NCT04757701

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

March 16, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

July 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

January 27, 2021

Last Update Submit

July 25, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

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.

Other: Social Behavioral surveys, interviews, and focus groups

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.

Other: Social Behavioral surveys, interviews, and focus groups

Interventions

Surveys with dentists/hygienists, interviews/focus groups with service learning center directors and key staff at federally qualified health centers.

Directors of Service-Learning Centers and their partnering FQHCsGeneral dentists and dental hygienists in North Carolina

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • licensed and active dentists and hygienists in NC
  • Directors/administrators of the identified CSLCs (n=8) and partnering FQHCs/Community clinics (n=8)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Carolina University

Winterville, North Carolina, 28590, United States

RECRUITING

MeSH Terms

Interventions

Interviews as TopicFocus Groups

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Essie Torres, PhD

    East Carolina University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Richman, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 17, 2021

Study Start

March 16, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

July 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations