Please select the eligibility criteria that correspond to the clinical trial below.
Title: Transplant Regimen Adherence for Kidney Recipients by Engaging Information Technologies: The TAKE IT Trial
Brief Summary: The investigators will evaluate a technology-enabled strategy designed to promote medication adherence, routinely monitor regimen use, and mobilize appropriate transplant center resources to respond early to kidney transplant recipients demonstrating inadequate adherence.


Options:
A: Inclusion Criteria

1. Signed informed consent and or/assent
2. Between the ages of 18 and 70 years, inclusive
3. Current or future kidney transplant recipients, no more than 14 days after transplant and prior to hospital discharge. Inclusion of future kidney transplant recipients cannot exceed 30-days pre-transplant.
4. Able to swallow tablets and capsules at the time of randomization
5. Subjects must be receiving a primary or secondary kidney allograft from a deceased donor or from a non- HLA identical living donor
6. Negative cross match test, and compatible (A, B, AB or O) blood type
7. Subjects must have no known contraindications to tacrolimus
8. Women of childbearing potential (WOCBP) must have a negative pregnancy test and be willing to use 2 methods of contraception during the study and for 6 weeks after stopping the study drug.

WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level \> 35 mIU/cc). Women who are using oral, implanted, or injectable contraceptive hormones (intrauterine device), mechanical products or barrier methods (diaphragm, condoms, spermicides), are practicing abstinence, or have a sterile partner (e.g., vasectomy), will be considered of child bearing potential.

In addition, WOCBP who are taking MMF must use methods of birth control as stipulated in the package insert, namely:

Either intrauterine device, or partner with vasectomy, or one hormone (oral contraceptive pill, transdermal patch, vaginal ring, or progesterone injection or implant) and one barrier method (diaphragm or cervical cap with spermicide, contraceptive sponge, or male or female condom), or two barrier methods as described above.

WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) at the time of transplant.

Exclusion Criteria

1. Those who receive simultaneous combined organ transplants
2. Subjects with clinically significant active infections (for example, those requiring hospitalization, or as judged by the Investigator) or malignancies
3. Recipients who are concurrently receiving belatacept or anticipate to receive belatacept as part of their immunosuppressive regimen
4. Subjects currently enrolled in another investigational device or drug study
5. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for 6 weeks after stopping the study drug
6. Women who are breast-feeding or pregnant with a positive pregnancy test on enrollment or prior to study drug administration
7. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
8. Any psychiatric or medical condition that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
B: Inclusion Criteria:

* 1) age 21 or older
* 2) 5 weeks to 24 months post kidney transplant
* 3) English speaking
* 4) primarily responsible for administering own medication
* 5) owns a cell phone and comfortable receiving text messages
* 6) has access to and proficiency using internet in home

Exclusion Criteria:

* any severe, uncorrectable vision, hearing or cognitive impairments
C: Inclusion Criteria:

* 18 or older
* can speak and understand and read English
* receive their first kidney transplant at one of the participating sites during enrolment

Exclusion Criteria:

* do not meet inclusion criteria
* have previously participated in a study entitle "Improving health outcomes of kidney recipients: A randomized controlled trial of a pre-transplant education intervention"
D: Inclusion Criteria:

* Recipients of first kidney transplants (deceased or living donor) with stable allograft function
* 6 or more months after transplantation
* Currently on a stable dose of twice-daily tacrolimus and mycophenolate mofetil (MMF) or enteric coated mycophenolic acid (EC-MPA)± corticosteroids for a minimum of 6 months prior (patient has remained on a dosing that has changed no greater than ± 0.5mg/dose for a minimum of 4 months)
* Ability to comply with study procedures for the entire length of the study
* Patient and/or parent/legal guardian has been informed about the study survey and has signed an informed consent form.

Exclusion Criteria:

* Detectable donor specific anti-HLA antibody prior to enrollment (pre- or post-transplant)
* Actively being treated for an episode of biopsy proven acute cellular rejection (ACR) (Banff 1A or greater)
* Post-transplant history of biopsy proven ACR (Banff 1B or greater) or antibody mediated rejection (AMR)
* Currently receiving, planning to receive, or received within 7 days prior to study enrollment any drug interacting or interfering with tacrolimus metabolism (azole antifungals, erythromycin, clarithromycin, diltiazem, protease inhibitors, statins, grapefruit juice, rifampin or anti-seizure medications shown to interact with tacrolimus)
* Currently receiving an mTOR inhibitor (sirolimus, everolimus)
* Gastrointestinal illness that might affect the absorption of tacrolimus
* Unable or unwilling to complete study survey questionnaire
* Professional care taker is responsible for dispensing subject's medication
* Recipient of HLA identical or zero HLA mismatched organ transplant
* Documented history of medication non-adherence following transplantation prior to enrollment

Answer: B