**-**-**** **:**am Dyone Davis, Version: v* June *022, Type: UConn - Adult Consent projectredcap.org

Consent Form Page 1

Response was added on 12-07-2022 10:01am.

Overview of the Research

You are being asked to provide consent to participate in a research study. This study is under the supervision of Seth Kalichman, PhD, but other staff may act for him. Participation is completely voluntary. You may accept or decline participating. If you accept participation now, you can still change your mind later. Some key points to consider in deciding to participate are summarized in this overview. You should consider all of the information in this document carefully before making your decision as to whether you wish to participate in the research. The research is being conducted to better understand how people living with HIV engage in their healthcare and how they manage their HIV medications. Participation involves approximately 6 hours of your time over the next month for the Start Study and a maximum of 12 hours over the next 12 months for the Persist Study, should you be eligible. You will be asked to complete phone assessments, provide blood samples from a pin stick of your finger, and complete 28 days of brief daily text message surveys on your phone. You may also be asked to participate in health improvement phone coaching sessions with a trained professional. The main risks of the study include a slight bruising or soreness from the finger stick collection of blood and any inconvenience you may experience by participating. There may be benefits from participating in the study, which include learning new methods to improve your own health. A more detailed description of this research follows. WHY IS THIS STUDY BEING DONE? I understand and agree The purpose of the Start Study is to better understand the health of people living with HIV in relation to their healthcare and the medications they take. The Persist Study will test a health coaching program that may help people engage in healthcare and take their medications.

WHAT ARE THE STUDY PROCEDURES - WHAT WILL I BE ASKED TO DO?

The research is being done in two parts: the first part is called the Start Study and the second part is called the Persist Study. Activities for each study are described below.

START STUDY

Today, if you decide to consent to take part in the research project, you will be asked to complete a Start Study Enrollment Appointment. Today's Enrollment Appointment will take about 2 hours. You will be paid for the Enrollment Appointment Activities after the completion of the call. The Enrollment Appointment Activities consist of: ENROLLMENT APPOINTMENT

1. Contact Information: You will be asked to provide contact information in order that the study staff may mail you supplies, text or email you a survey and call you to complete study activities. The contact information will not be shared with anyone outside the project and will only be labeled with your Study ID Number. 2. Medication Information: You will be asked to provide information about your HIV medications, if you are taking any. In the event the information on bottle is unclear in the video chat, you will be asked to send a picture of the label via text message or email.

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3. First Phone Assessment: You will be asked to count your HIV medications, if you are taking any. 4. Blood Sample Collection

You will be asked to provide a self- collected blood sample with the assistance of a staff member. You will be asked to provide 3-4 drops of blood using a finger stick procedure. Your sample will only be labeled with your Study ID Number and a viral load test will be run on your blood sample. The viral load test is done to determine how much HIV is in your blood and is similar to the viral load testing that doctors do in healthcare. You may receive the results from the viral load test if you wish. You have been provided with all of the supplies to collect a finger stick blood sample. You will be paid for providing the sample after the staff receives notification that the sample has been received by the shipping company (UPS or FedEX).

BASELINE SURVEY

After you complete the Enrollment Appointment, you will be sent a link to the Baseline Survey, either in an email or text message. The survey includes questions about your health, healthcare, experience with medications, mood, substance use and other aspects of health. You do not have to answer any questions that you do not want to answer. Your name will not appear anywhere in the survey. The survey will take approximately 45 minutes to complete. You will be paid for the Baseline Survey within 24 hours of completion Monday through Friday. If the survey is completed on Saturday or Sunday, your payment will be placed on your study debit card on Monday. The Baseline Survey is time sensitive and must be completed within 48 hours of receiving the link. You will not be permitted to continue with any of the study activities listed below until you complete the Baseline Survey.

DAILY TEXT MESSAGE SURVEY I understand and agree

You will be asked to respond to brief daily

phone-delivered text message surveys. The survey will ask you about your social interactions and use of

alcohol or other substances during the previous day. Each daily text survey has 12 questions and requires about 3 to 5 minutes to complete. Text surveys are delivered for 28 consecutive days. Your text message surveys will begin after you complete your Baseline Survey. You must complete all of questions on a given day to receive the payment for that day. You will be paid on Day 15 and Day 29 by 5 PM for any surveys you completed during the previous 14 days. Payments will be placed on your study debit card by 5 PM.

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SECOND PHONE CALL AND SURVEY I understand and agree The Second Phone Call is NOT scheduled in advance but will occur any time from 28-35 days from the

Enrollment Appointment. If the staff member calls and you are not available, they will call you at a more convenient time. During this phone call, you will be asked to count your medications, if you are taking any. You must be home to complete this call.

Following the call, you will be sent a link to

complete a survey which will ask you questions about your health, healthcare and medications. The call and survey will take approximately 30 minutes to complete. You will be paid for the Second Phone Call and Survey after the staff receives notification that the Survey has been completed.

OTHER STUDY OPPORTUNITIES

Completion of the Second Phone Call and Survey

completes the Start Study. At the end of the Second Phone Call, the staff member will let you know if you may continue on into the Persist Study. Continuation is dependent upon the study needs.

PERSIST STUDY I understand and agree

REVIEW PREVIOUS DATA

Your signature on this Informed Consent indicates you are giving the researchers your permission to look at the information you provided the project in earlier studies, including the Start Study. Your previous

information will be identified by matching up your unique code number with other previous surveys.

If you continue into the Persist Study, the

information and data you provided during the Start Study will be linked to the Persist Study by your

Study ID Number. You will only be allowed to continue in the Persist Study if you complete the first Health Counseling Call within 2 weeks of completing the

Second Phone Call and Assessment.

The Persist Study takes place over 12 months, during which you will be asked to complete health coaching sessions conducted over the phone, monthly pill counts and surveys, and collection of finger stick blood for viral load testing.

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PHONE HEALTH COACHING CALLS I understand and agree You will be asked to attend a maximum of 16 weeks of phone health coaching calls. The number of coaching calls you are asked to attend will be determined by a process called randomization, which is like a "flip of a coin".

You will be randomized to receive either a maximum of 5 health coaching sessions OR as many coaching

sessions as you find helpful for up to 16 weeks.

During the coaching sessions, you will have the

opportunity to talk about different aspects of your healthcare, including strategies for attending

healthcare appointments and taking HIV medications. Additionally, you will talk with the coach about

successes or challenges you may face in staying

healthy. Each of the coaching sessions will last

20-40 minutes. Your coaching sessions will be audio recorded. Audio recordings will be used only for

research purposes and will be deleted within one year of study completion. The audio recordings are labeled only with your study number and not your name.

MONTHLY PHONE ASSESSMENTS AND SURVEY I understand and agree You will be asked to complete 11 monthly phone

assessments and surveys. The phone assessments will not be scheduled in advance, but we will try to call you during times that are best for you and your

schedule. If we call and you are not available, we will only leave a message if you have given us

permission to do so. During the phone assessment, you will be asked to provide the prescription label

information for each bottle of HIV medication you have and count your HIV medications (if you are taking

any). The staff member may ask you to connect via

video chat to verify the information on the

prescription label. The phone assessment will take about 15 minutes. Following each phone assessment, you will be sent a link by text message or email to

complete a brief survey. The survey will require about 15-20 minutes to complete. You will be paid for the Monthly Phone Assessment and Survey after the staff receives notification that the Survey has been

completed.

QUARTERLY FOLLOW-UP SURVEYS I understand and agree You will also be asked to complete 3 quarterly

surveys-at 4, 8 and 12 months from your enrollment into the Persist Study. You will receive a link to each survey via a text message or an email. The

surveys include questions about your health,

healthcare, experience with medications, your mood, substance use and other aspects of health-related

behaviors. You do not have to answer any questions that you do not want to answer. Each survey will take approximately 45 minutes to complete. Your name will not appear anywhere in the surveys.

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FINGER STICK BLOOD COLLECTION I understand and agree Using the same self-collection procedures described above for the Start Study, we will ask you to

self-collect a blood sample 6 more times during the Persist Study. You will be asked to do this

approximately every 6 weeks for the first 8 months of the study and one more time at the end of the study or about 12 months from now. The blood will only be

tested for HIV viral load. You may receive the results of these viral load tests.

If the lab is unable to obtain a viral load result from the sample you provide, you may be asked to

provide an additional blood sample.

ADDITIONAL STUDY ACTIVITIES I understand and agree FEEDBACK

Study staff may call you at some point during the

study to get feedback from you and your experience thus far in the study. This is completely voluntary and you are not required to do this. If you receive a phone call for this purpose and choose not to take part, this will have no impact on your study

participation.

REFERRALS

You will have the opportunity to tell others, who you think may want to participate, about the study.

Referring people to the study is completely voluntary and you do not have to tell others about the study or your participation. Payment for referrals only happens when the person you refer is eligible for and enrolls in the Start Study.

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WHAT ARE THE RISKS OR INCONVENIENCES OF THE STUDIES? I understand and agree There are minimal risks from participating in these studies.

• The finger stick procedure used to collect drops of blood uses a sterile, one-time use only pin that may cause minor irritation or soreness on your

fingertip.

• Some of the questions in the surveys may make you uncomfortable or cause you to become upset. You do not have to answer any question that you do not want to and you can stop participating at any time.

• If you become distressed, we will have someone for you to talk with.

• If you receive a phone call from a staff member

for a phone interview and it is not a convenient time to talk, you may ask that the staff member to call you back.

• Electronic transfer of any personal health

information such as an image of a medication bottle, may pose a risk of someone finding out your HIV

status.

WHAT ARE THE BENEFITS OF PARTICIPATING? I understand and agree

• This study may help us better understand behaviors related to the health of people living with HIV.

• This information could help in the development of ways to improve the health of people living with HIV.

• It is possible that the health coaching calls

could result in improving your understanding of your own health.

However, these benefits cannot be guaranteed.

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HOW WILL MY PERSONAL INFORMATION BE PROTECTED? I understand and agree The following procedures will be used to protect the confidentiality of your data.

• Under no circumstances, will any information

collected from you in this study be provided to

anyone.

• Your name will not be included with any of the

information collected from you. Research records will be labeled with a code. The code will be derived by a sequential number that reflects how many people have enrolled in the study.

• All electronic files (e.g., database, spreadsheet, etc.) containing identifiable information will be

password protected. Any computer hosting such files will be encrypted and also have password protection to prevent access by unauthorized users. Only the members of the research staff will have access to the

passwords.

• Any personal information being sent electronically will be deleted immediately from all staff devices without retention of any kind.

• At the conclusion of this study, the researchers may publish their findings. Identifying information will not appear in any publication.

• Only the researchers will have access to the

information you provide.

• A description of this clinical trial will be

available on http://www.ClinicalTrials.gov, as

required by U.S. 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.

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Your information will remain confidential with I understand and agree exception to the following:

We discover that you plan to cause serious harm to yourself or others.

If you reveal that a child or elderly person is at risk for abuse or harm, actions may be taken to

protect others and you.

In the above circumstances, we may be legally required to take action to protect you or that person.

To help us protect your privacy, we have received a Confidentiality Certificate from the US Department of Health and Human Services. The Confidentiality

Certificate says that the investigators cannot be

forced (for example by court subpoena) to give

information that may identify you in any federal,

state, or local civil, criminal, administrative,

legislative, or other proceedings.

You should also know that the UConn Institutional

Review Board (IRB) and the Office of Research

Compliance may inspect study records as part of their auditing program, but these reviews will only focus on the researchers and not on your responses or

involvement. The IRB is a group of people who review research studies to protect the rights and welfare of research participants.

WILL I RECEIVE PAYMENT FOR PARTICIPATION? ARE THERE COSTS TO PARTICIPATE? Participation in the study requires you to use your own phone, video chat, and text messaging. You will be provided with payments to reimburse you for your time and effort, as well as any phone expenses. 12-07-2022 10:01am Dyone Davis, Version: v7 June 2022, Type: UConn - Adult Consent projectredcap.org Page 9

I understand and agree

CAN I STOP BEING IN THE STUDY AND WHAT ARE MY RIGHTS? I understand and agree

• You do not have to be in the Start Study or

Persist Study if you do not want to. If you agree to be in the study, but later change your mind, you may drop out at any time. There are no penalties or

consequences of any kind if you decide that you do not want to participate.

• You will be notified of all significant new

findings during the course of the study that may

affect your willingness to continue.

• You do not have to answer any question that you do not want to answer.

WHOM DO I CONTACT IF I HAVE QUESTIONS ABOUT THE STUDY? I understand and agree Take as long as you like before you decide. We will answer any question you have about this study. You may call the Principal Investigators, Seth Kalichman at 404-***-**** if you have questions about this

project. You may also call the University of

Connecticut Institutional Review Board (IRB) at

860-***-****. They can answer any question about your rights as a research subject.

Documentation of Consent: Dyone Davis

I have read this form and decided that I will

participate in the project described above. Its

general purposes, the particulars of involvement, and possible hazards and inconveniences have been

explained to my satisfaction. I understand that I can withdraw at any time. My typed signature also

indicates that I have received a copy of this consent form.

Please type your FULL NAME here:

Please enter today's date here: 12-07-2022

For your records, in the next page you will be able to save a pdf copy of the above consent form.

Contact this candidate