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PREVENT HPV-Related Cancers - BootCamp Translation

PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - BootCamp Translation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06290206
Acronym
PREVENT
Enrollment
18
Registered
2024-03-04
Start date
2024-02-02
Completion date
2024-03-31
Last updated
2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV Vaccination, Vaccination; Series Completion, Vaccine; Uptake

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, Reminder Systems / instrumentation, Social Norms, Vaccination Refusal, Health Knowledge, Attitudes, Practice, Health Promotion / methods, Motivation, Communication, Patient Acceptance of Health Care, Parents / education, Religion, Religiosity, Stakeholder Participation, Participatory Approach, Qualitative Research, Quantitative Research, Randomized Control Trial, Surveys and Questionnaires

Brief 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. 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.

Interventions

BEHAVIORALPREVENT - BCT

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).

Sponsors

Kaiser Permanente
CollaboratorOTHER
University of Arizona
CollaboratorOTHER
Sea Mar Community Health Centers
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
University of Utah
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Parents/Caregivers (P/C) of children/adolescents (C/A) ages 9-17 years of age (i.e., age-eligible for HPV vaccination); 2. P/C with active clinic patients (i.e., have been seen in the clinic in the last 12 months); and 3. P/C who speak either English or Spanish.

Exclusion criteria

1. P/C of C/A with previous excluding HPV vaccination history (e.g., completed vaccination, or not due); 2. P/C of C/A with clinical conditions that influence the CDC HPV vaccination recommendations (e.g., pregnancy); 3. P/C of C/A with other factors that would influence CDC HPV recommendations; and 4. P/C that does not speak Spanish or English.

Design outcomes

Primary

MeasureTime frameDescription
Number of Parents Participating in BCT1 day after study enrollmentThis 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.

Secondary

MeasureTime frameDescription
Likelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearAfter the in-person session (1 day)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.
Satisfaction With BCT SessionAfter the in-person session (1 day)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.

Countries

United States

Participant flow

Participants by arm

ArmCount
English Language Session and Messaging
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.
8
Spanish Language Session and Messaging
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.
10
Total18

Baseline characteristics

CharacteristicEnglish Language Session and MessagingSpanish Language Session and MessagingTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
8 Participants10 Participants18 Participants
Age, Continuous43.13 years
STANDARD_DEVIATION 7.43
40.50 years
STANDARD_DEVIATION 7.06
41.67 years
STANDARD_DEVIATION 7.14
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants9 Participants12 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants1 Participants6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Likelihood of Parents to Get the HPV Vaccination for Their Child(ren) This Year
Extremely likely
3 Participants0 Participants3 Participants
Likelihood of Parents to Get the HPV Vaccination for Their Child(ren) This Year
Extremely unlikely
0 Participants0 Participants0 Participants
Likelihood of Parents to Get the HPV Vaccination for Their Child(ren) This Year
Likely
1 Participants3 Participants4 Participants
Likelihood of Parents to Get the HPV Vaccination for Their Child(ren) This Year
My child(ren) has already received the HPV vaccine
1 Participants1 Participants2 Participants
Likelihood of Parents to Get the HPV Vaccination for Their Child(ren) This Year
Neutral
2 Participants1 Participants3 Participants
Likelihood of Parents to Get the HPV Vaccination for Their Child(ren) This Year
Prefer not to answer
0 Participants4 Participants4 Participants
Likelihood of Parents to Get the HPV Vaccination for Their Child(ren) This Year
Unlikely
1 Participants1 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants0 Participants2 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants8 Participants8 Participants
Race (NIH/OMB)
White
4 Participants1 Participants5 Participants
Region of Enrollment
United States
8 participants10 participants18 participants
Sex: Female, Male
Female
8 Participants10 Participants18 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

Time frame: 1 day after study enrollment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
English Language Session and MessagingNumber of Parents Participating in BCT8 Participants
Spanish Language Session and MessagingNumber of Parents Participating in BCT10 Participants
Secondary

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.

Time frame: After the in-person session (1 day)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
English Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearNeutral0 Participants
English Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearExtremely unlikely0 Participants
English Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearLikely1 Participants
English Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearMy child(ren) has already received the HPV vaccine1 Participants
English Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearUnlikely0 Participants
English Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearPrefer not to answer0 Participants
English Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearExtremely likely6 Participants
Spanish Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearPrefer not to answer0 Participants
Spanish Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearExtremely likely1 Participants
Spanish Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearLikely5 Participants
Spanish Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearNeutral1 Participants
Spanish Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearUnlikely0 Participants
Spanish Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearExtremely unlikely2 Participants
Spanish Language Session and MessagingLikelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This YearMy child(ren) has already received the HPV vaccine1 Participants
Secondary

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.

Time frame: After the in-person session (1 day)

Population: One participant in the English Language Session did not answer this item.

ArmMeasureValue (MEAN)Dispersion
English Language Session and MessagingSatisfaction With BCT Session9.71 units on a scaleStandard Deviation 0.49
Spanish Language Session and MessagingSatisfaction With BCT Session9.10 units on a scaleStandard Deviation 1.29

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026