The Role of Dentists in Human Papillomavirus Vaccination

HPV Clinical Trial

Official title:

The Role of Dentists in HPV Vaccination: Building the Infrastructure Between Co-located Dental Practices and Federally Qualified Health Centers to Facilitate HPV Vaccination Uptake

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04757701
• Other study ID #: 60585
• Status: Recruiting
• Start date: March 16, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2023
• Source: East Carolina University
• Contact: Alice Richman, PhD
• Phone: 252-328-6431
• Email: richmana[@]ecu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project involves the research into understanding the functioning of co-located/partnering dental practices and federally qualified health centers/community health clinics in North Carolina and how dental health providers may play a role in facilitating HPV vaccination uptake for under-vaccinated populations in these co-located/partnering sites.

Description:

Objective 1): To assess HPV-related Oropharyngeal Cancer (OPC) knowledge, perceptions, practices and barriers of general dentists and dental hygienists in North Carolina (NC).

Objective 2): To understand key infrastructure elements and policies, as well as HPV prevention strategies in place at East Carolina University School of Dental Medicine Community Service-Learning Centers (CSLCs) and their partnering Community Health Clinics/Federally Qualified Health Clinics (FQHCs).

Objective 3): Develop and assess the feasibility of a model for collaborative and effective HPV prevention strategies between dental practices (CSLCs) and co-located Community Health Clinics (FQHCs).

Hypotheses:

H1. It is hypothesized that HPV OPC knowledge, perceptions, and practices will be informed by level of HPV health literacy; where higher levels of HPV health literacy will correlate with higher levels of HPV prevention practices (i.e., oral cancer screening, education on HPV risk behaviors, HPV vaccine recommendation). The investigators expect to find gaps in one or more of the surveyed areas (knowledge, attitudes, societal norms, perceived behavior control, and current prevention practices) among dentists and dental hygienists. Last, the investigators expect to find barriers to HPV prevention practices among our sample.

H2: It is hypothesized that there will be key infrastructure elements and policies identified through interviews that will both inhibit and facilitate the navigation of patients for HPV vaccination between dental clinics (CSLCs) and partnering health clinics (community clinics/FQHCs). The investigators also expect to find a variation of HPV prevention strategies currently being employed at CSLCs and partnering community clinic/FQHCs.

H3: It is hypothesized that the investigators will employ the data identified in Objectives 1 and 2 to develop a feasible model for collaborative and effective HPV prevention between dental clinics (CSLCs) and health clinics (FQHCs). Specifically, the investigators will address barriers identified in Objective 2 and capitalize on the facilitators identified to develop a model of HPV prevention care and navigation between dental clinics (CSLCs) and health clinics (FQHCs). This model can then be evaluated for effectiveness and serve as a model for replication in other rural and under-resourced settings.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• licensed and active dentists and hygienists in NC

• Directors/administrators of the identified CSLCs (n=8) and partnering FQHCs/Community clinics (n=8)

Exclusion Criteria:

-

Related Conditions & MeSH terms

• HPV

Intervention

Other:
• Social Behavioral surveys, interviews, and focus groups
Surveys with dentists/hygienists, interviews/focus groups with service learning center directors and key staff at federally qualified health centers.

Locations

Country	Name	City	State
United States	East Carolina University	Winterville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative measurements of the following variables: HPV-related Oropharyngeal Cancer knowledge, perceptions, practices and barriers as measured by a dental questionnaire to be developed by study team	HPV-related Oropharyngeal Cancer (OPC) knowledge, perceptions, practices and barriers of general dentists and dental hygienists in North Carolina. The dental questionnaire will be developed by study investigators and will use validated survey items, and will be piloted, and tested for readability, reliability, and validity by the research team.; Use of the survey is a quantitative technique; the resulting validated data of the dental questionnaire suggests predictable outcomes.	Year 1
Primary	Qualitative open ended statements will be assessed through qualitative interviews and focus groups which will generate a list of key infrastructure elements and policies, and HPV prevention strategies	Through qualitative assessments of interviews and focus groups with East Carolina University School of Dental Medicine Community Service-Learning Centers and their partnering community clinic/FQHCs, study investigators will develop a list of key infrastructure elements and policies, as well as HPV prevention strategies in place at East Carolina University School of Dental Medicine Community Service-Learning Centers and their partnering Community Health Clinics/Federally Qualified Health Clinics.; Use of qualitative assessments with comparative reviews of EMR data suggests a validation schema to predict infrastructure needs and outcomes.	Year 2
Primary	Study investigators will also conduct a review of the Electronic Medical Records of both dental and partnering medical clinic to assess how HPV-related screenings, vaccinations, and malignancies are reported	Study investigators will also conduct a review of the Electronic Medical Records of both dental and partnering medical clinic to assess how HPV-related screenings, vaccinations, and malignancies are reported	Year 2