TAKE‐IT 2014.

Methods	Study design: prospective, parallel, unblinded RCT Study duration: February 2012 to May 2016 Study follow‐up: 12 months, with 3 month non‐intervention run‐in period
Participants	Country: USA and Canada Setting: multicentre (8 sites) Adolescents at least 3 months post kidney transplant aged 11 to 24 years Number: intervention group (81); control group (88) Median age (IQR) (years): intervention group (15.5 (13.2‐17.4)); control (15.8 (13.3‐17.5) Sex: 59% male; intervention group (61%); control group (57%) Exclusion criteria: impending graft failure; severe neurocognitive disabilities lack of electronic pillbox connectivity; use of liquid immuno‐suppressive medications; having a sibling participating in the study; participating in another adherence‐promoting intervention study; inability to communicate comfortably in English or French
Interventions	Intervention type classification: behavioural counselling eHealth intervention used: blue‐tooth, electronic monitors Intervention group Usual clinical care plus electronic pill box with alerts Adherence Support Team (AST) comprised of the participant, 1‐2 parents, trained site Coach. The coach delivered standardized education on immunosuppressive medications by slide presentation, identified adherence barriers using the AMBS/PMBS27 and the last 3 months of electronic monitoring data, and then used “Action‐Focused Problem Solving” to address barriers selected as most important by the patient. The patient chose 1 or 2 barriers to address at each session. At subsequent sessions, the coach, patient, and parent jointly reviewed the electronic adherence monitoring data from the prior 3 months to identify adherence patterns and guide the development and revision of action plans. Patients could continue to work on the same barrier(s) or select a new barrier to address. Participant chose to receive text message, email or visual cue dose reminders throughout the study Control group Usual clinical care Control group study visits were conducted at the same intervals as intervention visits consisted of the coach engaging in active listening and providing nonspecific support only Adherence was not discussed with participants. Electronic pill box to track adherence, however no alerts or feedback given to participants
Outcomes	Primary outcome (12 months) Medication "taking adherence" defined as proportion of prescribed doses taken. Measured through electronic monitoring, pharmacy dispensing records, self reporting and variability in tacrolimus and sirolimus trough levels. Each day was scored as 0%, 50%, or 100%, depending on whether the patient took none, half, or all prescribed doses. "Timing adherence" defined as proportion of prescribed doses taken within 1 hour before to 2 hours after the prescribed dosing time. Timing adherence scores were given the values 0%, 50%, or 100%. Secondary outcomes (12 months) Adherence: standard deviation of tacrolimus trough concentrations and self‐reported (MAM‐MM). Graft outcomes: graft failures or deaths, acute rejections, percentage change in glomerular filtration rate adverse events: death, opportunistic viral infections, hospitalisations, other medical conditions requiring treatment
Notes	Funding source: The study was funded by the American NIH, National Institutes of Diabetes, Digestive and Kidney Diseases (R01DK092977)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Block randomisation
Allocation concealment (selection bias)	Low risk	Allocation is maintained until 3 month visit
Blinding of participants and personnel (performance bias) Blinding of participants	High risk	Not blinded
Blinding of participants and personnel (performance bias) Blinding of personnel	High risk	Not blinded
Blinding of outcome assessment (detection bias) Objective outcome	Low risk	primary and secondary outcomes predominantly measured objectively
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Subjective assessment of adherence used in addition to objective methods
Incomplete outcome data (attrition bias) All outcomes	Low risk	12% loss after randomisation in intervention group, groups were balanced with respect to age, time since transplant, gender. Analyses conducted using intention‐to‐treat and as‐treated
Selective reporting (reporting bias)	Low risk	All stated outcomes were reported
Other bias	Unclear risk	Insufficient information to permit judgement