Maitland 2008.

Methods	Randomized controlled trial
Participants	The study location was not reported 48 participants were randomized to the intervention group and 48 participants were randomized to the control group The inclusion criteria were HIV‐1 infected patients with established viral load below the limits of assay detection (< 50 HIV‐1 RNA copies/ml), taking separate abacavir (ABC) 300 mg and lamivudine (3TC) 150 mg bid in combination with any other antiretroviral agent(s) suitable for once daily dosing, and be stable for 16 weeks prior to screening The exclusion criteria were pregnancy or declined the use of effective contraception, had a proven or suspected active opportunistic infection, weighed less than 40 kg or had a creatinine clearance < 50 ml/min
Interventions	Intervention: ONCE DAILY DOSING Patients were switched to a fixed‐dose combination tablet of ABC and 3TC dosed once‐daily. All other antiretroviral agent(s) in the patient's regimen were dosed once‐daily from or before screening Control: USUAL DOSING (TWICE DAILY) Patients remained on ABC and 3TC twice daily. All other antiretroviral agent(s) in the patient's regimen were dosed once daily from or before screening
Outcomes	The measures of adherence were drug monitoring via MEMS. At baseline patients in arm 1 had the fixed‐dose combination tablet of ABC and 3TC dispensed in a bottle with a MEMS cap, while patients in arm 2 had their 3TC dispensed in a bottle with a MEMS cap. Data were collected at week 4. Patients were advised only to open the bottle at the time of dosing and were aware of the function of the MEMS cap. MEMS data were calculated in 3 ways. Taking compliance (TAC) (the percentage of prescribed number of doses taken); correct dosing compliance (COD) (the percentage of days with correct number of doses taken); and timing compliance (TIC) (the percentage of doses taken within beta 3 hours of the prescribed dosing interval) The patient outcomes were viral load and hospital anxiety and depression (HAD). Viral load was measured at baseline and at 4 weeks. HAD was measured with a questionnaire at baseline and 4 weeks
Notes	Only looking at results at 4 weeks ‐ before the control group got switched to treatment
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Sequence generation not specified. Eligible patients were randomized (using shuffled opaque envelopes in a 1:1 ratio) at baseline to either switch immediately to the fixed‐dose combination tablet of ABC and 3TC dosed once daily (arm 1) or to remain on ABC and 3TC twice daily until week 4 before switching to the fixed‐dose combination tablet of the 2 agents for the final 4 weeks of the study (arm 2)
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes. Eligible patients were randomized (using shuffled opaque envelopes in a 1:1 ratio) at baseline to either switch immediately to the fixed‐dose combination tablet of ABC and 3TC dosed once daily (arm 1) or to remain on ABC and 3TC twice daily until week 4 before switching to the fixed‐dose combination tablet of the 2 agents for the final 4 weeks of the study (arm 2)
Selective reporting (reporting bias)	Unclear risk	No protocol available
Other bias	Low risk	None noted
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ The lack of blinding is not likely to affect the outcome
Blinding of outcome assessment (detection bias) Patient outcome	High risk	(PRIMARY) HAD SCORE ‐ Open‐label study ‐ staff not blinded; therefore high risk of bias
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) MEMS ‐ Patients could open bottle and not take medication (or take medication out and then not open bottle later when actually taken)
Blinding of participants (performance bias) Patient outcome	High risk	(PRIMARY) HAD SCORE ‐ Open‐label study ‐ staff not blinded; therefore high risk of bias
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ The lack of blinding is not likely to affect the outcome
Blinding of personnel (performance bias) Patient outcome	High risk	(PRIMARY) HAD SCORE ‐ Open‐label study ‐ staff not blinded; therefore high risk of bias
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ "No randomized patients were lost to follow‐up or failed to complete all study visits." (pg 669)
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) HAD SCORE ‐ "No randomized patients were lost to follow‐up or failed to complete all study visits." (pg 669)