Patient Interview Consent Form

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Columbia University
Consent and HIPAA Authorization Form
Protocol Information
TITLE:

mChoice: Improving PrEP Uptake and Adherence among Minority MSM through
Tailored Provider Training and Adherence Assistance in Two High Priority
Settings

PROTOCOL NO.:

AAAT8812

SPONSOR:

Centers for Disease Control (CDC)

INVESTIGATOR:

Rebecca Schnall, PhD, MPH, RN-BC, FAAN
560 West 168th Street
New York, New York
10032 United States

STUDY-RELATED
PHONE NUMBERS:

(212) 342-6886 or (212) 305-8198

General Information
Participation Duration: 1 hour
Anticipated Number of Subjects: 30
Concise Summary:
•

The purposes of this study are to 1) implement evidence-based education and support tools in
clinics in order to improve the overall pre-exposure prophylaxis (PrEP) experience for providers
and gay, bisexual, and other men who have sex with men (MSM); and 2) increase our
understanding of factors that influence the PrEP choices.

•

What is involved in this Study Aim? 1) An in-depth interview about your participation in the
mChoice intervention study period.

•

The time frame for your involvement is approximately 1 hour.

•

Risks for the study include the potential risk for loss of confidentiality. There may be other risks of
taking part in this research study that we don’t know about. If we learn about other risks, we will
let you know what they are so that you can decide whether or not you want to continue to be in
the study. Detailed information of all the known risks can be found in the Risks section.

•

There may be no direct benefits for participants in the study.

•

It is your choice if you want to be in this study. The alternative is to not participate. If you decide
to take part in the study, it should be because you really want to volunteer. You can choose to
withdraw at any time during the study. If you choose not to volunteer, you will not lose any
services, benefits or rights you would normally have.

Contacts

IRB-AAAT8812 (Y02M05)
IRB Approval Date: 03/22/2023
For use until: 07/25/2023

Page 2 of 6

Contact
Rebecca Schnall

Title
Principal Investigator, Columbia
University

Contact Information
Phone: (212) 342-6886 or (212)
305-8198
Email:
rb897@cumc.columbia.edu

Detailed Information on Research
Introduction
The purpose of this form is to give you information to help you decide if you want to take part in a
research study. This consent and HIPAA authorization form includes information about:
-

Why the study is being done;
The things that you will be asked to do if you are in the study;
Any known risks involved;
Any potential benefit;
Options, other than taking part in this study, that you have; and
The way your health information will be used and shared for research purposes.

The study staff will discuss the study with you. If at any time you have questions about the study, please
ask a member of the study team. Take all the time you need to decide whether you want to take part in
this research study.
The purpose of this research is described below in the ‘What is Involved in This Study?’ section of this
consent and HIPAA authorization form.
This consent and HIPAA authorization form is written to address a research subject.
What is involved in this study?
The purposes of this study are to 1) implement evidence-based education and support tools in clinics in
order to improve the overall pre-exposure prophylaxis (PrEP) experience for providers and gay, bisexual,
and other men who have sex with men (MSM); and 2) increase our understanding of factors that
influence the PrEP choices.
If you agree to be in this study, the following will happen:
-

You will participate in an approximately 1-hour long interview so that we can hear about your
experience with PrEP, the reasons for your PrEP choice, and your impression of the mChoice
intervention period.

Risks
General risks

IRB-AAAT8812 (Y02M05)
IRB Approval Date: 03/22/2023
For use until: 07/25/2023

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There may be risks or discomforts in participating in this study. You may feel uncomfortable about some
of the HIV prevention/PrEP-related questions during the interview. You may ask to skip questions that
make you feel uncomfortable or stop the research procedures at any time.
Loss of confidentiality
A risk of taking part in this study is the possibility of a loss of confidentiality. Loss of confidentiality
includes having your personal information shared with someone who is not on the study team and was
not supposed to see or know about your information. The study team plans to protect your confidentiality.
Their plans for keeping your information private are described in the Confidentiality section of this consent
and HIPAA authorization form.

Benefits
There are no direct benefits to you as a study participant. Your participation will assist the study in
improving the overall PrEP experience of providers and MSM patients and increase our understanding of
factors that influence the choice of PrEP regimen.

Alternative Procedures
The alternative is to not participate. You are free to refuse to participate or to withdraw from this research
at any time. You can still get all your usual clinical care and can obtain PrEP from your usual provider
outside of this study.

Confidentiality
What about Confidentiality?
Any information collected during this study that can identify you by name will be kept confidential. We will
do everything we can to keep your data secure, however, complete confidentiality cannot be promised.
Additionally, your individual-level data will not be shared through unrestricted- or controlled-access
repositories. Despite all our efforts, unanticipated problems such as a stolen computer may occur,
although it is highly unlikely.
Access to your health information is required to be a part of this study. If you choose to take part in this
study, you are giving us the authorization (I.e. your permission) to use the protected health information
and information collected during the research that can identify you. The health information that we may
collect and use for this research may include medical history that may be considered sensitive. The
health information that may be collected, used, or disclosed includes:
-

All health information collected during the research described in this consent and authorization;
Health information in your medical and pharmacy records that is relevant to the research. This
may include medical information that may be considered sensitive, including HIV/STI testing, HIV
status, history of drug use or alcohol abuse, pharmacy re-fills, and mental health information.
Information about you may be obtained from any pharmacy, hospital, doctor, and any other health
care provider involved in your care that is needed for this research purpose. Any research
information that is shared with people outside of Columbia University Medical Center and New

IRB-AAAT8812 (Y02M05)
IRB Approval Date: 03/22/2023
For use until: 07/25/2023

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York-Presbyterian Hospital will not include your name, address, telephone number, or any other
direct identifiers unless disclosure of the information is required by law, or you have authorized
the disclosure.
Once your health information has been disclosed to a third party, federal privacy laws may no longer
protect it from further disclosure.
Your audio recordings will be assigned a code number and separated from your name or any other
information that could identify you. The research file that links your name to the code number will be kept
in a locked file cabinet, an encrypted data file, and/or a password-protected database and only the
investigator and authorized study staff will have access to the file. The technical platform is designed to
be a safe and secure environment as much as possible, for data input, data sharing, synthesis, storage,
and retrieval. Your participation in this research study will be documented in your electronic health record.
This record can be viewed by authorized personnel from Columbia University Irving Medical Center, Weill
Cornell Medical Center and New York-Presbyterian Hospital and its affiliated institutions, because these
institutions share the electronic medical record system.
Identifiers might be removed from the participant’s identifiable private information or biospecimens and,
after such removal, the information or biospecimens could be used for future research studies or given
to another investigator for future research studies, without asking for additional informed consent. If
information from this study is published or presented at scientific meetings, your name and other
personal information about you will not be used.
The following individuals and/or agencies will be able to look at, copy, use, and share your research and
health information:
-

The investigator, Columbia University Medical Center, New York-Presbyterian Hospital, and the
study staff and other medical professionals who may be evaluating the study;
Authorities from Columbia University including the Institutional Review Board (‘IRB’);
The Office of Human Research Protections (‘OHRP’)
Our sponsor of this study, Centers for Disease Control (‘CDC’);
Food and Drug Administration (FDA).

Certificate of Confidentiality
This research project has a Certificate of Confidentiality from the Centers for Disease Control and
Prevention (CDC). Unless you give permission, researchers cannot release information that may identify
you for a legal action, a lawsuit, or as evidence. This protection applies to requests from federal, state, or
local civil, criminal, administrative, legislative, or other proceedings. As an example, the Certificate would
protect your information from a court subpoena.
There are some important things that you need to know. The Certificate DOES NOT protect your
information if a federal, state or local law says it must be reported. For example, some laws require
reporting of abuse, communicable diseases, and threats of harm to yourself or others. The Certificate
CANNOT BE USED to stop a federal or state government agency from checking records or evaluating
programs. The Certificate DOES NOT stop reporting required by the U.S. Food and Drug Administration
(FDA). The Certificate also DOES NOT stop your information from being used for other research if
allowed by federal regulations.
Researchers may release your information when you say it is okay. For example, you may give them
permission to release information to insurers, your doctors, or any other person not connected with the
research. The Certificate of Confidentiality does not stop you from releasing your own information. It also
does not stop you from getting copies of your own information.
IRB-AAAT8812 (Y02M05)
IRB Approval Date: 03/22/2023
For use until: 07/25/2023

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Recordings
We are asking for your permission to allow us to audiotape your voice as part of the in-depth interviews in
this research. The recordings will only be used for analysis by the research team. The recording(s) will
include your words. The audio recording(s) will be stored on a password-protected computer in a locked
office in the Columbia University School of Nursing and will be destroyed after transcription, which is to
happen 2 weeks after the original recording. However, the transcriptions will remove any information that
may identify you. The investigator and the study staff will have secured access to the audio recording(s).
Your signature on this form grants the investigator named above permission to record you as described
above during participation in the above-referenced study. The investigator will not use the recording(s) for
any other reason than that/those stated in the consent and HIPAA authorization form without your written
permission. The following investigators and/or agencies will be able to access your recording(s):
-

The investigator, Columbia University Medical Center, New York-Presbyterian Hospital, and the
study staff and other medical professionals who may be evaluating the study;
Authorities from Columbia University including the Institutional Review Board (‘IRB’);
The Office of Human Research Protections (‘OHRP’)
Our sponsor of this study, Centers for Disease Control (‘CDC’);
Food and Drug Administration (FDA).

There is no additional incentive for allowing yourself to be taped, aside from the $25 you will be given for
completing the in-depth interview (see Tokens of Appreciation section).
1. I give permission to record:
2. I do NOT give permission to record:
Participant signature granting permission to record:

Revoking this Consent and HIPAA Authorization

You may change your mind and revoke (take back) this consent and authorization at any time
and for any reason. To revoke this consent and authorization, you must contact the Principal
Investigator, Rebecca Schnall at rb897@cumc.columbia.edu or (212) 342-6886. However, if you
revoke your consent and authorization, the researchers, and the sponsor (if applicable) may
continue to use and disclose the information they have already collected.
Tokens of Appreciation
You will receive $25 for your participation in this in-depth interview.

Additional Costs
There are no additional costs to you for taking part in this study.

Additional Information
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.

IRB-AAAT8812 (Y02M05)
IRB Approval Date: 03/22/2023
For use until: 07/25/2023

Page 6 of 6
Questions or Concerns about Research
If you have any questions, concerns, or complaints about the study, or if you have experienced injury or
harm that may be related to the research, you may contact: Dr. Rebecca Schnall at (212) 342-6886 or
(212) 305-8198 or rb897@cumc.columbia.edu.
If you have any questions about your rights as a research participant, or if you have questions, concerns,
or complaints about this study, you may contact:

Human Research Protection Office,
Institutional Review Board Columbia
University Medical Center
Address: 154 Haven Avenue, 2nd Floor; New York, NY 10032
Telephone: (212) 305-5883
Email: irboffice@columbia.edu
An Institutional Review Board is a committee organized to protect the rights and welfare of human
subjects involved in research. More information about taking part in a research study can be found on the
Columbia University IRB website at: http://www.cumc.columbia.edu/dept/irb.

Statement of Consent
Statement of Consent and HIPAA Authorization
I have read the consent and HIPAA authorization form and talked about this research study, including the
purpose, procedures, risks, benefits, and alternatives with the researcher. Any questions I had were
answered to my satisfaction. I am aware that by signing below, I am agreeing to take part in this research
study and that I can stop being in the study at any time. I am not waiving (giving up) any of my legal rights
by signing this consent form. I will be given a copy of this consent and HIPAA authorization form to keep
for my records.

Signatures
Participant Signature Lines:
Study Participant
Print Name:
Signature:
Date:

IRB-AAAT8812 (Y02M05)
IRB Approval Date: 03/22/2023
For use until: 07/25/2023