|Rockers, Peter C.
|Wirtz, Veronika J.
|Onyango, Monica A.
|Ashigbie, Paul G.
|Rockers, Peter C. et al. (2016). Study protocol for a clusterrandomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya. BMJ Open, 6: e013386.
|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 nonprofit
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 clusterrandomised
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 intentionto-
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.
|BMJ Publishing Group
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|non-communicable diseases (NCDs)
|Study protocol for a cluster-randomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya