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 |
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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‐) |
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Outcomes | Virological success (< 400 copies/mL), change in viral load | |
Notes | All participants provided informed consent. Funding: Visible Genetics Trial acronym: Havana |
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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. |