Agizew 2019a.
Study characteristics | ||
Methods | Stepped‐wedge cluster‐randomized trial. A cluster was defined as HIV care and treatment clinic. Twenty‐two clusters, located at five district hospitals and 17 primary healthcare facilities, were purposively selected to: (1) be representative of HIV treatment clinics in Botswana, and (2) have new antiretroviral therapy (ART) initiation rates sufficient to meet sample size requirements per protocol | |
Participants | Participants were new HIV clinic attendees, regardless of age, and who were not prisoners at
the time of the first HIV clinic visit between August 2012 and November 2014. Female: 66% in the Xpert arm, 68% in the smear arm HIV infection: all were HIV infected Settings:primary healthcare facilities Country: Botswana Sample size: 4225 Xpert arm, 1816 smear arm |
|
Interventions | Participants who screened positive for at least one tuberculosis symptom were requested to provide four sputa samples: two were provided on the screening day (spot 1 and 2) and two on the following day. On day 2, one sputum sample was collected at home early in the morning (morning sample), and another sample was taken at the clinic (spot 3). Participants in the smear arm were enrolled in XPRES before Xpert MTB/RIF instrument implementation; therefore, spots 1 and 3 were tested only with Ziehl–Nielson smear at the peripheral laboratory. However, if participants in the smear arm screened positive for tuberculosis during a follow‐up appointment after Xpert MTB/RIF instrument implementation, spots 1 and 3 were tested by Xpert MTB/RIF at the peripheral laboratory or point of care sites. For the Xpert arm, all spot 1 and 3 samples were tested by Xpert MTB/RIF either at the peripheral laboratory or at point of care sites. Spot 2 and morning samples were submitted to the National tuberculosis Reference Laboratory for liquid culture. |
|
Outcomes | Treatment outcome Time to treatment initiation |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The authors reported that the statistician randomly selected one of the roll‐out permutations |
Allocation concealment (selection bias) | Unclear risk | No details on how the allocation list was concealed |
Baseline characteristics similar (selection bias) | Low risk | There were no substantial differences |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not done, however, blinding is not feasible for a diagnostic test, and knowledge of the test is part of the intervention |
Protection against contamination (performance bias) | Low risk | Allocation of the intervention replaced smear microscopy at different periods in a stepped‐wedge design |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding was not done, however, blinding was not feasible given pragmatic nature of the trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The rate of loss to follow‐up was similar between the Xpert MTB/RIF arm and smear microscopy arm |
Selective reporting (reporting bias) | Low risk | All outcomes in the trial were reported |
Other bias | Low risk | Not detected |