Consent Form: Testing, PEP, and PrEP Group

Approved
6/8/2020
UW IRB

UNIVERSITY OF WASHINGTON
CONSENT FORM
GAIN (Greater Access & Impact with NAT) Study: Testing, PEP & PrEP Group
Joanne Stekler, MD MPH
Andy Cornelius
Dilpreet Kochhar
Lisa Niemann, MSW/MPH
Emergency 24-hour number

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

206-744-8312
206-616-5578
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 have
never been diagnosed with HIV and that you have come to this clinic to either get an HIV/STI
test or for a PEP (post-exposure prophylaxis) or PrEP (pre-exposure prophylaxis) visit. The
purpose of this research is to determine the acceptability and feasibility of integrating the pointof-care nucleic acid test (POC NAT) into clinical care. The particular test we will use is called
the SAMBA II Qual test, and it is not yet FDA approved. It can detect both HIV RNA in blood
plasma and also HIV DNA in someone’s cells. It should detect HIV when someone’s viral load
is more than 400 copies or when someone has been infected and the virus has been incorporated
into someone’s cell DNA, which happens quickly after infection.
We want to understand if obtaining a POC NAT result helps a patient start PrEP faster or begin
HIV treatment more quickly if they test positive. 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. After the POC NAT test has
been started, you will be connected with the clinic staff for your regular visit procedures. When
you are done, we will complete your study visit.
We 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.
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UW IRB

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 try to draw the blood for your clinical tests
at the same time, to minimize the number of needlesticks you have today. The study procedures
should take at most 45 minutes to complete.
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 HIV infection.
We will take steps to minimize any stress or anxiety by providing you with factual information
about HIV and risks for getting HIV 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 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
If you have recently become HIV infected, the POC NAT test may be able to detect your HIV
infection several days or even weeks earlier than the HIV tests you would normally get at the
clinic.
SOURCE OF FUNDING

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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 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.
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.

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UW IRB

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 if your result is positive. We will help you
interpret your test results. We may need to wait for the results of the laboratory-based tests
before we can be certain about your HIV status. 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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Signature of subject

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Date

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