title: Implementation Research to Inform the Use of Xpert MTB/RIF in Primary Health Care Facilities in High TB and HIV Settings in Resource Constrained Settings.
abstract: BACKGROUND
  The current cost of Xpert MTB RIF (Xpert) consumables is such that algorithms are needed to select which patients to prioritise for testing with Xpert.
  
  
  OBJECTIVE
  To evaluate two algorithms for prioritisation of Xpert in primary health care settings in a high TB and HIV burden setting.
  
  
  METHODS
  Consecutive, presumptive TB patients with a cough of any duration were offered either Xpert or Fluorescence microscopy (FM) test depending on their CXR score or HIV status. In one facility, sputa from patients with an abnormal CXR were tested with Xpert and those with a normal CXR were tested with FM ("CXR algorithm"). CXR was scored automatically using a Computer Aided Diagnosis (CAD) program. In the other facility, patients who were HIV positive were tested using Xpert and those who were HIV negative were tested with FM ("HIV algorithm").
  
  
  RESULTS
  Of 9482 individuals pre-screened with CXR, Xpert detected TB in 2090/6568 (31.8%) with an abnormal CXR, and FM was AFB positive in 8/2455 (0.3%) with a normal CXR. Of 4444 pre-screened with HIV, Xpert detected TB in 508/2265 (22.4%) HIV positive and FM was AFB positive in 212/1920 (11.0%) in HIV negative individuals. The notification rate of new bacteriologically confirmed TB increased; from 366 to 620/ 100,000/yr and from 145 to 261/100,000/yr at the CXR and HIV algorithm sites respectively. The median time to starting TB treatment at the CXR site compared to the HIV algorithm site was; 1(IQR 1-3 days) and 3 (2-5 days) (p<0.0001) respectively.
  
  
  CONCLUSIONS
  Use of Xpert in a resource-limited setting at primary care level in conjunction with pre-screening tests reduced the number of Xpert tests performed. The routine use of Xpert resulted in additional cases of confirmed TB patients starting treatment. However, there was no increase in absolute numbers of patients starting TB treatment. Same day diagnosis and treatment commencement was achieved for both bacteriologically confirmed and empirically diagnosed patients where Xpert was used in conjunction with CXR.
authors.affiliation: ZAMBART Project, University of Zambia, School of Medicine, Lusaka, Zambia.
authors.forename: Monde
authors.initials: M
authors.lastname: Muyoyeta
authors.affiliation: ZAMBART Project, University of Zambia, School of Medicine, Lusaka, Zambia.
authors.forename: Maureen
authors.initials: M
authors.lastname: Moyo
authors.affiliation: ZAMBART Project, University of Zambia, School of Medicine, Lusaka, Zambia.
authors.forename: Nkatya
authors.initials: N
authors.lastname: Kasese
authors.affiliation: ZAMBART Project, University of Zambia, School of Medicine, Lusaka, Zambia.
authors.forename: Mapopa
authors.initials: M
authors.lastname: Ndhlovu
authors.affiliation: ZAMBART Project, University of Zambia, School of Medicine, Lusaka, Zambia.
authors.forename: Deborah
authors.initials: D
authors.lastname: Milimo
authors.affiliation: ZAMBART Project, University of Zambia, School of Medicine, Lusaka, Zambia.
authors.forename: Winfridah
authors.initials: W
authors.lastname: Mwanza
authors.affiliation: National TB program, Ministry of Health, Lusaka, Zambia.
authors.forename: Nathan
authors.initials: N
authors.lastname: Kapata
authors.affiliation: ZAMBART Project, University of Zambia, School of Medicine, Lusaka, Zambia; Clinical research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Albertus
authors.initials: A
authors.lastname: Schaap
authors.affiliation: Clinical research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Peter
authors.initials: P
authors.lastname: Godfrey Faussett
authors.affiliation: ZAMBART Project, University of Zambia, School of Medicine, Lusaka, Zambia; Clinical research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Helen
authors.initials: H
authors.lastname: Ayles
mesh_terms: D000328:Adult; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006268:Health Facilities; D006295:Health Resources; D006801:Humans; D008297:Male; D011320:Primary Health Care; D013902:Radiography, Thoracic; D011933:Reagent Kits, Diagnostic; D012293:Rifampin / Q000627:therapeutic use*; D013997:Time Factors; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy*; D014397:Tuberculosis, Pulmonary / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy
chemical_list: D011933:Reagent Kits, Diagnostic; D012293:Rifampin