Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Vaccines

Providers in participating in the PCOM-standard intervention will be trained on optimizing an in-person provider communication technique about HPV vaccination by training primary care providers in a 2-step verbal communication process: 1) to start the HPV vaccine discussion using a "presumptive" format, and 2) to use motivational interviewing (MI) techniques to address parental vaccine hesitancy.

Providers participating in the PCOM2-virtual arm will receive training on this communication method through an adapted virtual model of PCOM-standard.

PCOM2-Virtual intervention will result in a "shelf ready" intervention and associated "User Manual" that can be easily incorporated into practices broadly to improve the practice's adolescent HPV vaccination rates. PCOM-Virtual arm will then be compared to that of the original PCOM-standard intervention in its efficacy for increasing HPV vaccination among adolescents.

The PCOM-standard intervention is based off of a provider communication training that utilizes presumptive technique when initiating the vaccine discussion followed by motivational interviewing if a parent continues to show hesitation. While this provider communication technique previously showed success in increasing HPV vaccination uptake, it is neither easy to disseminate nor sustainable due to it's nature of direct, intensive in-person training. Therefore, the intervention is to compare the standard-PCOM intervention to a new, PCOM2 intervention, that will be adapted virtually.

Physician Communication 2 Virtual (PCOM2-virtual)

The PCOM-standard intervention is based off of a provider communication training that utilizes presumptive technique when initiating the vaccine discussion followed by motivational interviewing if a parent continues to show hesitation. PCOM-standard will be conducted in-person with providers.

Physician Communication Standard (PCOM-standard)

Christine Spina, MSPH

Julian Dedeaux

Sean O'Leary, MD, MPH

Gretchen Homan, MD, FAAP

Julian Dedeaux, PhD

Poor quality of primary care providers' vaccine recommendations lead to low adolescent human papillomavirus vaccination rates and hundreds of thousands of adolescents unnecessarily at risk for HPV-associated cancers and diseases. Though a previous provider communication intervention, called PCOM, was found to be effective for increasing adolescent HPV vaccination in primary care, its dissemination is limited by the need for significant research team involvement to teach providers how to use the intervention's components. To address this, investigators propose to develop and test a virtual version of PCOM, use mixed methods to assess contextual factors affecting its use compared to the original PCOM intervention, and develop an optimized version of PCOM for broad dissemination to increase adolescent HPV vaccination nationally.

The overarching goal is to develop a "Virtual" version of the PCOM intervention ("PCOM-Virtual") and compare its efficacy for increasing HPV vaccination among adolescents to that of the original PCOM intervention ("PCOM-Standard"). Using Dissemination \& Implementation (D\&I) science principles to develop and evaluate the PCOM-Virtual intervention for non-inferiority, investigators anticipate that to have a "shelf ready" intervention and associated "User Manual" that can be easily incorporated into practices broadly to improve the practice's adolescent HPV vaccination rates.

Specific Aims are to: (1) develop the "PCOM-Virtual" intervention using principles of D\&I Science; (2) compare the efficacy of "PCOM-Virtual" versus "PCOM-Standard" in improving adolescent HPV vaccine utilization; and (3) examine whether practice, patient and provider characteristics are associated with variability in the efficacy of PCOM-Virtual and PCOM-Standard.

PCOM2 - The Physician Communication Intervention, Version 2.0

PCOM2 - The Physician Communication Intervention, Version 2.0" for "Linking the Provider Recommendation to Adolescent HPV Vaccine Uptake"

The primary outcome to be assessed in the trial is HPV vaccine series initiation among 11-12-year-olds as 11-12 year-olds are the preferred target population for HPV vaccination and the PCOM intervention had its strongest effect on series initiation rather than completion.

Secondary outcome to assess HPV series completion among 11-12-year-olds

Secondary outcome to assess "catch-up" HPV vaccine series initiation among 13-17-year-olds

Secondary outcome to assess "catch-up" HPV vaccine series completion among 13-17 year-olds.

University of Kansas Medical Center

Children's Mercy Hospital Kansas City

University of Colorado, Denver

Neoplasms

Papilloma

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Participants in this group will be randomly assigned to use the Women's Stories intervention.

Participants in this group will be randomly assigned participate in their usual programming.

Women's Stories is a brief, HPV vaccination promotion intervention. It presents vaccine information and videos of HPV vaccine decision making. It also includes follow up vaccine reminder text messages.

Women's Stories

Michael Hecht, Ph.D.

The overall goal of this SBIR Phase II project is to reduce cancer rates by marketing a brief, easily implemented technology-based intervention that increases human papillomavirus (HPV) vaccination among Planned Parenthood and other clients. The intervention's innovative technology allows for the investigators' narrative videos to be presented along will reminder texts. It will be evaluated for use in waiting rooms and promises to overcome vaccination barriers among high risk but underserved low SES and minority populations.

The purpose of this Phase II research project is to evaluate and market an innovative health message intervention to increase uptake of the human papillomavirus (HPV) vaccine and reduce women's cervical cancer risk through partnership with Planned Parenthood. The overall aim is to reach a broad population through Planned Parenthood, the nation's leading sexual and reproductive health care center, especially among low socioeconomic status (SES) and historically underserved populations. Despite an overall increase in vaccination and reduction in HPV-related infections in younger populations targeted by previous health promotion efforts, young adult women who are recommended for vaccination demonstrate much lower vaccination rates and higher rates of infection. In a recent Phase I grant, the investigators developed and demonstrated the usability and feasibility of an innovative, culturally-grounded, technology-based narrative intervention that delivers decision narratives in the form of videos via a health kiosk, an underutilized communication strategy for reaching less involved audiences. This brief, low-cost, easily implementable intervention doubled the uptake of the vaccine in a separate pilot study. The proposed Phase II project will: (1) Complete development of the intervention, (2) Evaluate its effectiveness through a randomized clinical trial, and (3) Prepare the product for the market. To accomplish these aims, the investigators will develop the intervention for implementation in waiting rooms as part of check-in procedures. Development includes programming and installing tablets to accomplish these tasks (Aim 1). The investigators will then conduct the evaluation study in four Planned Parenthood clinics in southeastern Pennsylvania (Aim 2). Eligible women will be consented, complete a pretest, and then randomized to view the brief intervention or attention control messages via the tablet. After viewing the messages, the participants will complete a short posttest. Treatment participants will receive follow up texts/emails as reminders to vaccinate, and all participants will receive texts/emails with links that allow completion of posttest surveys at 3- and 9 months. Finally, the investigators will prepare the intervention for the market that includes not only Planned Parenthood but other clinics that are currently served by the project partners as well as the broader market for HPV vaccination (Aim 3). In summary, the proposed communication strategy has wide reaching implications not only for reducing cancer risk, but more broadly for designing brief and easily implemented prevention messages across many domains of public health. The research will also close the health disparities gap in minority, under-served young adult women's access to preventive health care.

Participants randomly assigned to one of two arms (intervention, no intervention). Intervention participants receive Women's Stories. No intervention participants receive treatment as usual. All participants are administered a pretest and two post tests, and clinical records are examined for vaccination outcomes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PCOM2 - The Physician Communication Intervention, Version 2.0	NCT05336240	HPV Infection Preventive Heal...	Physician Commu... Physician Commu...	9 Years - 17 Years	University of Colorado, Denver
Marketability of a Technology-based Intervention to Increase HPV Vaccination	NCT03497936	Human Papilloma...	Women's Stories	18 Years - 26 Years	Real Prevention, LLC
Marketability of a Technology-based Intervention to Increase HPV Vaccination	NCT03497936	Human Papilloma...	Women's Stories	18 Years - 26 Years	Real Prevention, LLC
PCOM2 - The Physician Communication Intervention, Version 2.0	NCT05336240	HPV Infection Preventive Heal...	Physician Commu... Physician Commu...	9 Years - 17 Years	University of Colorado, Denver

Spots Global Cancer Trial Database for hpv prevention