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. 2018 Nov 9;2018(11):CD006495. doi: 10.1002/14651858.CD006495.pub5

Tural 2002.

Methods A randomized open‐label multi‐centre factorial design trial at 13 hospitals in 10 cities in Spain
Participants 326 participants
Inclusion: plasma RNA > 1000 copies/mL, on stable ART combination for longer than 6 months
Exclusion: substantial antiretroviral‐related adverse events history, poor adherence or active drug abuse reported by the treating physician
Interventions Intervention 1: genotyping without expert advice (G+/EA‐)
Intervention 2: genotyping and expert advice (G+/EA+)
Intervention 3: no genotyping with expert advice (G‐/EA+)
Control: no genotyping and no expert advice (G‐/EA‐)
Outcomes Virological success (< 400 copies/mL), change in viral load
Notes All participants provided informed consent.
Funding: Visible Genetics
Trial acronym: Havana
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomization was not reported.
Allocation concealment (selection bias) Low risk Central location randomization was conducted.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk This was an open‐label study (knowledge of allocation is unlikely to introduce bias).
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Trial authors did not report this information (knowledge of allocation is unlikely to introduce bias).
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Losses to follow‐up were balanced between groups. Trial authors performed ITT analyses.
Selective reporting (reporting bias) Low risk All relevant outcomes were reported.
Other bias Low risk We found no other sources of bias.
Overall risk assessment Low risk We had no serious risk of bias concerns.