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A tailored HPV education and professional skills intervention.

General/publicly available educational materials on HPV and communication skills.

The provider education and professional skills intervention will involve audio and visual content and will be delivered in the English language.

Tailored HPV Education and Professional Skills Intervention Group

The general provider education intervention will involve audio and visual content and will be delivered in the English language.

General HPV Education and Communication Skills Control Group

Kristin Gosselink, PhD

Eva M Moya, PhD, LMSW

Burrell College Office of Research and Sponsored Programs

Border Biomedical Research Center

UTEP Institutional Review Board

Gabriel A Frietze, PhD

Margie M Padilla, PharmD

Jacob Martinez, PhD, RN

Jacquelin Cordero, LMSW

Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among the populations they serve.

A sample of emerging \[in training\] and current \[in practice\] health professionals from the El Paso U.S.-Mexico Border Region will be recruited to participate in a human papillomavirus (HPV) educational and professional skills intervention. Hypothesis: improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among eligible individuals through a tailored multi-media intervention to strengthen providers' ability to discuss HPV and vaccination in an informed and culturally competent manner, and increase subsequent provider recommendations.

A parallel trial design will be used to examine the effectiveness of a tailored HPV education and professional skills intervention. Emerging and current healthcare providers will be randomly assigned to one of two conditions: 1) treatment condition in which they will receive a tailored Education and Professional Skills Intervention, and 2) control condition in which they will receive general, publicly available information about HPV and communication skills. Participants will then be followed over time and the responses will be compared between groups.

* Participants \[blinding\]: participants will be randomly assigned to treatment and control groups, they will not be made aware of other participant's receipt of treatment or control materials. Participants will be asked not to discuss this project outside of the intervention; delivery of the intervention or other educational materials will be virtual, limiting the ability of participants to interact with one another during the study.
* Outcome assessor \[blinding\]: to reduce bias in the implementation and assessment of the clinical trial, participant information and pre-post survey responses will be maintained separately from the assignment and delivery of the intervention.

Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention

Implementing Innovative and Strategic Approaches to Prevent and Mitigate the Deleterious Effects of HPV Across the Lifespan of Hispanics of Mexican Origin: Healthcare Provider Intervention

Collected deidentified individual participant data (IPD), all IPD that underlie results in a publication.

8-item HCP Practices scale (HCP vaccine recommendations, HCP screening recommendations, HCP communication practices) scored on a Likert scale from Never (1) to Always (5)

9-item HPV Vaccine Attitudes scale (perceived safety, perceived harm, perceived effectiveness) scored on a Likert scale from Strongly disagree (1) to Strongly agree (5)

14-item HPV Knowledge scale scored as True (1) or False (0)

National Institute on Minority Health and Health Disparities (NIMHD)

Burrell College of Osteopathic Medicine

University of Texas, El Paso

Associate Professor

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Communicable Diseases

Sexually Transmitted Diseases

Mothers or female primary caregivers of active patients (aged 9-17) and young adult female patients aged 18-26 in the After Completion of Therapy (ACT) clinic at SJCRH. Mothers or female primary caregivers of active patients (aged 9-17) and young adult female patients aged 18-26 in the ACT clinic surviving childhood cancer will be asked to complete a questionnaire which queries sociodemographic, medical, and psychological variables which may relate to HPV vaccination.

Mothers or female primary caregivers ( with daughters aged 9-17) and young adult females aged 18-26 referred for study participation by participants from the ACT clinic. Participants have daughters aged 9-17 years or young adult females aged 18-26 at the time of study enrollment For those acquaintance controls electing to complete the paper-and-pencil questionnaire, the study team will send it to them in the mail along with a pre-addressed, stamped, return envelope. For those electing to complete the on-line questionnaire, the participant's email address will be collected and a secured link to our on-line questionnaire will be sent to them in an email.

A supplemental community control sample (meeting the inclusion and exclusion criteria outlined above) will also be utilized via the subject pool in the Department of Psychology at The University of Memphis.

James Klosky, Ph.D

This study will focus on the primary objectives:

* To estimate the prevalence of HPV vaccination among a large cohort of childhood cancer survivors and an acquaintance control group.
* To describe the difference in HPV vaccination rate and HPV vaccination intent among preadolescent/adolescent females surviving childhood cancer and an acquaintance control group.

This study will also focus on the secondary objectives:

* To examine sociodemographic, medical, and psychological differences between those who have/have not initiated HPV vaccination and between those who do/do not intend to get vaccinated in the future.
* To assess the general predictive influence of sociodemographic, medical, and psychological variables on HPV vaccination and intent among mothers with preadolescent/adolescent daughters.

Effective vaccination is now available to prevent human papillomavirus (HPV), the most common sexually transmitted infection and the cause of cervical cancer, the second most common cancer among women worldwide. HPV vaccine uptake is particularly important for females surviving childhood cancer, many of whom are at high risk for HPV complications due to the direct and indirect effects of cancer treatment. Thus, Version 3.0 of the Children's Oncology Group Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent and Young Adult Cancer has recently recommended HPV vaccination for all eligible females surviving childhood cancer. Because this vaccine was only FDA approved in 2006, little is known about the complexity of vaccination uptake among those surviving cancer, and how the factors influencing vaccination decision-making differ among families with and without a history of pediatric cancer.

The purpose of this exploratory study is to estimate the prevalence of HPV vaccination and to assess predictors of HPV vaccination (and intent) among 9-26 year old females who have survived childhood cancer, while making comparisons to healthy acquaintance controls. In a cross-sectional design, those surviving childhood cancer (and acquaintance controls) will be asked to complete a questionnaire which queries sociodemographic, medical, and psychological variables which may relate to HPV vaccination or intent. Current vaccination rates will be examined and factors which associate with HPV vaccination (and intent) will be identified. Findings of the present study will inform recruitment strategies for future studies examining the immunogenicity, safety, tolerability, and behavioral outcomes of HPV vaccination among females surviving childhood cancer. More immediately, this work will further our understanding of familial decision-making regarding HPV vaccination among female survivors of childhood cancer and will determine whether vaccination recruitment models developed for healthy adolescents and young adults generalize to the pediatric cancer population.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention	NCT05120869	Health Personne... Health Knowledg...	Tailored HPV Ed... General HPV Edu...	18 Years - 65 Years	University of Texas, El Paso
Human Papillomavirus (HPV) Vaccination Among Survivors of Childhood Cancer	NCT01117389	Human Papilloma...		9 Years - 26 Years	St. Jude Children's Research Hospital
Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention	NCT05120869	Health Personne... Health Knowledg...	Tailored HPV Ed... General HPV Edu...	18 Years - 65 Years	University of Texas, El Paso
Human Papillomavirus (HPV) Vaccination Among Survivors of Childhood Cancer	NCT01117389	Human Papilloma...		9 Years - 26 Years	St. Jude Children's Research Hospital

Spots Global Cancer Trial Database for human papillomavirus vaccination