Cooper 2010.

Methods	36 patients were randomized to the Cognitive Adaptation Training (PharmCAT), which was focused only on medication and appointment adherence; 37 were randomized to the Cognitive Adaptation Training (Full‐CAT), which focused on many aspects of community adaptation; 32 participants were randomized to the control group. Randomized controlled trial
Participants	The study location was 9 sites across UK (Brighton, Birmingham Heartlands, Kings College London, Birmingham Whittall Street, Newcastle General, Leicester, St. Mary's London, Oxford, Newham) UK 44 participants were randomized to the intervention group and 43 participants were randomized to the control group The inclusion criteria were being HIV positive, age > 18 years, able to give informed consent, being antiretroviral naive, with CD4 lymphocyte count, < 350 cells per cubic millimeter and/or HIV viral load > 20,000 copies per milliliter and/or AIDS‐defining illness, and likely to live more than 2 years with antiviral therapy The exclusion criteria were alkaline phosphatase or hepatic transaminases > 5 times upper limit of normal, neutrophil count of < 0.5 X 10 9/L, medical history of pancreatitis, prior exposure to any antiretroviral agent, pregnancy or female patient trying to become pregnant, patients who do not self medicate, those unwilling or unable to use Medication Event Monitoring Systems (MEMS) monitors, patients who are unable to comprehend the written questionnaires with the help of a clinician or interpreter, and those needing medication other than their proposed antiretrovirals that is either more than 3 additional tablets or capsules per day, that cannot be taken at the same time as their antiretrovirals, or that may have a significant pharmacological interaction with their proposed antiretrovirals
Interventions	Intervention: ONCE NIGHTLY REGIMEN Patients in the once nightly regimen group received 1 x Didanosine (DDI) enteric‐coated (EC) capsule 400 mg (250 mg if weight less than 60 kg), 2 x lamivudine (3TC) 150 mg tablet, 1 x efavirenz (Sustiva) 600 mg tablet each evening Control: TWICE DAILY REGIMEN Patients in the control group received Combivir (zidovudine 300 mg + 3TC 150 mg): 1 tablet twice daily, 1 x efavirenz 600 mg tablet taken nightly
Outcomes	The measures of adherence were persistence with treatment and execution of the dosing regimen and measured using MEMS 6 to collect 3TC drug dosing histories. Persistence was defined as the length of time during which the medication is taken, that is, the time from the first‐taken dose to the last taken dose, measured using MEMS. Execution of the Dosing Regimen measured how closely the patient's dosing history corresponds to the prescribed drug‐dosing regimen by reporting the proportion of prescribed doses taken and was summarized as binary time series where for each consecutive day that the patient was still engaged with treatment, the variable indicated whether or not the patient had taken at least the prescribed number of doses. MEMS data were downloaded at 4, 12, 24, 36, and 48 weeks after each patient initiated treatment The patient outcomes were measured in the clinic before patients initiated treatment (baseline) and each subsequent time point (4, 12, 24, 36, and 48 weeks). Patient outcomes included: 1) Beliefs about HAART measured using the Beliefs about Medicines Questionnaire–HAART specific version, which comprises 2 scales: HAART necessity scale which consists of 8 items assessing individuals' beliefs about their personal need for HAART for controlling their HIV, maintaining their health, and preventing illness, and HAART concerns scale which consists of 11 items which bring together a range of separate concerns about the potential adverse effects of HAART that have been identified across studies. Participants were presented with a series of statements about which they were told "these are statements that other people have made about combination therapy". They were then asked to rate their level of agreement with each item on a scale, where responses ranged from strongly agree (scored 5) to strongly disagree (scored 1). Scores for the individual items within each scale were summed to give a total scale score. A mean scale score was computed by dividing each scale by the number of items, giving a range of 1 to 5 for both necessity and concerns scales. This was done to facilitate comparison of scores between scales and to calculate a necessity–concerns differential (NCD) by subtracting concerns scores from necessity scores. The NCD score can be thought of as a crude indicator of the way the individual rates their perceived need for the treatment relative to their concerns about taking it. 2) HAART Intrusiveness Scale Consists of 10 items addressing the degree to which HAART is perceived to interfere with 10 aspects of daily life, each ranked on a scale from 1 to 5, where 1 indicates low interference and 5 indicates high interference. A total score was computed by adding up responses to each item. For comparison with other scales, an average score was computed by dividing the total score by the number of items. Possible responses ranged from 1 to 5 with higher scores indicating higher perceived intrusiveness. 3) Viral load was assessed at 4, 12, 24, 36, and 48 weeks after each patient initiated treatment using locally available method in each case. Viral load failure was defined as viral load >50 copies per milliliter at 48 weeks
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random number table used (pg 370) ‐ The sequential allocation of consecutive patients was predetermined by random number tables
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment of 'Low risk' or 'High risk'
Selective reporting (reporting bias)	Unclear risk	None detected but protocol unavailable
Other bias	Unclear risk	Insufficient information provided to make a judgment. But noted that the study was not powered to compare the effect on viral load between the 2 dose regimens (pg 375)
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ Not likely to be affected by staff and personnel collecting the data
Blinding of outcome assessment (detection bias) Patient outcome	High risk	(PRIMARY) HAART BELIEFS AND INTRUSIVENESS ‐ Open‐label study; subjective measure; no mention of blinding
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) MEMS ‐ Patients likely to be non‐blinded because of the nature of the intervention
Blinding of participants (performance bias) Patient outcome	High risk	(PRIMARY) HAART BELIEFS AND INTRUSIVENESS ‐ Open‐label study; subjective measure; no mention of blinding
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ Not likely to be affected key study personnel collecting the data
Blinding of personnel (performance bias) Patient outcome	High risk	(PRIMARY) HAART BELIEFS AND INTRUSIVENESS ‐ Open‐label study; subjective measure; no mention of blinding
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ Low dropout rate and excellent follow‐up
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) HAART BELIEFS AND INTRUSIVENESS ‐ Low dropout, high follow‐up