Dejesus 2009.

Methods	Randomized controlled trial
Participants	The study location was 53 sites in the United States and 2 sites in Puerto Rico 203 participants were randomized to the intervention group and 97 participants were randomized to the control group The inclusion criteria were male or nonpregnant female patients 18 years or older with adequate renal function, documented HIV‐1 seropositivity, demonstrated maintenance of virologic suppression for at least 3 months on their current regimen and patients have a life expectancy of greater than or equal to 1 year The exclusion criteria were taking an nonnucleoside reverse transcriptase inhibitor (NNRTI)‐based regimen consisting of EFV plus TDF and FTC, had taken NRTI‐only therapy for > 7 days before their current therapy, individuals with known hypersensitivity to any of the components of EFV/FTC/TDF, have resistance to any of the study agents at any time in the past, a new AIDS defining condition (with the exception of CD4 criteria) diagnosed within 30 days of baseline, taking nephrotoxic medications or agents known to interact with EFV
Interventions	Intervention: SINGLE TABLET REGIMEN (EFV/FTC/TDF) Intervention group patients were prescribed a single‐tablet regimen consisting of efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) Control: ART Control group patients were prescribed to be on regular multi‐drug ART
Outcomes	The measures of adherence were self reported adherence and pill count. Visual analog scale (VAS) was used to measure self reported adherence. Subjects were required to estimate adherence to their antiretroviral therapy regimen by marking a linear scale. Both the measures were taken at baseline and 48 months The patient outcomes were virologic suppression, health‐related quality of life (assessed by SF‐36 questionnaire), and HIV symptom index. The measurements were performed at 4, 12, 24, 36, and 48 weeks
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information to permit judgment of 'Low risk' or 'High risk' of bias. (pg 164) "Patients on stable ART with HIV‐1 RNA < 200 copies per milliliter for > or = 3 months were stratified by prior nonnucleoside reverse transcriptase inhibitor‐based or protease inhibitor‐based therapy and randomized (2:1) to simplify treatment to EFV/FTC/TDF or to stay on their baseline regimen (SBR)."
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment of 'Low risk' or 'High risk' of bias. (pg 164) "Patients on stable ART with HIV‐1 RNA < 200 copies per milliliter for > or = 3 months were stratified by prior nonnucleoside reverse transcriptase inhibitor‐based or protease inhibitor‐based therapy and randomized (2:1) to simplify treatment to EFV/FTC/TDF or to stay on their baseline regimen (SBR)."
Selective reporting (reporting bias)	Low risk	The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified
Other bias	Unclear risk	(pg 173) Authors indicate that there are certain limitations to this study. In general, studies that involve switching therapy tend to attract patients motivated to make a change in treatment, and such studies can have an intrinsic bias toward favoring the switch strategy under evaluation. More than 90% of subjects cited regimen simplification as a reason for participation. This is not surprising given that the median duration of prior ART was 3 years, and individuals showing poor regimen tolerability would be much less likely to be receiving such long‐term therapy. Thus, the motivation to simplify therapy in this stable population could have affected patients reporting of AEs, adherence, and/or medication preference
Blinding of outcome assessment (detection bias) Adherence measure	High risk	(PRIMARY) VISUAL ANALOG SCALE (VAS) ‐ This is an open‐label study and the outcome is subjective. Therefore, lack of blinding is likely to have an impact on the outcome results
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) VIROLOGIC SUPPRESSION ‐ Blood test are objective. The lack of blinding of data collectors in this study is not likely to affect the outcome
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) VISUAL ANALOG SCALE (VAS) ‐ This is an open‐label study and the outcome is subjective. Therefore, lack of blinding is likely to have an impact on the outcome results
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) VIROLOGIC SUPPRESSION ‐ Blood test are objective. The lack of blinding of data collectors in this study is not likely to affect the outcome
Blinding of personnel (performance bias) Adherence measure	High risk	(PRIMARY) VISUAL ANALOG SCALE (VAS) ‐ This is an open‐label study and the outcome is subjective. Therefore, lack of blinding is likely to have an impact on the outcome results
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) VIROLOGIC SUPPRESSION ‐ Blood tests are objective. The lack of blinding of data collectors in this study is not likely to affect the outcome
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) VISUAL ANALOG SCALE (VAS) ‐ Author's note: this is a 2:1 randomization to intervention arm:control arm, so the percentage of attrition is 11% versus 12%; there is no imbalance
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) VIROLOGIC SUPPRESSION ‐ Author's note: this is a 2:1 randomization to intervention arm:control arm, so the percentage of attrition is 11% versus 12%; there is no imbalance