Label Comp Study Questionnaire Proposed Label

Respondent ID:_____________ OMB Control #_____________________

OMB Expiration Date________________

PROPOSED LABEL

US Public Health Service

Condom Label Study

Paperwork Reduction Act Statement

Public reporting burden for this collection of information is estimated to average .5 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, completing, and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

Food and Drug Administration

CDRH/OCER/DDUPSA (HFZ-230)

1350 Piccard Drive

Rockville, MD 20850

“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.”

Recruitment Script/Instrument

Hello, I am _____________________from (Research Company) and I am doing a study for the US Public Health Service about a sensitive subject. The study takes about 20 minutes. If you are eligible you will be paid $XX.XX for your participation.

I should tell you that the study is confidential and your name will not be shared with anyone. The study is not for any manufacturer and is about information located on and inside condom packages. We will ask questions about condoms but none of the questions are about your sexual behavior. (Do not ask if they remain interested but assume they are unless they state they are not interested)

Label Test

Condom Label Comprehension Study

Survey steps:

1. Intercept – ask if he/she would like to participate in a study about information located on and inside condom packages

Refer to interviewer training guide for wording

in approaching potential participants.

2. Administer screening instrument to determine eligibility (terminate if not eligible) (Refer to interviewer training guide)

3. Informed consent

4. Administer REALM

5. Provide condom package information for study subject to read

6. Administer questionnaire - Tell subject they may refer back to condom package information to answer questions (Refer to interviewer training guide)

Screening and Eligibility Instrument

I would like to ask you a few questions to determine whether or not you are eligible to participate. The study is about condom package information, and includes questions about sexually transmitted diseases and condom use, so some of the questions may be a little sensitive. However, your answers will be anonymous and kept confidential. Please remember, the study is NOT about your sexual behavior. It is ONLY about what you understand from reading the package information.

The study is not being done for any company or organization that sells condoms. Again, this study is for the US Public Health Service.

It will take about 5 minutes to see if you are eligible. If you are eligible, and you still

wish to participate; the entire survey will take about 20 minutes.

Your name will not be on the questionnaire and your responses will remain anonymous and completely confidential. The information collected from you is for research only.

If you are eligible to participate, you will be paid $XX.XX to participate.

Now, I am going to ask you some questions to see if you qualify to participate in the research study.

1. Which of the following age categories applies to you? Are you: (Read List. Check only one answer)

Under 18 - Not eligible to participate and terminate interview

18-24

25-34

35-44

45-54

55 or older - Not eligible to participate and terminate interview

Refuse to answer - Not eligible to participate and terminate interview

2. When reading printed materials, can you read English?

YES

NO --- Not eligible to participate and terminate interview

3. Have you ever used or would you consider using male latex condoms with a past, current or future partner?

YES

NO - Not eligible to participate and terminate the interview

4. Do you or does anyone in your household work in any of the following?

(Household is defined as all relatives living in the home of the potential respondent)

Medical or health care field (For example as a doctor, physician’s assistant, nurse, pharmacist, medical researcher, health educator, medical assistant)	YES	NO
Food and Drug Administration (FDA)	YES	NO
National Institute of Health (NIH)	YES	NO
Centers for Disease Control and Prevention (CDC)	YES	NO
Drug or medical device company	YES	NO
Research company (For example market research, health research)	YES	NO
Company or organization that is involved with condom use, HIV/AIDS, sexually transmitted diseases, and/or birth control	YES	NO

If any of the boxes are checked “yes”, the individual is not eligible and terminate the interview.

5. Have you participated in any research study in the past two months?

YES  Not eligible to participate and terminate interview

NO  Continue

6. Have you personally ever read the information on or inside a condom package? (Check only one answer)

Yes

No

Do not read below but check if mentioned.

Do not know/Cannot remember

Great, based on your answers you can participate in this study.

Your opinions are very important and we appreciate your time.

Before we can begin we need you to read a document and sign that you understand the study and agree to participate. (Please read the consent form to respondent before handing it to them.)

Here is the consent form for you to review and sign. Please take as much time as you need.

If you have any questions feel free to ask me.

Check here that consent has been signed

Now that you have agreed to participate, the first set of questions we have for you are regarding medical words.

REALM TEST

Instructions for scoring the test (adapted from the REALM manual):

1. Record the results using the scoring sheet on the following page.

2. Place a check mark () in the box next to each word the participant pronounces correctly.

3. Place an “O” in the box next to each word the participant does not attempt or mispronounces.

Read Instructions and

Record The Responses On The Next Page

Read:

I will be showing you the package information for male latex condoms. In order to test the package information, please read this and take all the time you need. When you are done reading I will ask you some questions about what you have read.

When they have finished reading the package information, read:

Please answer the following questions based on your understanding of what you read in the package information. Please feel free to refer to the package information to answer the questions. The questions are about the package information and not a test of you.

1. According to the package information, will correctly using a male latex condom every time a person has sex reduce the risk of catching or spreading sexually transmitted diseases? Read list and check only one answer.

XYes

No

Maybe If answer choice, ask respondent to please explain. _________________

(Do not read answers below. Check one that applies.)

Not clear

Not addressed

2. According to the package information, how often should a man use a latex condom when engaging in sex to reduce the risk of catching or spreading sexually transmitted diseases? Please wait until I read all choices before you answer. (Read list/check only one answer.)

XEvery time

Most of the time

Some of the time

Rarely

Never

Do not read below but check if mentioned.

Not clear

Not addressed

3. According to the package information, when should a condom be put on to most effectively reduce the risk of catching or spreading sexually transmitted diseases? Please wait until I read all choices before you answer. (Read list/check only one answer.)

XBefore any intimate contact

Just before vaginal, oral or anal penetration

Just before ejaculation

Does not matter when it is put on

Do not read below but check if mentioned.

Not clear

Not addressed

4. According to the package information, how should the penis be withdrawn after sex? Please wait until I read all choices before you answer. (Read List)

XHold on to the rim of the condom when withdrawing the penis

It doesn’t matter when or how the penis is withdrawn

Wait until the penis is no longer erect before withdrawing the penis

Do not read below but check if mentioned.

Not Clear

Not addressed

5. According to the methods listed in the package information, which is the most effective way sexually active people can help prevent pregnancy? (Do not read list. Record answer by checking the one that applies if respondent only says condom, then ask male or female.)

XMale latex (rubber) condom

Cervical cap

Diaphragm

Female condom

No Method

Other (List)________________________________________-

Do not read below but check if mentioned.

Not clear

Not addressed

6. According to the package information, does correctly using a male latex condom every time a person has sex, help to reduce the risk of:

(Read the sentence above for each disease. After each disease, read the 3 answer choices, circle the answer that best matches the respondent’s answer, and repeat for each of the diseases on the list.)

Read Answer Choices Below Do Not Read Answers

But, circle if mentioned.

	Yes	No	Maybe		Not Clear	Not Addressed
Genital Herpes	1	2	3		4	5
Chlamydia	1	2	3		4	5
Genital Warts	1	2	3		4	5
Human Papillomavirus (HPV)	1	2	3		4	5
Gonorrhea	1	2	3		4	5
Cervical Cancer	1	2	3		4	5
Influenza	1	2	3		4	5
HIV/AIDS	1	2	3		4	5

7. According to the package information, how much does the condom, if used correctly every time, reduce the risk of catching or spreading HIV/AIDS? Please wait until I read all choices before you answer. Read list and check only one answer.

Completely

XGreatly

Slightly

Very little

Not at all

Do not read below but check if mentioned.

Not clear

Not addressed

8. I am about to read a list of sexually transmitted diseases (STD’s), two at a time. Please, tell me which sexually transmitted disease (STD), in each pair, male latex condoms are more likely to reduce the risk of catching or spreading? (Check one answer for each pair.)

Genital herpes or X Gonorrhea No difference

X HIV or HPV No difference

X Chlamydia or HPV No difference

X Gonorrhea or HPV No difference

9. According to the package information, if a person has HIV/AIDS, which of the following male latex condoms should the person use? (READ LIST)

Condom with nonoxynol-9 (pronounced “non-OX-e-nol-9”) (N-9)

X Condom without nonoxynol-9 (pronounced “non-OX-e-nol-9”) (N-9)

Condom with petroleum jelly

Do not read below but check if mentioned.

No condom at all

Not Clear

Not Addressed

10. According to the package information, can a person get the human papillomavirus (pronounced “pap-ah-LO-ma-VI-rus”) (HPV) from an infected partner if a male latex condom is used? (READ LIST)

XYes

No

Maybe Please explain ________________

Do not read below but check if mentioned.

Not Clear

Not Addressed

11. According to the package information, a woman with an HPV infection would have a higher chance of getting which of the following? Please answer all that apply (Read the choice for each one and get an answer.) (Check Yes or No.)

Pregnant Yes XNo

Cervical Cancer X Yes No

A cold or the flu Yes XNo

Mumps Yes XNo

Genital Warts X Yes No

12. According to the package information, are there people or partners who should not use male latex condoms with the spermicide (pronounced “SPER-ma-side”) nonoxynol-9 (pronounced “non-OX-e-nol-9”) (N-9)? Do not read answer choices.

XYes If yes, who should not use it? (Check all that are mentioned, but do not read the list.)

XPeople and partners who don’t know if they have HIV/AIDS

XPeople having anal sex

XPeople with HIV/AIDS

Other (Please Specify): _____________________

No

Maybe

Do not read below but check if mentioned.

Not clear

Not addressed

13. According to the package information, does a condom with the spermicide (pronounced SPER-ma-side) nonoxynol-9 (pronounced non-OX-e-nol-9) (N-9) provide additional pregnancy protection?

(Read list and check only one answer.)

Yes

No

X Maybe

Do not read below but check if mentioned.

Not clear

Not Addressed

Ask after checking the answer above:

Can you add more explanation to your answer? ____________________

14. According to the package information, what does the spermicide (pronounced “SPER-ma-side”) nonoxynol-9 (pronounced “non-OX-e-nol-9”) (N-9) on a condom do? (Read list and check only one answer.)

Protects against pregnancy better than a condom without N-9

X Kills sperm

Reduces the risk of getting HIV/AIDS from an infected partner

Do not read below but check if mentioned.

Other (Please Specify): ______________________________________

Not clear

Not Addressed

15. We want to be sure to have the best package information possible. To help us, as you read the package information did you find any words or phrases that you did not fully understand or thought were a little confusing?

(Check only one answer – yes or no,)

Yes - Which ones? (Write in answers. When they have finished, probe “anything else”)

___________________________________________________________

___________________________________________________________

___________________________________________________________

___________________________________________________________

No

To help with our analysis of your answers we would like to ask some questions about you such as your race, education, and income.

16. Which of the following best describes you? Please wait until I read all choices before you answer.

Are you: (Read list/check only one answer.)

American Indian or Alaskan Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

White

Do not read below but check if mentioned.

Other (Please Specify):__________________________

Refused

17. Which of the following best describes you? Are you: (Read list/check only one answer.)

Hispanic or Latino

Not Hispanic or Latino

Do not read below but check if mentioned.

Other (Please Specify):_______________________________________

Refused

18. What is the highest level of education you have completed? (Read list/check only one answer)

Did not complete high school

Completed high school / GED

Some college or technical school

Graduated from college / technical school

Post-graduate degree

Do not read below but check if mentioned.

Other (Please Specify):______________________________

Refused

19. Which of the following best describes your household income last year? (Read list and check only one answer.)

(Household income is defined as the income of the individual, or the individual and their spouse/ significant other.)

Under $15,000

$15,000 to $24,999

$25,000 to $34,999

$35,000 to $49,999

$50,000 to $74,999

$75,000 or over

Do not read below but check if mentioned.

Refused

20. Which of the following best describes the area where you live today? Please wait until I read all choices before you answer.

(Read list/check only one answer.)

Rural

Suburbs

Urban area

21. Do not read. Check the appropriate box that fits the respondent.

Female

Male

Read:

Thank you very much for your time today. Here is your payment for your participation today.

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