Making Effective Human Papillomavirus (HPV) Vaccine Recommendations

NCT02377843 | Completed DMC

• 1 other identifier: 14-1873
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus

Keywords

vaccine; physician training; adolescent health

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (37)

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

  Baseline, month 6

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

  Baseline, month 3

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

  Baseline, month 3

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

  Baseline, month 6

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

  Baseline, month 3

Study Arms (3)

Participatory

EXPERIMENTAL

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

Efficient

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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: 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

Participatory

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: 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

Efficient

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Harvard Medical School (HMS and HSDM): collaborator
• North Carolina Department of Health and Human Services: collaborator
• Pfizer: collaborator

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

• 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.

  PMID: 29673374 DERIVED

• 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.

  PMID: 27940512 DERIVED

MeSH Terms

Interventions

Community-Based Participatory Research

Intervention Hierarchy (Ancestors)

Health Services Research; Health Care Quality, Access, and Evaluation

Study Officials

• Noel T Brewer, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Melissa B Gilkey, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 4, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 12, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)