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Protocol - Human Papillomavirus Vaccine Use

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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.

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.

Availability

Available

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
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Interviewer-administered questionnaire

Lifestage

Adult

Participants

Ages 18-49

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
caDSR Form PhenX PX100802 - Human Papillomavirus Vaccine Use 6910414 caDSR Form
Logical Observation Identifiers Names and Codes (LOINC) PhenX - human papillomavirus vaccine use protocol 100802 94327-4 LOINC
Derived Variables

None

Process and Review

The 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)

Protocol Name from Source

Behavioral Risk Factor Surveillance System (BRFSS), 2014

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 Name Variable IDVariable DescriptiondbGaP Mapping
PX100802_Human_Papillomavirus_Vaccine_HPV_Vaccination_Ever
PX100802010100 A vaccine to prevent the human more
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 vaccin show less
N/A
PX100802_Human_Papillomavirus_Vaccine_HPV_Vaccination_Number
PX100802020100 How many HPV shots did you receive? N/A
PX100802_Human_Papillomavirus_Vaccine_HPV_Vaccination_Number_Encoded
PX100802020200 How many HPV shots did you receive? N/A
Reproductive Health
Measure Name

Human Papillomavirus Vaccine Use

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.

Keywords

Reproductive health, human papillomavirus, HPV, vaccination, infectious disease prevention, genital wart prevention, Behavioral Risk Factor Surveillance System, BRFSS

Measure Protocols
Protocol ID Protocol Name
100802 Human Papillomavirus Vaccine Use
Publications

There are no publications listed for this protocol.