Focus Group Testing of Consumer Messaging on Participation of Diverse Women in Clinical Trials

OMB: 0910-0497

Exp. Date: 03/16

FDA OFFICE OF WOMEN’S HEALTH

Diverse Women in Clinical Trials

F

Introduction: Hello, I am {INTERVIEWER NAME}, and I am calling to invite women in your area to participate in a small group discussion about diverse women in clinical trials. Clinical trials help to show if medical products, tests, and other treatments are safe and effective. This discussion will be confidential and anonymous. Your name or other identifying information will not be shared with anyone outside this research project. You do not need to prepare to participate. We are interested in your opinions and comments on health education materials. You will receive $75 for your participation and light refreshments will be provided during the discussion. May I ask you a few questions to determine if you are eligible to participate?

Voicemail Message: Hi, my name is {INTERVIEWER NAME} I am calling about participating in a women’s health project about diverse women in clinical trials. We will try to call you back over the next few days to see if you may be interested in participating.

ocus Group Screener Guide

01 CONTINUE

02 TERMINATE (RECORD REASON AND THANK) _____________________

Questions

1. [INTERVIEWER: INDICATE LOCATION OF FOCUS GROUP AREA]

1. Rockville, MD

2. Dallas, TX

3. Los Angeles, CA (surrounding area)

2. Is participant female? [INTERVIEWER: ASK ONLY IF NECESSARY]

01 Male (TERMINATE)

02 Female (CONTINUE)

3. What is the highest grade or year of school you completed? [INTERVIEWER: DO NOT READ LIST]

01 6^th grade or less (TERMINATE)

02 7^th grade-11^th grade (CONTINUE)

03 12^th grade/GED (CONTINUE)

04 Some college/Associate (CONTINUE)

05 College graduate or higher (TERMINATE)

99 Refused (TERMINATE)

4. Have you participated in a focus group in the past 6 months?

01 Yes (TERMINATE)

2. No (CONTINUE)

5. Are you comfortable reading and writing English?

1. Yes (CONTINUE)

2. No (TERMINATE)

6. Do you currently have health insurance?

01 Yes

02 No

7. Do you regularly visit a health care provider?

01 Yes

02 No

9. Have you ever participated in a clinical trial?

1. Yes

2. No

10. Have you been diagnosed with any of the following conditions? (MAY SELECT MORE THAN ONE CONDITION)

1. Diabetes

2. Lung Disease (e.g. COPD)

3. Heart disease (CVD)

4. Depression or Anxiety

5. Other: _______________________________________

6. NONE

11. How old are you? _________

[INTERVIEWER: RECORD AGE AND SELECT AGE CATEGORY. IF RESPONDENT PREFERS NOT TO PROVIDE AGE, READ THE LIST OF CATEGORIES]

01 18 to 20 (TERMINATE)

02 21 to 30

03 31 to 40

04 41 to 50

05 51 to 60

06 61 to 65

07 Over 65 (TERMINATE)

99 Refused

12. How would you best describe yourself? [INTERVIEWER: READ LIST]

01 White, non-Hispanic

02 Black, non-Hispanic

03 Hispanic/Latino

04 Asian, describe: __________________

05 American Indian/Native American

06 Other, describe: ________________________________

99 Refused

13. Last question: please stop me when I reach the category that includes your household’s total annual income for last year, 2014.

01 Under $15,000

02 From $15,000 to less than $30,000

03 From $30,000 to less than $50,000

04 From $50,000 to less than $75,000

05 From $75,000 to less than $100,000

06 From $100,000 to less than $125,000

07 $125,000 or more

08 Don’t Know

99 Refused

Thank you for answering the questions. We would like to invite you to participate in discussion about women in clinical trials with a small group of 5-7 other women from the {Washington DC/Dallas/LA} area on {July/Aug XX at 6pm}. Again, you will receive $75 for your participation and it should take approximately 90 minutes of your time, if you choose to participate. Light refreshments will also be provided. During the discussion we will ask your opinion and comments and everything discussed will be confidential and anonymous. No identifying information will be used. Participation is voluntary and you may leave at any time. Would you like to participate in this group?

1. Yes (CONTINUE TO COLLECTING CONTACT INFORMATION)

2. No (THANK FOR TIME AND TERMINATE)

INTERVIEWER: Recruit women with a variety of:

• income levels

• target health conditions (Diabetes, Heart Disease/CVD, Lung Diseases, Depression) also want healthy women

• ages, and

• ethnicities

PARTICIPANT CONTACT INFORMATION

Thank you very much for your interest in participating. The last thing I need to ask is for contact information to send you a letter with details about participating including location/directions to the focus group on July/Aug XX at 6pm. We will also call before the discussion to confirm. Again, this information will be used only to confirm participation and will not be used for any other purposes.

Lastly, we will make every effort to accommodate persons with physical disabilities or special needs. Do you require special accommodations due to a disability?

1. Yes. Describe: _______________________________________________

2. No

Respondent name____________________________________________________

Telephone __________________________ Alternate ___________________________

Address _____________________________________________________________

_____________________________________________________________________

E-mail __________________________________________________________

Best time and way to be reached __________________________________________

Participant # _______ Group # __________

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