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Innovation to Impact – Implementation research

KNCV has conducted research on the implementation of Xpert MTB/Rif in Brazil and China, in collaboration with AIGHD. The Bill & Melinda Gates Foundation has given financial support to these studies.

The research project in Brazil has been finalized. See the publication titles (1-4), below. A cost-effectiveness analysis based on this study will be published soon.

The China research project is now in its final phase and results will come out this year. A description of a previous version of one component of the model intended to improve TB control in China that we are currently evaluating is given below, in research paper 5.

  1. A pilot implementation study was conducted in two Brazilian cities to explore the replacement of sputum smear microscopy with Xpert. Laboratory technicians were trained to operate Xpert machines and health workers were taught how to interpret the results.
    Operational lessons drawn from pilot implementation of Xpert MTB/Rif in Brazil. Betina Durovni, Valeria Saraceni, Marcelo Cordeiro-Santos, Solange Cavalcante, Elizabeth Soares, Cristina Lourenço, Alexandre Menezes, Susan van den Hof, Frank Cobelens & Anete Trajman
  2. It was assessed in a phased implementation trial whether the implementation of Xpert MTB/RIF would increase the notification rate of pulmonary TB and reduce the time to TB treatment initiation. Replacing smear microscopy with Xpert MTB/RIF in Brazil increased confirmation of pulmonary TB by 60%. However, no increase on overall notification rates was observed. Impact of Replacing Smear Microscopy with Xpert MTB/RIF for Diagnosing Tuberculosis in Brazil: A Stepped-Wedge Cluster-Randomized Trial. Betina Durovni, Valeria Saraceni, Susan van den Hof, Anete Trajman, Marcelo Cordeiro-Santos, Solange Cavalcante, Alexandre Menezes, Frank Cobelens.
  3. Treatment outcomes in a stepped wedge cluster randomized trial for patients diagnosed with XpertMTB/RIF were compared to patients diagnosed with sputum smear examination in public health facilities in Brazil. The proportion of patients successfully treated did not increase with Xpert MTB/RIF implementation. Impact on Patients’ Treatment Outcomes of XpertMTB/RIF Implementation for the Diagnosis of Tuberculosis: Follow-Up of a Stepped-Wedge Randomized Clinical Trial. Anete Trajman, Betina Durovni, Valeria Saraceni, Alexandre Menezes, Marcelo Cordeiro-Santos, Frank Cobelens, Susan Van den Hof.
  4. A pilot implementation study was conducted to evaluate the positive predictive value of rifampicin-resistant Xpert results in patients who had never been treated for TB and in countries with a low prevalence of rifampicin-resistance and multidrug- resistance. The findings suggest that, even among new cases, Xpert has a very high positive predictive value for rifampicin resistance and that even among previously untreated TB patients, second-line drug treatment could be started immediately. High predictive value of Xpert for rifampicin resistance even in new TB cases from a low MDR-TB prevalence setting. Anete Trajman, Betina Durovni, Valeria Saraceni, Marcelo Cordeiro-Santos, Frank Cobelens and Susan van den Hof.
  5. In a before-and-after study the effect of a comprehensive program to provide universal access to diagnosis, treatment, and follow-up for MDR-TB in four Chinese cities was assessed. The comprehensive program substantially increased access to diagnosis, quality treatment, and affordable treatment for MDR-TB. The program could help China to achieve universal access to MDR-TB care but greater financial risk protection for patients is needed. Effect of a comprehensive programme to provide universal access to care for sputum-smear-positive multidrug-resistant tuberculosis in China: a before-and-after study. Renzhong Li, Yunzhou Ruan, Qiang Sun, Xiexiu Wang, Mingting Chen, Hui Zhang, Yanlin Zhao, Jin Zhao, Cheng Chen, Caihong Xu, Wei Su, Yu Pang, Jun Cheng, Junying Chi, Qian Wang, Yunting Fu, Shitong Huan, Lixia Wang, Yu Wang, Daniel P Chin.