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Completed

NCT Number: NCT02377843

Making Effective Human Papillomavirus (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.

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Key information

Conditions

Human Papillomavirus

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Participatory

Behavioral

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

Behavioral

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

Primary outcomes

  1. 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds

    Time frame: Baseline, month 6

    Analysis controlling for sex. Vaccination as measured by North Carolina Immunization Registry (NCIR).

Secondary outcomes

  1. 6 month % change in HPV vaccination (≥ 1 dose), efficient arm vs. participatory arm, 11-12 year olds

    Time frame: Baseline, month 6

    Analysis controlling for sex. Vaccination as measured by NCIR.

  2. 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year olds

    Time frame: Baseline, month 3

    Analysis controlling for sex. Vaccination as measured by NCIR.

  3. 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds

    Time frame: Baseline, month 3

    Analysis controlling for sex. Vaccination as measured by NCIR.

  4. 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds

    Time frame: Baseline, month 6

    Analysis controlling for sex. Vaccination as measured by NCIR.

  5. 3 month % change in tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, control arm vs. each intervention arm, 11-12 year olds

    Time frame: Baseline, month 3

    Vaccination as measured by NCIR.

  6. 6 month % change in Tdap vaccination, control arm vs. each intervention arm, 11-12 year olds

    Time frame: Baseline, month 6

    Vaccination as measured by NCIR.

  7. 3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds

    Time frame: Baseline, month 3

    Vaccination as measured by NCIR.

  8. 6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds

    Time frame: Baseline, month 6

    Vaccination as measured by NCIR.

  9. 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds

    Time frame: Baseline, month 3

    Analysis controlling for sex. Vaccination as measured by NCIR.

  10. 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds

    Time frame: Baseline, month 6

    Analysis controlling for sex. Vaccination as measured by NCIR.

  11. 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds

    Time frame: Baseline, month 3

    Analysis controlling for sex. Vaccination as measured by NCIR.

  12. 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds

    Time frame: Baseline, month 6

    Analysis controlling for sex. Vaccination as measured by NCIR.

  13. 3 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds

    Time frame: Baseline, month 3

    Vaccination as measured by NCIR.

  14. 6 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds

    Time frame: Baseline, month 6

    Vaccination as measured by NCIR.

  15. 3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds

    Time frame: Baseline, month 3

    Vaccination as measured by NCIR.

  16. 6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds

    Time frame: Baseline, month 6

    Vaccination as measured by NCIR.

  17. Change in clinician HPV vaccine knowledge, efficient arm vs. participatory arm

    Time frame: Pre-training, Post-training

    3-item knowledge scale (low vaccine coverage, vaccine effectiveness, recommendation impact on vaccine uptake).

  18. Change in clinician self-efficacy, efficient arm vs. participatory arm

    Time frame: Pre-training, Post-training, week 2

    2-item self-efficacy scale (effectively recommending HPV vaccination, addressing parents' concerns).

  19. Change in clinician recommendation quality, efficient arm vs. participatory arm

    Time frame: Pre-training, week 2

    4-item recommendation quality scale (urgency, consistency, timeliness, strength of endorsement) (Gilkey et al.).

  20. Change in clinician communication of routine use, efficient arm vs. participatory arm

    Time frame: Pre-training, Post-training, week 2

    1 item on communicating HPV vaccination as part of routine adolescent care.

  21. Change in clinician communication of HPV vaccination as cancer prevention, efficient arm vs. participatory

    Time frame: Pre-training, Post-training, week 2

    1 item on communicating HPV vaccination as cancer prevention.

  22. 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females

    Time frame: Baseline, month 3

    Vaccination as measured by NCIR.

  23. 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males

    Time frame: Baseline, month 3

    Vaccination as measured by NCIR.

  24. 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females

    Time frame: Baseline, month 6

    Vaccination as measured by NCIR.

  25. 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males

    Time frame: Baseline, month 6

    Vaccination as measured by NCIR.

  26. 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females

    Time frame: Baseline, month 3

    Vaccination as measured by NCIR.

  27. 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males

    Time frame: Baseline, month 3

    Vaccination as measured by NCIR.

  28. 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females

    Time frame: Baseline, month 6

    Vaccination as measured by NCIR.

  29. 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males

    Time frame: Baseline, month 6

    Vaccination as measured by NCIR.

  30. 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females

    Time frame: Baseline, month 3

    Vaccination as measured by NCIR.

  31. 3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males

    Time frame: Baseline, month 3

    Vaccination as measured by NCIR.

  32. 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females

    Time frame: Baseline, month 6

    Vaccination as measured by NCIR.

  33. 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males

    Time frame: Baseline, month 6

    Vaccination as measured by NCIR.

  34. 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females

    Time frame: Baseline, month 3

    Vaccination as measured by NCIR.

  35. 3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males

    Time frame: Baseline, month 3

    Vaccination as measured by NCIR.

  36. 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females

    Time frame: Baseline, month 6

    Vaccination as measured by NCIR.

  37. 6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males

    Time frame: Baseline, month 6

    Vaccination as measured by NCIR.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • North Carolina Department of Health and Human Services
  • Pfizer

Registry information

Official study title

Making Effective HPV Vaccine Recommendations

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2015
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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