Clinical trial NCT02377843: Making Effective Human Papillomavirus (HPV) Vaccine Recommendations
Official title: Making Effective HPV Vaccine Recommendations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus
Keywords: vaccine
physician training
adolescent health
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: North Carolina Department of Health and Human Services
name: Pfizer
First posted: 2015-03-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds
timeFrame: Baseline, month 6
Secondary outcomes:
measure: 6 month % change in HPV vaccination (≥ 1 dose), efficient arm vs. participatory arm, 11-12 year olds
timeFrame: Baseline, month 6
measure: 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year olds
timeFrame: Baseline, month 3
measure: 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds
timeFrame: Baseline, month 3
measure: 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds
timeFrame: Baseline, month 6
measure: 3 month % change in tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, control arm vs. each intervention arm, 11-12 year olds
timeFrame: Baseline, month 3
measure: 6 month % change in Tdap vaccination, control arm vs. each intervention arm, 11-12 year olds
timeFrame: Baseline, month 6
measure: 3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds
timeFrame: Baseline, month 3
measure: 6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds
timeFrame: Baseline, month 6
measure: 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds
timeFrame: Baseline, month 3
measure: 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds
timeFrame: Baseline, month 6
measure: 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds
timeFrame: Baseline, month 3
measure: 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds
timeFrame: Baseline, month 6
measure: 3 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds
timeFrame: Baseline, month 3
measure: 6 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds
timeFrame: Baseline, month 6
measure: 3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds
timeFrame: Baseline, month 3
measure: 6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds
timeFrame: Baseline, month 6
measure: Change in clinician HPV vaccine knowledge, efficient arm vs. participatory arm
timeFrame: Pre-training, Post-training
measure: Change in clinician self-efficacy, efficient arm vs. participatory arm
timeFrame: Pre-training, Post-training, week 2
measure: Change in clinician recommendation quality, efficient arm vs. participatory arm
timeFrame: Pre-training, week 2
measure: Change in clinician communication of routine use, efficient arm vs. participatory arm
timeFrame: Pre-training, Post-training, week 2
measure: Change in clinician communication of HPV vaccination as cancer prevention, efficient arm vs. participatory
timeFrame: Pre-training, Post-training, week 2
measure: 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females
timeFrame: Baseline, month 3
measure: 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males
timeFrame: Baseline, month 3
measure: 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females
timeFrame: Baseline, month 6
measure: 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males
timeFrame: Baseline, month 6
measure: 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females
timeFrame: Baseline, month 3
measure: 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males
timeFrame: Baseline, month 3
measure: 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females
timeFrame: Baseline, month 6
measure: 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males
timeFrame: Baseline, month 6
measure: 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females
timeFrame: Baseline, month 3
measure: 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males
timeFrame: Baseline, month 3
measure: 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females
timeFrame: Baseline, month 6
measure: 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males
timeFrame: Baseline, month 6
measure: 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females
timeFrame: Baseline, month 3
measure: 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males
timeFrame: Baseline, month 3
measure: 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females
timeFrame: Baseline, month 6
measure: 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males
timeFrame: Baseline, month 6
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Noel T Brewer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Medical School (HMS and HSDM)
name: Melissa B Gilkey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.