Linking clinic and community digital records and local teams to boost antenatal clinic visits
Official title: A Pragmatic Open-label, Community-based, Cluster Randomised Controlled Superiority Trial to Evaluate the Efficacy and Cost-effectiveness of Digital Data Linkage and Scheduling ('C-it') With or Without Community Data Use ('DU-it') to Increase Antenatal Clinic Uptake in Western Kenya.
Run by Liverpool School of Tropical Medicine · NCT05929586 · Data updated 2026-11-12
This project will test whether linking facility and community digital health records and training local Work Improvement Teams to use those data increases antenatal clinic visits for pregnant women in Homa Bay County, Kenya.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 1440 (estimated) |
| Sponsor | Liverpool School of Tropical Medicine Academic / other |
| Locations | 1 site (Homa Bay) |
| Status | Recruiting |
| Started | November 29, 2024 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | June 27, 2025 |
| Trial ID | NCT05929586 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are pregnant women (or women within six weeks postpartum as specified) who live in the study catchment area and are willing to provide written informed consent for participation.
✕Probably not a fit
Women who live outside the study catchment, are enrolled in another interventional pregnancy study, unwilling to consent, or who do not use local health services are unlikely to benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a 2-arm, cluster-randomised superiority trial in Homa Bay County comparing a combined 'C-it DU-it' intervention (linked digital platforms plus community data use by Work Improvement Teams) to an enhanced standard of care with digital platforms only. The intervention links community eCHIS records with facility KenyaEMR maternal health data and trains community WITs to 'see' the linked data and 'do' local improvement actions to raise ANC contacts. Clusters are health facility catchment areas, and outcomes focus on number of antenatal contacts per pregnancy and uptake of community and facility ANC services. The trial tests whether strengthened data linkage plus local data-driven problem solving increases adherence to WHO-recommended ANC contacts.
Why it matters
Potential benefit: If successful, the intervention could increase antenatal clinic contacts and improve timely detection and management of pregnancy risks, potentially improving maternal and newborn outcomes.
How similar studies have gone: Related digital reminders and community health worker interventions have increased ANC uptake in some settings, but integrated linkage of community eCHIS and facility EMR data together with local Work Improvement Teams is a relatively novel, less-tested approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women of all ages willing to participate * Written informed consent * A resident of the study area (catchment area) for the duration of the pregnancy * Delivered and still within the 6-week post-partum period. Exclusion Criteria: * Currently enrolled in another interventional study targeting pregnant women * Outside the 6-week post-partum period.
Where it's running
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KEMRI Centre for Global Health Research
Homa Bay, Kenya Recruiting
Study contacts
- Principal investigator: Miriam Taegtmeyer, PhD — Liverpool School of Tropical Medicine
- Study coordinator: Hellen C Barsosio, MD
- Email: hbarsosio@kemri.go.ke
- Phone: +254724464507
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.