title: Outcomes and Diagnostic Processes in Outpatients with Presumptive Tuberculosis in Zomba District, Malawi.
abstract: BACKGROUND
  In Malawi, outpatients who have presumptive tuberculosis (TB), i.e. fever, night sweats, weight loss and/or any-duration cough (HIV-infected) or cough of at least 2 weeks (HIV-uninfected), are registered in chronic cough registers. They should receive a diagnostic work-up with first-step provider-initiated HIV testing and sputum testing which includes XpertMTB/RIF, following a national algorithm introduced in 2012.
  
  
  METHODS
  An operational study, in which we prospectively studied 6-month outcomes of adult outpatients who were registered in chronic cough registers in Zomba Central Hospital and Matawale peri-urban Health Center, between February and September 2013. We recorded implementation of the diagnostic protocol and outcomes at 6 months from registration.
  
  
  RESULTS
  Of 348 patients enrolled, 165(47%) were male, median age was 40 years, 72(21%) had previous TB. At registration 154(44%) were known HIV-positive, 34(10%) HIV-negative (26 unconfirmed) and 160(46%) had unknown HIV status; 104(56%) patients with unknown/unconfirmed HIV status underwent HIV testing. At 6 months 191(55%) were HIV-positive, 87(25%) HIV-negative (26 unconfirmed) and 70(20%) still had unknown HIV status. Higher age and registration in Matawale were independently associated with remaining unknown HIV status after 6 months. 62% of patients had sputum tested, including XpertMTB/RIF, according to the algorithm. TB was diagnosed in 54(15%) patients. This was based on XpertMTB/RIF results in 8(15%) diagnosed cases. In 26(48%) TB was diagnosed on clinical grounds. Coverage of ART in HIV-positive patients was 89%. At 6 months, 236(68%) were asymptomatic, 48(14%) symptomatic, 25(7%) had been lost-to-follow-up and 39(11%) had died. Mortality among those HIV-positive, HIV-negative and with unknown HIV-status was 15%, 2% and 10%, respectively. Male gender, being HIV-positive-not-on-ART and not receiving antibiotics were independent risk factors for mortality.
  
  
  CONCLUSIONS
  HIV prevalence among patients with presumptive TB was high (55%). One quarter was not HIV tested and mortality in this group was substantial (10%). The impact of XpertMTB/RIF on TB diagnosis was limited.
authors.affiliation: Dignitas International, Zomba, Malawi.|Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
authors.forename: Monique
authors.initials: M
authors.lastname: van Lettow
authors.affiliation: Dignitas International, Zomba, Malawi.
authors.forename: Richard
authors.initials: R
authors.lastname: Bedell
authors.affiliation: Dignitas International, Zomba, Malawi.
authors.forename: Sonia
authors.initials: S
authors.lastname: Maosa
authors.affiliation: Dignitas International, Zomba, Malawi.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Phiri
authors.affiliation: Dignitas International, Zomba, Malawi.|Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.|Division of Infectious Diseases, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.
authors.forename: Adrienne K
authors.initials: AK
authors.lastname: Chan
authors.affiliation: Dignitas International, Zomba, Malawi.
authors.forename: Edson
authors.initials: E
authors.lastname: Mwinjiwa
authors.affiliation: Dignitas International, Zomba, Malawi.
authors.forename: Aunex
authors.initials: A
authors.lastname: Kwekwesa
authors.affiliation: Dignitas International, Zomba, Malawi.
authors.forename: Harry
authors.initials: H
authors.lastname: Kawonga
authors.affiliation: Zomba Central Hospital, Ministry of Health, Zomba, Malawi.
authors.forename: Martias
authors.initials: M
authors.lastname: Joshua
authors.affiliation: The International Union against Tuberculosis and Lung Disease, Paris, France.|London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Harries
authors.affiliation: Dignitas International, Zomba, Malawi.|Department of Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.
authors.forename: Joep J
authors.initials: JJ
authors.lastname: van Oosterhout
mesh_terms: D000328:Adult; D000367:Age Factors; D023241:Antiretroviral Therapy, Highly Active; D015897:Comorbidity; D003371:Cough / Q000209:etiology*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000453:epidemiology; D015528:HIV Seroprevalence; D006801:Humans; D008295:Malawi / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification; D010045:Outpatients; D011446:Prospective Studies; D013183:Sputum / Q000382:microbiology; D016019:Survival Analysis; D016896:Treatment Outcome; D014376:Tuberculosis / Q000175:diagnosis* / Q000453:epidemiology