Community-based tuberculosis triage testing after symptom screening in hard-to-reach African populations: CAD4TB versus C-reactive protein

The main objective of the proposed TB TRIAGE+ project is to assess the accuracy, impact and cost-effectiveness ofCAD4TB and POC-CRP as triage tools for community-based TB screening. To test these tools, we will implementtwo trials in rural and semi-rural Lesotho and KwaZulu Natal, South Africa.In the first trial -TB TRIAGE+-ACCURACY- we will assess the diagnostic accuracy of POC-CRP and CAD4TB in 1400presumptive TB patients and determine the optimal cut-offs for triage testing. In the second, community-basedcluster-randomized trial -TB TRIAGE+-RCT- we will assess the impact of CAD4TB and POC-CRP triage tests on TBnotification rate, diagnostic/treatment delays and patient outcomes, and we will perform health economic andequity analyses based on the trial data. The triage tests will be used after symptom screening and prior toconfirmatory on-site Xpert MTB/RIF testing. The control arm follows current standard of care with referral forconfirmatory Xpert TB/RIF Ultra at the clinic in individuals presenting TB symptoms. The demonstration phasedesign with 35000 participants has been chosen to generate high-level evidence to inform policy.

The main objective of the proposed TB TRIAGE+ project is to assess the accuracy, impact and cost-effectiveness ofCAD4TB and POC-CRP as triage tools for community-based TB screening. To test these tools, we will implementtwo trials in rural and semi-rural Lesotho and KwaZulu Natal, South Africa.In the first trial -TB TRIAGE+-ACCURACY- we will assess the diagnostic accuracy of POC-CRP and CAD4TB in 1400presumptive TB patients and determine the optimal cut-offs for triage testing. In the second, community-basedcluster-randomized trial -TB TRIAGE+-RCT- we will assess the impact of CAD4TB and POC-CRP triage tests on TBnotification rate, diagnostic/treatment delays and patient outcomes, and we will perform health economic andequity analyses based on the trial data. The triage tests will be used after symptom screening and prior toconfirmatory on-site Xpert MTB/RIF testing. The control arm follows current standard of care with referral forconfirmatory Xpert TB/RIF Ultra at the clinic in individuals presenting TB symptoms. The demonstration phasedesign with 35000 participants has been chosen to generate high-level evidence to inform policy.