Making Effective Human Papillomavirus (HPV) Vaccine Recommendations
- Conditions
- Human Papillomavirus
- Interventions
- Behavioral: ParticipatoryBehavioral: Efficient
- Registration Number
- NCT02377843
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participatory 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. Efficient 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.
- Primary Outcome Measures
Name Time Method 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds Baseline, month 6 Analysis controlling for sex. Vaccination as measured by North Carolina Immunization Registry (NCIR).
- Secondary Outcome Measures
Name Time Method 6 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds Baseline, month 6 Vaccination as measured by NCIR.
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year olds 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, 13-17 year olds Baseline, month 3 Analysis controlling for sex. Vaccination as measured by NCIR.
Change in clinician self-efficacy, efficient arm vs. participatory arm Pre-training, Post-training, week 2 2-item self-efficacy scale (effectively recommending HPV vaccination, addressing parents' concerns).
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females 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 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 olds 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 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 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 olds 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 Baseline, month 3 Vaccination as measured by NCIR.
3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds Baseline, month 3 Vaccination as measured by NCIR.
Change in clinician communication of HPV vaccination as cancer prevention, efficient arm vs. participatory Pre-training, Post-training, week 2 1 item on communicating HPV vaccination as cancer prevention.
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females 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 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 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 Baseline, month 3 Vaccination as measured by NCIR.
6 month % change in HPV vaccination (≥ 1 dose), efficient arm vs. participatory arm, 11-12 year olds Baseline, month 6 Analysis controlling for sex. Vaccination as measured by NCIR.
6 month % change in Tdap vaccination, control arm vs. each intervention arm, 11-12 year olds 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 Baseline, month 3 Vaccination as measured by NCIR.
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds 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 Baseline, month 6 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 old females Baseline, month 6 Vaccination as measured by NCIR.
6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds Baseline, month 6 Vaccination as measured by NCIR.
6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds Baseline, month 6 Vaccination as measured by NCIR.
Change in clinician HPV vaccine knowledge, efficient arm vs. participatory arm Pre-training, Post-training 3-item knowledge scale (low vaccine coverage, vaccine effectiveness, recommendation impact on vaccine uptake).
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males 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 males 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 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 males Baseline, month 3 Vaccination as measured by NCIR.
Change in clinician recommendation quality, efficient arm vs. participatory arm 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 Pre-training, Post-training, week 2 1 item on communicating HPV vaccination as part of routine adolescent care.
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females 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 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 females 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 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 Baseline, month 6 Vaccination as measured by NCIR.
Trial Locations
- Locations (1)
University of North Carolina, Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States