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HPV VaccinationNCT06738355

PREVENT Pilot HPV - Related Cancers Trial

A study testing PREVENT in people with HPV Vaccination and Uptake Vaccination, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
PREVENT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
335 participants
Where
1 siteUnited States
Study dates
17 May 2025to 12 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

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

Other trials in United States

About this study

Official title: PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - Pilot Trial

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 feasibility of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington.

Read the detailed description

This is a randomized, pilot study 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 PILOT study will administer a three-arm, patient-randomized controlled trial that will assess the feasibility of clinic-based outreach to increase vaccination rates. The study arms 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 PILOT study 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 primary objective of this pilot study is the feasibility of the trial, which will be assessed by the number of patients randomized to the study intervention. Other secondary outcome measures include the correctness of the randomization, successful receipt of a text message intervention, the proportion of participants who responded to the text intervention, and the proportion of participants who were successfully contacted.

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.

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, 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.

  • PREVENTBehavioural

    The proposed study will assess the feasibility of an RCT for clinic-based outreach to increase vaccination rates for HPV at community clinics in rural counties. The study is a pilot trial that will assign adult parent/caregiver participants to a timeline for receiving the vaccination messaging intervention. Auto and Auto-Plus intervention arms may use some of the same components (automated calls, live calls, text messages, emails, and mailings).

Study groups in NCT06738355
Study groupRoleWhat they receive
Automated Intervention (Auto)ExperimentalAuto 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)ExperimentalAuto-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. Activities selected from a list of possible options from the National HPV Vaccination Roundtable and our ranking of the effectiveness of language- and culturally-tailored intervention materials.
Receives: Behavioral: PREVENT
Usual Care (UC)No interventionThe 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.

  1. Number of Participants Correctly Randomized

    To assess the feasibility of the study intervention. This outcome measure will report the count of participants who were correctly randomized according to the study protocol.

    Measured: up to 1 day after randomization

Secondary outcomes (2)
  1. Number of Participants Who Responded to the Text Intervention

    To assess the feasibility of the study intervention. This outcome measure will report the number of participants who responded to the text-based intervention, as defined by the study protocol.

    Measured: up to 1 month after randomization

  2. Proportion of Participants Successfully Contacted

    To assess the feasibility of the study intervention. This outcome measure will report the proportion of participants who were successfully contacted out of the total number of attempted contacts.

    Measured: up to 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2024
  2. Study start17 May 2025
  3. Primary completion12 Aug 2025
  4. Study completion12 Aug 2025

Resources

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
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 pilot trial to assess the feasibility of a RCT comparing 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 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
335 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06738355
Sponsor's protocol ID
161649-PILOT
Other IDs
1R01CA279973-01, DSS_10065815
Status last verified
Jun 2026
First submitted
12 Dec 2024
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 27434803
  • Tabak 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 25946700
  • Brownson 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 24355671
  • Shea 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 24410955
  • Wutich 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 27720554
  • Patton 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 26613970
  • Silverman 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 28967520
  • Choi 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 29074185
  • Warner 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 28801303
  • Garcia 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 27114390
  • Kim 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 30382707
  • Coronado 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 23728821
  • Jackson 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

Questions about this trial

What is this clinical trial studying?

A 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: finished, 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Participants Correctly Randomized (time frame: up to 1 day after randomization). 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 NCT06738355, which also lists 118 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.

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