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Study protocol for a cluster-randomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya
  1. Peter C Rockers1,
  2. Veronika J Wirtz1,
  3. Taryn Vian1,
  4. Monica A Onyango1,
  5. Paul G Ashigbie1,
  6. Richard Laing1,2
  1. 1Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA
  2. 2School of Public Health, University of the Western Cape, Cape Town, South Africa
  1. Correspondence to Dr Peter C Rockers; prockers{at}bu.edu

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

Trial registration number NCT02773095.

  • HEALTH ECONOMICS
  • PRIMARY CARE

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Footnotes

  • Contributors RL is the principal investigator. PCR, VJW, TV, MAO and PGA are co-investigators. PCR, VJW, TV, MAO, PGA and RL designed the study. PCR wrote the initial draft of the manuscript. VJW, TV, MAO, PGA and RL contributed substantially to revising the manuscript. All authors give final approval of the version of the manuscript to be published.

  • Funding This study is supported through a service agreement with Sandoz, the generic pharmaceuticals division of Novartis.

  • Disclaimer The funder will play no role in the design, management, analysis and reporting of the trial. The study team maintains all rights to the data generated by the trial and to the publication of results. Novartis has agreed to implement Novartis Access according to the randomised allocation procedure described in this paper to allow for a rigorous evaluation.

  • Competing interests RL was provided with travel and accommodation to present at two meetings held in Geneva, Switzerland about the evaluation of Novartis Access in May 2016.

  • Ethics approval This protocol was approved by the Institutional Review Boards at Strathmore University in Kenya and at Boston University in the USA. Additional approvals have been obtained from the Kenyan National Council for Science and Technology.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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