Making Effective Human Papillomavirus (HPV) Vaccine Recommendations

Human Papillomavirus Clinical Trial

Official title:

Making Effective HPV Vaccine Recommendations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377843
• Other study ID #: 14-1873
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: September 9, 2016
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Harvard Medical School, North Carolina Department of Health and Human Services, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	6 month % change in Tdap vaccination, control arm vs. each intervention arm, 11-12 year olds	Vaccination as measured by NCIR.	Baseline, month 6	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	3 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds	Vaccination as measured by NCIR.	Baseline, month 3	No
Secondary	6 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds	Vaccination as measured by NCIR.	Baseline, month 6	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No