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dc.contributor.authorRockers, Peter C.
dc.contributor.authorWirtz, Veronika J.
dc.contributor.authorVian, Taryn
dc.contributor.authorOnyango, Monica A.
dc.contributor.authorAshigbie, Paul G.
dc.contributor.authorLaing, Richard
dc.date.accessioned2018-08-30T19:56:13Z
dc.date.available2018-08-30T19:56:13Z
dc.date.copyright2016
dc.date.issued2017-11
dc.identifier.citationRockers PC, Wirtz VJ, Vian T, et al. Study protocol for a cluster randomized controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya. BMJ Open 2016;6:e013386. https://doi.org/10.1136/bmjopen-2016-013386
dc.identifier.urihttps://hdl.handle.net/2144/31150
dc.description.abstractINTRODUCTION: 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: 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.
dc.language.isoen_US
dc.publisherBMJ Publishing Group Ltd
dc.rightsThis is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.subjectKenya
dc.subjectNovartis Access
dc.subjectMedicine access
dc.subjectRandomized controlled trial
dc.titleStudy protocol for a cluster-randomized controlled trial of an NCD access to medicines initative: Evaluation of Novartis Access in Kenya
dc.typeArticle
dc.rights.holderWirtz et al.
dc.identifier.doi10.1136/bmjopen-2016-013386.


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This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Except where otherwise noted, this item's license is described as This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/