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Protocol - Human Papillomavirus Vaccine Use

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Protocol Name from Source:

Behavioral Risk Factor Surveillance System (BRFSS)

Availability:

Publicly available

Description:

The interviewer asks the individual whether s/he ever received a human papillomavirus (HPV) vaccination. If the response is yes, the interviewer asks about number of shots received.

Protocol:

1. A vaccine to prevent the human papillomavirus or HPV infection is available and is called the cervical cancer or genital warts vaccine, HPV shot [Fill: if female “GARDASIL or CERVARIX”; if male “ or GARDASIL”]. Have you EVER had an HPV vaccination?

[ ] 1 Yes

[ ] 2 No (skip to end)

[ ] 3 Doctor refused when asked (skip to end)

[ ] 7 Don’t know/Not sure (skip to end)

[ ] 9 Refused (skip to end)

2. How many HPV shots did you receive?

[ ] __ Number of shots;

[ ] 03 All shots;

[ ] 77 Don’t know/Not sure;

[ ] 99 Refused

GARDASIL® is a registered trademark of Merck & Co., Inc.

CERVARIX® is a registered trademark of GlaxoSmithKline, Inc.

Personnel and Training Required

The interviewer must be trained to conduct personal interviews with individuals from the general population. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews.

Equipment Needs

Paper and pencil

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Adult

Specific Instructions:

If the participant answers "yes" to question 1, the interviewer should complete the rest of the protocol. If the participant answers "no," then the protocol is deemed complete.

The PhenX Working Group notes that GARDASIL® is also known internationally as Silgard.

  • European Medicines Agency. (2009, September 25). Silgard European Public Assessment Report.
  • Waknine, Y. (2006, October 2). International approvals: Singulair and Gardasil/Silgard. Medscape Today.

Note: GARDASIL® by Merck & Co. is approved by the U.S. Food and Drug Administration (FDA) for use in females ages 9-26 and males ages 9-26.

Note: CERVARIX® is manufactured by GlaxoSmithKline Biologicals and approved by the FDA for use in females ages 10-25.

Research Domain Information

Release Date:

April 11, 2017

Definition

Questions to assess use of the human papillomavirus vaccine.

Purpose

These questions ascertain if an individual received the human papillomavirus vaccine (HPV) and, if so, the number of doses received. Use of HPV impacts a man’s risk of penile cancer, a woman’s risk of developing cervical cancer and the overall incidence rate of cervical cancer.

Selection Rationale

The Behavioral Risk Factor Surveillance System (BRFSS) is a telephone interview surveillance system sponsored by the U.S. Centers for Disease Control and Prevention gathering data in all 50 states and the District of Columbia. BRFSS introduced questions about human papillomavirus (HPV) vaccine in 2009. As HPV vaccine was approved by the U.S. Food and Drug Administration (June 2006), earlier national surveys did not include the HPV vaccine in their protocols. BRFSS 2014 questionnaires include updated HPV vaccine questions.

Language

English

Standards

StandardNameIDSource
Common Data Elements (CDE)Person Human Papillomavirus Vaccine Use3007465CDE Browser

Process and Review

The [link[www.phenx.org/node/110|Expert Review Panel #5]] (ERP 5) reviewed the measures in the Reproductive Health domain.

Guidance from ERP 5 includes the following:

· Updated protocol

· New Data Dictionary

Back-compatible: there are changes to the Data Dictionary, previous version of the Data Dictionary and Variable mapping in Toolkit archive ([link[www.phenxtoolkit.org/index.php?pageLink=browse.archive.protocols&id=100000|link]])

Source

U.S. Centers for Disease Control and Prevention. Behavioral Risk Factor Surveillance System (BRFSS) 2014. Module 11, questions 1 and 2.

General References

Hariri, S., Markowitz, L. E., Bennett, N. M., Niccolai, L. M., Schafer, S., Bloch, K., . . . Williams, M. L.; HPV-Impact Working Group. (2015). Monitoring effect of human papillomavirus vaccines in US population, Emerging Infections Program, 2008-2012. Emerging Infectious Diseases, 21(9), 1557-1561.

Williams, W. W., Lu, P., O’Halloran, A., Kim, D. K., Grohskopf, L. A., Pilishvili, T., . . . Bridges, C. B.; Centers for Disease Control and Prevention. (2016). Surveillance of vaccination coverage among adult populations-United States, 2014. MMWR Surveillance Summaries, 65(1), 1-36.

Protocol ID:

100802

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping