Outcome Follow-up Questionnaire in Person

ATTACHMENT 13: SCREENER WITH INFORMED CONSENT FOR RETURNING PARTICIPANTS (LONGITUDINAL)

[FOR RETURNING (LONGITUDINAL) RESPONDENTS THE FOLLOWING TEXT WILL BE THE FIRST SCREEN THAT RESPONDENTS SEE UPON LAUNCHING THE SURVEY]

ZA3. [IF LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1)] The RESPECT LGBT survey asks LGBT young adults about opinions and behaviors related to tobacco and use of media. If you recall, in spring of 2016, you were asked to participate in the study. RTI, a non-profit research organization, is working with the FDA to conduct this study. We are contacting you again to determine whether anything has changed, or if it has stayed the same. Before beginning the study, please answer a few questions to determine whether you are eligible. You are one of approximately 6,500 young adults within 24 cities across the United States that is being invited to take part. Your answers to the questions will be kept private to the fullest extent allowable by law, and your participation is voluntary. If we determine you are eligible for the study, you will have the opportunity to complete one or more additional online surveys on your own as part of this study for $20-$25 each.

Do you consent to participate in this survey?

1. Yes, I consent to participate in this survey

2. No, I do not want to participate in this survey

REFSCRN. [IF ZA3 (SCREENER CONSENT) AND LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1) = NO] Thank you for your time.

Z0. [IF LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1)] Before we begin, we have a couple of general questions about you. You may have seen these questions before, but we appreciate you responding to them again.

NEXT

Z0a. [IF LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1)] Please confirm the email address where you received the survey invitation.

Email Address: ________________

Re-enter Email Address: _______________

PROGRAMMER: VALIDATE FORMAT FOR EMAIL ADDRESS. IF FORMAT IS INCORRECT, PLEASE DISPLAY “Please enter a valid email address.” IF THE EMAIL ADDRESSES DON’T MATCH PLEASE DISPLAY “The email addresses do not match. Please try again.”

Z1. [IF LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1)] What is the 5-digit zip code where you currently live?

__ __ __ __ __ (5-digit, numeric responses only)

Z2. [IF LONGITUDINAL (RFU1=1)] What is your date of birth?

PROGRAMMER: DISPLAY A DROP DOWN LIST OF 12 MONTHS AND ANOTHER OF YEARS 1985 – 2005.

Z3. [IF LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1)] What is your current gender identity?

₁ Male

₂ Female

₃ Trans male/Trans man

₄ Trans female/Trans woman

₅ Genderqueer/Gender non-conforming

₆ Different identity (please state)

₉ Prefer not to answer

Z4. [IF LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1)] What sex were you assigned at birth, on your original birth certificate?

₁ Female

₂ Male

₉ Prefer not to answer

[If Z3= 1 or 3 (male or trans male) display Z5, ELSE display Z6]

Z5. [IF LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1)] Which of the following best represents how you think of yourself?

₁ Gay

₂ Straight, that is, not gay

₃ Bisexual

₄ Something else

₅ I don’t know the answer

₉ Prefer not to answer

[If Z5= 4, go to Z7, if Z5= 5 go to Z8, else go to Z9]

Z6. [IF LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1)] Which of the following best represents how you think of yourself?

₁ Lesbian or gay

₂ Straight, that is, not lesbian or gay

₃ Bisexual

₄ Something else

₅ I don’t know the answer

₉ Prefer not to answer

[If Z6= 4, go to Z7, if Z6= 5 go to Z8, else go to Z9]

Z7. [IF LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1)] What do you mean by something else?

₁ You are not straight, but identify with another label such as queer, trisexual, omnisexual, or pansexual

₂ You are transgender, transsexual, or gender variant

₃ You have not figured out or are in the process of figuring out your sexuality

₄ You do not think of yourself as having sexuality

₅ You do not use labels to identify yourself

₆ You mean something else (please state)

₉ Prefer not to answer

[All Skip to Z9]

Z8. [IF LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1)] What do you mean by don’t know?

₁ You don’t understand the words

₂ You understand the words, but you have not figured out or are in the process of figuring out your sexuality

₃ You mean something else

₉ Prefer not to answer

Z9. [IF LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1)] What is your age? ____________ (Range: 15-80)

[IF LONGITUDINAL OR LONGITUDINAL NR (RNE=1)] SET ELIGFLAG. IF [Z0 MATCHES SAMPLE FRAME INFORMATION AND Z1 IS THE SAME ZIP OR DMA AS FRAME INFORMATION AND Z2 MATCHES SAMPLE FRAME INFORMATION AND (LONGITUDINAL (RFU1=1) AND Z9= 18 to 24-years-old OR LONGITUDINAL NR (RNE=1) AND Z9= BASELINE AGE OR BASELINE AGE +1) AND [Z3= 3 to 5 OR Z5= 1 or 3 OR Z6= 1 or 3 OR Z7= 1 or 2 or 6] THEN ELIGFLAG=1. ELSE ELIGFLAG=2.

Ineligible due to survey responses (ELIGFLAG=2 AND LONGITUDINAL (RFU1=1) OR LONGITUDINAL NR (RNE=1)):

Thank you for your responses. Based on your responses, you are not eligible to participate in the study. We have no further questions at this time.

OMB No: 0910-0808 Expiration Date: 01/31/2019

Paperwork Reduction Act Statement: The public reporting burden for this collection of information has been estimated to average 5 minutes per response. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.