title: Sizanani: A Randomized Trial of Health System Navigators to Improve Linkage to HIV and TB Care in South Africa.
abstract: BACKGROUND
  A fraction of HIV-diagnosed individuals promptly initiate antiretroviral therapy (ART). We evaluated the efficacy of health system navigators for improving linkage to HIV and tuberculosis (TB) care among newly diagnosed HIV-infected outpatients in Durban, South Africa.
  
  
  METHODS
  We conducted a randomized controlled trial (Sizanani Trial, NCT01188941) among adults (≥18 years) at 4 sites. Participants underwent TB screening and randomization into a health system navigator intervention or usual care. Intervention participants had an in-person interview at enrollment and received phone calls and text messages over 4 months. We assessed 9-month outcomes via medical records and the National Population Registry. Primary outcome was completion of at least 3 months of ART or 6 months of TB treatment for coinfected participants.
  
  
  RESULTS
  Four thousand nine hundred three participants were enrolled and randomized; 1899 (39%) were HIV-infected, with 1146 (60%) ART-eligible and 523 (28%) TB coinfected at baseline. In the intervention, 212 (39% of outcome-eligible) reached primary outcome compared to 197 (42%) in usual care (RR 0.93, 95% CI: 0.80 to 1.08). One hundred thirty-one (14%) HIV-infected intervention participants died compared to 119 (13%) in usual care; death rates did not differ between arms (RR 1.06, 95% CI: 0.84 to 1.34). In the as-treated analysis, participants reached for ≥5 navigator calls were more likely to achieve study outcome.
  
  
  CONCLUSIONS
  ∼40% of ART-eligible participants in both study arms reached the primary outcome 9 months after HIV diagnosis. Low rates of engagement in care, high death rates, and lack of navigator efficacy highlight the urgency of identifying more effective strategies for improving HIV and TB care outcomes.
authors.affiliation: Divisions of *Infectious Diseases;†General Medicine, Massachusetts General Hospital, Boston, MA;‡Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA;§Harvard Medical School, Boston, MA;‖Harvard University Center for AIDS Research, Harvard University, Boston, MA;¶Data Coordinating Center, Boston University School of Public Health, Boston, MA;#McCord Hospital, Durban, South Africa;**Division of General Pediatrics, Department of Medicine, Boston Children's Hospital, Boston, MA;††St. Mary's Hospital, Durban, South Africa;‡‡Department of Epidemiology, Boston University School of Public Health, Boston, MA;§§Department of Health Policy and Management, Harvard School of Public Health, Boston, MA;Divisions of ‖‖Rheumatology;¶¶Infectious Diseases, Brigham and Women's Hospital, Boston, MA;##Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA; and***Department of Biostatistics, Boston University School of Public Health, Boston, MA.
authors.forename: Ingrid V
authors.initials: IV
authors.lastname: Bassett
authors.forename: Sharon M
authors.initials: SM
authors.lastname: Coleman
authors.forename: Janet
authors.initials: J
authors.lastname: Giddy
authors.forename: Laura M
authors.initials: LM
authors.lastname: Bogart
authors.forename: Christine E
authors.initials: CE
authors.lastname: Chaisson
authors.forename: Douglas
authors.initials: D
authors.lastname: Ross
authors.forename: Margo M
authors.initials: MM
authors.lastname: Jacobsen
authors.forename: Marion
authors.initials: M
authors.lastname: Robine
authors.forename: Tessa
authors.initials: T
authors.lastname: Govender
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Freedberg
authors.forename: Jeffrey N
authors.initials: JN
authors.lastname: Katz
authors.forename: Rochelle P
authors.initials: RP
authors.lastname: Walensky
authors.forename: Elena
authors.initials: E
authors.lastname: Losina
mesh_terms: D000328:Adult; D003191:Comprehensive Health Care / Q000458:organization & administration*; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D013019:South Africa; D014376:Tuberculosis / Q000150:complications / Q000188:drug therapy*