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Trial record 1 of 1 for:    NCT02377843
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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

Tracking Information
First Submitted Date  ICMJE February 27, 2015
First Posted Date  ICMJE March 4, 2015
Last Update Posted Date September 12, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • 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.
  • 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 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Making Effective Human Papillomavirus (HPV) Vaccine Recommendations
Official Title  ICMJE Making Effective HPV Vaccine Recommendations
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Human Papillomavirus
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Participatory
  • 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.
    Intervention: Behavioral: Efficient
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02377843
Other Study ID Numbers  ICMJE 14-1873
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • Harvard Medical School
  • North Carolina Department of Health and Human Services
  • Pfizer
Investigators  ICMJE
Principal Investigator: Noel T Brewer, PhD University of North Carolina, Chapel Hill
Principal Investigator: Melissa B Gilkey, PhD Harvard Medical School
PRS Account University of North Carolina, Chapel Hill
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP