08.046. Epub 2017 Sep 28.
PubMed 28967520Choi Y, Eworuke E, Segal R. What explains the different rates of human papillomavirus vaccination among adolescent males and females in the United States? Papillomavirus Res. 2016 Dec;2:46-51. doi: 10.1016/j.pvr.2016.02.001. Epub 2016 Mar 4.
PubMed 29074185Warner EL, Ding Q, Pappas L, Bodson J, Fowler B, Mooney R, Kirchhoff AC, Kepka D. Health Care Providers' Knowledge of HPV Vaccination, Barriers, and Strategies in a State With Low HPV Vaccine Receipt: Mixed-Methods Study. JMIR Cancer. 2017 Aug 11;3(2):e12. doi: 10.2196/cancer.7345.
PubMed 28801303Garcia AA, Zuniga JA, Lagon C. A Personal Touch: The Most Important Strategy for Recruiting Latino Research Participants. J Transcult Nurs. 2017 Jul;28(4):342-347. doi: 10.1177/1043659616644958. Epub 2016 Apr 25.
PubMed 27114390Kim SY, Chen S, Hou Y, Zeiders KH, Calzada EJ. Parental socialization profiles in Mexican-origin families: Considering cultural socialization and general parenting practices. Cultur Divers Ethnic Minor Psychol. 2019 Jul;25(3):439-450. doi: 10.1037/cdp0000234. Epub 2018 Nov 1.
PubMed 30382707Coronado GD, Petrik A, Spofford M, Talbot J, Do HH, Sanchez J, Kapka T, Taylor V. Perceptions of under and overutilization of cervical cancer screening services at Latino-serving community health centers. J Community Health. 2013 Oct;38(5):915-8. doi: 10.1007/s10900-013-9701-1.
PubMed 23728821Jackson ML, Henrikson NB, Grossman DC. Evaluating Washington State's immunization information system as a research tool. Acad Pediatr. 2014 Jan-Feb;14(1):71-6. doi: 10.1016/j.acap.2013.10.002.
PubMed 24369871
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - BootCamp Translation
- ClinicalTrials.gov ID
- NCT06290206
- Acronym / sponsor ID
- PREVENT / HCI161649-1
- Keywords
- Humans, Adolescent, Child, Male, Female, Caregivers, Parents, Hispanic or Latino
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Kaiser Permanente, University of Arizona, Sea Mar Community Health Centers, National Cancer Institute (NCI)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Posted 18 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Once implemented into practice, this intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States.
The proposed study will determine the components of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington. This study is a boot camp translation to tailor messaging based on patient and provider input.
This study will refine intervention components and messages to increase HPV vaccination among rural children and adolescents (C/A). The research team will use a validated patient-engaged approach for parents/caregivers (P/Cs), Bootcamp Translation (BCT), with separate sessions conducted in English and Spanish.
Detailed description
The PREVENT BootCamp Translation (BCT) study will determine the components and messages of reminders to encourage parents to obtain an HPV vaccine for their age-eligible children and adolescents (C/A)
This study will design format and content of an intervention to promote adolescent HPV vaccine coverage that will consider unique information needs of diverse rural parents/caregivers. The study team will use BCT to develop locally relevant intervention materials (e.g., reminder phone scripts for automated calls, text messages, and patient portal messages for P/C). Targeted promotional materials for HPV vaccination are available in Spanish and could be translated into other languages, as needed. Newly designed messages and materials will seek to counter anti-vaccination sentiment by leveraging cancer prevention, vaccine effectiveness, and vaccine safety messages. BCT methods will provide the framework to tailor HPV vaccination messages for rural and Hispanic IMW P/C.
Bootcamp Translation (BCT), a method for engaging diverse stakeholders in a consensus-building process, has been used by this research team to actively develop and adapt study interventions. It uses an iterative, flexible schedule of face-to-face meetings combined with short, focused teleconferences in a process that addresses 2 questions: "What do we need to say in our message to the community (newly HPV vaccine-eligible adolescents and adolescents who have not completed the HPV vaccination series)?" and "How do we deliver that message to our community?" BCT emphasizes no wrong answers and no hierarchy of expertise. The process requires up to nine (9) hours of participant time over 3-6 months. Participants will be surveyed before and after the in-person session to assess learning outcomes and capture basic sociodemographic information.
With Sea Mar's project manager and/or Sea Mar's designated team member(s), this study will recruit P/C (i.e., participants) for BCT sessions by generating a list of potential P/C of patients across 4 clinics. This study will recruit 6 participants from each clinic (24 total): 12 whose preferred language is English and 12 whose preferred language is Spanish. About two Sea Mar staff members will participate in BCT.
Two parallel sessions will be conducted, one in English and one in Spanish, with approximately 12 study participants per session. The in-person or live Zoom presentation will consist of an expert presentation, and/or subject matter experts. They will share research on the safety and effectiveness of the HPV vaccine and social norms about vaccination. They will educate participants about the six different types of cancers that are prevented by the HPV vaccine among women and men in the United States. The study Investigators and/or subject matter experts to whom they delegate this responsibility will also present up-to-date evidence on effective messaging by clinicians (e.g., using presumptive statements, bundling HPV vaccine recommendations with recommendations for other vaccines) as well as novel formats for educational messages (e.g., digital videos, narratives).
Participants will be assigned to a Spanish-language or English-language text message group, as appropriate, to provide iterative feedback to the research team on HPV vaccination messages over a 3-month period. Clinical partners in rural communities emphasized the high prevalence of mobile phone use among the parents/caregivers in their communities for seeking and sharing health information, and nationally 95% of adults ages 18-49 have a smartphone, including the majority of Hispanics (85%) and rural residents (80%). Further, obtaining feedback from P/C about the suitability of HPV vaccine messages through text messaging will facilitate more specific and tailored feedback from participants, increase accessibility for individuals who may have limited access to meet in person, and provide an opportunity where individuals may feel more comfortable sharing their opinions and perceptions than they would during a face-to-face or synchronous online experience. Text messages will emphasize individual involvement and personal meaning to enhance retention and promote engagement. Text messages between study staff and BCT participants will occur through the text messaging Twillio, which the research team has previously used to pilot HPV vaccine reminders. Text messages will be designed to elicit feedback on the HPV vaccination messages (which are suitable for girls vs. boys, English vs. Spanish speaking parents/caregivers) that are developed during the Bootcamp sessions, on reminder scripts (i.e., automated call scripts, text messages, patient portal messages), and on key intervention components (e.g., reminder type, number, sequence). The text messages will occur two times per week. This process can be automated using the text-messaging tool Twillio. Each text will ask participants to provide their feedback via text response. Messages will be pilot tested.
Because the BCT process is interactive and iterative, recording and transcribing sessions is often impractical. Instead, field notes will be taken by the study team in English and/or Spanish during each session and shared during weekly meetings of the project team. Reminder materials tailored through BCT and proposed protocols for the intervention will be reviewed by members of the IMW HPV Vaccination Coalition and tested in a later study. Following BCT, the research team will finalize the trial protocol, including procedures for the Auto and the Auto-Plus arms of the intervention, and the study team will finalize methods for data coordination, management, and ongoing monitoring. Because the goal of this study is to craft materials and messages that are motivating for English- and Spanish-speakers, this study does not anticipate directly translating materials from English to Spanish. Instead, the research team will rely on BCT and native speakers to craft messages from the ground up; this approach was successful in prior research. This study aims for a broad scale-up, all English and Spanish materials will be reviewed by the Sea Mar marketing and communications office for appropriateness and equivalency.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| English Language Session and Messaging | Experimental | Behavioral: PREVENT - BCTThe in-person or live Zoom presentation in English will consist of an expert presentation about the research on the safety and effectiveness of the HPV vaccine and social norms about vaccination. In this session, participants will receive up-to-date evidence on effective messaging by clinicians (e.g., using presumptive statements, bundling HPV vaccine recommendations with recommendations for other vaccines) in addition to novel formats for educational messages (e.g., digital videos, narratives). Participants in the English-language text message group will provide iterative feedback to the research team on HPV vaccination messages over a 3-month period. |
| Spanish Language Session and Messaging | Experimental | Behavioral: PREVENT - BCTThe in-person or live Zoom presentation in Spanish will consist of an expert presentation about the research on the safety and effectiveness of the HPV vaccine and social norms about vaccination. In this session, participants will receive up-to-date evidence on effective messaging by clinicians (e.g., using presumptive statements, bundling HPV vaccine recommendations with recommendations for other vaccines) in addition to novel formats for educational messages (e.g., digital videos, narratives). Participants in the Spanish-language text message group will provide iterative feedback to the research team on HPV vaccination messages over a 3-month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parents/Caregivers (P/C) of children/adolescents (C/A) ages 9-17 years of age (i.e., age-eligible for HPV vaccination);
- P/C with active clinic patients (i.e., have been seen in the clinic in the last 12 months); and
- P/C who speak either English or Spanish.
Key exclusion criteria (4 listed)
- P/C of C/A with previous excluding HPV vaccination history (e.g., completed vaccination, or not due);
- P/C of C/A with clinical conditions that influence the CDC HPV vaccination recommendations (e.g., pregnancy);
- P/C of C/A with other factors that would influence CDC HPV recommendations; and
- P/C that does not speak Spanish or English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREVENT - BCTBootcamp Translation (BCT), a method for engaging diverse stakeholders in a consensus-building process, has been used by this research team to actively develop and adapt study interventions. It uses an iterative, flexible schedule of face-to-face meetings combined with short, focused teleconferences. BCT emphasizes no wrong answers and no hierarchy of expertise. The process requires up to nine (9) hours of participant time over 3-6 months. Participants will be surveyed before and after the in-person session to assess learning outcomes and capture basic sociodemographic information. The BCT process will define the format (mode and frequency) and content of messages to promote vaccine series completion. Auto and Auto-Plus intervention arms may use some of the same components (automated calls, live calls, text messages, emails, and mailings). | Behavioural | English Language Session and Messaging, Spanish Language Session and Messaging |
Primary outcome
Number of Parents Participating in BCT
Time frame: 1 day after study enrollment
This outcome measure will report the number of participants who participant in the BCT English sessions and number of participants who participant in the BCT Spanish sessions. BCT is a community-based research approach to develop and evaluate messaging for health related issues. This study will employ BCT to determine the frequency and content of HPV messaging for future research.
2 secondary outcomes
Likelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This Year
Time frame: After the in-person session (1 day)
Satisfaction With BCT Session
Time frame: After the in-person session (1 day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27434803Saslow D, Andrews KS, Manassaram-Baptiste D, Loomer L, Lam KE, Fisher-Borne M, Smith RA, Fontham ET; American Cancer Society Guideline Development Group. Human papillomavirus vaccination guideline update: American Cancer Society guideline endorsement. CA Cancer J Clin. 2016 Sep;66(5):375-85. doi: 10.3322/caac.21355. Epub 2016 Jul 19.
- Background: PubMed 25946700Tabak RG, Duggan K, Smith C, Aisaka K, Moreland-Russell S, Brownson RC. Assessing Capacity for Sustainability of Effective Programs and Policies in Local Health Departments. J Public Health Manag Pract. 2016 Mar-Apr;22(2):129-37. doi: 10.1097/PHH.0000000000000254.
- Background: PubMed 24355671Brownson RC, Reis RS, Allen P, Duggan K, Fields R, Stamatakis KA, Erwin PC. Understanding administrative evidence-based practices: findings from a survey of local health department leaders. Am J Prev Med. 2014 Jan;46(1):49-57. doi: 10.1016/j.amepre.2013.08.013.
- Background: PubMed 24410955Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014 Jan 10;9:7. doi: 10.1186/1748-5908-9-7.
- Background: PubMed 27720554Wutich A, Bernard HR. Sharing qualitative data & analysis. With whom and how widely?: A response to 'Promises and pitfalls of data sharing in qualitative research'. Soc Sci Med. 2016 Nov;169:199-200. doi: 10.1016/j.socscimed.2016.09.041. Epub 2016 Sep 30. No abstract available.
- BackgroundPatton MQ. Qualitative research and evaluation methods. Thousand Oaks, CA: Sage Publications, Inc.; 2002
- Background: PubMed 26613970Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies: Guided by Information Power. Qual Health Res. 2016 Nov;26(13):1753-1760. doi: 10.1177/1049732315617444. Epub 2016 Jul 10.
- BackgroundSilverman D. Qualitative Research: A practical handbook. Thousand Oaks, CA: Sage Publications, Inc.; 2010.
- Background: PubMed 28967520Nonzee NJ, Baldwin SB, Cui Y, Singhal R. Disparities in parental human papillomavirus (HPV) vaccine awareness and uptake among adolescents. Vaccine. 2018 Feb 28;36(10):1243-1247. doi: 10.1016/j.vaccine.2017.08.046. Epub 2017 Sep 28.
- Background: PubMed 29074185Choi Y, Eworuke E, Segal R. What explains the different rates of human papillomavirus vaccination among adolescent males and females in the United States? Papillomavirus Res. 2016 Dec;2:46-51. doi: 10.1016/j.pvr.2016.02.001. Epub 2016 Mar 4.
- Background: PubMed 28801303Warner EL, Ding Q, Pappas L, Bodson J, Fowler B, Mooney R, Kirchhoff AC, Kepka D. Health Care Providers' Knowledge of HPV Vaccination, Barriers, and Strategies in a State With Low HPV Vaccine Receipt: Mixed-Methods Study. JMIR Cancer. 2017 Aug 11;3(2):e12. doi: 10.2196/cancer.7345.
- Background: PubMed 27114390Garcia AA, Zuniga JA, Lagon C. A Personal Touch: The Most Important Strategy for Recruiting Latino Research Participants. J Transcult Nurs. 2017 Jul;28(4):342-347. doi: 10.1177/1043659616644958. Epub 2016 Apr 25.
- PREVENT HPV Cancers study website hosted by Kaiser PermanenteLink provided by the sponsor.
- PREVENT HPV Cancers study website hosted by Kaiser PermanenteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. A plan for sharing IDP that maintains participant anonymity has not yet been developed.
Related trials for HPV Vaccination
Active, not recruiting
Implementation of Evidence-Based Strategy (PC TEACH) for the Optimization of HPV Vaccination in Rural Primary Care
Human Papillomavirus Infection
Recruiting
Interpersonal Communication Training and Vaccination Workflow Training Alone and in Combination to Improve Communication and Recommendations About HPV Vaccination in Pharmacies, IMPACT HPV Trial
Human Papillomavirus-Related Carcinoma
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
Recruiting
Culturally Targeted Health Communication and Receptivity to the Human Papillomavirus Vaccine Among Parents in Flint, MI
HPV Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna Kepka, PhD, MPH principal investigator
Huntsman Cancer Institute
Medical Director, MD study chair
Sea Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREVENT - BCT in people with HPV Vaccination and Vaccine; Uptake, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Parents Participating in BCT (time frame: 1 day after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06290206, which also lists 119 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.