Clinical trial NCT04757701: The Role of Dentists in Human Papillomavirus Vaccination
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HPV
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Objective 1 Population: licensed and active dentists in NC, and licensed and active dental hygienists.

Objective 2 Population: Current locations of the eight CSLCs include Ahoskie (Hertford County), Elizabeth City (Pasquotank County), Lillington (Harnett County), Sylva (Jackson County), Lumberton (Robeson County), Davidson (Davidson County), Spruce Pine (Mitchell County), and Brunswick (Brunswick County). The investigators will also identify key stakeholders from partnering FQHC/Community Health Clinics to include in qualitative interviews.

Brief 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.

Detailed 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: 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
timeFrame: Year 1
measure: 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
timeFrame: Year 2
measure: 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
timeFrame: Year 2
Secondary outcomes:
Other outcomes:
Locations:
city: Winterville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Essie Torres, PhD
role: PRINCIPAL_INVESTIGATOR
References: