title: Improving early infant HIV diagnosis in Kenya: study protocol of a cluster-randomized efficacy trial of the HITSystem.
abstract: BACKGROUND
  Early infant diagnosis among human immunodeficiency virus (HIV)-exposed infants is a critical component of prevention of mother-to-child transmission programs. Barriers to early infant diagnosis include poor uptake, low retention at designated re-testing intervals, delayed test results, passive systems of communication, and poor linkage to treatment. This study will evaluate the HIV Infant Tracking System (HITSystem), an eHealth intervention that streamlines communication and accountability between the key early infant diagnosis stakeholders: HIV+ mothers and their HIV-exposed infants, healthcare providers, and central laboratory personnel. It is hypothesized that the HITSystem will significantly improve early infant diagnosis retention at 9 and 18 months postnatal and the timely provision of services.
  
  
  METHODS
  Using a phased cluster-randomized controlled trial design, we will evaluate the impact of the HITSystem on eight primary benchmarks in the 18-month long cascade of care for early infant diagnosis. Study sites are six government hospitals in Kenya matched on geographic region, resource level, and patient volume. Early infant diagnosis outcomes of mother-infant dyads (n = 120 per site) at intervention hospitals (n = 3) where the HITSystem is deployed at baseline will be compared to the matched control sites providing standard care. After allowing for sufficient time for enrollment and 18-month follow-up of dyads, the HITSystem will be deployed at the control sites in the end of Year 3. Primary outcomes are retention among mother-infant dyads, initiation of antiretroviral therapy among HIV-infected infants, and the proportion of services delivered within the optimal time window indicated by national and study guidelines. Satisfaction interviews with participants and providers will inform intervention improvements. Cost-effectiveness analyses will be conducted to inform the sustainability of the HITSystem. Hypothesized outcomes include significantly higher retention throughout the 18-month early infant diagnosis process, significantly more services provided on-time at intervention sites, and a potential savings to the healthcare system.
  
  
  CONCLUSIONS
  This study will evaluate the public health impact of the HITSystem to improve critical early infant diagnosis outcomes in low-resource settings. Cost-effectiveness analyses will inform the feasibility of scale-up in other settings.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02072603.
authors.affiliation: Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, USA. Skessler2@kumc.edu.
authors.forename: Sarah
authors.initials: S
authors.lastname: Finocchario-Kessler
authors.affiliation: Children's Mercy Hospitals and Clinics, Health Services and Outcomes Research, University of Missouri-Kansas City, Schools of Medicine and Pharmacy, Kansas City, MO, USA.
authors.forename: Kathy
authors.initials: K
authors.lastname: Goggin
authors.affiliation: Kenya Medical Research Institute, Nairobi, Kenya.|Walter Reed U.S. Military HIV Research Program, Mbeya, Tanzania.
authors.forename: Samoel
authors.initials: S
authors.lastname: Khamadi
authors.affiliation: Global Health Innovations, Kansas City, MO, USA.
authors.forename: Brad
authors.initials: B
authors.lastname: Gautney
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.|University of Cincinnati, Cincinnati, OH, USA.
authors.forename: Jacinda K
authors.initials: JK
authors.lastname: Dariotis
authors.affiliation: Global Health Innovations, Kansas City, MO, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Bawcom
authors.affiliation: School of Nursing, University of Missouri-Kansas City, Kansas City, MO, USA.
authors.forename: An-Lin
authors.initials: AL
authors.lastname: Cheng
authors.affiliation: Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, USA.
authors.forename: Niaman
authors.initials: N
authors.lastname: Nazir
authors.affiliation: Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, USA.
authors.forename: Catherine
authors.initials: C
authors.lastname: Martin
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Ruff
authors.affiliation: Medical University of South Carolina, Psychiatry and Behavioral Sciences, Charleston, SC, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Sweat
authors.affiliation: Kenya Medical Research Institute, Nairobi, Kenya.
authors.forename: Vincent
authors.initials: V
authors.lastname: Okoth
mesh_terms: D003362:Cost-Benefit Analysis; D042241:Early Diagnosis; D005260:Female; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007630:Kenya; D017060:Patient Satisfaction; D058996:Quality Improvement; D013997:Time Factors