An interventional study of Participatory and Efficient in Human Papillomavirus, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2016-09-12.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research
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.
University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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
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
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).
Time frame: Baseline, month 6
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, month 3
6 month % change in Tdap vaccination, control arm vs. each intervention arm, 11-12 year olds
Vaccination as measured by NCIR.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, month 6
3 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds
Vaccination as measured by NCIR.
Time frame: Baseline, month 3
6 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds
Vaccination as measured by NCIR.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, month 6
Plan to share: No
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University of North Carolina, Chapel Hill