title: Study protocol for a cluster-randomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya.
abstract: Novartis recently launched Novartis Access, an initiative to provide a basket of reduced price medicines for non-communicable diseases (NCDs) to be sold through the public and private non-profit sectors in programme countries. This study will evaluate the impact of Novartis Access on the availability and price of NCD medicines at health facilities and households in Kenya, the first country to receive the programme.
  
  
  
  This study will be a cluster-randomised controlled trial. 8 counties in Kenya will be randomly assigned to the intervention or control group using a covariate constrained randomisation method to maximise balance on demographic and health characteristics. In intervention counties, public and private non-profit health facilities will be able to order Novartis Access NCD medicines from the Mission for Essential Drugs and Supplies (MEDS). Data will be collected from a random sample of 384 health facilities and 800 households at baseline, midline after 1-year of intervention, and end-line after 2 years. Quarterly surveillance data will also be collected from health facilities and a subsample of households through phone-based interviews. Households will be eligible if at least one resident has been previously diagnosed and prescribed a medicine for an NCD addressed by Novartis Access, including hypertension and diabetes. The primary outcomes will be availability and price of NCD medicines at health facilities, and availability, price, and expenditures on NCD medicines at households. Impacts will be estimated using intention-to-treat analysis.
  
  
  
  This protocol was approved by the Institutional Review Boards at Strathmore University and at Boston University. Informed consent will be obtained from all participants at the start of the trial. The findings of the trial will be disseminated through peer-reviewed journals, international conferences, and meetings and events organised with local stakeholders.
  
  
  
  NCT02773095.
authors.affiliation: Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Rockers
authors.affiliation: Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
authors.forename: Veronika J
authors.initials: VJ
authors.lastname: Wirtz
authors.affiliation: Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
authors.forename: Taryn
authors.initials: T
authors.lastname: Vian
authors.affiliation: Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
authors.forename: Monica A
authors.initials: MA
authors.lastname: Onyango
authors.affiliation: Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
authors.forename: Paul G
authors.initials: PG
authors.lastname: Ashigbie
authors.affiliation: Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.|School of Public Health, University of the Western Cape, Cape Town, South Africa.
authors.forename: Richard
authors.initials: R
authors.lastname: Laing
mesh_terms: D002908:Chronic Disease / Q000188:drug therapy*; D019049:Developed Countries; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D016527:Drug Costs; D018954:Drugs, Essential / Q000191:economics* / Q000600:supply & distribution*; D005191:Family Characteristics; D005382:Financing, Personal; D005102:Health Expenditures; D006268:Health Facilities; D006297:Health Services Accessibility; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D007630:Kenya; D012107:Research Design
chemical_list: D018954:Drugs, Essential
keywords: HEALTH ECONOMICS; PRIMARY CARE