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Making Effective Human Papillomavirus (HPV) Vaccine Recommendations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377843
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : September 12, 2016
Sponsor:
Collaborators:
Harvard Medical School
North Carolina Department of Health and Human Services
Pfizer
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

Coverage of HPV vaccination among US teens is low, far below Healthy People 2020 goals. A central reason for low coverage is infrequent and inadequate healthcare provider recommendation of HPV vaccine. The proposed intervention aims to train clinicians to provide effective recommendations for the vaccine using participatory or efficient communication strategies.

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.


Condition or disease Intervention/treatment Phase
Human Papillomavirus Behavioral: Participatory Behavioral: Efficient Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Making Effective HPV Vaccine Recommendations
Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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

Experimental: 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.
Behavioral: 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

No Intervention: 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.



Primary Outcome Measures :
  1. 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds [ Time Frame: Baseline, month 6 ]
    Analysis controlling for sex. Vaccination as measured by North Carolina Immunization Registry (NCIR).


Secondary Outcome Measures :
  1. 6 month % change in HPV vaccination (≥ 1 dose), efficient arm vs. participatory arm, 11-12 year olds [ Time Frame: Baseline, month 6 ]
    Analysis controlling for sex. Vaccination as measured by NCIR.

  2. 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year olds [ Time Frame: Baseline, month 3 ]
    Analysis controlling for sex. Vaccination as measured by NCIR.

  3. 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds [ Time Frame: Baseline, month 3 ]
    Analysis controlling for sex. Vaccination as measured by NCIR.

  4. 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds [ Time Frame: Baseline, month 6 ]
    Analysis controlling for sex. Vaccination as measured by NCIR.

  5. 3 month % change in tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, control arm vs. each intervention arm, 11-12 year olds [ Time Frame: Baseline, month 3 ]
    Vaccination as measured by NCIR.

  6. 6 month % change in Tdap vaccination, control arm vs. each intervention arm, 11-12 year olds [ Time Frame: Baseline, month 6 ]
    Vaccination as measured by NCIR.

  7. 3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds [ Time Frame: Baseline, month 3 ]
    Vaccination as measured by NCIR.

  8. 6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds [ Time Frame: Baseline, month 6 ]
    Vaccination as measured by NCIR.

  9. 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds [ Time Frame: Baseline, month 3 ]
    Analysis controlling for sex. Vaccination as measured by NCIR.

  10. 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds [ Time Frame: Baseline, month 6 ]
    Analysis controlling for sex. Vaccination as measured by NCIR.

  11. 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds [ Time Frame: Baseline, month 3 ]
    Analysis controlling for sex. Vaccination as measured by NCIR.

  12. 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds [ Time Frame: Baseline, month 6 ]
    Analysis controlling for sex. Vaccination as measured by NCIR.

  13. 3 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds [ Time Frame: Baseline, month 3 ]
    Vaccination as measured by NCIR.

  14. 6 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds [ Time Frame: Baseline, month 6 ]
    Vaccination as measured by NCIR.

  15. 3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds [ Time Frame: Baseline, month 3 ]
    Vaccination as measured by NCIR.

  16. 6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds [ Time Frame: Baseline, month 6 ]
    Vaccination as measured by NCIR.

  17. Change in clinician HPV vaccine knowledge, efficient arm vs. participatory arm [ Time Frame: Pre-training, Post-training ]
    3-item knowledge scale (low vaccine coverage, vaccine effectiveness, recommendation impact on vaccine uptake).

  18. Change in clinician self-efficacy, efficient arm vs. participatory arm [ Time Frame: Pre-training, Post-training, week 2 ]
    2-item self-efficacy scale (effectively recommending HPV vaccination, addressing parents' concerns).

  19. Change in clinician recommendation quality, efficient arm vs. participatory arm [ Time Frame: Pre-training, week 2 ]
    4-item recommendation quality scale (urgency, consistency, timeliness, strength of endorsement) (Gilkey et al.).

  20. Change in clinician communication of routine use, efficient arm vs. participatory arm [ Time Frame: Pre-training, Post-training, week 2 ]
    1 item on communicating HPV vaccination as part of routine adolescent care.

  21. Change in clinician communication of HPV vaccination as cancer prevention, efficient arm vs. participatory [ Time Frame: Pre-training, Post-training, week 2 ]
    1 item on communicating HPV vaccination as cancer prevention.

  22. 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females [ Time Frame: Baseline, month 3 ]
    Vaccination as measured by NCIR.

  23. 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males [ Time Frame: Baseline, month 3 ]
    Vaccination as measured by NCIR.

  24. 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females [ Time Frame: Baseline, month 6 ]
    Vaccination as measured by NCIR.

  25. 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males [ Time Frame: Baseline, month 6 ]
    Vaccination as measured by NCIR.

  26. 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females [ Time Frame: Baseline, month 3 ]
    Vaccination as measured by NCIR.

  27. 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males [ Time Frame: Baseline, month 3 ]
    Vaccination as measured by NCIR.

  28. 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females [ Time Frame: Baseline, month 6 ]
    Vaccination as measured by NCIR.

  29. 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males [ Time Frame: Baseline, month 6 ]
    Vaccination as measured by NCIR.

  30. 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females [ Time Frame: Baseline, month 3 ]
    Vaccination as measured by NCIR.

  31. 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males [ Time Frame: Baseline, month 3 ]
    Vaccination as measured by NCIR.

  32. 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females [ Time Frame: Baseline, month 6 ]
    Vaccination as measured by NCIR.

  33. 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males [ Time Frame: Baseline, month 6 ]
    Vaccination as measured by NCIR.

  34. 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females [ Time Frame: Baseline, month 3 ]
    Vaccination as measured by NCIR.

  35. 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males [ Time Frame: Baseline, month 3 ]
    Vaccination as measured by NCIR.

  36. 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females [ Time Frame: Baseline, month 6 ]
    Vaccination as measured by NCIR.

  37. 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males [ Time Frame: Baseline, month 6 ]
    Vaccination as measured by NCIR.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible clinics are pediatric and family medicine practice 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 must have at least one pediatric or family medicine physician who provides HPV vaccine to adolescents ages 11-12.

Exclusion Criteria:

  • Ineligible clinics include those that have participated in a quality improvement study to increase HPV vaccination rates in the last 6 months or plan to participate in such a study in the next 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377843


Locations
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United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Harvard Medical School
North Carolina Department of Health and Human Services
Pfizer
Investigators
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Principal Investigator: Noel T Brewer, PhD University of North Carolina, Chapel Hill
Principal Investigator: Melissa B Gilkey, PhD Harvard Medical School
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02377843    
Other Study ID Numbers: 14-1873
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of North Carolina, Chapel Hill:
vaccine
physician training
adolescent health