UNIVERSITY OF WASHINGTON
CONSENT FORM
GAIN (Greater Access & Impact with NAT) Study: Aim 1: Madison Clinic
Joanne Stekler, MD MPH Professor, Medicine 206-744-8312
Andy Cornelius, BA Research Study Coordinator, Madison Clinic 206-616-5578
Lisa Niemann, MSW/MPH Research Coordinator 206-744-8887
Emergency 24-hour number Dr. Joanne Stekler 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 point-of-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, 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 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 that you do not wish to answer.
Finally, we will draw about 10 mL of blood (which is about 2 teaspoons) 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. While the SAMBA II Qual POC NAT result is ready in 2 hours, the confirmatory laboratory HIV RNA test can take 1 week. 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 experience of getting the POC NAT 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. A positive SAMBA II Qual POC NAT result does not necessarily mean a person is HIV positive. You may experience anxiety if the test is positive and you need to wait a week for the confirmatory test result. If you have a positive SAMBA II Qual POC NAT result we will ask you questions to assess the likelihood of a true positive result. We will recommend referral sites for urgent antiretroviral therapy if you would like to get linked to care. 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. The results of the SAMBA II Qual POC NAT will not be used in clinical decision making.
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 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
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 1 year 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 six years after the study closes, 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. 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.
USE OF INFORMATION AND SPECIMENS
Returning Results to You
The result of your POC NAT 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. Because the SAMBA II Qual test is not yet FDA approved, we will rely on the laboratory based tests to make a final assessment of 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 may 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. It is also possible that in the future we may want to use or share study information that might identify you. If we do, a review board will decide whether or not we need to get additional permission from you.
Participants will be able to withdraw permission for use of their information at any time until the link between their identity and their study ID number is broken. This will be six years after the study closes, anticipated to be September 2030. Participants can write to Dr. Stekler at any time until this date to withdraw permission.
OTHER INFORMATION
You will receive $20 for participating in this study, and a $5 food voucher. 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 Signature of subject Date
UNIVERSITY OF WASHINGTON
CONSENT FORM
GAIN (Greater Access & Impact with NAT) Study: Aim 1: Seattle’s LGBTQ+ Center
Joanne Stekler, MD MPH Professor, Medicine 206-744-8312
Maggie Murphy Research Study Coordinator 206-486-1412
Lisa Niemann, MSW/MPH Research Coordinator 206-744-8887
Emergency 24-hour number Dr. Joanne Stekler 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 PrEP (pre-exposure prophylaxis) visit. 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 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, 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 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 that you do not wish to answer.
Finally, we will draw about 10 mL of blood (which is about 2 teaspoons) 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. While the SAMBA II Qual POC NAT result is ready in 2 hours, the confirmatory laboratory HIV RNA test can take 1 week. The study procedures should take at most 45 minutes to complete. We may follow up with you by phone at 1, 3, and 6 months after your study visit to discuss PrEP or, if you test positive, gotten connected to HIV care.
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 experience of getting the POC NAT 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. A positive SAMBA II Qual POC NAT result does not necessarily mean a person is HIV positive. You may experience anxiety if the test is positive and you need to wait a week for the confirmatory test result. If you have a positive SAMBA II Qual POC NAT result we will ask you questions to assess the likelihood of a true positive result. We will recommend referral sites for urgent antiretroviral therapy if you would like to get linked to care. 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. The results of the SAMBA II Qual POC NAT will not be used in clinical decision making.
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 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
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 1 year 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 six years after the study closes, 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. 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.
USE OF INFORMATION AND SPECIMENS
Returning Results to You
The result of your POC NAT 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. Because the SAMBA II Qual test is not yet FDA approved, we will rely on the laboratory based tests to make a final assessment of 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 may 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. It is also possible that in the future we may want to use or share study information that might identify you. If we do, a review board will decide whether or not we need to get additional permission from you.
Participants will be able to withdraw permission for use of their information at any time until the link between their identity and their study ID number is broken. This will be six years after the study closes, anticipated to be September 2030. Participants can write to Dr. Stekler at any time until this date to withdraw permission.
OTHER INFORMATION
You will receive a $25 gift card for participating in this study. 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 Signature of subject Date
Document Date & Version |
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Researcher Date & Version |
11/15/2019 |
TEMPLATE: Consent Form, Standard |
mm/dd/yyyy |
Version 10.5 |
Version 1 |
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#555 |
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Page
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| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | TEMPLATE Consent Form, Standard |
| Author | Helen McGough |
| File Modified | 0000-00-00 |
| File Created | 2022-09-14 |