Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Randomized, Single-center, Pilot Study of Envarsus XR® to Examine Safety, Medication Adherence, and Patient Reported Outcomes in Adolescent Renal Transplant Recipients
Brief Summary: Adolescents commonly experience barriers to adherence that entail forgetfulness, distraction, poor planning, and scheduling problems. A once daily oral regimen may be superior to the current regimens that require twice daily dosing. It is currently unclear if Envarsus XR® would improve outcomes in adolescent organ transplant recipients. Each patient will receive tacrolimus (twice daily immediate release oral formulation) which they are using as part of their standard of care immunosuppressive regimen for a portion of the study and Envarsus XR® (a once daily extended-release oral tacrolimus formulation) for a portion of the study in a cross-over design. Besides the advantage to adherence behaviors, a sustained-release tacrolimus preparation may decrease burdensome side effects and increase quality of life. Following enrollment, each patient will be maintained in the study for 9 months.


Options:
A: 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
B: 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"
C: Inclusion Criteria:

1. ≥21 years old;
2. First time recipient of a functioning solitary kidney transplant;
3. Prescribed ≥3 medications for immunosuppression and HTN;
4. Transplant MD's assent that patient is able to participate;
5. Ability to speak, hear and understand English;
6. Able to take their own BP;
7. Self-administers medications;
8. SBP \>129 mmHg at clinic visit(s) in 4 weeks prior, and at initial study evaluation at enrollment;
9. \*\*\*Only subjects with adherence score \<.85 after 1-month screening and SBP \>129 mmHg at baseline will be randomized.

Exclusion Criteria:

1. Failure to meet any inclusion criterion;
2. Ongoing substance abuse (e.g., \>21 alcoholic drinks/week);
3. Psychiatric illness requiring treatment beyond antidepressants;
4. Will attempt to become pregnant within the year;
5. Pregnant or nursing women, prisoners, and institutionalized persons.
D: Inclusion Criteria:

1. Male and female subjects (≥ 18 years old) who are liver transplant recipients.
2. Discharged home within 45 days of liver transplant.
3. Able and willing to provide informed consent.

Exclusion Criteria:

1. Post-transplant admission and care provided by University of Cincinnati Medical Center or rehab facility \> 45 days after liver transplant.
2. Unable to have 4G wireless connectivity or wifi in their home.
3. Patient has any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the investigator.
4. Inability to cooperate or communicate with the investigator.

Answer: A