A multi-country randomised controlled trial (RCT) to evaluate a scalable active case finding intervention for TB using a point-of-care molecular tool (Gene Xpert)
The TB reservoir of transmission remains concentrated in large peri-urban settlements in Africa and Asia. The cases are frequently minimally symptomatic but remain infectious. The danger with minimal symptoms is that people tend to refrain from seeking diagnosis and treatment until they feel very ill. However, the community will continue to be at risk of infection. Actively seeking TB-positive patients – regardless of the degree of symptoms – can help break the chains of TB transmission hopefully, see patients initiating treatment much sooner. However, the Active Case Finding (ACF) strategy needs optimisation – which is what this study aims to do!
Evaluate a scalable active case finding intervention using Gene Xpert at POC
Bio-phenotype microbiologically confirmed but minimally symptomatic TB from an Active Case Finding (ACF) strategy
Model the cost effectiveness of an ACF strategy using Xpert at POC vs centralised laboratories.
Primary: The proportion with pre-treatment LTFU (defined as test positive patients failing to initiate treatment by 60 days) and/ or the proportion of infectious TB patients (smear positive and/ or with cavitary lung disease) not initiating treatment within 14 days of diagnosis.
Secondary: Among many others, included are the Time to treatment initiation; Feasibility of Xpert being performed by minimally trained health care workers at point-of-care; and the Turn Around Time for Xpert testing in both arms.
Economic: These outcome measures include cost effectiveness of an ACF strategy using Xpert Ultra when placed at POC versus Centralised laboratories, taking various factors into account such as the impact on Drug Resistant-TB transmission and HIV prevention.
Zimbabwe, Harare Site: BRTI Team
Dr Shungu Munyati
Ashley Nyaradzai Chizema
Monitoring and Evaluation Officer
Dr J Mutsvangwa
Zimbabwe Site Principal Investigator
Advocacy, Communication and Social Mobilization (ACSM) Coordinator
Field Team-Research Nurse
Dr Shepherd Shamu
Programme ACSM coordinator