Notifications

attachment 6B: Notifications Related to the Point of Sale intervention for tobacco evaluation (positev)

Interview—Unable to Contact

<RTI letterhead>

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

[DATE]

[FILL: Resident / Respondent Name]

[STREET ADDRESS]

[CITY], [STATE] [ZIP]

Dear [FILL: Resident / R NAME]:

Recently, a Field Interviewer from RTI International came to your home and asked you to take part in a research study sponsored by the U.S. Food and Drug Administration (FDA) designed to collect information from adults about the types of advertisements they’ve seen and their opinions about these ads. You could not complete the interview at that time and have been away or were not free each time the interviewer has come back since then. Your help in this study is important—this is why we keep trying to reach you.

A limited number of people were randomly chosen to represent the population of the United States. You cannot be replaced. If you choose not to take part, your experiences and views—as well as the thousands of people you represent—will not be heard.

The results of the study will help policy makers and researchers understand the impact and effectiveness of public education activities aimed at reducing tobacco-related death and disease. The information collected by this study will improve our understanding of how public education campaigns affect adults’ attitudes, beliefs, and behaviors toward tobacco use.

Your help is critical to the success of this study, and we are happy to work around your schedule so that you can be included. Please feel free to call me to set up an interview time. The interview can also be done at another location such as a public library.

We know that your time is important. In appreciation of your time you will be given $25 at the end of the interview.

I hope you’ll choose to participate in this extremely important and beneficial study.

Sincerely,

[FS NAME], Field Supervisor

P.S. Please, if you have any questions or would like to set up an appointment, call me toll-free at [TOLL-FREE NUMBER].

Screening—Unable to Contact

<RTI letterhead>

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

[DATE]

Resident

[STREET ADDRESS]

[CITY], [STATE] [ZIP]

Dear Resident:

Recently, a Field Interviewer from RTI International tried to contact your household about taking part in a research study sponsored by the U.S. Food and Drug Administration (FDA). So far, we have not been able to speak with anyone in your household. Your help in this study is important, which is why we keep trying to reach you.

Some people are cautious about talking to a stranger at the door, and we understand that. Please know that we are not selling anything. We have a few general questions to ask that will take about 10 minutes. You do not have to let the interviewer into your home—you can answer the questions right at your door.

After these few questions, someone in your household may be chosen to take part in the full 30 to 40 minute interview. If he or she completes the 30 to 40 minute interview, he or she will be given $25 at the end of the interview in appreciation of his or her time.

A limited number of people were randomly selected to represent the population of the United States. You cannot be replaced. If you choose not to take part, your experiences and views—as well as the thousands of people you represent—will not be heard.

Thank you for your time. I hope you’ll choose to take part in this extremely important and beneficial study.

Sincerely,

[FS NAME], Field Supervisor

P.S. Please, if you have any questions or would like to set up an appointment, call me toll-free at [TOLL-FREE NUMBER].

Interview Call Me

<RTI letterhead>

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

[DATE]

[FILL: Resident / Respondent Name]

[NAME OF COMPLEX]

[ADDRESS]

[CITY], [STATE] [ZIP]

Dear [FILL: Resident / R NAME]:

Recently, an interviewer from RTI International came to your home and asked you to take part in a research study sponsored by the U.S. Food and Drug Administration designed to collect information from adults about the types of advertisements they’ve seen and their opinions about these ads. Your help in this study is important, which is why we keep trying to reach you.

We want to give you more information about the study:

• A limited number of people—including you—were chosen to take part.

• As a thank you, you will be given $25 at the end of the interview.

• All information provided is kept private to the fullest extent allowed by law and will be used only for statistical purposes.

We are happy to work around your schedule so that you can be included. Please call our supervisor for your area, [FIRST & LAST NAME], to set up an appointment.

Please call:

[FIRST & LAST NAME]

[PHONE NUMBER] (toll free)

Thank you for your time. You are very important to the success of this study, and I thank you in advance for your help.

Sincerely,

National Field Director

Interview—Needs Clarification

<RTI letterhead>

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

[DATE]

[FILL: Resident / Respondent Name]

[STREET ADDRESS]

[CITY], [STATE] [ZIPCODE]

Dear [FILL: Resident / R NAME]:

Recently, a Field Interviewer from RTI International came to your home and asked you to take part in a research study sponsored by the U.S. Food and Drug Administration (FDA) designed to collect information from adults about the types of advertisements they’ve seen and their opinions about these ads. At the time, you had some concerns about the study.

The study will provide the FDA, policy makers, and researchers with important information about how exposure to public education campaigns affect adults’ attitudes, beliefs, and behaviors toward tobacco use. By taking part in this study, you will make a direct impact on important tobacco-related education activities. We know that your time is important. To thank you for your time, you will be given $25 at the end of the interview.

A limited number of people were chosen to represent the population of the United States. You cannot be replaced. If you choose not to take part, your experiences and views—as well as the thousands of people you represent—will not be heard. Your answers to the survey questions are combined with the answers of thousands of others and reported only as overall numbers.

Your help is critical to the success of this study, and we are happy to work around your schedule so that you can be included. Thank you for your time. I hope you’ll reconsider and choose to take part in this very important and beneficial study.

Sincerely,

[FS NAME], Field Supervisor

P.S. Please, if you have any questions or would like to set up an appointment, call me toll-free at [TOLL-FREE NUMBER].

Interview —"Nothing in it for me"/Uncooperative

<RTI letterhead>

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

[DATE]

[FILL: Resident / Respondent Name]

[STREET ADDRESS]

[CITY], [STATE] [ZIPCODE]

Dear [FILL: Resident / R NAME]:

Recently, a Field Interviewer from RTI International came to your home and asked you to take part in a research study sponsored by the U.S. Food and Drug Administration (FDA) designed to collect information from adults about the types of advertisements they’ve seen and their opinions about these ads. At the time, you did not want to participate. We are writing this letter to ask you to reconsider.

The results of this study will provide the FDA, policy makers, and researchers with important information about how public education campaigns affect adults’ attitudes, beliefs, and behaviors toward tobacco use. By taking part in this study, you will make a direct impact on important tobacco-related education activities.

A limited number of people were chosen to represent the population of the United States—and you were one of them! You cannot be replaced. If you choose not to take part, your experiences and views—as well as the thousands of people you represent—will not be heard.

We know that your time is important. To thank you for your time, you will be given $25 at the end of the interview.

I hope you’ll reconsider and choose to take part in this very important and useful study.

Sincerely,

[FS NAME], Field Supervisor

P.S. Please, if you have any questions, call me toll-free at [TOLL-FREE NUMBER].

Interview—Too Busy/No Time

<RTI letterhead>

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

[DATE]

[FILL: Resident / Respondent Name]

[STREET ADDRESS]

[CITY], [STATE] [ZIPCODE]

Dear [FILL: Resident / R NAME]:

Recently, a Field Interviewer from RTI International came to your home and asked you to take part in a research study sponsored by the U.S. Food and Drug Administration (FDA) designed to collect information from adults about the types of advertisements they’ve seen and their opinions about these ads. At the time, you were reluctant to spend the time needed to do the interview.

A limited number of adults were chosen to represent the population of the United States—and you were one of them! You cannot be replaced. If you choose not to take part, your experiences and views—as well as the thousands of people they represent—will not be heard.

As you know, this country is made up of all kinds of people, and so we are interviewing all kinds of people—including busy people like you. If we only interviewed people who have a lot of free time, then active people like you would not be fairly represented. Your participation is critical to the success of this study, and we are happy to work around your schedule so that you can be included.

We know that your time is important. To thank you for your time, you will be given $25 at the end of the interview.

The results of this study will provide the FDA, policy makers, and researchers with important information about how public education campaigns affect adults’ attitudes, beliefs, and behaviors toward tobacco use. By taking part in this study, you will make a direct impact on important tobacco-related education activities.

Thank you for your time. I hope you’ll reconsider and choose to take part in this very important study.

Sincerely,

[FS NAME], Field Supervisor

P.S. Please, if you have any questions or would like to set up an appointment, call me toll-free at [TOLL-FREE NUMBER].

Controlled Access Letter

<RTI letterhead>

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

[DATE]

[NAME], [TITLE]

[COMPLEX/COMMUNITY NAME]

[ADDRESS]

[CITY], [STATE] [ZIP]

Dear [MR./MS.] [NAME]:

Recently, one of our field interviewers, [FIRST & LAST NAMES], tried to contact specific residences within [COMPLEX/COMMUNITY NAME] that were randomly chosen to participate in a national study conducted by RTI International for the U.S. Food and Drug Administration. So far, [MR./MS.] [LAST NAME] has been unable to [GAIN ACCESS/GAIN FULL ACCESS] to [NAME OF COMPLEX/COMMUNITY], and we are asking for your help.

We understand your responsibility to protect your residents and want to provide you with more information about the study:

• We are not selling anything. This is not a marketing survey.

• A limited number of household addresses were randomly chosen to take part. We do not have any information about the residents other than an address.

• The RTI interviewer only needs a few minutes of the residents’ time to see if someone in the household may be asked to participate in an interview. If selected, those completing the interview receive a cash incentive.

• All information provided is kept private to the fullest extent allowed by law.

By helping our interviewer access the selected households in [NAME OF COMPLEX/COMMUNITY], you will make a direct contribution to this important research effort. [FIRST & LAST NAMES], our supervisor in your area, may contact you soon to address any questions, or you may call [HIM/HER] toll-free at [TOLL FREE NUMBER].

Your assistance is very important to the success of this study, and I thank you in advance for your help.

Sincerely,

National Field Director, RTI

Screening—Too Busy/No Time [To be handed to reluctant householders, as needed, at the doorstep]

<RTI letterhead>

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

Dear Resident,

Recently, a Field Interviewer from RTI International came to your home and asked you to take part in a research study sponsored by the U.S. Food and Drug Administration (FDA) designed to collect information from adults about the types of advertisements they’ve seen and their opinions about these ads. At the time, you were reluctant to spend the time needed to participate.

We know that your time is important. We have a few general questions to ask that will take about 10 minutes. You do not have to let the interviewer into your home—you can answer the questions right at your door.

After these few questions, someone in your household may be chosen to take part in the full 30 to 40-minute interview. If he or she completes the 30 to 40-minute interview, he or she will be given $25 at the end of the interview in appreciation of his or her time.

A limited number of adults were chosen to represent the population of the United States—and you were one of them! You cannot be replaced. If you choose not to take part, your experiences and views—as well as the thousands of people they represent—will not be heard.

As you know, this country is made up of all kinds of people, and so we are interviewing all kinds of people—including busy people like you. If we only interviewed people who have a lot of free time, then active people like you would not be fairly represented. Your participation is critical to the success of this study, and we are happy to work around your schedule so that you can be included.

The results of this study will provide the FDA, policy makers, and researchers with important information about how public education campaigns affect adults’ attitudes, beliefs, and behaviors toward tobacco use. By taking part in this study, you will make a direct impact on important tobacco-related education activities.

Thank you for your time. I hope you’ll reconsider and choose to take part in this very important study.

Sincerely,

Kristine Wiant, PhD

National Field Director

Screening—Too Busy/No Time [To be shipped, as needed, to households that have refused to screen]

[DATE]

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

[FILL: Resident / Respondent Name]

[STREET ADDRESS]

[CITY], [STATE] [ZIPCODE]

Dear [FILL: Resident / R NAME]:

Recently, a Field Interviewer from RTI International came to your home and asked you to take part in a research study sponsored by the U.S. Food and Drug Administration (FDA) designed to collect information from adults about the types of advertisements they’ve seen and their opinions about these ads. At the time, you were reluctant to spend the time needed to participate.

We know that your time is important. We have a few general questions to ask that will take about 10 minutes. You do not have to let the interviewer into your home—you can answer the questions right at your door.

After these few questions, someone in your household may be chosen to take part in the full 30 to 40-minute interview. If he or she completes the 30 to 40-minute interview, he or she will be given $25 at the end of the interview in appreciation of his or her time.

A limited number of adults were chosen to represent the population of the United States—and you were one of them! You cannot be replaced. If you choose not to take part, your experiences and views—as well as the thousands of people they represent—will not be heard.

As you know, this country is made up of all kinds of people, and so we are interviewing all kinds of people—including busy people like you. If we only interviewed people who have a lot of free time, then active people like you would not be fairly represented. Your participation is critical to the success of this study, and we are happy to work around your schedule so that you can be included.

The results of this study will provide the FDA, policy makers, and researchers with important information about how public education campaigns affect adults’ attitudes, beliefs, and behaviors toward tobacco use. By taking part in this study, you will make a direct impact on important tobacco-related education activities.

Thank you for your time. I hope you’ll reconsider and choose to take part in this very important study.

Sincerely,

[FS NAME], Field Supervisor

P.S. Please, if you have any questions or would like to set up an appointment, call me toll-free at [TOLL-FREE NUMBER].

Screening—Needs Clarification [To be shipped, as needed, to households that have refused to screen]

[DATE]

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

[FILL: Resident / Respondent Name]

[STREET ADDRESS]

[CITY], [STATE] [ZIPCODE]

Dear [FILL: Resident / R NAME]:

Recently, a Field Interviewer from RTI International came to your home and asked you to take part in a research study sponsored by the U.S. Food and Drug Administration (FDA) designed to collect information from adults about the types of advertisements they’ve seen and their opinions about these ads. At the time, you had some concerns about the study.

Some people are cautious about talking to a stranger at the door, and we understand that. Please know that we are not selling anything. We have a few general questions to ask that will take about 10 minutes. You do not have to let the interviewer into your home—you can answer the questions right at your door.

After these few questions, someone in your household may be chosen to take part in the full 30 to 40-minute interview. If he or she completes the 30 to 40-minute interview, he or she will be given $25 at the end of the interview in appreciation of his or her time.

A limited number of people were chosen to represent the population of the United States. You cannot be replaced. If you choose not to take part, your experiences and views—as well as the thousands of people you represent—will not be heard. Your answers to the survey questions are combined with the answers of thousands of others and reported only as overall numbers.

Your help is critical to the success of this study, and we are happy to work around your schedule so that you can be included. Thank you for your time. I hope you’ll reconsider and choose to take part in this very important and beneficial study.

Sincerely,

[FS NAME], Field Supervisor

P.S. Please, if you have any questions or would like to set up an appointment, call me toll-free at [TOLL-FREE NUMBER].

Lead Letter for Nonresponse Follow up Cases that are Sent to the Field for Screening

<RTI letterhead >

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

Resident at:

1234 Main Street

Anywhere, XX 12345

Dear Resident:

We are writing to ask for your help with an important research study that the Food and Drug Administration (FDA) is conducting in 30 counties across the United States. The FDA will use the results from this study to develop public education programs that will improve the health of Americans. You are receiving this letter because of the importance of your input in the final results.

In the next few weeks, an interviewer from RTI International, an independent, non-profit organization, will visit your home to determine your eligibility to participate in an in-person interview as part of this study. The interviewer will be wearing an identification badge, like the one shown below. The interviewer will use a tablet computer to ask you questions to determine if anyone in your household is eligible for the full survey. These initial questions will only take approximately 10 minutes of your time. You do not have to let the interviewer into your home—you can answer these questions right at your door. After these few questions, someone in your household may be selected to take part in the full 30 to 40-minute interview. If he or she completes the 30- to 40-minute interview, he or she will be given $25 in cash at the end of the interview in appreciation of his or her time.

Your participation is voluntary. You can refuse to answer any and all questions. All information provided by you will be kept private to the extent allowable by law. Your name and address will never be identified in reports or articles. There are no physical risks or direct benefits to you from answering our questions. However, you will be contributing to important research about how to improve health programs and the health of Americans.

Please share this information with any others in your household. If you have any questions about the study, you may call our project assistance line at 1-800-957-6457 between 9 am and 5 pm, Eastern Time, Monday through Friday or email us at [email protected].

Your help is very important to this study’s success. Thank you for your cooperation.

Sincerely,

Matthew Farrelly, PhD

RTI International

[INSERT SAMPLE PICTURE OF FI ID BADGE]

Follow-up Interview—Needs Clarification

<RTI letterhead>

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

[DATE]

[FILL: Resident / Respondent Name]

[STREET ADDRESS]

[CITY], [STATE] [ZIPCODE]

Dear [FILL: Resident / R NAME]:

Thank you for your previous participation in the Point of Sale Intervention for Tobacco Evaluation (POSITEv), an important study sponsored by the U.S. Food and Drug Administration (FDA). The results of the study will help policy makers and researchers understand the impact and effectiveness of public education activities aimed at reducing tobacco-related death and disease.

We are currently in the process of conducting follow-up interviews with previous participants. These follow-up interviews allow us to determine what has changed and what has stayed the same since you last participated. By continuing to take part in this study, you are making a direct impact on important tobacco-related education activities! To thank you for your time, you will be given $25 at the end of the interview.

A limited number of people were chosen to represent the population of the United States. You cannot be replaced. If you choose not to take part, your experiences and views—as well as the thousands of people you represent—will not be heard. Your answers to the survey questions are combined with the answers of thousands of others and reported only as overall numbers.

Your help is critical to the success of this study, and we are happy to work around your schedule so that you can be included. Thank you for your time. I hope you’ll continue to choose to take part in this very important and beneficial study. To set up an appointment at a time and location most convenient to use, please call me toll-free at [TOLL-FREE NUMBER].

Sincerely,

[FS NAME], Field Supervisor

Follow-up Interview—Too Busy/No Time

<RTI letterhead>

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

[DATE]

[FILL: Resident / Respondent Name]

[STREET ADDRESS]

[CITY], [STATE] [ZIPCODE]

Dear [FILL: Resident / R NAME]:

Thank you for your previous participation in the Point of Sale Intervention for Tobacco Evaluation (POSITEv), an important study sponsored by the U.S. Food and Drug Administration (FDA). The results of the study will help policy makers and researchers understand the impact and effectiveness of public education activities aimed at reducing tobacco-related death and disease.

We are currently in the process of conducting follow-up interviews with previous participants. These follow-up interviews allow us to determine what has changed and what has stayed the same since you last participated. By continuing to take part in this study, you are making a direct impact on important tobacco-related education activities!

Recently, a Field Interviewer from RTI International came to your home and asked you to take part in a follow-up interview. At the time, you were busy and could not participate.

As you know, this country is made up of all kinds of people, and so we are interviewing all kinds of people—including busy people like you. If we only interviewed people who have a lot of free time, then active people like you would not be fairly represented. Your participation is critical to the success of this study, and we are committed to offering a convenient solution.

In-person participation: We can schedule an appointment at a time and location that is most convenient for you; just let us know what works for you. To thank you for your time, you will be given $25 in cash at the end of the interview. Call [TOLL-FREE NUMBER] to set up an appointment.

Online participation: If you prefer to complete the follow-up questionnaire online, the login information is below. We will send you a $25 check after we receive your completed online questionnaire.

• In your web browser type the study website address: <<address>>

• On the login screen, type your username and password exactly as shown below:

  • Username: [Case ID]

  • Password: [Password]

Thank you for your time. I hope you’ll continue to take part in this very important study.

Sincerely,

[FS NAME], Field Supervisor

P.S. Please, if you have any questions or would like to set up an appointment, call me toll-free at [TOLL-FREE NUMBER].

Follow-up Interview—Unable to Contact

OMB No. 0910-0851

Exp. Date 04/30/2021

RIHSC No. 17-082CTP

[CASEID]

[DATE]

[FILL: Resident / Respondent Name]

[STREET ADDRESS]

[CITY], [STATE] [ZIPCODE]

Dear [FILL: Resident / R NAME]:

Thank you for your previous participation in the Point of Sale Intervention for Tobacco Evaluation (POSITEv), an important study sponsored by the U.S. Food and Drug Administration (FDA). The results of the study will help policy makers and researchers understand the impact and effectiveness of public education activities aimed at reducing tobacco-related death and disease.

We are currently in the process of conducting follow-up interviews with previous participants. These follow-up interviews allow us to determine what has changed and what has stayed the same since you last participated. By continuing to take part in this study, you are making a direct impact on important tobacco-related education activities! So far we have been unable to reach you to schedule an appointment.

As you know, this country is made up of all kinds of people, and so we are interviewing all kinds of people—including busy people like you. If we only interviewed people who have a lot of free time, then active people like you would not be fairly represented. Your participation is critical to the success of this study, and we are committed to offering a convenient solution.

In-person participation: We can schedule an appointment at a time and location that is most convenient for you; just let us know what works for you. To thank you for your time, you will be given $25 in cash at the end of the interview. Call [TOLL-FREE NUMBER] to set up an appointment.

Online participation: If you prefer to complete the follow-up questionnaire online, the login information is below. We will send you a $25 check after we receive your completed online questionnaire.

• In your web browser type the study website address: <<address>>

• On the login screen, type your username and password exactly as shown below:

  • Username: [Case ID]

  • Password: [Password]

Thank you for your time. I hope you’ll continue to take part in this very important study.

Sincerely,

[FS NAME], Field Supervisor

P.S. Please, if you have any questions or would like to set up an appointment, call me toll-free at [TOLL-FREE NUMBER].

28