title: Rapid scale-up of antiretroviral therapy at primary care sites in Zambia: feasibility and early outcomes.
abstract: BACKGROUND
  The Zambian Ministry of Health has scaled-up human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) care and treatment services at primary care clinics in Lusaka, using predominately nonphysician clinicians.
  
  
  OBJECTIVE
  To report on the feasibility and early outcomes of the program.
  
  
  METHODS
  Open cohort evaluation of antiretroviral-naive adults treated at 18 primary care facilities between April 26, 2004, and November 5, 2005. Data were entered in real time into an electronic patient tracking system.
  
  
  METHODS
  Those meeting criteria for antiretroviral therapy (ART) received drugs according to Zambian national guidelines.
  
  
  METHODS
  Survival, regimen failure rates, and CD4 cell response.
  
  
  RESULTS
  We enrolled 21,755 adults into HIV care, and 16,198 (75%) started ART. Among those starting ART, 9864 (61%) were women. Of 15,866 patients with documented World Health Organization (WHO) staging, 11,573 (73%) were stage III or IV, and the mean (SD) entry CD4 cell count among the 15,336 patients with a baseline result was 143/microL (123/microL). Of 1142 patients receiving ART who died, 1120 had a reliable date of death. Of these patients, 792 (71%) died within 90 days of starting therapy (early mortality rate: 26 per 100 patient-years), and 328 (29%) died after 90 days (post-90-day mortality rate: 5.0 per 100 patient-years). In multivariable analysis, mortality was strongly associated with CD4 cell count between 50/microL and 199/microL (adjusted hazard ratio [AHR], 1.4; 95% confidence interval [CI], 1.0-2.0), CD4 cell count less than 50/microL (AHR, 2.2; 95% CI, 1.5-3.1), WHO stage III disease (AHR, 1.8; 95% CI, 1.3-2.4), WHO stage IV disease (AHR, 2.9; 95% CI, 2.0-4.3), low body mass index (<16; AHR,2.4; 95% CI, 1.8-3.2), severe anemia (<8.0 g/dL; AHR, 3.1; 95% CI, 2.3-4.0), and poor adherence to therapy (AHR, 2.9; 95% CI, 2.2-3.9). Of 11,714 patients at risk, 861 failed therapy by clinical criteria (rate, 13 per 100 patient-years). The mean (SD) CD4 cell count increase was 175/microL (174/microL) in 1361 of 1519 patients (90%) receiving treatment long enough to have a 12-month repeat.
  
  
  CONCLUSIONS
  Massive scale-up of HIV and AIDS treatment services with good clinical outcomes is feasible in primary care settings in sub-Saharan Africa. Most mortality occurs early, suggesting that earlier diagnosis and treatment may improve outcomes.
authors.affiliation: Schools of Medicine and Public Health, University of Alabama at Birmingham, Birmingham, USA. stringer@uab.edu
authors.forename: Jeffrey S A
authors.initials: JS
authors.lastname: Stringer
authors.forename: Isaac
authors.initials: I
authors.lastname: Zulu
authors.forename: Jens
authors.initials: J
authors.lastname: Levy
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Stringer
authors.forename: Albert
authors.initials: A
authors.lastname: Mwango
authors.forename: Benjamin H
authors.initials: BH
authors.lastname: Chi
authors.forename: Vilepe
authors.initials: V
authors.lastname: Mtonga
authors.forename: Stewart
authors.initials: S
authors.lastname: Reid
authors.forename: Ronald A
authors.initials: RA
authors.lastname: Cantrell
authors.forename: Marc
authors.initials: M
authors.lastname: Bulterys
authors.forename: Michael S
authors.initials: MS
authors.lastname: Saag
authors.forename: Richard G
authors.initials: RG
authors.lastname: Marlink
authors.forename: Alwyn
authors.initials: A
authors.lastname: Mwinga
authors.forename: Tedd V
authors.initials: TV
authors.lastname: Ellerbrock
authors.forename: Moses
authors.initials: M
authors.lastname: Sinkala
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006297:Health Services Accessibility; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011320:Primary Health Care; D015397:Program Evaluation; D016019:Survival Analysis; D016896:Treatment Outcome; D014505:Urban Population; D015024:Zambia
chemical_list: D019380:Anti-HIV Agents