About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Currently enrolled in another interventional study targeting pregnant women
Outside the 6-week post-partum period.
Trial design
Parallel
Treatments tested in this trial
The combined "C-it DU-it" intervention: community data use for ANC
Other interventionCombining 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)
Treatment groups
Trial outcomes
Primary outcomes
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.
Estimate socioeconomic impact and access to social protection
Defined as the proportion of women using financial coping strategies and their frequency and distribution
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
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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).
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.
Sponsors and contacts
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Liverpool School of Tropical Medicine
Lead sponsor
Kenya Medical Research Institute
Collaborator
LVCT Health
Collaborator