ImmuneSense Lyme Study

Now Enrolling | Register Below

Study Details

Compensation

You’ll receive $100 for each study visit to compensate you for your time and participation, up to $400.

Contribution

One blood draw for most participants – approximately 7 tablespoons. Some participants will have the option of contributing more blood in the future and a photograph of the tick bite rash, if visible.

Why Should I Participate?

Building a potentially better diagnostic could mean better results for the hundreds of thousands of people each year who are diagnosed with Lyme disease. Only 30% of people with acute Lyme infections receive a positive test result with existing laboratory tests.* Better tests mean earlier treatment, which can make all the difference in outcomes of the disease.

Flexible Participation

Participants are able to complete study visits at either clinical sites or from the comfort of their own home, using telehealth and mobile phlebotomy (blood draw).

*Branda, J. A., et al. Evaluation of Modified 2-Tiered Serodiagnostic Testing Algorithms for Early Lyme Disease. Clinical Infectious Diseases. 2017;64(8):1074-1080. doi: 10.1093/cid/cix043

What the study involves

See if you qualify

Fill out the survey above to see if you qualify.

Schedule your appointment

If you qualify, a study site will contact you to schedule a telehealth or in-person clinic visit – your choice.

Complete your visit

Donate a blood sample, take photographs of your rash and share relevant medical information with a study physician. All this can be done from the comfort of your home.

Why participate in the ImmuneSense™ Lyme study?

Millions of Americans have been affected by Lyme disease. The lack of accurate testing in the early stages of the disease makes it harder to get the right treatment at the right time, which is essential for better outcomes. By participating in the study you might help create a better test, which will help members of your community be treated earlier.

Why does this matter?

The immune system is nature’s most powerful diagnostic tool. It can detect viruses and bacteria your body come in contact with every day, including the bacteria that causes Lyme disease. Adaptive Biotechnology has developed a technology to read the immune system, and is using it to create new diagnostic tests.

About the sponsor

The study is sponsored by Adaptive Biotechnologies, an Immune Medicine company, in collaboration with Microsoft. Together we’re working to decode the immune response to Lyme disease and other infectious diseases, autoimmune conditions, and cancers.

Frequently asked questions

What is the purpose of this study?

Lyme disease is transmitted to humans via infected ticks. If left untreated, Lyme disease can become a serious illness for many people, but if caught early, Lyme disease can typically be treated with antibiotics and long-term complications can be avoided. However, many people are misdiagnosed or undiagnosed because the disease is difficult to detect in its earliest stage, when it is easiest to treat. The goal of this study is to see if we can detect Lyme disease earlier than currently available tests.

ImmuneSense™ Lyme is a study designed to better understand the immune response to Lyme disease. This is critically important, because the immune system may be able to tell us important information about how our own bodies detect and respond to the disease, which current tests cannot. If you have a rash that is specific to Lyme disease, photographs will be taken of that rash, and measures will be put in place to protect your privacy. All study information will be stored with a code in place of your name. All study information that will be held by the sponsor of the study will be stored with a code in place of your name, in accordance with HIPAA standards.

The ImmuneSense™ Lyme study is part of a collaboration between Adaptive Biotechnologies and Microsoft to use artificial intelligence (AI) to accelerate the ability to map how the immune system responds to diseases. To learn more about this collaboration, click here. This is an experimental process. “Experimental” means that the process is currently being tested and is not yet certain to work as it is supposed to work. Standard testing will be done as well, to see how the results compare.

If I think I have Lyme disease, can I participate in this study?

Yes: we will be enrolling participants matching the criteria below, in these locations: Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, West Virginia, Wisconsin.

We are also looking for people with confirmed diagnoses for diseases that overlap with Lyme disease. These include:

1. Viral illness: influenza or COVID-19
2. Tick-borne diseases: babesiosis, anaplasmosis, or ehrlichiosis
3. Bacterial infections: syphilis
4. Autoimmune/rheumatologic/neurologic diseases: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), multiple eclerosis (MS), chronic fatigue syndrome

If ImmuneSense™ Lyme is not in my area, can I go to a nearby area where it is operating?

Yes, you may travel to a site if you wish. If you do not wish to travel, participants are eligible for a virtual telehealth visit and home blood draw by a trained phlebotomist.

If ImmuneSense™ Lyme is operating at a site not covered by my insurance plan, can I still participate?

Yes, you will be eligible to participate. For this study, we will not be providing routine healthcare or treatment. This means that routine clinical care for Lyme disease should be followed by your in-network physician, but can be provided by an out-of-network doctor if needed. Please check with your insurer to determine any out-of-pocket costs for routine healthcare outside the study. You and your insurance will not be billed for any study-related procedures.

This study will not alter or interfere with the normal care you receive in any way. You can see a doctor who is affiliated with this study without interfering with your normal care.

If you receive a diagnosis from your own provider, you can enroll in the study. You will have a study visit with the site doctor or a virtual telehealth visit to collect any study-related medical information, and your relevant medical records will be accessed. You will not be charged, nor will your insurance be billed for the study visit. You will also provide your blood sample at no cost to you or your insurance.

How do I know if I’m eligible? What should I ask my doctor?

Through the ImmuneSense™ Lyme study, we are looking for participants who suspect they have Lyme disease or are recently diagnosed, but are within 7 days of starting their course of treatment for Lyme disease.

A confirmed diagnosis can be obtained through three routes; either:

– Through the ImmuneSense™ Lyme study’s telemedicine option
– Through the ImmuneSense™ Lyme study’s site healthcare provider(s)
– Through participants’ own doctor.*

If you have recently spent time outdoors taking part in activities such as hiking, camping, gardening, dog-walking, or more, and you present with some of the symptoms listed below, that might be cause to suspect Lyme disease and seek a diagnosis:

– Bullseye or other rash after tick bite
– Body aches
– Fever
– Breathlessness
– Eye pain
– Diarrhea
– Chest tightness
– Headache
– Fatigue
Joint pain

*A diagnosis of Lyme disease from your own doctor will require confirmation from an ImmuneSense™ Lyme study site healthcare provider via a review of medical records.

What should I expect if I participate in the ImmuneSense™ Lyme study?

Your participation in this study may to last up to one year, including a total of three follow-up visits during that time frame if you are in the Lyme disease group. If you choose to take part in this study, you will review and sign the Adult & Parental Informed Consent Form. If you meet all the study requirements, you will be entered into the study.

Study visit or telehealth visit

1. Study medical information

a. The study doctor will collect information about your medical history, symptoms, exposure history, and medical information related to Lyme disease that will help us better analyze and understand the data we collect about your immune system.

b. If you have a rash that is specific to Lyme disease, a photograph will be taken of that rash, and measures will be put in place to protect your privacy. All study information that will be held by the sponsor of the study will be stored with a code in place of your name, in accordance with HIPAA standards.

2. Blood draw

a. You will have the option to complete your blood draw(s) at the study doctor’s office, or a mobile phlebotomist can come to you. The blood draw will be approximately 7 tablespoons.

Once you have completed all responses to the questionnaire and you have had the blood draw, you will be compensated $100 for your participation.

Follow-up study visits

If you have been diagnosed with Lyme disease or you suspect you have Lyme disease, you will be asked to participate in three additional study visits over a 12-month time period, at 1 month, 6 months, and 12 months. Completion of each visit includes both a blood draw and discussing your symptoms and medical information relating to Lyme disease with a study doctor to collect study-related medical information.

You may withdraw your consent at any time. You can complete the ImmuneSense™ Lyme study without participating in or consenting to additional blood draws and study visits or telehealth visits. Each additional blood draw will be approximately 7 tablespoons.

You will receive additional compensation of $100 for each follow-up blood draw and study site or telehealth visit you complete, up to four draws/visits total.

Are there risks and discomforts to me by participating in this study?

Potential physical risks associated with drawing blood include soreness at the site of puncture, bruising, and in rare cases, infection of the blood draw site, fainting, or nerve or tendon damage.

Will I receive any results from the ImmuneSense™ Lyme study?

The overall results of the study may be published; however, all protected health information (PHI) that could potentially identify you will be completely removed and all data presented will be de-identified in accordance with HIPAA. If you are in the Lyme disease cohort (group), your healthcare provider will have access to the results of the standard two-tiered test (STTT) for Lyme disease completed during the study. Adaptive, as the Sponsor, will not return any additional individual results from this study, nor provide results directly to participants.

Are there any direct benefits to me being in the ImmuneSense™ Lyme study?

You will not receive any direct benefits from being in this study.

The new test will potentially offer earlier-stage detection of Lyme disease. Building a potentially better diagnostic test will mean better results for the hundreds of thousands of people who contract Lyme disease each year.

Are there any direct costs to me for my participation?

No, all study related procedures will be covered and your insurance will not be billed. This includes a medical record review and collecting relevant medical information by a study doctor, plus a study-related blood draw. If you receive care outside the study by a study doctor, this visit or procedures will be billed to your insurance.

For example, if you believe you have symptoms consistent with Lyme disease, and you would like to see a study doctor for routine care to treat and diagnose Lyme disease, this is outside the scope of the study. Therefore, this visit will be billed to your insurance. If the study site is in your insurance network, then it will incur the normal cost; if it is out-of-network, you may be responsible for the full cost of the visit. You will not incur cost for any aspects of the blood draw associated with this study, or for any medical information review by the study doctor that is for this study.

Will I be compensated for my participation?

You will be given $100 for your participation in the ImmuneSense™ Lyme study. You must discuss any study-related medical information with the doctor (all questions answered) and complete a blood draw to qualify.

If you are diagnosed with Lyme disease or suspected of having Lyme disease, and you complete the longitudinal study visits (at 1 month, 6 months, and 12 months), you will be compensated an additional $100 for each study visit and blood draw.

What does mean if I select to to share my story on the consent form??

If you mark that you’re willing to share your story, Adaptive may contact you to discuss your experience with Lyme disease and your journey to a diagnosis. This is entirely optional, and separate from any medical information that you share through your general participation with the study.

If you have questions on this, you can contact ImmunseSenseLyme@adaptivebiotech.com

May I withdraw or revoke (cancel) my authorization for use and disclosure of my health information?

Yes, you may withdraw (revoke) your permission to use and disclose your health information at any time. You can do this by sending written notice to the enrolling site or study doctor. However, if you withdraw your permission for use and disclosure of your health information, you will not be able to stay in this study. Also, although withdrawing your permission will prevent further uses and disclosures of your health information, it will not invalidate uses and disclosures that have already been made at the time the permission is withdrawn. This permission will be good until December 31, 2060.

Is my health information protected after it has been given to others?

Every effort will be made to ensure confidentiality of your personal information.

Is the confidentiality of my health information protected?

Total confidentiality cannot be guaranteed, but disclosures of your health information will be very limited, as described above. And, as mentioned, to the extent the results of this research study are presented at meetings or in publications, your identity will never be included in the information that is disclosed. Government agencies or staff sometimes review studies such as this one to make sure they are being done safely and legally. If a review of this study takes place, your records may be examined. The reviewers will protect your privacy. The study records will not be used to put you at legal risk.

Is my participation voluntary, and can I withdraw at any time?

Your participation in this study is voluntary. You do not have to provide blood for this study, and if you do provide samples and then later change your mind about your samples being stored and used, you can ask for any remaining samples to be destroyed. If you do change your mind, please notify your study staff in writing. If you withdraw your permission to use your samples, no new testing will be done; however, the results of any tests already performed will remain in the study data.

Your participation in this study may be stopped at any time by the study doctor or the Sponsor without your consent, for any of the following reasons:

· If it is in your best interest

· If you do not consent to continue in the study after being told of changes in the research that may affect you, or

· For any other reason.

Will I be informed if there are any changes to the study that affect me?

You will be told about any new information that might change your decision to be in this study. You may be asked to sign a new consent form if this occurs.

I have additional questions; who can I contact?

Please email the study staff at: AdaptiveLymeStudy@iqvia.com for any of the following reasons:

· If you have any questions about the ImmuneSense Lyme study or your part in it

· If you feel you have had a research-related injury, or

· If you have questions, concerns or complaints about the research

If you have questions about your rights as a research participant, or if you have questions, concerns, or complaints about the research, you may contact:

Western Institutional Review Board® (WIRB®), 1019 39th Avenue SE Suite 120, Puyallup, Washington 98374-2115

Telephone: 1-800-562-4789 or 360-252-2500

Email: Help@wirb.com

WIRB is a group of people who independently review research. You may contact WIRB if the study research staff cannot be reached or if you wish to talk to someone other than the research staff.