Consent Form: Gay City HIV+ Group

Approved
6/8/2020
UW IRB

UNIVERSITY OF WASHINGTON
CONSENT FORM
GAIN (Greater Access & Impact with NAT) Study: Gay City HIV+ Group
Joanne Stekler, MD MPH
Dilpreet Kochhar
Lisa Niemann, MSW/MPH
Emergency 24-hour number

Professor, Medicine
Research Study Coordinator, Gay City
Research Coordinator
Dr. Joanne Stekler

206-744-8312
206-860-6969
206-744-8887
206-744-3000

We are asking you to be in a research study. This form gives you information to help you decide
whether or not to be in the study. Being in the study is voluntary. Please read this carefully. You
may ask any questions about the study. Then you can decide whether or not you want to
participate.
PURPOSE OF THE STUDY
You are being asked to volunteer for this research study because you have told us that you are
HIV-positive. The purpose of this research is to determine the acceptability and feasibility of
integrating the point-of-care nucleic acid test (POC NAT) into clinical care. The POC NAT we
will use is called the SAMBA II Semi-Q test, and it is not yet FDA approved. It can detect
whether your viral load is greater or less than about 1000 copies. The viral load refers to how
many copies of HIV are present in a milliliter sample of blood.
We want to understand if obtaining a POC NAT result is helpful for patients who are HIVpositive and seeking sexual health services at a community clinic such as Gay City. Up to 7,100
people in the Seattle area will be participating in this study. This study is being conducted by the
University of Washington and the Centers for Disease Control and Prevention (CDC). The
information below is to help you decide whether to take part in the study.
STUDY PROCEDURES
If you agree to participate in this study, we will ask you to have a fingerstick done for the POC
NAT test, complete a blood draw for laboratory testing, and answer a few questions for a survey.
The study staff will prick your finger once to collect the small blood sample necessary to run the
POC NAT. This test takes about 2 hours to run before it can be read.
Study staff will ask you some questions about yourself for our study visit survey, including
questions about things like your race and ethnicity, gender identity, and insurance status. The
answers that you give in the survey will not be stored with your name. This data will be stored
along with your test results to potentially be used for future research. You may refuse to answer
any question or item in the interview that you do not wish to answer.
Finally, we will draw about 10 mL of blood to use for a laboratory HIV RNA test for the study,
in order to supplement the POC NAT result. We will draw the blood for your clinical tests at the
same time, to minimize the number of needle sticks you have today. The study procedures
should take at most 45 minutes to complete.
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We will invite some participants to do an additional 20-minute survey via email, a 45-60 minute
long in-person, Zoom, or phone interview, or a 45-60 minute long in-person or online focus
group to learn more about the participant’s experience of getting the POC NAT test and opinions
on the test.
RISKS, STRESS, OR DISCOMFORT
The fingerstick or blood draw could cause a small amount of discomfort, bleeding, or bruising.
You may experience increased stress or anxiety while having discussions about your viral load.
We will take steps to minimize any stress or anxiety by providing you with factual information
about what your result means in language that you can understand. We will answer any questions
that you may have.
You may feel that participating in a research study is a breach of privacy since we are collecting
information about you related to your HIV status and may access to your clinic records. We will
take steps to minimize this by talking with you about the research, the purpose of the research,
and who may have access to your clinic records as part of this research. We will discuss all of
this information with you in a private room.
For participants who participate in the surveys, interviews, or focus groups, some of the
questions we may ask you about your sexual behavior and drug use may make you feel
uncomfortable. However, you do not have to answer any questions that you do not want to
answer, and you can stop the survey at any time. We will email you the survey up to 3 times to
remind you to take it. The survey must be taken within 1 week of receiving the link, or it will
expire.
For participants invited to participate in an interview or focus group, the conversations will be
audio-recorded so that we can have a transcription company listen to the recording and create a
written transcript of the conversation. This way we can capture all the details of the conversation.
Once we review the transcript for accuracy, the audio recording will be deleted. We anticipate
this will happen within approximately 1 month of the interview or focus group.
ALTERNATIVES TO TAKING PART IN THIS STUDY
Your alternative to participating in this study would be to not participate. You will not lose any
other benefits in the clinic just because you do not want to be in the study. You may choose to
have your regular visit done at the clinic instead of participating in this study.
BENEFITS OF THE STUDY
The POC NAT test may be able to detect your HIV RNA level to a cutoff level of +/- 1000
copies within 2 hours. It may be useful to you to know if your viral load is greater than 1000
copies at your visit today because you could then go on or change your anti-HIV medications.
This may help you to live a longer and heathier life. If you have a viral load of greater than 1000
copies, Gay City staff may call you in the future to check in to see how things are going. Gay
City staff can help connect you with HIV care. It may also be helpful for you to know if your
viral load is less than 1000 copies at your visit today because that would mean that your
medications are working, you are taking care of your health, and you are less likely to transmit
HIV to anyone else.

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SOURCE OF FUNDING
The study team and the University of Washington are receiving financial support from the
Centers for Disease Control and Prevention (CDC) to conduct this study.
CONFIDENTIALITY OF RESEARCH INFORMATION
All of the information you provide will be confidential. We will record your name and other
personal identifying information and have you sign an additional consent in order to access your
medical records to obtain information about your follow up with your care for the 6 months after
this study visit. The data we collect for the study will be coded with a unique study ID. Some
members of the UW study staff team will have access to the link between your personal identity
and your study ID, in order to contact you or connect your test results from your clinic record to
your study record. The study sponsor, CDC, will not have access to any of your personal
identifying information. The link for this data will be destroyed within six years after the last
date of study enrollment, expected on August 31, 2030.
All of the data we collect will be kept in a locked cabinet or password-protected computer files.
Results that are published from this study will not include any personal information about you.
If we learn that you intend to harm yourself or others, we must report that to the authorities
A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required
by U.S. Law. This Web site will not include information that can identify you. At most, the Web
site will include a summary of the results. You can search this Web site at any time.
We have a Certificate of Confidentiality from the federal Centers for Disease Control &
Prevention. This helps us protect your privacy. The Certificate means that we do not have to give
out information, documents, or samples that could identify you even if we are asked to by a court
of law. We will use the Certificate to resist any demands for identifying information.
We cannot use the Certificate to withhold your research information if you give your written
consent to give it to an insurer, employer, or other person. Also, you or a member of your family
can share information about yourself or your part in this research if you wish.
There are some limits to this protection. We will voluntarily provide the information to:
 a member of the federal government who needs it in order to audit or evaluate the
research;
 individuals at the institution(s) conducting the research, the funding agency, and other
groups involved in the research, if they need the information to make sure the research is
being done correctly;
 the federal Food and Drug Administration (FDA), if required by the FDA;
 individuals who want to conduct secondary research if allowed by federal regulations and
according to your consent for future research use as described in this form;
 authorities, if we learn of child abuse, elder abuse, or the intent to harm yourself or
others.

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The Certificate expires when the CDC funding for this study ends. Currently this is 8/31/2024.
Any data collected after expiration is not protected as described above. Data collected prior to
expiration will continue to be protected.
USE OF INFORMATION AND SPECIMENS
Returning Results to You
The result of your POC NAT test will be ready to read about 2 hours after the test is started. If
you wish to stay at the clinic to obtain your result, you may. If you wish to leave the clinic before
the result is ready to read, we will contact you with your result if it comes back with a read of
greater than 1000 copies. We will help you interpret your test results. Your POC NAT result and
laboratory-based HIV RNA test from the study will also be noted in your clinical record and may
be available via your patient portal.
Using Your Data in Future Research
The information that we obtain from you for this study might be used for future studies. We will
remove anything that might identify you from the information. If we do so, that information may
then be used for future research studies or given to another investigator without getting
additional permission from you.
OTHER INFORMATION
Participants that complete the survey will be emailed a $10 Amazon gift card upon completion.
Participants that complete an interview or focus group will be provided a $40 gift card.
RESEARCH-RELATED INJURY
If you think you have been harmed as a result of participating in this research, contact Joanne
Stekler by paging her (206-744-3000) right away. She will treat you or refer you for treatment.

Printed name of study staff obtaining consent

Signature

Date

Subject’s statement
This study has been explained to me. I volunteer to take part in this research. I have had a
chance to ask questions. If I have questions later about the research, or if I have been harmed by
participating in this study, I can contact one of the researchers listed on the first page of this
consent form. If I have questions about my rights as a research subject, I can call the Human
Subjects Division at (206) 543-0098 or call collect at (206) 221-5940. I give permission to the
researchers to use my medical records as described in this consent form. I will receive a copy of
this consent form.

Printed name of subject

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