title: Clinical versus rapid molecular HIV diagnosis in hospitalized African infants: a randomized controlled trial simulating point-of-care infant testing.
abstract: OBJECTIVE
  Many African infants fail to receive their diagnostic HIV molecular test results and subsequently, antiretroviral therapy (ART). To determine whether a point-of-care molecular HIV test increases ART access for hospitalized Malawian infants, we simulated a point-of-care test using rapid HIV RNA polymerase chain reaction (Rapid PCR) and compared patient outcomes with an optimized standard care that included assessment with the World Health Organization clinical algorithm for HIV infection plus a DNA PCR with a turnaround time of several weeks (standard care).
  
  
  METHODS
  Randomized controlled trial.
  
  
  METHODS
  Hospitalized HIV-exposed Malawian infants aged <12 months were randomized into Rapid PCR or standard care. Rapid PCR infants obtained molecular test results within 48 hours to facilitate immediate ART, similar to a point-of-care test. Standard care infants meeting clinical criteria were also offered inpatient ART. The primary outcome was appropriate in-hospital ART for DNA or RNA PCR-confirmed HIV-infected infants.
  
  
  RESULTS
  Three hundred infants were enrolled. A greater proportion of HIV-infected infants receiving Rapid PCR, versus standard care, started inpatient ART (72.3% vs 47.8%, P = 0.016). Among molecular test-negative infants, 26.9% receiving standard care unnecessarily initiated inpatient ART, versus 0.0% receiving Rapid PCR (P < 0.001). Rapid PCR modestly reduced the median days to ART (3.0 vs 6.5, P = 0.001) but did not influence outpatient follow-up for HIV-infected infants (78.1% vs 82.4%, P = 0.418).
  
  
  CONCLUSIONS
  Rapid PCR, versus an optimized standard care, increased the proportion of hospitalized HIV-infected infants initiating ART and reduced ART exposure in molecular test-negative infants, without meaningfully impacting time to ART initiation or follow-up rates.
authors: *University of North Carolina Project, Lilongwe, Malawi; †Department of Pediatrics, Division of Pulmonology, Johns Hopkins School of Medicine, Baltimore, MD; ‡Department of Pediatrics, Baylor College of Medicine, Houston, TX; §Department of Pediatrics, Division of Infectious Diseases, University of Colorado, Aurora, CO; ‖Baylor College of Medicine Children's Foundation Malawi, Lilongwe, Malawi; and ¶Department of Medicine, Division of Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, NC.
authors: Eric D
authors: ED
authors: McCollum
authors: Geoffrey A
authors: GA
authors: Preidis
authors: Madalitso
authors: M
authors: Maliwichi
authors: Dan
authors: D
authors: Olson
authors: L Madeline
authors: LM
authors: McCrary
authors: Peter N
authors: PN
authors: Kazembe
authors: Charles van der
authors: Cv
authors: Horst
authors: Irving
authors: I
authors: Hoffman
authors: Mina C
authors: MC
authors: Hosseinipour
mesh_terms: D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D019411:Clinical Laboratory Techniques / Q000379:methods*; D015510:Clinical Medicine / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007297:Inpatients; D008295:Malawi; D008297:Male; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D019095:Point-of-Care Systems; D011897:Random Allocation
chemical_list: D044966:Anti-Retroviral Agents