HPVNCT04757701
The Role of Dentists in Human Papillomavirus Vaccination
An observational study of HPV, run by East Carolina University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV
- What is being tested?
- Social Behavioral surveys, interviews, and focus groups
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- licensed and active dentists and hygienists in NC
- Directors/administrators of the identified CSLCs (n=8) and partnering FQHCs/Community clinics (n=8)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
East Carolina University
Winterville, North Carolina, 28590
Alice Richman, 252-328-6431, richmana@ecu.edu
About this study
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
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.
Read the 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.
- Conditions
- HPV
- Being tested
- Social Behavioral surveys, interviews, and focus groups
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Behavioral surveys, interviews, and focus groupsOther
Surveys with dentists/hygienists, interviews/focus groups with service learning center directors and key staff at federally qualified health centers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Social Behavioral surveys, interviews, and focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start16 Mar 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Essie Torres, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757701
- Sponsor's protocol ID
- 60585
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04757701
- Acronym / sponsor ID
- 60585
- Conditions
- HPV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General dentists and dental hygienists in North Carolina | – | Other: Social Behavioral surveys, interviews, and focus groupsThis objective will be met by administering a quantitative survey to active and licensed NC dentists and dental hygienists. |
| Directors of Service-Learning Centers and their partnering FQHCs | – | Other: Social Behavioral surveys, interviews, and focus groupsThis 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- licensed and active dentists and hygienists in NC
- Directors/administrators of the identified CSLCs (n=8) and partnering FQHCs/Community clinics (n=8)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Behavioral surveys, interviews, and focus groupsSurveys with dentists/hygienists, interviews/focus groups with service learning center directors and key staff at federally qualified health centers. | Other | Directors of Service-Learning Centers and their partnering FQHCs, General dentists and dental hygienists in North Carolina |
Primary outcome
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
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.
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
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.
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Essie Torres, PhD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice Richman, PhD (252-328-6431, richmana@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Year 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.