- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04068571
Enhancing Universal Health Coverage and Maternal, Newborn and Child Health in Kenya Through Digital Innovations (UHC)
August 23, 2019 updated by: Amanuel Abajobir, African Population and Health Research Center
Innovative Partnership for Universal Health Coverage
This study aims at providing insights into Universal Health Coverage and evaluates the impact of I-PUSH program on maternal healthcare utilization, financial protection and women's empowerment, as well as to evaluate the impact of the LEAP training tool on community health volunteers and women's health literacy including their knowledge, behavior and uptake of respective services.
Study Overview
Detailed Description
The study will use a three-pronged approach: year-long weekly Financial and Health Diaries, Baseline and Endline surveys, and qualitative interviews.
The Diaries and the Surveys will be carried out in two Counties, Kakamega and Kisumu (Kenya).
The qualitative interviews will be carried out in the two counties and in Nairobi as an additional county.
The study will use a cluster randomized control trial design in Kakamega to evaluate the impact of I-PUSH program.
In Kisumu, selected households will be followed-up to capture the health-seeking behavior, health insurance, and health expenditure pattern of households over time.
The study will be initially for 17 months and will continue for three years subject to additional funding.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Targets for the intervention
Exclusion Criteria:
- Non-targets for the intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: I-PUSH intervention sites
Clusters with I-PUSH intervention
|
Innovative partnership for universal and sustainable healthcare
|
|
No Intervention: No I-PUSH intervention sites
Clusters with no I-PUSH intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health Care Utilization
Time Frame: 17 months
|
Financial and health diaries will be collected on a weekly basis throughout the indicated study period
|
17 months
|
|
Maternal, Newborn and Child Health outcomes through out the continuum of care
Time Frame: 17 months
|
Questionnaire based survey questions will be used to measure these outcomes
|
17 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2019
Primary Completion (Anticipated)
April 1, 2020
Study Completion (Anticipated)
April 1, 2020
Study Registration Dates
First Submitted
July 31, 2019
First Submitted That Met QC Criteria
August 23, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 23, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- AfricanPHRC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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