Conditional cash transfers to retain rural Kenyan women in the continuum of care during pregnancy, birth and the postnatal period: protocol for a cluster randomized controlled trial

Abstract

Background: Antenatal care (ANC), facility delivery and postnatal care (PNC) are proven to reduce maternal and child mortality and morbidity in high-burden settings. However, few pregnant rural women use these services sufficiently. This study aims to assess the impact, cost-effectiveness and scalability of conditional cash transfers to promote increased contact between pregnant women or women who have recently given birth and the formal healthcare system in Kenya.

Methods: The intervention tested is a conditional cash transfer to women for ANC health visits, a facility birth and PNC visits until their newborn baby reaches 1 year of age. The study is a cluster randomized controlled trial in Siaya County, Kenya. The trial clusters are 48 randomly selected public primary health facilities, 24 of which are in the intervention arm of the study and 24 in the control arm. The unit of randomization is the health facility. A target sample of 7200 study participants comprises pregnant women identified and recruited at their first ANC visit over a 12-month recruitment period and their subsequent newborns. All pregnant women attending one of the selected trial facilities for their first ANC visit during the recruitment period are eligible for the trial and invited to participate. Enrolled mothers are followed up at all health visits during their pregnancy, at facility delivery and for a number of visits after delivery. They are also contacted at three additional time points after enrolling in the study: 5-10days after enrolment, 6 months after the expected delivery date and 12 27 months after birth. If they have not delivered in a facility, there is an additional follow-up 2 wees after the expected due date. The impact of the conditional cash transfers on maternal healthcare services and utilization will be measured by the trial's primary outcomes: the proportion of all eligible ANC visits made during pregnancy, delivery at a health facility, the proportion of all eligible PNC visits attended, the proportion of referrals attended during the pregnancy and the postnatal period, and the proportion of eligible child immunization appointments attended. Secondary outcomes include; health screening and infection control, live birth, maternal and child survival 48 h after delivery, exclusive breastfeeding, post-partum contraceptive use and maternal and newborn morbidity. Data sources for the measurement of outcomes include routine health records, an electronic card-reader system and telephone surveys and focus group discussions. A full economic evaluation will be conducted to assess the cost of delivery and cost effectiveness of the intervention and the benefit incidence and equity impact of trial activities and outcomes.

Discussion: This trial will contribute to evidence on the effectiveness and cost-effectiveness of conditional cash transfers in facilitating health visits and promoting maternal and child health in rural Kenya and in other comparable contexts.

Trial registration: ClinicalTrials.gov, NCT03021070 . Registered on 13 January 2017.

Keywords: Antenatal care; Child immunization; Cluster randomized controlled trial; Conditional cash transfers; Facility delivery; Kenya; Maternal and child health; Postnatal care.

Conflict of interest statement

Ethics approval and consent to participate

The study has received ethics approval from the Maseno University Ethics Review Committee, REF MSU/DRPI/MUERC/00294/16. The trial has been registered with Prior to enrolment into the study, participants are given information about the study (see Additional file 3: Participant information sheet) by the enrolling facility staff. The information is shared verbally in the participant’s local language (Dholuo and Swahili), and augmented by an animated video produced for the study that is shown to eligible participants when they visit the clinic. All potential participants are informed that their participation in the study is voluntary, and that even after enrolment they can elect to withdraw from the study at any time they choose Participants are also informed that their choice to participate or not participate in the study would not affect their access to health services or treatment, and that there is no penalty for not participating in the study. Those who agree to participate sign the informed consent form (see Additional file 4: Informed consent forms). Study participants are given a take-home information sheet in the form of a calendar. The calendar contains contact information of the research team who they can call if they have any follow-up questions.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Schedule of enrolment, interventions and assessments. *MNCH appointments/visits – Standard maternal and child health visits described in Additional file 1. **Covariates - see Table 1. ***Health outcomes - see Additional file 2. MNCH, maternal, newborn and child health; ANC, antenatal care; PNC, postnatal care

Fig. 2

Theory of change. MNCH, maternal, newborn and child health; ANC, antenatal care; PNC, postnatal care; EBF, Exclusively breastfeeding