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. 2021 May 6;2021(5):CD012972. doi: 10.1002/14651858.CD012972.pub2

Ngwira 2019.

Study characteristics
Methods Cluster‐randomized trial in 12 primary healthcare centres in rural Thyolo district Malawi
Participants Participants included were newly diagnosed with HIV
18 years old and older
Female: 55%
HIV infection: 100% (HIV clinic)
setting: primary healthcare facilities
Country: Malawi
Sample size: 1842
Interventions Primary healthcare clinics were randomized to either screen tuberculosis in newly HIV participants by Xpert MTB/RIF, or light emitting diode fluorescence microscopy (LED FM). Symptom screening and sputum evaluation were performed on‐site by trained study personnel, and results were provided to participants on the same day. Participants testing positive for active tuberculosis were referred for treatment. Participants with tuberculosis symptoms but negative Xpert or LED FM results were asked to return in one month, and provided with Isoniazid Preventive Therapy (IPT) at that time if asymptomatic. All participants with positive Xpert or LED FM results had sputum taken for confirmatory culture, performed at a central laboratory. All participants were asked to return to study clinics for assessment every three months (with one extra visit when on IPT).
Outcomes Primary outcome:
  • all‐cause mortality within 12 months following HIV diagnosis


Secondary outcomes:
  • tuberculosis treatment outcomes,

  • tuberculosis incidence,

  • mortality in subgroups of age (≤ 35 versus > 35 years old), sex, clinical stage (stage I/II versus III/IV), and ART eligibility/CD4 count

Notes Target condition: tuberculosis in newly diagnosed HIV‐positive participants
Case definition: positive Xpert MTB/RIF, LED FM, or positive culture
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization was done by study statistician who identified possible randomization that would result in prespecified balance, and the randomization was carried out by an official using the coin flip method
Allocation concealment (selection bias) Low risk Investigators and laboratory staffs were blinded to allocation
Baseline characteristics similar (selection bias) Low risk Baseline characteristics were reported to be similar, no detection of selection bias
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and clinics were not blinded
Protection against contamination (performance bias) Low risk Intervention was allocated at a cluster, and recruitment done in waves based on geography
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinding was not possible, mortality is an objective outcome
Incomplete outcome data (attrition bias)
All outcomes Low risk Loss to follow‐up was similar in both arms
Selective reporting (reporting bias) Low risk All pre‐specified outcomes in the methods were reported
Other bias Low risk Not detected