title: Do clinical decision-support reminders for medical providers improve isoniazid preventative therapy prescription rates among HIV-positive adults? Study protocol for a randomized controlled trial.
abstract: BACKGROUND
  This document describes a research protocol for a study designed to estimate the impact of implementing a reminder system for medical providers on the use of isoniazid preventative therapy (IPT) for adults living with HIV in western Kenya. People living with HIV have a 5% to 10% annual risk of developing active tuberculosis (TB) once infected with TB bacilli, compared to a 5% lifetime risk in HIV-negative people with latent TB infection. Moreover, people living with HIV have a 20-fold higher risk of dying from TB. A growing body of literature suggests that IPT reduces overall TB incidence and is therefore of considerable benefit to patients and the larger community. However, in 2009, of the estimated 33 million people living with HIV, only 1.7 million (5%) were screened for TB, and about 85,000 (0.2%) were offered IPT.
  
  
  METHODS
  This study will examine the use of clinical decision-support reminders to improve rates of initiation of preventative treatment in a TB/HIV co-morbid population living in a TB endemic area. This will be a pragmatic, parallel-group, cluster-randomized superiority trial with a 1:1 allocation to treatment ratio. For the trial, 20 public medical facilities that use clinical summary sheets generated from an electronic medical records system will participate as clusters. All HIV-positive adult patients who complete an initial encounter at a study cluster and at least one return encounter during the study period will be included in the study cohort. The primary endpoint will be IPT prescription at 3 months post the initial encounter. We will conduct both individual-level and cluster-level analyses. Due to the nature of the intervention, the trial will not be blinded. This study will contribute to the growing evidence base for the use of electronic health interventions in low-resource settings to promote high-quality clinical care, health system optimization and positive patient outcomes. Trial registration ClinicalTrials.gov NCT01934309, registered 29 August 2013.
authors.affiliation: Kijani Consulting, 1289 Fordham Blvd, Suite 165, Chapel Hill, 27514, NC, USA. eric.green@duke.edu.|Duke Global Health Institute, Durham, PO Box 9051927708, NC, USA. eric.green@duke.edu.
authors.forename: Eric P
authors.initials: EP
authors.lastname: Green
authors.affiliation: InSTEDD, 955 Benecia Ave, Sunnyvale, 94085, CA, USA. caricia@instedd.org.|School of Public Health, University of California, Berkeley, University Hall, Berkeley, 94720-7360, CA, USA. caricia@instedd.org.
authors.forename: Caricia
authors.initials: C
authors.lastname: Catalani
authors.affiliation: Academic Model Providing Access to Healthcare (AMPATH), Eldoret, PO Box 460630100, Kenya. LDiero@africaonline.co.ke.|Department of Medicine, School of Medicine, College of Health Sciences, Moi University, Eldoret, PO Box 4606 030100, Kenya. LDiero@africaonline.co.ke.
authors.forename: Lameck
authors.initials: L
authors.lastname: Diero
authors.affiliation: Academic Model Providing Access to Healthcare (AMPATH), Eldoret, PO Box 460630100, Kenya. e_jane_carter@brown.edu.|Division of Medicine, Alpert Medical School of Brown University, Box G-A, Providence, 02912, RI, USA. e_jane_carter@brown.edu.
authors.forename: E Jane
authors.initials: EJ
authors.lastname: Carter
authors.affiliation: Academic Model Providing Access to Healthcare (AMPATH), Eldoret, PO Box 460630100, Kenya. adriangardner1@gmail.com.|Division of Medicine, Alpert Medical School of Brown University, Box G-A, Providence, 02912, RI, USA. adriangardner1@gmail.com.|Department of Medicine, School of Medicine, College of Health Sciences, Moi University, Eldoret, PO Box 4606 030100, Kenya. adriangardner1@gmail.com.|Department of Medicine, School of Medicine, Indiana University, 340 W 10th St 6200, Indianapolis, 46202, IN, USA. adriangardner1@gmail.com.
authors.forename: Adrian
authors.initials: A
authors.lastname: Gardner
authors.affiliation: Population Council, General Accident House, Ralph Bunche Road, Nairobi, Kenya. cndwiga@popcouncil.org.
authors.forename: Charity
authors.initials: C
authors.lastname: Ndwiga
authors.affiliation: Regenstrief Institute, 1050 Wishard Blvd, Indianapolis, 46202, IN, USA. agris57@yahoo.com.
authors.forename: Aggrey
authors.initials: A
authors.lastname: Keny
authors.affiliation: Academic Model Providing Access to Healthcare (AMPATH), Eldoret, PO Box 460630100, Kenya. p_owiti@yahoo.com.
authors.forename: Philip
authors.initials: P
authors.lastname: Owiti
authors.affiliation: School of Medicine, Stanford University, 291 Campus Dr, Stanford, 94305, CA, USA. israelski@stanford.edu.
authors.forename: Dennis
authors.initials: D
authors.lastname: Israelski
authors.affiliation: Regenstrief Institute, 1050 Wishard Blvd, Indianapolis, 46202, IN, USA. pbiondic@regenstrief.org.
authors.forename: Paul
authors.initials: P
authors.lastname: Biondich
mesh_terms: D000995:Antitubercular Agents / Q000627:therapeutic use*; D002985:Clinical Protocols; D060085:Coinfection / Q000517:prevention & control*; D003661:Decision Support Techniques; D011307:Drug Prescriptions; D057286:Electronic Health Records; D015658:HIV Infections / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D006801:Humans; D007538:Isoniazid / Q000627:therapeutic use*; D007630:Kenya / Q000453:epidemiology; D010818:Practice Patterns, Physicians'; D017010:Reminder Systems; D012107:Research Design; D016896:Treatment Outcome; D014376:Tuberculosis / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D000995:Antitubercular Agents; D007538:Isoniazid