Digital Data Linkage and Scheduling to Track Pregnancy With or Without Community Data Use to Increase Antenatal Clinic Uptake in Western Kenya.

NCT05929586 | Recruiting DMC

• 1 other identifier: 22-073
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 1

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).

Conditions

Health Systems; Electronic Community Health Information Systems; Antenatal Clinic Uptake; Pregnancy

Outcome Measures

Primary Outcomes (3)

• Increasing antenatal clinic uptake

  The proportion of women having at least eight ANC contacts during the antenatal period, defined as either a scheduled ANC visit in the facility or a scheduled ANC contact with a CHV in the community assessed at birth (or within the first 6-8 weeks for home births) using the ANC cards.

  14 months

• Estimate socioeconomic impact and access to social protection

  Defined as the proportion of women using financial coping strategies and their frequency and distribution

  14 months

• Estimate the costs to pregnant women and their households

  Absolute costs to the pregnant woman and their household and the costs as a proportion of the pregnant woman and their household's monthly income or expenditure/consumption will be calculated for the following variables: * Out-of-pocket medical costs * Out-of-pocket non-medical costs * Lost income, time, and productivity

  14 months

Secondary Outcomes (11)

• The proportion of women having at least four scheduled ANC visits in the facility

  14 months

• The proportion of women having at least eight scheduled ANC visits in the facility

  14 months

• The frequency (count) of scheduled ANC visits

  14 months

• The frequency (count) of of ANC visits in the community

  14 months

• Early antenatal clinic attendance

  14 months

Other Outcomes (2)

• Improving uptake of four ANC tests.

  14 months

• Improving uptake of HIV prevention services.

  14 months

Study Arms (2)

Digital data linkage and scheduling ('C-it'): The "C-it" enhanced standard of care

NO INTERVENTION

Linking facility to community digital data via linkage-app: Data between electronic Community Health Information System (eCHIS) and facility-based Kenya Electronic Medical Record (Kenya EMR) do not link. We do not have an existing digital data linkage module or app to track successful pregnancy referrals or allow the facility staff to view community contacts and vice versa. We will engage with national and county teams and software developers to build a digital data linkage module, linking eCHIS and Kenya EMR Maternal and Child Health (MCH) module.

The combined "C-it DU-it" intervention: community data use for ANC

EXPERIMENTAL

Combining "C-it" and work improvement teams (WITs) for community data use: We will establish and train integrated WITs in intervention sites consisting of community health members, health facility staff and community members and train them on how they will use linkage-app. The resultant combined "C-it DU-it" intervention has three building blocks: We make the following assumptions about the building blocks at the bottom of figure 1. 1. Building block 1: We assume that high-quality digital data that can trace the entire journey through pregnancy is accessible to CHVs 2. Building block 2: We also assume that integrated work improvement teams (WITs) will have the right people around the table with clearly defined roles and responsibilities will use the data. 3. Building block 3: Community ANC contacts will be implemented.

Other: The combined "C-it DU-it" intervention: community data use for ANC

Interventions

The combined "C-it DU-it" intervention: community data use for ANC OTHER

Combining data linkage ("C-it") with work improvement teams for community data use ("DU-it") to improve antenatal clinic uptake. 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)

Also known as: community data use (DU-it)

The combined "C-it DU-it" intervention: community data use for ANC

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Currently enrolled in another interventional study targeting pregnant women
• Outside the 6-week post-partum period.

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• Kenya Medical Research Institute: collaborator
• LVCT Health: collaborator

Study Sites (1)

KEMRI Centre for Global Health Research

Homa Bay, Kenya

RECRUITING

Study Officials

• Miriam Taegtmeyer, PhD

  Liverpool School of Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Tom Wingfield, PhD

  Liverpool School of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hellen C Barsosio, MD

CONTACT

+254724464507; hbarsosio@kemri.go.ke

Lilian Otiso, MD

CONTACT

+254722293139; lilian.otiso@lvcthealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Allocation: cluster randomised; intervention model: parallel assignment; arms: 2; allocation ratio: 1:1; restricted or stratified randomisation. Masking: none

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: July 3, 2023
• Study Start: November 29, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The full anonymised research database will be made publicly available as soon as the full study findings have been published or based on any data requests that may occur during the study or analysis is still ongoing.
• Access Criteria: Data access will be provided to researchers after a proposal has been approved by an independent review committee identified for this purpose. An agreement on how to collaborate will be reached based on any overlap between the proposal and any ongoing efforts. Proposals can be directed to email addresses provided in the publications and websites. To gain access, data requesters will need to sign a data-sharing agreement.

Locations

KE (1)