HPV Vaccination, Series Completion, Uptake Vaccination
Conditions
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, 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, 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.
Interventions
BEHAVIORALPREVENT
The proposed study will assess the effectiveness of clinic-based outreach to increase vaccination rates for HPV at community clinics in rural counties.
Sponsors
University of Utah
Kaiser Permanente
University of Arizona
Sea Mar Community Health Centers
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Clinic analysts will create a real-time list of patients due for an initial HPV vaccine dose. P/C of remaining C/A patients will be individually randomized to either Auto or Auto-Plus intervention or usual care (UC) in a 1:1:1 ratio. The PREVENT study will only target one child/adolescent per parent/caregiver (siblings will be excluded from intervention assessments). The investigators will use automated codes to manage interventions so that eligible patients get initial HPV vaccines on time and P/C are prompted to repeat vaccination, as recommended. The investigators will select a cohort of approximately 1,038 P/C patients from the 4 clinics, randomized to intervention arms (UC, Auto, and Auto-Plus). Intervention activities largely mimic clinic processes, and clinicians and participants will be unaware of which intervention study arm the P/C has been assigned.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RCT Arm Effectiveness: Next HPV Vaccination Step Completion | 6 Months | 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. |
| Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion) | 13 Months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDeanna Kepka, PhD, MPH
University of Utah
Outcome results
None listed