NCT02773095

Brief Summary

Countries throughout the world are facing a growing non-communicable disease (NCD) burden. In developing countries, medicines to treat NCDs are often difficult to access or too expensive for many households. Novartis/Sandoz has recently launched Novartis Access, an initiative to subsidize a basket of NCD medicines sold to purchasers in program countries and delivered through the public and non-profit health sectors. 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 program.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
966

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

3.5 years

First QC Date

May 9, 2016

Last Update Submit

April 27, 2020

Conditions

Cardiovascular DiseaseDiabetes Type IIBreast CancerAsthma

Keywords

Novartis Accessnoncommunicable disease burdenmedicine availability and priceKenya

Outcome Measures

Primary Outcomes (7)

  • Availability of Novartis Access medicines and equivalents at public and private non-profit facilities: proportion of Novartis Access NCD medicines and equivalents that a facility has in stock on the day of data collection

    One year

  • Price of Novartis Access medicines and equivalents at public private non-profit facilities

    One year

  • Availability of Novartis Access medicines and equivalents at alternative for-profit drug sellers: proportion of Novartis Access NCD medicines and equivalents in stock on the day of data collection

    One year

  • Availability of Novartis Access medicines and equivalents in households with NCD patients: proportion of prescribed Novartis Access medicines and equivalents in the home on the day of data collection

    One year

  • Price per unit for Novartis Access medicines and equivalents in households with NCD patients

    One year

  • Expenditure on Novartis Access medicines and equivalents in households with NCD patients

    One year

  • Price of Novartis Access medicines and equivalents at alternative for-profit drug sellers

    One year

Study Arms (2)

Intervention counties

EXPERIMENTAL

In intervention counties, a Novartis Access portfolio of 15 medicines will be sold to local purchasers at a cost of 150 Kenyan Shillings (KES), around US$1.50, per monthly dose.

Other: Novartis Access

Control counties

NO INTERVENTION

Control counties not exposed to the intervention.

Interventions

Novartis AccessOTHER

Eight counties will be matched in pairs and randomized within each pair to either receive Novartis Access portfolio low-cost medications or to remain a control county.

Intervention counties

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least one household member diagnosed and prescribed treatment for an NCD condition targeted by Novartis Access (asthma; diabetes; breast cancer; hypertension)
  • Eligible household members must be at least 18 years of age to participate

You may not qualify if:

  • Households who are unwilling to provide informed consent
  • Households that plan to move from their location during the two year period of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Rockers PC, Laing RO, Ashigbie PG, Onyango MA, Mukiira CK, Wirtz VJ. Effect of Novartis Access on availability and price of non-communicable disease medicines in Kenya: a cluster-randomised controlled trial. Lancet Glob Health. 2019 Apr;7(4):e492-e502. doi: 10.1016/S2214-109X(18)30563-1. Epub 2019 Feb 21.

    PMID: 30799142DERIVED

  • Rockers PC, Wirtz VJ, Vian T, Onyango MA, Ashigbie PG, Laing R. Study protocol for a cluster-randomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya. BMJ Open. 2016 Nov 25;6(11):e013386. doi: 10.1136/bmjopen-2016-013386.

    PMID: 27888177DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes Mellitus, Type 2Breast NeoplasmsAsthma

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Richard Laing, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 16, 2016

Study Start

June 1, 2016

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share