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Eligibility

Name:

Age:

Date of Birth: //

Year of HIV Diagnosis:

State:

Zipcode:

Email:

Phone:

I affirm that I own or have access to an iOS or Android smartphone:

I affirm I have been diagnosed with HIV:

How did you hear about Positive Peers?:

App Username:

Consent:

Human Investigation Consent from and HIPPA Authorization

Development of the Positive Peers Mobile Application for HIV Support

Introduction

You are being asked to participate in a research study investigating the Positive Peers mobile application for people living with HIV. The investigator is interested in your perceptions of the application and how you might use it as well as if using the application improves your health. Participation in this study is voluntary. There is no change in your medical care if you are or are not involved in the study. Your involvement will include: 1) agreeing to share protected information about your health and care with MetroHealth study staff, 2) downloading the Positive Peers application to your phone or tablet and using it, 3) participating in an electronic survey when you enroll in the study and at 3 and 6 and 12 months, and 4) potentially participating in recorded interviews with one of the investigators. You do not have to participate in all parts of the study to complete the study. We currently have over 100 people in the Positive Peers app and expect to enroll another 900 people to participate in this study.

Procedures

If you agree to participate the investigator will review your medical record to collect care related information 12 months prior to your enrollment and over the 12 months of the study. The following are descriptions of general study procedures:

When you register with the study you will be asked to read and sign various forms as well as take a short electronic survey via our virtual onboarding platform. This will be done by yourself in a private place and on whatever electronic device you choose to use. This survey may take up to 30 minutes of your time.
After you complete the survey, you will be emailed instructions explaining how to download the Positive Peers application to your phone from either the Google Play Store or Apple Store. Tutorials and support from the Positive Peers Admin (PP Admin) are available to teach you about the many features of the Positive Peers app (PPA). You are expected to use the application for the next 12 months.
You may be contacted during the 12 month timeframe to participate in an interview with one of the investigators. This interview could be up to 60 minutes and focus on how you use the app and what you think about it. The interview will be recorded and written out verbatim by a medical transcriptionist. All identifiable data (any names, places, events) will be removed from the recording before sending to the transcriptionist. This interview might happen once or not at all during the study period.
You will be asked to complete the same or a similar electronic survey that you completed at the beginning of the study three more times: at 3 and 6 months after your enrollment, and at 12 months when you complete your participation at the end of the study. Each survey may take about 20-30 minutes to complete.
As you use the application, data about how you use the app will be stored on our study server. User trends will be studied only as part of the whole group or subgroups, not you personally.
Participants will be withdrawn if they are not able to follow stated guidelines for application participation: No bullying, harassing, stalking, or partner seeking activity.
After all the data have been collected and reviewed, your medical record number and any other identifying information (PHI) will be destroyed to protect your privacy.

Possible risks:

Because PHI is collected as part of this study, a minimal risk of breach of confidentiality exists. We have designed the Positive Peers mobile application carefully to make sure that someone who sees it on your phone cannot easily figure it out. We will not include your name or other identifiable information on any study documents or products. We will not tell anybody outside of our study staff and your HIV care staff that you are participating. Additionally, you may experience discomfort from revealing some personal information about yourself, such as your health issues. However, you will not be forced to disclose anything about yourself that you choose to keep private. If you feel discomfort and want to talk to someone about it, you may call Jennifer McMillen-Smith, LISW-S at (216)778-4051. In addition, you may choose not to answer a particular question. You may stop your participation in the study at any time if you feel too uncomfortable.

Activity on the mobile application is monitored. Subjects can be withdrawn if they are not able to follow stated guidelines for application participation, including bullying, harassing, stalking and/or partner seeking activity. In the event of an offense, we will warn users through a tiered violation system This means that the first offense will result in a warning. If there is a second offense you will be locked out of the app until you have an in-person or phone conversation with the app administrator about your actions. A third offense will result in your removal from the app and removal from the study.

Possible benefits:

There are some potential benefits to participation in this study including sustained retention in care, improved self-management, and feeling less stigmatized about being HIV+. You may also feel good knowing that you are helping others living with HIV in the future or learn new things about living with HIV.

Options:

This is a research study. You may decide not to participate or withdraw from the study anytime. Just call Dr. Avery at (216)778 8305 or email her at aavery@metrohealth.org if you want to stop your participation.

Confidentiality:

Because we want you to answer the questions honestly, we will keep your answers completely private. We will protect the confidentiality of this information. If information from this research project is published in a journal or presented at a conference, your identity will not be revealed. All collected information will remain confidential.

Costs:

There is no cost to you or your insurance company for participation in this study. You will be responsible for any mobile data charges that you may incur due to using this application for this study. If you don’t have data, note that the app does work on wifi as well.

What happens if I am injured while participating in this study?

All research involves a chance that something bad might happen to you. This may include the risk of personal injury. In spite of all safety measures, you might develop a reaction or injury from being in this study. If such problems occur during the course of the study, you must contact your study doctor, Dr. Ann Avery, at (216) 778-8305. Necessary medical care will be provided to you by The MetroHealth System. The MetroHealth System has not set aside funds to pay you for any such reactions or injuries or for the related medical care. This medical care is not free. You and/or your insurance company will be responsible for the costs.

Compensation:

You will be eligible for an incentive if you participate in different study parts. Participants will be compensated up to $50.00 for their time spent in evaluation activities. This compensation will be awarded in $10 increments at data collection points set at baseline, three months, six months, and at 12 months. Your compensation will be in the form of an electronic gift card to Walmart or Target or Amazon. If you participate in a qualitative interview, then you will earn an additional $10 electronic gift card for completion of the interview. Study investigators will determine interview participants on the basis of needed subgroup analyses. Additionally, you may receive occasional care packages that may include an Amazon music download cards worth approximately $1.50/ each, candy/snacks, Positive Peers magazines, and study related information/news. No compensation for treatment is available if injury occurs.

HIPAA:

As part of this study, we are collecting PHI such as:

Your name,
Medical record number,
Telephone number,
Address
Email address
Social media handles (e.g. Instagram, Facebook, Youtube, and/or Twitter names)
HIV diagnosis date and related data,
HIV and treatment related data.

This information is being collected to determine eligibility, set up your Positive Peers account, make contact as needed, and as study variables of interest. All information will be kept electronically on our MetroHealth server in a password protected file on our secure network.

Any paper files or data management files will be kept in a locked file in a locked office. Only Dr. Ann Avery, the Positive Peers study staff including Dr. Mary Step with Kent State University and Key Health Partners will have access to these files. Key Health Partners will only receive data on participants living in their jurisdiction or receiving care from their clinic(s). The following department will also have access to your PHI: MetroHealth Institutional Review Board (IRB) for the purpose of monitoring regulatory compliance, study analysis, and distribution of incentives. The investigator will have access to your PHI collected until data analysis is complete. At that time, the PHI will be destroyed.

The study file will be kept for four (4) years after study completion, at which time it too will be destroyed. You have the right to withdraw your permission/authorization for us to access your PHI at any time except to the extent the PHI already collected by the investigators before your withdrawal has already been acted upon based on your signed Authorization. No new PHI about you will be collected for study purposes unless required by law.

What are my rights as a study participant?

Taking part in this study is voluntary. You have the right to choose not to take part in this study. If you do not take part in the study, your doctor will still take care of you. You will not lose any benefits or medical care to which you are entitled. If you withdraw from the study, with your written permission, clinical data will continue to be collected from your medical records.

If you chose to take part, you have the right to stop at any time. You will be told of any new findings from this or other studies that may affect your health, welfare, or willingness to stay in this study. By signing this consent form you are not waiving any of your legal rights.

Does MetroHealth or any member of the research team have a financial conflict of interest in this study?

A portion of this study is being sponsored by a grant from the National Institutes of Health. Portions of Dr. Avery’s and her research team’s salaries are paid for by this grant.

Whom do I call if I have questions, concerns, or complaints?

If you have questions about any part of the study now or in the future, or if you wish to communicate concerns or a complaint you should contact Dr. Ann Avery who may be reached at (216) 778-8305 or by email: aavery@metrohealth.org. If you experience any side effects or injuries while participating in this study, please contact Dr. Avery, at the same number. If you have any questions about your rights as a research participant, or if you wish to express any concerns or complaints please contact the MetroHealth Medical Center’s Institutional Review Board (which is a group of people who review the research to protect your rights) at (216) 778-2021.

Patient/Subject Acknowledgement:

The procedures, purposes, known discomforts and risks, possible benefits to me and to others, and the availability of alternative procedures regarding this research study have been explained to me. I have read this consent form or it has been read to me, and I have been given the opportunity to ask questions or request clarifications for anything I do not understand. I voluntarily agree to participate in this study. I will print or save a copy of this consent form.

I have read, understand, and consent to the Positive Peers Human Investigation Study:

Release of Information:

Healthcare Provider:
Patient of Partner Organization:
Doctor's Name:

If not a MetroHealth or Partner Organization patient:
Hospital/Clinic:
Facility City:
Facility State:
Phone:
Fax:

Authorization to Obtain Medical Records from Another Facility

I hereby grant permission to:
NAME OF PROVIDER:
CITY/STATE: ,
FAX:

TO release a copy of my medical records. I understand that the information released upon authority of this authorization may contain information concerning treatment for a sexually transmitted disease, alcohol, drug abuse, a psychiatric condition, or HIV test results, an AIDS diagnosis, or AIDS-Related condition. I further understand this authorization does not include permission to release outpatient Psychotherapy notes. The release of Psychotherapy notes requires a separate authorization (Psychotherapy notes are separated from the rest of a patient's medical record).

This authorization is valid for a period of 1 year from the date of completion of this authorization, and may be revoked by me in writing at any time, except to the extent that action has been taken in reliance. The revocation must be provided to the MetroHealth Medical Record Department.

SPECIFIC INFORMATION TO BE RELEASED: HIV status, attendance at HIV-related medical visits, CD4 counts and viral loads.

For the following time period: One year prior to today through one year after today.

FOR THE PURPOSE OF: Patient Care

The copy of the medical records is to be released to:
MetroHealth Medical Center
ATTN: Jen McMillen Smith, LISW
Department: Medicine/Infectious Diseases
2500 MetroHealth Drive
Cleveland, OH 44109-4662
Phone: 216-778-4051
Fax: 216-778-4695

PATIENT NAME:
DATE OF BIRTH: Date of Birth: //
PATIENT ADDRESS: ,
TELEPHONE NUMBER:

I have read, understand, and agree to the Authorization to Obtain Medical Records from Another Facility:

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Signed by Positive Peers
Signed On: January 8, 2026

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November 18, 2025 9:29 am EDT

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