Universal Health CoverageUHCNCT04068571
Enhancing Universal Health Coverage and Maternal, Newborn and Child Health in Kenya Through Digital Innovations
A study testing I-PUSH in people with Universal Health Coverage, run by African Population and Health Research Center.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Universal Health Coverage
- What is being tested?
- I-PUSH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Targets for the intervention
Who cannot join
- Non-targets for the intervention
About this study
Official title: 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.
Read the 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.
- Conditions
- Universal Health Coverage
- Being tested
- I-PUSH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-PUSHBehavioural
Innovative partnership for universal and sustainable healthcare
| Study group | Role | What they receive |
|---|---|---|
| I-PUSH intervention sites | Active comparator | Clusters with I-PUSH intervention Receives: Behavioral: I-PUSH |
| No I-PUSH intervention sites | No intervention | Clusters with no I-PUSH intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Care Utilization
Financial and health diaries will be collected on a weekly basis throughout the indicated study period
Measured: 17 months
Maternal, Newborn and Child Health outcomes through out the continuum of care
Questionnaire based survey questions will be used to measure these outcomes
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startSep 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Universal Health CoverageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- African Population and Health Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam Institute for Global Health and Development, PharmAccess
- Responsible party
- Principal investigator, Amanuel Abajobir, African Population and Health Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068571
- Sponsor's protocol ID
- AfricanPHRC
- Acronym
- UHC
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abajobir A, Maina D, Wambui E, Sidze EM. Association between maternal mental health and early childhood development, nutrition, and common childhood illnesses in Khwisero subcounty, Kenya. PLoS One. 2025 Jan 17;20(1):e0317762. doi: 10.1371/journal.pone.0317762. eCollection 2025.
PubMed 39823401Abajobir A, de Groot R, Wainaina C, Njeri A, Maina D, Njoki S, Mbaya N, Donfouet HPP, Pradhan M, Janssens W, Sidze EM. The impact of i-PUSH on maternal and child health care utilization, health outcomes, and financial protection: study protocol for a cluster randomized controlled trial based on financial and health diaries data. Trials. 2021 Sep 15;22(1):629. doi: 10.1186/s13063-021-05598-7.
PubMed 34526072
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Partnership for Universal Health Coverage
- ClinicalTrials.gov ID
- NCT04068571
- Acronym / sponsor ID
- UHC / AfricanPHRC
- Conditions
- Universal Health Coverage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- African Population and Health Research CenterUniversity, hospital or other
- Collaborators
- Amsterdam Institute for Global Health and Development, PharmAccess
- Study start
- Sep 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-PUSH intervention sites | Active comparator | Behavioral: I-PUSHClusters with I-PUSH intervention |
| No I-PUSH intervention sites | No intervention | –Clusters with no I-PUSH intervention |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Targets for the intervention
Key exclusion criteria (1 listed)
- Non-targets for the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-PUSHInnovative partnership for universal and sustainable healthcare | Behavioural | I-PUSH intervention sites |
Primary outcome
Health Care Utilization
Time frame: 17 months
Financial and health diaries will be collected on a weekly basis throughout the indicated study period
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 39823401Abajobir A, Maina D, Wambui E, Sidze EM. Association between maternal mental health and early childhood development, nutrition, and common childhood illnesses in Khwisero subcounty, Kenya. PLoS One. 2025 Jan 17;20(1):e0317762. doi: 10.1371/journal.pone.0317762. eCollection 2025.
- Derived from this study: PubMed 34526072Abajobir A, de Groot R, Wainaina C, Njeri A, Maina D, Njoki S, Mbaya N, Donfouet HPP, Pradhan M, Janssens W, Sidze EM. The impact of i-PUSH on maternal and child health care utilization, health outcomes, and financial protection: study protocol for a cluster randomized controlled trial based on financial and health diaries data. Trials. 2021 Sep 15;22(1):629. doi: 10.1186/s13063-021-05598-7.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing I-PUSH in people with Universal Health Coverage, run by African Population and Health Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Care Utilization (time frame: 17 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04068571, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.