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

Pregnancy Clinical Trial

— C-it-DU-it  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05929586
• Other study ID #: 22-073
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: June 2023
• Source: Liverpool School of Tropical Medicine
• Contact: Hellen C Barsosio, MD
• Phone: +254724464507
• Email: hbarsosio[@]kemri.go.ke
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1440
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Liverpool School of Tropical Medicine	Kenya Medical Research Institute, LVCT Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improving uptake of four ANC tests.	The proportion of women receiving testing and management of all four common conditions in pregnancy (HIV, syphilis, malaria, anaemia).	14 months
Other	Improving uptake of HIV prevention services.	The proportion of HIV-negative women receiving testing and management for HIV in the 3rd trimester or at delivery.; The proportion of HIV-exposed infants with negative HIV PCR DNA tests at 6-8 weeks.	14 months
Primary	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
Primary	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
Primary	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	The proportion of women having at least four scheduled ANC visits in the facility	assessed at birth (or within the first 6-8 weeks after birth for home births) using the ANC cards.	14 months
Secondary	The proportion of women having at least eight scheduled ANC visits in the facility	assessed at birth (or within the first 6-8 weeks after birth for home births) using the ANC cards.	14 months
Secondary	The frequency (count) of scheduled ANC visits	assessed at birth (or within the first 6-8 weeks after birth for home births) using the ANC cards.	14 months
Secondary	The frequency (count) of of ANC visits in the community	assessed at birth (or within the first 6-8 weeks after birth for home births) using the ANC cards.	14 months
Secondary	Early antenatal clinic attendance	The proportion of women with a first ANC contact before 16 weeks gestation.	14 months
Secondary	Quality of antenatal care	The proportion of women with at least three courses of IPTp; The proportion of women who received iron and folate for 90 days.; The proportion of women receiving testing and management for HIV.; The proportion of women receiving testing and management for malaria.; The proportion of women receiving testing and management for syphilis.; The proportion of women receiving testing and management for anaemia.	14 months
Secondary	Uptake of skilled birth attendance.	The proportion of women who had a skilled birth attendance.	14 months
Secondary	Reducing the risk of adverse pregnancy outcomes.	The proportion of women with adverse pregnancy outcomes- defined as a composite of foetal loss (stillbirth or spontaneous miscarriage), low birth weight or neonatal mortality)	14 months
Secondary	prevalence of catastrophic health expenditure (CHE) of accessing ANC care with "C-it" enhanced standard of care	CHE prevalence at two World Health Organization-defined thresholds: out-of-pocket medical costs of more than 10% of a patient household's total monthly expenditure/consumption (10%-threshold); and out-of-pocket medical costs of more than 40% of a patient household's monthly capacity to pay (non-food/housing/utilities expenditure/consumption); • A sensitivity analysis of the proportion of women's households incurring CHE due to pregnancy and ANC visits using varying additional recognised calculations and thresholds including, as per WHO Tuberculosis Patient Cost Survey methodology, the addition of non-medical out-of-pocket costs and lost income in the numerator	14 months
Secondary	Cost-effectiveness of "C-it" and "C-it DU-it" intervention	Incremental cost-effectiveness ratios (ICERs) compared across trial arms	14 months
Secondary	Assess equity of access to ANC and "C-it" and "C-it DU-it" intervention.	Equity of access to ANC and the interventions will be evaluated by exploratory distributional (or "extended") cost-effectiveness analysis of the intervention across the following sub-groups: poverty quintiles, age groups including adolescents vs adults, study sites, HIV status, and by eligibility for health insurance including NHIF and Linda Mama.	14 months