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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773095
Recruitment Status : Active, not recruiting
First Posted : May 16, 2016
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
Innovations for Poverty Action
Information provided by (Responsible Party):
Richard Laing, Boston University

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Diabetes Type II Breast Cancer Asthma Other: Novartis Access Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 966 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Novartis Access; a Non-communicable Disease (NCD) Access Initiative
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention counties
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
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.

No Intervention: Control counties
Control counties not exposed to the intervention.



Primary Outcome Measures :
  1. 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 [ Time Frame: One year ]
  2. Price of Novartis Access medicines and equivalents at public private non-profit facilities [ Time Frame: One year ]
  3. 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 [ Time Frame: One year ]
  4. 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 [ Time Frame: One year ]
  5. Price per unit for Novartis Access medicines and equivalents in households with NCD patients [ Time Frame: One year ]
  6. Expenditure on Novartis Access medicines and equivalents in households with NCD patients [ Time Frame: One year ]
  7. Price of Novartis Access medicines and equivalents at alternative for-profit drug sellers [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Household Inclusion Criteria:

  • 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

Household Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773095


Sponsors and Collaborators
Boston University
Innovations for Poverty Action
Investigators
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Principal Investigator: Richard Laing, MD Boston University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Richard Laing, Professor, Boston University
ClinicalTrials.gov Identifier: NCT02773095    
Other Study ID Numbers: H-34873
9550302332 ( Other Grant/Funding Number: Sandoz )
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Laing, Boston University:
Novartis Access
noncommunicable disease burden
medicine availability and price
Kenya
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Noncommunicable Diseases
Cardiovascular Diseases
Chronic Disease
Disease Attributes
Pathologic Processes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lactitol
Cathartics
Gastrointestinal Agents