Making Effective Human Papillomavirus (HPV) Vaccine Recommendations
NCT ID: NCT02377843
Last Updated: 2016-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2015-03-31
2016-03-31
Brief Summary
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This study will evaluate the effectiveness of two communication trainings to increase HPV vaccination coverage among adolescent patients. We will compare HPV vaccination for pediatric and family medicine clinics receiving a participatory communication training, efficient communication training, or no training. Ten clinics will be randomly assigned to each study arm for a total of 30 clinics. The primary outcome of this study is to compare the change in clinics' levels of HPV vaccination initiation coverage among 11-12 year old adolescent patients from baseline to 6 month follow-up. Secondarily, we will compare the change in HPV vaccination initiation coverage in 13-17 year old adolescents.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Participatory
This arm includes 10 pediatric or family medicine clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics randomized to the participatory study arm will receive a 1-hour in-person communication training.
Participatory
The participatory intervention is a 1-hour training to help clinicians improve their ability to make strong and effective recommendations for HPV vaccine, and address parental concerns regarding HPV vaccination. The training includes four components:
1. Review of information on HPV vaccine, including effectiveness, safety, rationale for targeting adolescents ages 11-12, and low HPV vaccine coverage rates compared to Tdap and meningococcal vaccine
2. Skills building on how to recommend HPV vaccine using a participatory communication strategy based in shared decision making
3. Practice using the communication strategy via role play
4. Discussion on applying the communication strategy to medical practice
Efficient
This arm includes 10 pediatric or family medicine clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics randomized to the efficient study arm will receive a 1-hour in-person communication training.
Efficient
The efficient intervention is a 1-hour training to help clinicians improve their ability to make strong and effective recommendations for HPV vaccine, and address parental concerns regarding HPV vaccination. The training includes four components:
1. Review of information on HPV vaccine, including effectiveness, safety, rationale for targeting adolescents ages 11-12, and low HPV vaccine coverage rates compared to Tdap and meningococcal vaccine
2. Skills building on how to recommend HPV vaccine using an efficient communication strategy based on first announcing the child is due for 3 vaccines
3. Practice using the communication strategy via role play
4. Discussion on applying the communication strategy to medical practice
Control
This arm includes 10 pediatric or family medicine clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics randomized to the control study arm will not receive a 1-hour in-person communication training.
No interventions assigned to this group
Interventions
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Participatory
The participatory intervention is a 1-hour training to help clinicians improve their ability to make strong and effective recommendations for HPV vaccine, and address parental concerns regarding HPV vaccination. The training includes four components:
1. Review of information on HPV vaccine, including effectiveness, safety, rationale for targeting adolescents ages 11-12, and low HPV vaccine coverage rates compared to Tdap and meningococcal vaccine
2. Skills building on how to recommend HPV vaccine using a participatory communication strategy based in shared decision making
3. Practice using the communication strategy via role play
4. Discussion on applying the communication strategy to medical practice
Efficient
The efficient intervention is a 1-hour training to help clinicians improve their ability to make strong and effective recommendations for HPV vaccine, and address parental concerns regarding HPV vaccination. The training includes four components:
1. Review of information on HPV vaccine, including effectiveness, safety, rationale for targeting adolescents ages 11-12, and low HPV vaccine coverage rates compared to Tdap and meningococcal vaccine
2. Skills building on how to recommend HPV vaccine using an efficient communication strategy based on first announcing the child is due for 3 vaccines
3. Practice using the communication strategy via role play
4. Discussion on applying the communication strategy to medical practice
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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Harvard Medical School (HMS and HSDM)
OTHER
North Carolina Department of Health and Human Services
OTHER_GOV
Pfizer
INDUSTRY
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Noel T Brewer, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Melissa B Gilkey, PhD
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School (HMS and HSDM)
Locations
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University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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References
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Malo TL, Hall ME, Brewer NT, Lathren CR, Gilkey MB. Why is announcement training more effective than conversation training for introducing HPV vaccination? A theory-based investigation. Implement Sci. 2018 Apr 19;13(1):57. doi: 10.1186/s13012-018-0743-8.
Brewer NT, Hall ME, Malo TL, Gilkey MB, Quinn B, Lathren C. Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial. Pediatrics. 2017 Jan;139(1):e20161764. doi: 10.1542/peds.2016-1764. Epub 2016 Dec 5.
Other Identifiers
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14-1873
Identifier Type: -
Identifier Source: org_study_id
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