- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04757701
The Role of Dentists in Human Papillomavirus Vaccination
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alice Richman, PhD
- Phone Number: 252-328-6431
- Email: richmana@ecu.edu
Study Locations
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North Carolina
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Winterville, North Carolina, United States, 28590
- Recruiting
- East Carolina University
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Contact:
- Alice Richman
- Phone Number: 252-328-6431
- Email: richmana@ecu.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
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:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
General dentists and dental hygienists in North Carolina
This objective will be met by administering a quantitative survey to active and licensed NC dentists and dental hygienists.
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Surveys with dentists/hygienists, interviews/focus groups with service learning center directors and key staff at federally qualified health centers.
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Directors of Service-Learning Centers and their partnering FQHCs
This objective will be met by conducting qualitative assessments with ECU's SoDM's CSLCs and their partnering community clinic/FQHCs.
The investigators will interview the Directors of the eight existing CSLCs and focus groups with clinical staff at each CSLC.
In collaboration with the Directors of the CSLCs, the investigators will identify key stakeholders in the co-located/partnering medical clinics, and conduct interviews with the administrators and focus groups with medical clinic staff.
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Surveys with dentists/hygienists, interviews/focus groups with service learning center directors and key staff at federally qualified health centers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
Time Frame: Year 1
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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
|
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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
Time Frame: Year 2
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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
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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
Time Frame: Year 2
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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
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Year 2
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Essie Torres, PhD, East Carolina University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 60585
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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