title: Lack of Effectiveness of Antiretroviral Therapy in Preventing HIV Infection in Serodiscordant Couples in Uganda: An Observational Study.
abstract: BACKGROUND
  We examined the real-world effectiveness of ART as an HIV prevention tool among HIV serodiscordant couples in a programmatic setting in a low-income country.
  
  
  METHODS
  We enrolled individuals from HIV serodiscordant couples aged ≥18 years of age in Jinja, Uganda from June 2009 - June 2011. In one group of couples the HIV positive partner was receiving ART as they met clinical eligibility criteria (a CD4 cell count ≤250 cells/ μL or WHO Stage III/IV disease). In the second group the infected partner was not yet ART-eligible. We measured HIV incidence by testing the uninfected partner every three months. We conducted genetic linkage studies to determine the source of new infections in seroconverting participants.
  
  
  RESULTS
  A total of 586 couples were enrolled of which 249 (42%) of the HIV positive participants were receiving ART at enrollment, and an additional 99 (17%) initiated ART during the study. The median duration of follow-up was 1.5 years. We found 9 new infections among partners of participants who had been receiving ART for at least three months and 8 new infections in partners of participants who had not received ART or received it for less than three months, for incidence rates of 2.09 per 100 person-years (PYRs) and 2.30 per 100 PYRs, respectively. The incidence rate ratio for ART-use was 0.91 (95% confidence interval 0.31-2.70; p=0.999). The hazard ratio for HIV seroconversion associated with ART-use by the positive partner was 1.07 (95% CI 0.41-2.80). A total of 5/7 (71%) of the transmissions on ART and 6/7 (86%) of those not on ART were genetically linked.
  
  
  CONCLUSIONS
  Overall HIV incidence was low in comparison to previous studies of serodiscordant couples. However, ART-use was not associated with a reduced risk of HIV transmission in this study.
authors.affiliation: The AIDS Support Organisation, Kampala, Uganda.
authors.forename: Josephine
authors.initials: J
authors.lastname: Birungi
authors.affiliation: BC Centre for Excellence in HIV/ AIDS, Vancouver, Canada.
authors.forename: Jeong Eun
authors.initials: JE
authors.lastname: Min
authors.affiliation: BC Centre for Excellence in HIV/ AIDS, Vancouver, Canada; University of British Columbia, Faculty of Medicine, Vancouver, Canada.
authors.forename: Katherine A
authors.initials: KA
authors.lastname: Muldoon
authors.affiliation: Medical Research Council (UK)-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda; London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Pontiano
authors.initials: P
authors.lastname: Kaleebu
authors.affiliation: University of California, San Francisco, Kampala, Uganda.
authors.forename: Rachel
authors.initials: R
authors.lastname: King
authors.affiliation: The AIDS Support Organisation, Kampala, Uganda.
authors.forename: Sarah
authors.initials: S
authors.lastname: Khanakwa
authors.affiliation: The AIDS Support Organisation, Kampala, Uganda.
authors.forename: Maureen
authors.initials: M
authors.lastname: Nyonyintono
authors.affiliation: BC Centre for Excellence in HIV/ AIDS, Vancouver, Canada.
authors.forename: YaLin
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Faculty of Health Sciences, University of Ottawa, Ottawa, Canada.
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Mills
authors.affiliation: Medical Research Council (UK)-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda.
authors.forename: Fred
authors.initials: F
authors.lastname: Lyagoba
authors.affiliation: Institute of Evolutionary Biology, University of Edinburgh, Edinburgh, United Kingdom.
authors.forename: Manon
authors.initials: M
authors.lastname: Ragonnet-Cronin
authors.affiliation: The AIDS Support Organisation, Kampala, Uganda.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Wangisi
authors.affiliation: BC Centre for Excellence in HIV/ AIDS, Vancouver, Canada.
authors.forename: Lillian
authors.initials: L
authors.lastname: Lourenco
authors.affiliation: BC Centre for Excellence in HIV/ AIDS, Vancouver, Canada; University of British Columbia, Faculty of Medicine, Vancouver, Canada.
authors.forename: David M
authors.initials: DM
authors.lastname: Moore
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000494:pharmacology*; D018791:CD4 Lymphocyte Count; D002944:Circumcision, Male; D005191:Family Characteristics; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000276:immunology / Q000517:prevention & control* / Q000635:transmission; D006558:Herpes Genitalis / Q000150:complications; D018258:Herpesvirus 2, Human / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D014454:Uganda
chemical_list: D019380:Anti-HIV Agents