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PROJECT EQUIP
WELCOME TO THE SCREENING SURVEY!

When taking this research survey, if at any time you lose your Internet connection or need to stop, please use the same link to come back and complete the survey.

You are free not to answer any question that you do not wish to answer, and can refuse to participate or withdraw from participation at any time without penalty.

THANK YOU FOR YOUR INTEREST!
Welcome to Project EQUIP

Title of Research:
Project EQUIP: Enhancing Quality In Protective strategies

Principal Investigator:
Melissa A. Lewis, Ph.D., melissa.lewis@unthsc.edu, 817-735-5136

Collaborative Investigators:
Dana Litt, Ph.D., dana.litt@unthsc.edu
Anne Fairlie, Ph.D., afairlie@uw.edu
Jason Kilmer, Ph.D., jkilmer@uw.edu

Research Staff:
Emma Kannard, BA, Research Assistant, emma.kannard@unthsc.edu
Haleigh Hicks, BS, Research Assistant, haleigh.hicks@unthsc.edu
Allison Cross, MS, Graduate Student Research Assistant, allisoncross@my.unthsc.edu

Collaborating Research Institutions:
University of North Texas Health Science Center
University of Washington

Key Information for Project EQUIP
You are being invited to participate in Project EQUIP, a research study which aims to explore motivations for use and non-use of drug and alcohol protective behavioral strategies among young adults ages 18-24. The purpose of this study is to develop an online and text message intervention program that would improve health practices in these areas. This research study conducted by investigators at the University of North Texas Health Science Center is completely voluntary. If you consent, you will be asked to complete a 5-minute screening survey and complete a 60-minute online focus group or one-on-one cognitive interview via Zoom Video Communications. After your focus group or cognitive interview, we will mail you a Greenphire Mastercard and load it with $50 for your participation. Although there is a chance you may not benefit from the focus group or cognitive interview, may experience loss of confidentiality, or may feel uncomfortable, these risks are minimal. To protect you from the risks of hacking, the Zoom meeting rooms will be encrypted and participants will be screened before being allowed to enter. To protect your confidentiality, we store your non-identifiable data separately from your identifiable information, and you will not be asked to give your full name during the focus groups or cognitive interviews. You are also welcome not to answer any questions that may make you feel uncomfortable. For a complete description of risks and how they are managed, refer to the detailed consent that follows. While there is no direct benefit for participating in this study, benefits to society include the opportunity to evaluate the program and provide suggestions for future development of programs like this that aim to reduce substance misuse and related issues among young adults. Participants also often find participating in focus groups to be illuminating and empowering. You do not have to participate in this study.

This research is being conducted by Dr. Melissa Lewis at the School of Public Health at the University of North Texas Health Science Center located in Fort Worth, TX. This study has been approved by the North Texas Regional Institutional Review Board.

We would like to invite you to participate in a confidential research study. The purpose of Project EQUIP is to explore motivations for use or non-use of protective behavioral strategies for behaviors, including alcohol and drug use, among young adults ages 18-24. We are interested in young adults' feedback on potential online and text message materials for future substance use programming. The information you provide for this study may help our research team better understand motivations for use or non-use of protective behavioral strategies among young adults.

The details:

  • You will be asked to complete demographic questions (e.g., age, birth sex, race, ethnicity, pregnancy status [i.e., if female, you cannot enroll in the research study if you are pregnant or trying to get pregnant]), as well as questions about your alcohol and marijuana use or non-use (e.g., On average, over the past month, how often have you consumed alcohol?; On average, during the past month, how often have you used marijuana?) to see if you fit our study needs. We also ask for your contact information and whether you would like to be contacted for future research studies. This information will be confidential.

  • If you are not a good fit for our study, you will receive an email following the completion of this initial screening survey notifying you that you are ineligible for the study.

  • This short survey takes approximately 5 minutes. The overall purpose of this initial screening survey is to determine if you are eligible to participate in the main study where you will be asked to provide feedback on potential online and text message materials for substance use programming among young adults. You will not be compensated for this short eligibility survey. If you are eligible and agree to be in our research study, you will be invited to (1) schedule a one-time online focus group via Zoom Video Communications with same-sex participants, which will take approximately 60 minutes to complete or (2) schedule a one-on-one cognitive interview via Zoom Video Communications, which will also take approximately 60 minutes to complete.

  • You will be paid $50 on a Greenphire Mastercard to compensate for your time, which will be mailed to you after attending the online focus group or the online cognitive interview (see below).

  • You will be asked to present a government ID (current driver's license or state issued ID) during the focus group/cognitive interview to verify age and identity in a private breakout room prior to beginning the focus group/cognitive interview.

  • If you decide to end participation before the end of the focus group/cognitive interview, you will not be paid the $50.

  • If you are eligible, you will receive up to 5 emails, 5 text messages, and 5 phone call reminders to schedule your one-time online focus group/cognitive interview.

  • Once you have scheduled a focus group/cognitive interview, you will receive 2 email reminders and 2 text message reminders to attend your focus group/cognitive interview.

  • If you miss your scheduled focus group/cognitive interview, you will receive up to 3 texts and 3 emails to reschedule.

  • Participation in the focus group or cognitive interview will involve discussing a potential alcohol and marijuana protective behavioral strategies intervention.

  • In total, you can earn $50 loaded onto your Greenphire Mastercard. You will also receive additional information about how the Greenphire Mastercard works. When you receive this in the mail, you will be asked to contact us via email or phone so we can load your card with your compensation.

  • Unless you withdraw from the research study, the researchers can continue to use or share your de-identified (no identifiers) information indefinitely. De-identified data could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative. The researchers will be publishing articles about the project and presenting de-identified data at conferences and through other platforms such as online databases. Data will be de-identified (no identifiers) by the end of the study.

  • To withdraw from the study any time, please contact the researchers using phone 817-735-2371, or by emailing us at equip@unthsc.edu.

  • A description of this clinical trial will be available on www.clinicaltrials.gov as required by US law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time using the following ID: NCT04978129.

Focus Groups/Cognitive Interviews:

If eligible, what you will be asked to do:

  • Information obtained in the focus group/cognitive interview is intended to assist in the development of future programs aimed at enhancing the use of protective behavioral strategies for alcohol and marijuana users. In particular, focus groups/cognitive interview participants can offer ideas to help us evaluate potential online and text message materials for substance use programs among young adults. These focus groups/cognitive interviews will help us evaluate the content and procedures we plan to use in these online and text messaging programs for young adults. You will be given the opportunity to discuss alcohol use (e.g., "What are times or instances when someone may choose to drink alcohol?"), marijuana use (e.g., "What are some things people can do to limit the amount of marijuana they use?"), motivations for use of protective behavioral strategies (e.g., "What are reasons some might not want to use any of those strategies?"), as well as provide your opinions and feedback on possible online and text messaging content (i.e., "What areas, if any, could be made more attractive or more geared towards people your age?") for these future programs. Approximately 135 young adults will be invited to participate in focus groups/cognitive interviews.

  • The online focus groups will be held in a private Zoom meeting room with approximately 6-10 other participants of your identified sex and will last 60 minutes.

  • The online cognitive interviews will be held in a private Zoom meeting room without other participants and will last 60 minutes.

  • You will not be asked to sign up for a Zoom account. However, you will be asked to download and install the Zoom application on your personal device and agree to the Zoom Terms of Service to participate.

  • To download and run Zoom on your personal device, you will need an iPhone (iOS 8.0 or later), an Android cell phone (Android 4.0x or later), a PC/laptop (with Windows 7, 8, or 10), or a Mac computer/laptop (MACOS 10.9 or later).

  • You will need a stable internet connection during your participation in the online focus group/cognitive interview and maintain your video camera on for the duration of the session.

  • You will be asked to present a government ID (current driver's license or state issued ID) in a private online break out room to verify age and identity prior to starting the focus group with the other participants or prior to beginning your cognitive interview.

  • You will be paid $50 on a Greenphire Mastercard to compensate for your time, which will be mailed to you at the end of the focus group/cognitive interview. You will also receive information about how the Greenphire Mastercard works. When you receive your Greenphire Mastercard in the mail, you will be asked to contact us via phone or email so we can load it with the $50 for participating in the focus group/cognitive interview.

  • If you decide to end participation and leave the Zoom meeting before the end of the focus group/cognitive interview, you will not be paid the $50.

  • If you miss your scheduled focus group/cognitive interview, you will receive up to 3 texts and 3 emails to reschedule your focus group/cognitive interview.

  • Focus groups/cognitive interviews will be moderated by the research investigators. In order to help protect your privacy, it is important to not disclose any personal use information in the focus group/cognitive interview. You will NOT be asked to discuss your personal behavior (e.g., your own alcohol or marijuana use), but will be instructed to only discuss your thoughts and reactions about the study materials and procedures.

  • You may choose not to answer any questions that you do not wish to answer.

  • The online focus group/cognitive interview will be audio and video-recorded and notes will be transcribed into electronic documents. The digital recording feature in Zoom will not be accessible to participants since only the moderator has automatic access to this feature in Zoom. Unless the moderator chooses to make this feature available to the participants, no one will be able to record the focus group/cognitive interview through Zoom. The moderator will not grant participants the ability to record in Zoom and this feature will only be used for the focus groups/cognitive interviews. Your name or any identifying information will not be included in these transcriptions. Identifiable information in audio and video recordings will be kept for 1 year and then destroyed. De-identified data (i.e., no identifiers) including study transcripts and notes will be kept indefinitely. After recordings are destroyed, your information cannot be removed if you wish to withdraw your participation.

  • Unless you withdraw from the research study, the researchers can continue to use or share your de-identified (no identifiers) information indefinitely.De-identified data could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative. The researchers will be publishing articles about the project and presenting de-identified data at conferences and through other platforms such as online databases. Data will be de-identified (no identifiers) by the end of the study.

  • To withdraw from the study any time, please contact the researchers using the phone number 817-735-2371 or by emailing equip@unthsc.edu.

  • A description of this clinical trial will be available on www.clinicaltrials.gov as required by US law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time using the following ID: NCT04978129.

RISKS, STRESS, OR DISCOMFORT

The risks associated with participation in this short online survey and the focus group/cognitive interview are primarily related to the sensitivity of some of the questions, including alcohol and drug use, and the possibility of hacking during the online focus group/cognitive interview. These questions may make you feel uncomfortable or may seem intrusive, or you may become concerned about your drinking, marijuana use, or other health behaviors as you answer the questions. You are asked to report on illegal behaviors, such as using controlled substances. Answers to these questions could pose a risk if the information were known and linked to identifiable individuals. It is possible that you will feel uncomfortable while taking the survey, or feel as if you should share information that you don't want to share. Lastly, due to the online nature of the focus groups/cognitive interview, there exists a probability that the session could be hacked, which would result in loss of confidentiality.

However, we have taken steps to protect you from these risks. All of your data will be kept confidential and data will be identified only by a PIN (personalized identification number) randomly generated for research purposes, and will not be directly identified by your name. The PIN is always embedded in survey links, meaning the link is specific to you and your survey data. Thus, you will never need to enter your PIN to complete the study survey. Further, to ensure that online focus groups/cognitive interviews are not hacked, online connection to the sessions via Zoom will be encrypted and through the use of waiting rooms, only the correct participants will be allowed to join the online focus group/cognitive interview. This will minimize the potential for loss of confidentiality if an attempt to hack the online session was made.

You may feel uncomfortable participating in the focus group/cognitive interview or feel as if you should share opinions you may not want to share. For focus groups, while we ask group participants to respect each other's confidentiality, we cannot guarantee that what is said in the group will remain confidential. While potential study risks include discomfort, potential loss of confidentiality, and not benefitting from the focus group/cognitive interview, researchers have implemented safety measures to minimize these risks. We are obligated by law to report any suspicions of child abuse, neglect, or imminent harm to others.

While there may be no direct benefit to you for participating in this research, benefits to society include the opportunity to evaluate the program and provide suggestions for future development of programs like this that aim to reduce health and behavioral problems among young adults.

OTHER INFORMATION

Participating in this study is voluntary. You may refuse to answer any question and still submit your survey without penalty or loss of benefits to which you are otherwise entitled. You are free to withdraw at any time without penalty or loss of benefits to which you are otherwise entitled. To withdraw from the study at any time, please contact the researchers using the phone number 817-735-2371 or by emailing equip@unthsc.edu.

Researchers will only retain your contact information if you are eligible for this study or if you agree to be contacted for future research studies. If you are ineligible for this study and do not agree to be contacted for future research studies, your contact information and research data will be deleted within 120 days and not be used in any way. If you are ineligible for this study and agree to be contacted for future research studies, your contact information will only be used for the purposes of contacting you about future research studies and we will retain your contact information indefinitely. If you are eligible for this study and agree to be contacted for future research studies, your contact information will only be used for the purposes of contacting you about the study or future research studies and we will retain your contact information indefinitely. If you are eligible for the study but do not agree to be contacted for future research studies, your contact information will only be used for the purposes of contacting you about the study and we will retain your contact information until the end of the study. If you choose to "like" or "follow" our Facebook, Instagram, or Twitter Fan Page, you may see more posts from us about our latest projects/activities, general updates and other fun things.

To help us protect your privacy, we have obtained a Certificate of Confidentiality from the U.S. Department of Health and Human Services. With this certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.

The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of federal agencies. A Certificate of Confidentiality does not protect you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information. The protection offered by the Certificate does not stop us from voluntarily reporting information about suspected or known sexual, physical, or other abuse of a child or older person, or a subject's threat of violence to self or others. If any member of the research team is given such information, he or she will make a report to the appropriate authorities, and will do so without disclosing your participation in this study.

A description of this clinical trial will be available on www.clinicaltrials.gov as required by US law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time using the following ID: NCT04978129.

Who do I contact if I have questions about the study? Project EQUIP Staff equip@unthsc.edu, 817-735-2371

If you would like to participate in the screening survey and focus group/cognitive interview (if eligible), please indicate your consent below.

Melissa Lewis - Signature

Melissa A. Lewis, Ph.D.
Principal Investigator
Melissa.Lewis@unthsc.edu, 817-735-5136


First, we will ask for you to provide consent for your own participation in the screening survey and focus group/cognitive interview (if eligible):


PARTICIPANT'S STATEMENT

This study has been explained to me. I have had a chance to ask questions. If I have questions later about the research, I can call 817-735-2371. If I have questions about my rights as a research subject, I can call the North Texas Regional Institutional Review Board at 817-735-0409.

Your research records will be kept as confidential as possible under current local, state, and federal law. However, federal regulatory agencies and the North Texas Regional Institutional Review Board (IRB) may examine your records.

Please answer the question below and hit NEXT (regardless of your answer).


Please indicate whether or not you would like to participate.

(Note: by checking YES you are consenting to this initial screening phase of the project and participating in the online focus group/cognitive interview, if eligible. You will also be asked to provide a drawn e-signature and asked to type your full name).

Please provide a response.

Please sign and complete the information below if you checked “YES” above. This information will document your consent for this initial screening survey. All of your responses will be kept confidential.


Electronic Signature: (click or tap to sign)

To be eligible for this study your signature is required.

Typed Full Name:

To be eligible for this study your full name is required.

Please enter your email to receive a copy of this statement for your records. If you later decide you would like a printed copy of the consent form, contact project staff and request to be mailed a printed copy.

Email (e.g. equip@unthsc.edu)

To be eligible for this study your email is required.

Please submit your completed consent form by pressing the 'Next' button below.


You indicated that you DO NOT want to participate in Project EQUIP at this time.

If this is INCORRECT, and you DO want to participate, please press [Back] and change your response.


If this is CORRECT, please confirm:

Please provide a response.

Thank you.


HIPAA Header

Study Title:
Project EQUIP: Enhancing Quality In Protective strategies

Principal Investigator Name:
Melissa A. Lewis


A. What is the purpose of this form?

The purpose of this form is to give your permission to the research team at the University of North Texas Health Science Center (“UNTHSC”) to obtain, use or share your protected health information (PHI). This protected health information will be used to do the research named above. UNTHSC understands that information about you and your health is personal and we are committed to protecting the privacy of that information in accordance with state and federal privacy laws. Because of this commitment, we must obtain your written authorization before we may collect, use or share your protected health information for the research study listed above. This form provides authorization and helps us make sure you are properly informed of how this information will be used or disclosed. You do not have to sign this permission form. If you do not sign, UNTHSC will not obtain, use or share your protected health information for research. Please note though that you will not be able to participate in the research study. Your decision to not sign this permission will not affect any treatment, health care, enrollment in health plans or eligibility for benefits.


B. What is considered Protected Health Information (PHI)?

In this form, “protected health information” (PHI) refers to any health information that identifies you, such as:

  • Your past, present, or future physical or mental health or condition (e.g., responses to surveys)

C. What Protected Health Information will be obtained, used or shared?

If you sign this form, you give UNTHSC permission to obtain, use or share the following health information as part of this research study:

  • Alcohol use collected from surveys
  • Substance use collected from surveys

UNTHSC is required by law to protect your health information. By signing this form you authorize UNTHSC to obtain, use or share your health information for this research. Those persons who receive your health information may not be required by Federal privacy laws to protect it and may share your information with others without your permission, if permitted by laws governing them.


D. From whom, or where will you obtain my Protected Health Information?

Health information about you created or generated during the course of this research study.


E. Who may obtain, use or share my Protected Health Information?

Your protected health information may be obtained, used, or shared with these individuals or organizations for the following purposes:

  1. To the research team for the research described in the Research Consent Form
  2. To others with authority to oversee the research (i.e., Institutional Review Board (IRB), safety monitoring committee, oversight board, etc.)
  3. To others who are required by law to review the quality and safety of the research, including: U.S. government agencies, such as the Food and Drug Administration or the Office of Human Research Protections, the research sponsor National Institutes of Health, or the sponsor’s representatives including but not limited to the National Institutes on Alcohol Abuse and Alcoholism, other federal or state agencies, and government agencies in other countries.

Any protected health information disclosed pursuant to the authorization may be subject to re-disclosure by the recipient and is no longer protected.


F. How will my Protected Health Information be used or shared for the research?

If you agree to be in this study, the research team may use or share your protected health information in the following ways:

  1. To perform the research
  2. Share it with researchers in the U.S. or other countries
  3. Use it to improve the design of future studies

G. Am I required to sign this document?

No, you are not required to sign this document. If you decide not to sign this document, you will still receive the same clinical care, or any services you were already entitled to receive. However, if you do not sign the document, you will not be able to participate in this research study.


H. Does my permission expire?

This permission to release your Protected Health Information expires when the research ends and all required study monitoring is over.


I. Can I cancel my permission?

You can cancel your permission at any time.

You can do this by writing to the researcher. Please send your written request to:

Project EQUIP Staff
Department of Health Behavior and Health Systems
School of Public Health
3500 Camp Bowie Blvd; EAD 708
Fort Worth, TX 76107-2699
Telephone: 817-735-2371
Email: equip@unthsc.edu

You have the right to take back your permission at any time, except to the extent that the research team has already taken action in reliance on your permission. If you cancel your permission, you may no longer be in the research study.

If you cancel, no more health information about you will be collected. However, information that has already been collected and disclosed about you may continue to be used as necessary to maintain the integrity of the study (i.e., complete the research). Also, if the law requires it, the sponsor and government agencies may continue to look at your protected health information to review the quality or safety of the study.


J. QUESTIONS CONCERNING YOUR PRIVACY RIGHTS?

Please call us at 817-735-2371 with any questions.


K. Authorization

If you agree to the use and release of your Protected Health Information, please sign using your electronic signature below.


Consent for Specific Health Information and Use

The following information will only be released if you give your specific permission, which is required by Federal and state laws, by putting your initials on the line(s). The federal rules bar any use of the information to criminally investigate or prosecute any alcohol or drug abuse patient.


I agree to the release of information pertaining to alcohol use.

To be eligible for this study your initials are required.

I agree to the release of information pertaining to substance use.

To be eligible for this study your initials are required.

Required Signature for HIPAA Authorization:


Subject Typed Name:

To be eligible for this study your full name is required.

Subject Electronic Signature: (click or tap to sign)

To be eligible for this study your signature is required.

Witness
If this form is being read to the subject because s/he cannot read the form, a witness must be present and is required to type his/her name and sign here.


Witness’ Typed Name:

Please use only alphabetical characters. Ex: James.

Witness’ Electronic Signature: (click or tap to sign)

Please provide a response.

If you provided your email, you will receive a copy of this statement for your records.

Please submit your completed HIPAA form by pressing the ‘Next’ button below.


Please click Submit to complete your survey.