Evaluation of Novartis Access; a Non-communicable Disease (NCD) Access Initiative
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ClinicalTrials.gov Identifier: NCT02773095 |
Recruitment Status :
Completed
First Posted : May 16, 2016
Last Update Posted : April 29, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cardiovascular Disease Diabetes Type II Breast Cancer Asthma | Other: Novartis Access | Not Applicable |

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 : | November 30, 2019 |
Actual Study Completion Date : | November 30, 2019 |

Arm | Intervention/treatment |
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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.
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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.
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- 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 ]
- Price of Novartis Access medicines and equivalents at public private non-profit facilities [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: One year ]
- Price per unit for Novartis Access medicines and equivalents in households with NCD patients [ Time Frame: One year ]
- Expenditure on Novartis Access medicines and equivalents in households with NCD patients [ Time Frame: One year ]
- Price of Novartis Access medicines and equivalents at alternative for-profit drug sellers [ Time Frame: One year ]

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

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
Principal Investigator: | Richard Laing, MD | Boston University |
Responsible Party: | 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: | April 29, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Novartis Access noncommunicable disease burden medicine availability and price Kenya |
Cardiovascular Diseases Diabetes Mellitus, Type 2 Noncommunicable Diseases Chronic Disease Disease Attributes Pathologic Processes Diabetes Mellitus |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Lactitol Cathartics Gastrointestinal Agents |