Clinical trial · Interventional
PREVENT HPV -Related Cancers Trial
PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - Randomized Controlled Trial (RCT)
NCT07217145CI-TRIAL-00113830active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Vaccination | — | UNRESOLVED | — |
| Series Completion | — | UNRESOLVED | — |
| Uptake Vaccination | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PREVENT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Automated Intervention (Auto)
- description
- 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.
- interventionNames
- Behavioral: PREVENT
- type
- EXPERIMENTAL
- label
- Automated Intervention Plus (Auto-Plus)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (115)
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- BACKGROUNDTabak 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. PMID 25946700
- BACKGROUNDBrownson 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. PMID 24355671
- BACKGROUNDShea 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. PMID 24410955
- BACKGROUNDWutich 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. PMID 27720554
- BACKGROUNDPatton MQ. Qualitative research and evaluation methods. Thousand Oaks, CA: Sage Publications, Inc.; 2002
- BACKGROUNDMalterud 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. PMID 26613970