Skip to content

Digital data linkage and scheduling to track pregnancy (‘C-it’) with or without community data use (‘C-it DU-it’) to increase antenatal clinic uptake in western Kenya:a cluster randomised trial

A pragmatic open-label, community-based, cluster randomised controlled superioritytrial 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202304517187726
Enrollment
1440
Registered
2023-04-19
Start date
2023-10-25
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Systems, electronic Community Health Information Systems, Antenatal clinic uptake, Pregnancy

Interventions

C it control or standard of care
The combined C it DU it intervention

Sponsors

Liverpool School of Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Inclusion criteria of clusters Government or faith-based ANC clinics. Located in Homa Bay County mainland. Health facilities have at least 80 attended births per year ANCs linked with at least one fully-functional community health unit Eligibility criteria for participants 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. Inclusion criteria health economic evaluation 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 Attending ANC clinic at a study site

Exclusion criteria

Exclusion criteria: Exclusion criteria clusters Referral hospitalsCitDUit Trial Protocol Located in Homa Bay County islands Hard to reach like very limited road and public transport access and or seasonal Currently involved in another study targeting pregnant women directly Exclusion criteria for participants Currently enrolled in another interventional study targeting pregnant women Outside the 6-week post-partum period. Exclusion criteria health economic evaluation Currently enrolled in another interventional study targeting pregnant women Attending ANC clinic in non-study sites

Design outcomes

Primary

MeasureTime frame
Efficacy- 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.;Health Economics- 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 and Socioeconomic impact and access to social protection will be measured by:Proportion of women using financial coping strategies and their frequency and distribution, Proportion of women eligible for, covered by and/or using health insurance including the National Hospital Insurance Fund (NHIF) and Linda Mama scheme for pregnant women

Secondary

MeasureTime frame
Efficacy-The proportion of women having at least four scheduled ANC visits in the facility The proportion of women having at least eight scheduled ANC visits in the facility The frequency (count) of scheduled ANC visits in the facility The frequency (count) of ANC visits in the community ;Health economics-CHE prevalence at two World Health Organization-defined thresholds: out-ofpocket 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. Incremental cost-effectiveness ratios (ICERs) compared across trial arms and also 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 subgroups: poverty quintiles, age groups including adolescents vs adults, study sites, HIV status, and by eligibilty insurance including NHIF and Linda Mama.;Exploratory-The proportion of women receiving testing and management of all four common conditions in pregnancy (HIV, syphilis, malaria,anaemia). The proportion of HIV-negative women receiving testing and management for HIV in the 3rd trimester or at delivery and also The proportion of HIV-exposed infants with negative HIV PCR DNA tests at 6-8 weeks.

Countries

Kenya

Contacts

Public ContactHellen;Feiko Barsosio;ter Kuile

principle investigator;chief investigator

hbarsosio@kemri.go.ke;feiko.terkuile@lstmed.ac.uk+254724464507;+447846377

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026