title: Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol.
abstract: In the absence of early infant diagnosis (EID) and immediate antiretroviral therapy (ART), some 50% of untreated HIV-infected infants die before age 2. Conventional EID requires sophisticated instruments that are typically placed in centralized or reference laboratories. In low-resource settings, centralized systems often lead to result turnaround times of several months, long delays in diagnosis, and adverse outcomes for HIV-infected children. Our clinical trial tests the effectiveness of a new point-of-care (POC) diagnostic technology to identify HIV-infected infants and start providing them life-saving ART as soon as possible.
  
  
  
  The study uses a randomized, controlled design to test whether the Alere q platform for HIV DNA polymerase chain reaction (PCR) testing improves outcomes of HIV-infected children in Zambia. We aim to enroll 2867 HIV-exposed infants aged 4-12 weeks and to follow those who are HIV infected for 12 months as they receive HIV care at 6 public health facilities in Lusaka. The trial's primary endpoint is the proportion of HIV-infected infants in each study arm who start ART and remain alive, in care, and virally suppressed 12 months after their diagnostic blood draw.
  
  
  
  Our trial will provide evidence for the incremental benefit of implementing a POC EID strategy in low-resource settings where only off-site PCR services are currently available. The results will be useful in guiding future decisions regarding investments in POC virologic testing as part of overall pediatric AIDS mitigation strategies in sub-Saharan Africa.
  
  
  
  clinicaltrials.gov NCT02682810.
authors.affiliation: *Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC; †Department of Obstetrics and Gynaecology, University Teaching Hospital, Lusaka, Zambia; and ‡Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Carla J
authors.initials: CJ
authors.lastname: Chibwesha
authors.forename: Catherine E
authors.initials: CE
authors.lastname: Ford
authors.forename: Katie R
authors.initials: KR
authors.lastname: Mollan
authors.forename: Jeffrey S A
authors.initials: JS
authors.lastname: Stringer
mesh_terms: D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D015658:HIV Infections / Q000175:diagnosis / Q000821:virology*; D006801:Humans; D008991:Monitoring, Physiologic; D019095:Point-of-Care Systems; D019562:Viral Load; D015024:Zambia