Clinical trial NCT05929586: Digital Data Linkage and Scheduling to Track Pregnancy With or Without Community Data Use to Increase Antenatal Clinic Uptake in Western Kenya.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health Systems
Electronic Community Health Information Systems
Antenatal Clinic Uptake
Pregnancy
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: LVCT Health
First posted: 2023-07-03
Enrollment: 1440
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation: cluster randomised; intervention model: parallel assignment; arms: 2; allocation ratio: 1:1; restricted or stratified randomisation. Masking: none
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators propose to increase ANC uptake through a health systems strengthening approach that links digital data platforms and trains community Work Improvement Teams (WITs) to use these data to identify problems and come up with local solutions. Our short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it). The trial design is a 2-arm, cluster-randomised controlled superiority trial in Homa Bay County to determine the efficacy of 'C-it DU-it' intervention (data use arm) to increase ANC contacts when compared to the 'C-it' enhanced standard of care (control arm).

Detailed description: Facility and community health data is being rapidly digitised using multiple parallel systems across the 47 devolved counties in Kenya, but data do not link. Setting up community-based antenatal care (ANC) to complement facility-based ANC and data systems that link these platforms is essential to support Kenya in adopting WHO's ambitious target of 8 ANC contacts. As of February 2023, national scale up of the national electronic community health information systems (eCHIS) for standard of care is ongoing, and there are increased efforts to scale-up use of the nationally approved Kenya Electronic Medical Records (KenyaEMR) Maternal and Child Health Module (MNH) to capture ANC, delivery and postnatal (PNC) data at health facilities. Data between eCHIS and Kenya EMR do not link. There are plans within the Community Health Division at national level to link eCHIS to facility EMRs, but this has yet to be developed. The investigators propose to increase ANC uptake through a health systems strengthening approach that links digital data platforms and trains community Work Improvement Teams (WITs) to use these data to identify problems and come up with local solutions. The short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it). The overarching research question the investigators will seek to answer is "what is the effect of 'C-it DU it' on community health systems strengthening and what is required for effective transfer and scale-up?" The investigators will use mixed methods implementation research to evaluate this in 4 counties in Western Kenya (Homa Bay, Migori, Kisumu, Kakamega) over a period of four years. The proposed methods include: (a) Realist evaluation to generate, empirically test and refine a transferrable programme theory to understand the causal relationship between context, participant response and outcomes; (b) A 2-arm, cluster-randomised controlled superiority trial in Homa Bay County to determine the efficacy of 'C-it DU-it' intervention (data use arm) to increase ANC contacts when compared to the 'C-it' enhanced standard of care (control arm); (c) Health economic evaluation and equity analysis to compare costs and catastrophic health expenditure of women accessing and engaging with ANC care and determine costs and cost-effectiveness of C-it Du-it from a health systems perspective; and (d) Qualitative interviews will assess transferability and iterative scale-up of C-it DU-it across the three remaining counties using toolkits developed in Homa Bay. This protocol describes the pragmatic cluster randomised trial and health economic evaluation. The realist evaluation and scale up will be addressed in a separate sister protocol.

Eligibility 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.

Primary outcomes:
measure: Increasing antenatal clinic uptake
timeFrame: 14 months
measure: Estimate socioeconomic impact and access to social protection
timeFrame: 14 months
measure: Estimate the costs to pregnant women and their households
timeFrame: 14 months
Secondary outcomes:
measure: The proportion of women having at least four scheduled ANC visits in the facility
timeFrame: 14 months
measure: The proportion of women having at least eight scheduled ANC visits in the facility
timeFrame: 14 months
measure: The frequency (count) of scheduled ANC visits
timeFrame: 14 months
measure: The frequency (count) of of ANC visits in the community
timeFrame: 14 months
measure: Early antenatal clinic attendance
timeFrame: 14 months
measure: Quality of antenatal care
timeFrame: 14 months
measure: Uptake of skilled birth attendance.
timeFrame: 14 months
measure: Reducing the risk of adverse pregnancy outcomes.
timeFrame: 14 months
measure: prevalence of catastrophic health expenditure (CHE) of accessing ANC care with "C-it" enhanced standard of care
timeFrame: 14 months
measure: Cost-effectiveness of "C-it" and "C-it DU-it" intervention
timeFrame: 14 months
measure: Assess equity of access to ANC and "C-it" and "C-it DU-it" intervention.
timeFrame: 14 months
Other outcomes:
measure: Improving uptake of four ANC tests.
timeFrame: 14 months
measure: Improving uptake of HIV prevention services.
timeFrame: 14 months
Locations:
Study officials:
affiliation: Liverpool School of Tropical Medicine
name: Miriam Taegtmeyer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liverpool School of Tropical Medicine
name: Tom Wingfield, PhD
role: PRINCIPAL_INVESTIGATOR
References: