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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorLiverpool School of Tropical Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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)

Treatment groups

1,440 Participants
are divided into 2 treatment groups
Group A: Digital data linkage and scheduling ('C-it'): The "C-it" enhanced standard of careNo intervention 0 interventions
Group B: The combined "C-it DU-it" intervention: community data use for ANCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
14 months
2

Estimate socioeconomic impact and access to social protection

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

Time frame
14 months
3

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

Time frame
14 months

Secondary outcomes

1

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.

Time frame
14 months
2

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.

Time frame
14 months
3

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.

Time frame
14 months
4

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.

Time frame
14 months

Other outcomes

1

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).

Time frame
14 months
2

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.

Time frame
14 months

Sponsors and contacts

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Liverpool School of Tropical Medicine

Lead sponsor

Kenya Medical Research Institute

Collaborator

LVCT Health

Collaborator