Evidence map›Paper›PMID 27888177›Full record

Trial reportBMJ open2016

Study protocol for a cluster-randomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya.

Peter C Rockers, Veronika J Wirtz, Taryn Vian, Monica A Onyango, Paul G Ashigbie, Richard Laing

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02773095 (Evaluation of Novartis Access; a Non-communicable Disease), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
10.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02773095 nacompletednot on this map

Evaluation of Novartis Access; a Non-communicable Disease (NCD) Access Initiative

TypeinterventionalSponsorBoston UniversityRan2016 to 2019Enrolled966ConditionsCardiovascular Disease, Diabetes Type II, Breast Cancer, AsthmaArmsNovartis Access
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Peter C RockersDepartment of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
Veronika J WirtzDepartment of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
Taryn VianDepartment of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
Monica A OnyangoDepartment of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
Paul G AshigbieDepartment of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
Richard LaingDepartment of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.
Boston University · USUniversity of the Western Cape · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNovartis 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.

Indexed as

Financing, PersonalChronic DiseaseDeveloped CountriesDiabetes Mellitus, Type 2Drug CostsDrugs, EssentialFamily CharacteristicsHealth ExpendituresHealth FacilitiesHealth Services AccessibilityHumansHypertensionKenyaResearch DesignDrugs, EssentialHEALTH ECONOMICSPRIMARY CARE

Identifiers

PMID27888177
PMCPMC5168521
OpenAlexW2556311538

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.