HPV VaccinationPhase 3NCT07217145
PREVENT HPV -Related Cancers Trial
A Phase 3 study testing PREVENT in people with HPV Vaccination and Uptake Vaccination, 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, Uptake Vaccination, Series Completion
- What is being tested?
- PREVENT
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,455 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2025to 1 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 - Randomized Controlled Trial (RCT)
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, our intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States.
The proposed study will assess the effectiveness of a clinic-based behavioral outreach intervention to increase HPV vaccination rates at community clinics in rural counties. The intervention consists of communication and engagement strategies delivered within routine care settings and is designed to pose no more than minimal risk to participants.
Read the detailed description
The clinical trial in the PREVENT study is a patient-randomized control trial (RCT) of two human papillomavirus (HPV) vaccination patient reminder intervention arms that will take place in rural clinics operated by Sea Mar Community Health Centers.
The PREVENT RCT will administer a three-arm patient randomized controlled trial that will assess completion of the next needed dose of HPV vaccination and on-time completion of the multi-dose HPV vaccine series. The study arms for each trial will consist of automated reminders, automated plus live reminders, and usual care. Parents/caregivers of children and adolescents selected for the trial will be chosen using established study criteria applied to the electronic health records linked to state immunization registries. As a minimal-risk study, for the intervention only, the investigators will apply for a waiver of informed consent. The RCT will be delivered as part of standard care, and patients will be unaware they are in the trial. Delivered vaccination messages will include opt-out choices.
Parents/caregivers (P/C) of children and adolescents (C/A) will be sent any number of reminders to encourage parents to obtain an HPV vaccine for their age-eligible C/A. Reminders may include text messages, automated phone calls, mailed letters, live calls, or patient navigation. Reminders will be delivered by a vendor (automated reminders) or clinic staff (live reminders). Reminders will be delivered in English and Spanish, and interpreter services may be used for live reminders to the small proportion of patients who speak languages other than English or Spanish. The investigators will use electronic health record data to document HPV vaccination events as our primary outcome of interest. The investigators will also assess the reach for each intervention component, defined as the proportion of patients who receive a given intervention component. The investigators will also assess missed opportunities, defined as the proportion of patients who receive other recommended vaccines (e.g., Tdap or meningococcal) but not HPV, for each study arm, during the study. Aim 3 will gather patient- and provider-level qualitative data to assess reaction to the program, factors associated with implementation and long-term sustainability, and opportunities for additional clinic-based interventions. During active study recruitment, the investigators will convene a meeting of our data safety monitor board every six months. The investigators will disseminate study findings and research products in accordance with our dissemination plan. The study findings will serve as a basis for a larger multi-level trial of HPV vaccination in rural communities.
- Conditions
- HPV Vaccination, Uptake Vaccination, Series Completion
- Being tested
- PREVENT
- 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, 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.
PREVENTBehavioural
The proposed study will assess the effectiveness of clinic-based outreach to increase vaccination rates for HPV at community clinics in rural counties.
| Study group | Role | What they receive |
|---|---|---|
| Automated Intervention (Auto) | Experimental | Auto intervention participants will be eligible for outreach delivered using automated phone calls, text, or email messages with the mode, frequency, timing of reminders, and message content. Automated outreach may also include innovative communication strategies, such as text-linked videos, P/C, or patient narratives. Auto outreach to P/C will invite P/Cs to attend free HPV vaccination visits and emphasize family-friendly hours. Receives: Behavioral: PREVENT |
| Automated Intervention Plus (Auto-Plus) | Experimental | Auto-Plus intervention participants will be eligible for automated reminders, plus additional P/C prompts for patients who do not undergo vaccination within three weeks. These prompts may be delivered via live phone call outreach or patient navigation. Working with clinic leadership and previous research, activities will be selected from a list of possible options from the National HPV Vaccination Roundtable (previously chaired by Dr. Brewer) and our ranking of the effectiveness of language- and culturally- tailored intervention materials. Receives: Behavioral: PREVENT |
| Usual Care (UC) | No intervention | The UC group will not receive tailored reminders but will only receive opportunistic vaccine reminders that are delivered during clinic visits or MyChart EHR-based patient portal reminders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion)
The investigators will track intervention reach using the Proctor Implementation and RE-AIM frameworks. The primary outcome is whether patients initiate the next step in the HPV vaccination series at 6 months, which will be captured via the EHR and the state vaccine registry. Completing the next step in the vaccine series outcome will be compared via logistic generalized estimating equations (GEE) models, with bias-reduced robust sandwich variance estimators clustered by the clinic. These logistic GEEs will be adjusted for P/C and patient features that may influence the HPV vaccination series next step and completion, including age, sex, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment. Pre-defined subgroup analyses will be performed by P/C and/or patient sex, age group, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment, and each of these characteristics will be assessed for effect moderation.
Measured: 6 Months
Secondary outcomes (3)
RCT Arm Effectiveness: Next HPV Vaccination Step Completion
The investigators will track intervention effectiveness using the Proctor Implementation and RE-AIM frameworks. The primary comparisons are the rates of completing the next step in the HPV vaccination series at 6 months (N C/A complete next HPV vaccine dose/ N anticipated) between the Auto, Auto-Plus, and UC arms. Little missing data is expected for these outcomes. Completing the next step in the vaccine series outcome will be compared via logistic generalized estimating equations (GEE) models, with bias-reduced robust sandwich variance estimators clustered by the clinic. The GEEs will be adjusted for P/C and patient features that may influence the HPV vaccination series next step and completion, including age, sex, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment. Pairwise differences between arms will be assessed with a Bonferroni correction to achieve type I error control at 0.05, with p<0.017=0.05/3 needed for statistical significance.
Measured: 6 Months
Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion)
Using the Proctor Implementation and RE-AIM frameworks, the investigators will track intervention reach. The primary outcome is whether patients initiate the next step in the HPV vaccination series at 13 months, which will be captured via the EHR and the state vaccine registry. Completing the next step in the vaccine series outcome will be compared via logistic generalized estimating equations (GEE) models, with bias-reduced robust sandwich variance estimators clustered by the clinic. These logistic GEEs will be adjusted for P/C and patient features that may influence the HPV vaccination series next step and completion, including age, sex, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment. Pre-defined subgroup analyses will be performed by P/C and/or patient sex, age group, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment, and each of these characteristics will be assessed for effect moderation.
Measured: 13 Months
RCT Arm Effectiveness: Next HPV Vaccination Step Completion
The investigators will track intervention effectiveness using the Proctor Implementation and RE-AIM frameworks. The primary comparisons are the rates of completing the next step in the HPV vaccination series at 13 months (N C/A complete next HPV vaccine dose/ N anticipated) between the Auto, Auto-Plus, and UC arms. The investigators anticipate little missing data for these outcomes. Completing the next step in the vaccine series outcome will be compared via logistic generalized estimating equations (GEE) models. These GEEs will be adjusted for P/C and patient features that may influence the HPV vaccination series next step and completion, including age, sex, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment. Pairwise differences between arms will be assessed with a Bonferroni correction to achieve type I error control at 0.05, with p<0.017=0.05/3 needed for statistical significance.
Measured: 13 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start6 Oct 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (115)Papers the sponsor has linked to this study.
- Other trials for HPV VaccinationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The investigators will use intervention mapping (IM) to plan each intervention step. The investigators will apply IM to develop and test HPV vaccination reminders for parents/caregivers (P/C). Intervention: The investigators propose a 3-arm RCT to compare rates of completing the next step in the HPV vaccination series at six months and completing the HPV vaccination series at 13 months between Auto, Auto-Plus, and UC arms. P/C of children/adolescents (C/A) who have not initiated and/or not completed the series will be randomized 1:1:1 to study arms. Participants will be assessed for eligibility and enrolled, with a total participant time in the study of 13 months, for a total of 25 months of enrollment, participation, and follow-up.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,455 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, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217145
- Sponsor's protocol ID
- 161649
- Other IDs
- 1R01CA279973-01, DSS_10065815
- Status last verified
- Jun 2026
- First submitted
- 25 Sep 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- 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 5 Jun 2026. 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 - Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT07217145
- Acronym / sponsor ID
- 161649
- Conditions
- HPV Vaccination, Uptake Vaccination, Series Completion
- Keywords
- Humans, Adolescent, Child, Male, Female, Caregivers, Parents, Hispanic or Latino
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,455 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
- 6 Oct 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
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, our intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States.
The proposed study will assess the effectiveness of a clinic-based behavioral outreach intervention to increase HPV vaccination rates at community clinics in rural counties. The intervention consists of communication and engagement strategies delivered within routine care settings and is designed to pose no more than minimal risk to participants.
Detailed description
The clinical trial in the PREVENT study is a patient-randomized control trial (RCT) of two human papillomavirus (HPV) vaccination patient reminder intervention arms that will take place in rural clinics operated by Sea Mar Community Health Centers.
The PREVENT RCT will administer a three-arm patient randomized controlled trial that will assess completion of the next needed dose of HPV vaccination and on-time completion of the multi-dose HPV vaccine series. The study arms for each trial will consist of automated reminders, automated plus live reminders, and usual care. Parents/caregivers of children and adolescents selected for the trial will be chosen using established study criteria applied to the electronic health records linked to state immunization registries. As a minimal-risk study, for the intervention only, the investigators will apply for a waiver of informed consent. The RCT will be delivered as part of standard care, and patients will be unaware they are in the trial. Delivered vaccination messages will include opt-out choices.
Parents/caregivers (P/C) of children and adolescents (C/A) will be sent any number of reminders to encourage parents to obtain an HPV vaccine for their age-eligible C/A. Reminders may include text messages, automated phone calls, mailed letters, live calls, or patient navigation. Reminders will be delivered by a vendor (automated reminders) or clinic staff (live reminders). Reminders will be delivered in English and Spanish, and interpreter services may be used for live reminders to the small proportion of patients who speak languages other than English or Spanish. The investigators will use electronic health record data to document HPV vaccination events as our primary outcome of interest. The investigators will also assess the reach for each intervention component, defined as the proportion of patients who receive a given intervention component. The investigators will also assess missed opportunities, defined as the proportion of patients who receive other recommended vaccines (e.g., Tdap or meningococcal) but not HPV, for each study arm, during the study. Aim 3 will gather patient- and provider-level qualitative data to assess reaction to the program, factors associated with implementation and long-term sustainability, and opportunities for additional clinic-based interventions. During active study recruitment, the investigators will convene a meeting of our data safety monitor board every six months. The investigators will disseminate study findings and research products in accordance with our dissemination plan. The study findings will serve as a basis for a larger multi-level trial of HPV vaccination in rural communities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- The investigators will use intervention mapping (IM) to plan each intervention step. The investigators will apply IM to develop and test HPV vaccination reminders for parents/caregivers (P/C). Intervention: The investigators propose a 3-arm RCT to compare rates of completing the next step in the HPV vaccination series at six months and completing the HPV vaccination series at 13 months between Auto, Auto-Plus, and UC arms. P/C of children/adolescents (C/A) who have not initiated and/or not completed the series will be randomized 1:1:1 to study arms. Participants will be assessed for eligibility and enrolled, with a total participant time in the study of 13 months, for a total of 25 months of enrollment, participation, and follow-up.
| Arm | Type | Receives |
|---|---|---|
| Automated Intervention (Auto) | Experimental | Behavioral: PREVENTAuto intervention participants will be eligible for outreach delivered using automated phone calls, text, or email messages with the mode, frequency, timing of reminders, and message content. Automated outreach may also include innovative communication strategies, such as text-linked videos, P/C, or patient narratives. Auto outreach to P/C will invite P/Cs to attend free HPV vaccination visits and emphasize family-friendly hours. |
| Automated Intervention Plus (Auto-Plus) | Experimental | Behavioral: PREVENTAuto-Plus intervention participants will be eligible for automated reminders, plus additional P/C prompts for patients who do not undergo vaccination within three weeks. These prompts may be delivered via live phone call outreach or patient navigation. Working with clinic leadership and previous research, activities will be selected from a list of possible options from the National HPV Vaccination Roundtable (previously chaired by Dr. Brewer) and our ranking of the effectiveness of language- and culturally- tailored intervention materials. |
| Usual Care (UC) | No intervention | –The UC group will not receive tailored reminders but will only receive opportunistic vaccine reminders that are delivered during clinic visits or MyChart EHR-based patient portal reminders. |
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 |
|---|---|---|
| PREVENTThe proposed study will assess the effectiveness of clinic-based outreach to increase vaccination rates for HPV at community clinics in rural counties. | Behavioural | Automated Intervention (Auto), Automated Intervention Plus (Auto-Plus) |
Primary outcome
Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion)
Time frame: 6 Months
The investigators will track intervention reach using the Proctor Implementation and RE-AIM frameworks. The primary outcome is whether patients initiate the next step in the HPV vaccination series at 6 months, which will be captured via the EHR and the state vaccine registry. Completing the next step in the vaccine series outcome will be compared via logistic generalized estimating equations (GEE) models, with bias-reduced robust sandwich variance estimators clustered by the clinic. These logistic GEEs will be adjusted for P/C and patient features that may influence the HPV vaccination series next step and completion, including age, sex, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment. Pre-defined subgroup analyses will be performed by P/C and/or patient sex, age group, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment, and each of these characteristics will be assessed for effect moderation.
3 secondary outcomes
RCT Arm Effectiveness: Next HPV Vaccination Step Completion
Time frame: 6 Months
Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion)
Time frame: 13 Months
RCT Arm Effectiveness: Next HPV Vaccination Step Completion
Time frame: 13 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- 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.
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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
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PREVENT in people with HPV Vaccination and Uptake Vaccination, 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion) (time frame: 6 Months). 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 NCT07217145, which also lists 115 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 5 Jun 2026.