Making Effective Human Papillomavirus (HPV) Vaccine Recommendations

Making Effective HPV Vaccine Recommendations

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.

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus
• Intervention / Treatment: Behavioral: Participatory; Behavioral: Efficient

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina, Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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: 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; Skills building on how to recommend HPV vaccine using a participatory communication strategy based in shared decision making; Practice using the communication strategy via role play; 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: 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; Skills building on how to recommend HPV vaccine using an efficient communication strategy based on first announcing the child is due for 3 vaccines; Practice using the communication strategy via role play; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 month % change in HPV vaccination (≥ 1 dose), efficient arm vs. participatory arm, 11-12 year olds	Analysis controlling for sex. Vaccination as measured by NCIR.	Baseline, month 6
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year olds	Analysis controlling for sex. Vaccination as measured by NCIR.	Baseline, month 3
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds	Analysis controlling for sex. Vaccination as measured by NCIR.	Baseline, month 3
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds	Analysis controlling for sex. Vaccination as measured by NCIR.	Baseline, month 6
3 month % change in tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, control arm vs. each intervention arm, 11-12 year olds	Vaccination as measured by NCIR.	Baseline, month 3
6 month % change in Tdap vaccination, control arm vs. each intervention arm, 11-12 year olds	Vaccination as measured by NCIR.	Baseline, month 6
3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds	Vaccination as measured by NCIR.	Baseline, month 3
6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds	Vaccination as measured by NCIR.	Baseline, month 6
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds	Analysis controlling for sex. Vaccination as measured by NCIR.	Baseline, month 3
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds	Analysis controlling for sex. Vaccination as measured by NCIR.	Baseline, month 6
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds	Analysis controlling for sex. Vaccination as measured by NCIR.	Baseline, month 3
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds	Analysis controlling for sex. Vaccination as measured by NCIR.	Baseline, month 6
3 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds	Vaccination as measured by NCIR.	Baseline, month 3
6 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds	Vaccination as measured by NCIR.	Baseline, month 6
3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds	Vaccination as measured by NCIR.	Baseline, month 3
6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds	Vaccination as measured by NCIR.	Baseline, month 6
Change in clinician HPV vaccine knowledge, efficient arm vs. participatory arm	3-item knowledge scale (low vaccine coverage, vaccine effectiveness, recommendation impact on vaccine uptake).	Pre-training, Post-training
Change in clinician self-efficacy, efficient arm vs. participatory arm	2-item self-efficacy scale (effectively recommending HPV vaccination, addressing parents' concerns).	Pre-training, Post-training, week 2
Change in clinician recommendation quality, efficient arm vs. participatory arm	4-item recommendation quality scale (urgency, consistency, timeliness, strength of endorsement) (Gilkey et al.).	Pre-training, week 2
Change in clinician communication of routine use, efficient arm vs. participatory arm	1 item on communicating HPV vaccination as part of routine adolescent care.	Pre-training, Post-training, week 2
Change in clinician communication of HPV vaccination as cancer prevention, efficient arm vs. participatory	1 item on communicating HPV vaccination as cancer prevention.	Pre-training, Post-training, week 2
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females	Vaccination as measured by NCIR.	Baseline, month 3
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males	Vaccination as measured by NCIR.	Baseline, month 3
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females	Vaccination as measured by NCIR.	Baseline, month 6
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males	Vaccination as measured by NCIR.	Baseline, month 6
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females	Vaccination as measured by NCIR.	Baseline, month 3
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males	Vaccination as measured by NCIR.	Baseline, month 3
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females	Vaccination as measured by NCIR.	Baseline, month 6
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males	Vaccination as measured by NCIR.	Baseline, month 6
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females	Vaccination as measured by NCIR.	Baseline, month 3
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males	Vaccination as measured by NCIR.	Baseline, month 3
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females	Vaccination as measured by NCIR.	Baseline, month 6
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males	Vaccination as measured by NCIR.	Baseline, month 6
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females	Vaccination as measured by NCIR.	Baseline, month 3
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males	Vaccination as measured by NCIR.	Baseline, month 3
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females	Vaccination as measured by NCIR.	Baseline, month 6
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males	Vaccination as measured by NCIR.	Baseline, month 6

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Harvard Medical School (HMS and HSDM); Pfizer; North Carolina Department of Health and Human Services
• Investigators: Principal Investigator: Noel T Brewer, PhD, University of North Carolina, Chapel Hill; Principal Investigator: Melissa B Gilkey, PhD, Harvard Medical School (HMS and HSDM)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimate): March 4, 2015

Study Record Updates

• Last Update Posted (Estimate): September 12, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: vaccine; adolescent health; physician training
• Other Study ID Numbers: 14-1873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO