Provider Consent Form

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Columbia University
Consent 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
General Information

Participation Duration: 36 months
Anticipated Number of Subjects: 20
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.
o

What is involved in this Study Aim? 1) We will provide training to improve knowledge of
PrEP clinical recommendations and enhance provider communication; 2) We will be
conducting interviews to gather feedback on the provider training video and its impact
on your clinical practices; 3) You may be asked to complete a clinic assessment tool so
that we can gather information on your clinic.

o

The time frame for your involvement in the study is 36 months.

o

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.

o

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

o

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. Your participation
in this study does not affect your employment at the clinic.
Contacts

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

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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 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 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 form.
This consent 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 take part in a provider training module on PrEP options and recommendations for PrEP
care that is culturally congruent and relevant for Black and Latino YMSM. The module will include
education on daily, 2-1-1, and long-acting injectable PrEP, and will be aligned with the most recent
CDC PrEP guidelines. The provider training will be an asynchronous online training module so that
you can access the training without the trainer being present in-person at the clinical site. As part of
the training, we will teach you how to have these conversations with Black and Latino YMSM with
cultural competence to create a safe and non-judgmental environment. You will complete a pre- and
post- knowledge assessment as part of the training module. The assessment aims to identify the
potential impact of the provider education training module on PrEP knowledge, attitudes, and
practice. You will complete this survey once before receiving the training and a second time after
completing the training. You will complete this provider training over a period of up to 6 months.
- After completing the provider training, you will be asked to participate in a 45-60 minute interview.
During the interview, research staff will ask you about the provider training and its relevance and
IRB-AAAT8812 (Y02M05)
usefulness.
IRB Approval Date: 03/22/2023
For use until: 07/25/2023

-

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You may be asked to complete a clinic assessment tool for your clinic, which will be collected from
your clinic every 6 months over the course of the study (36 months).

Permission to Receive Reminders and Notifications
During this research, we would like to contact you for appointment reminders or for other study-related
questions that we may have for you. To contact you, we may want to call you, send you text (SMS)
messages and/or emails, or use your address, if provided.
1. I give permission to be contacted by the study team (please select how you would like to be
contacted if giving permission):
o Text
o Phone Call
o Email
2. I do NOT give permission to be contacted by the study team.

Risks
General risks
There may be risks or discomforts in participating in this study. You may feel uncomfortable discussing
HIV prevention/PrEP-related information that is provided and completing some questions in the
assessments. You may feel uncomfortable discussing HIV prevention-related practices within your clinic
with a practice coach or 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
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.

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.
Your survey data and audio recordings will be assigned a code number and separated from your name or
IRB-AAAT8812 (Y02M05)
any other information that could identify you. The research file that links your name to aIRB
code
number
will
Approval
Date: 03/22/2023
For use until: 07/25/2023
be kept in a locked file cabinet, an encrypted data file, and/or a password-protected database
and only

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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 study will not affect your employment at the clinic.
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 information:
-

The investigator, 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 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.
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 form without your written permission. The following
investigators and/or agencies will be able to access your recording(s) without asking for additional
consent:
-

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

There is no additional incentive for your time and effort for allowing yourself to be taped aside from the

$150 incentive (see Tokens of Appreciation section).

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1. I give permission to record:
2. I do NOT give permission to record:
Participant signature granting permission to record:
Revoking this Consent
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 $150 for your participation in this study.
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.
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

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

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I have read the consent 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 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