NHANES oral HPV Follow-Up Feasibility Study Questioinnai

Attachment A

National Health and Nutrition Examination Survey (NHANES)

Oral HPV Follow-up Feasibility Study Adults 18-69 Years Old

OMB no. 0920-0950

Expires: 11/30/2016

Assurance of confidentiality – All information which would permit identification of an

individual, a practice, or an establishment will be held confidential, will be used for

statistical purposes only by NCHS staff, contractors, and agents only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 USC 242m) and the Confidential Information Protection and Statistical Efficiency Act (PL-107-347).

Public reporting burden of this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333. ATTN: PRA (0920-0950).

NHANES Oral HPV Follow-up: Self-Collection Feasibility Study (18-69 years)

Eligibility: All NHANES participants 18-69 years who provided a baseline oral HPV specimen in the mobile examination center (MEC), beginning in 2015, are eligible. The maximum number of respondents would be 225.

Informed Consent: Written informed consent will be obtained as part of the regular National Health

and Nutrition Examination Survey (NHANES) consent process for the examination in the

Mobile Examination Center (MEC). It will be described as one of the follow-up activities on the Health

Measurements list.

Exclusion Criteria: There are no exclusion criteria for this study.

Specimen Collection: A kit containing materials for oral rinse self-collection will be sent to eligible participant’s homes six months from the time of the MEC visit. Instructions and a postage-paid return envelope will be included. The burden for specimen collection is estimated at 5 minutes.

Questionnaire: Eligible participants will also be asked to answer 9 questions on sexual behavior, tobacco and alcohol use. Questions are similar to those previously asked in the Mobile Examination Center. Respondents will have the option of answering the questions using a web-based Internet application, by telephone or with paper and pencil. The burden for responding to the questionnaire is estimated at 5 minutes.

Report of Findings: No report of findings will be provided. The specimens will not be tested for the HPV virus. Evaluations of oral rinse samples will be conducted for the quality and quantity of DNA, amount of endogenous retrovirus-3 (ERV-3), and amplifiability of the virus beta-globin gene.

Proposed Questionnaire

Both Male and Female participants

1. In the past 6 months, how often did you drink any type of alcoholic beverage?

Please answer either by how many days per week or how many days per month or how many days per year you usually drink?

_____________ days per week

NUMBER

OR

______________ days per month

NUMBER

OR

______________ days per year

NUMBER

☐ NEVER

2. Do you now smoke cigarettes every day, some days, or not at all?

☐ EVERY DAY (Go To 3.)

☐ SOME DAYS (Go To 3.)

☐ NOT AT ALL (Skip To 4.)

3. During the past 30 days, when you smoked, about how many cigarettes did {you/SP} usually smoke per day?

_______________

NUMBER

4. Smokeless tobacco products are placed in the mouth or nose and include chewing tobacco, snuff, snus, or dissolvables.

During the past 30 days, including today, did {you/he/she} use any smokeless tobacco?

(Please do not include nicotine replacement to help you stop smoking.)

☐Yes

☐ No

Questions for Males Only

The next questions are about your recent sexual history. By sex, we mean vaginal, oral, or anal sex. Please remember that your answers are strictly confidential.

5. In the past 6 months, with how many women have you had any kind of sex?

Please write a number or write zero for none.

­­­­­­­­­­ _______________

NUMBER

6. In the past 6 months, with how many women have you had vaginal sex? Vaginal sex means your penis in her vagina.

Please write a number or write zero for none.

­­­­­­­­­­ _______________

NUMBER

7. In the past 6 months, on how many women have you performed oral sex? Performing oral sex means your mouth on a woman’s vagina or genitals.

Please write a number or write zero for none.

­­­­­­­­­­ _______________

NUMBER

8. In the past 6 months, with how many men have you had sex? By sex, we mean sexual contact with another man’s penis or genitals.

Please write a number or write zero for none.

­­­­­­­­­­ _______________

NUMBER

9. In the past 6 months, did you have any kind of sex with a person that you have never had sex with before?

☐Yes

☐ No

Questions for Females Only

The next questions are about your recent sexual history. By sex, we mean vaginal, oral, or anal sex. Please remember that your answers are strictly confidential.

1. In the past 6 months, with how many men have you had any kind of sex?

Please write a number or write zero for none.

­­­­­­­­­­ _______________

NUMBER

2. In the past 6 months, with how many men have you had vaginal sex? Vaginal sex means a man’s penis in your vagina.

Please write a number or write zero for none.

­­­­­­­­­­ _______________

NUMBER

3. In the past 6 months, on how many men have you performed oral sex? Performing oral sex means your mouth on a man’s penis or genitals.

Please write a number or write zero for none.

­­­­­­­­­­ _______________

NUMBER

4. In the past 6 months, with how many women have you had sex? By sex, we mean sexual contact with another woman’s vagina or genitals.

Please write a number or write zero for none.

­­­­­­­­­­ _______________

NUMBER

5. In the past 6 months, did you have any kind of sex with a person that you have never had sex with before?

☐Yes

☐ No