NCT03021070

Brief Summary

Antenatal care (ANC), facility delivery and postnatal care (PNC) are proven strategies that can tackle the high burden of maternal and child mortality and morbidity currently witnessed in sub-Saharan Africa. However very few pregnant women utilize these services. This study aims to assess the impact, cost-effectiveness, and scalability of conditional cash transfers (CCTs) to promote increased and uninterrupted contact between pregnant women and the formal healthcare system in Siaya County, Kenya. The study is a cluster randomized controlled trial with the intervention being a conditional cash transfer to women each time they honour their health appointments for ANC, facility birth and PNC visits until their new-borns reach 1 year of age. Study participants are pregnant women identified during their first ANC visit (n = 7200), and their subsequent new-borns. Mothers and their children are followed up throughout their health visits and at 3 additional time points. Trial clusters are 48 public primary health facilities, (24 in the intervention arm and 24 in the control arm). The primary outcomes are: a) proportion of all eligible ANC visits made during pregnancy; b) delivery at health facility; c) proportion of all eligible PNC visits honoured; d) proportion of referrals honoured during pregnancy and postnatal period; e) proportion of child immunizations received. Secondary outcomes include; health screening and infection control, live birth, maternal and child survival 48 hours after delivery, exclusive breastfeeding, birth spacing and self-rated wellness of mother and new-born at respective time points. Primary outcomes will be measured through abstraction of health records at the health facilities attended by the women during the trial period and supplemented by data collection using an electronic based system that comprises of a card and reader system installed at recruited study facilities. Secondary data will be abstracted from the women's medical records at the health facilities and supplemented by telephone surveys administered at three time-points over the course of the study. Additional quantitative and qualitative data will be collected through questionnaires and phone interviews for process and economic evaluations. This trial will contribute to evidence on effectiveness and cost-effectiveness of conditional cash transfers in facilitating health visits and promoting maternal and child health in Kenya and other similar contexts.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

January 9, 2017

Last Update Submit

January 12, 2017

Conditions

Maternal and Child Health

Keywords

Ante natal visitFacility deliveryPost natal visitContinuum of careConditional cash transferMaternal and child healthCluster randomized trial

Outcome Measures

Primary Outcomes (5)

  • Ante Natal visits honoured after recruitment

    The proportion of required ANC visits honoured after recruitment into the study in the intervention arm compared to the control arm

    up to 18 months

  • Delivery at health facility

    The proportion of health facility deliveries made by pregnant women recruited in the study in the intervention arm compared to the control arm

    up to 18 months

  • Post natal visits honoured after recruitment

    The proportion of required post natal visits honoured after recruitment into the study in the intervention arm compared to the control arm

    1 year

  • Immunization visits honoured by children recruited into the study

    The proportion of eligible immunization visits honoured by children after recruitment into the study in the intervention arm compared to the control arm

    1 year

  • Refferal visits honoured by study particpants

    The proportion of health referrals for ANC, PNC and (children) immunization honoured by study particpants

    up to 18 months

Secondary Outcomes (7)

  • Maternal death 48 hours post partum

    up to 1 year

  • Live birth and child survival 48-hours after birth

    up to 1 year

  • Timeliness of health visits (summary across ANC, PNC, immunization as appropriate)

    up to 18 months

  • Self rated wellness

    up to 1 year

  • Exclusive breastfeeding

    Up to 1 year

  • +2 more secondary outcomes

Study Arms (2)

Cash transfer arm

EXPERIMENTAL

The intervention is a conditional cash transfer payment for each health facility appointment honoured for ANC, delivery, postnatal care and childhood immunization; and referrals related to any of these visits.

Other: Conditional cash transfer

Non-cash transfer arm

NO INTERVENTION

The control is a mobile phone airtime transfer value of 50 Ksh. transferred through the electronic system for each health facility appointment honoured for ANC, delivery, postnatal care and childhood immunization; and referrals related to any of these visits.

Interventions

Conditional cash transferOTHER

For each honoured and verified health visit that is made on time following enrollment, a woman receives a cash transfer. The value reduces by one quarter for each week of delayed visit, and no reward is offered for any visit made 3 weeks after the appointment date. Transportation cost by a local taxi to the health facility, and is a value that has been approved by the research ethics committee for many studies in the region as reasonable compensation for research participants.

Cash transfer arm

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant woman is attending her first ANC visit, A long-term resident in the catchment area served by the health facility Women in both study groups to have access to a mobile phone that belongs to them or to a member of their household or anyone else who they trust

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm Environment Institute

Nairobi, Nairobi County, 00100, Kenya

Location

Related Publications (4)

  • Dickin S, Vanhuyse F, Stirrup O, Liera C, Copas A, Odhiambo A, Palmer T, Haghparast-Bidgoli H, Batura N, Mwaki A, Skordis J. Implementation of the Afya conditional cash transfer intervention to retain women in the continuum of care: a mixed-methods process evaluation. BMJ Open. 2022 Sep 19;12(9):e060748. doi: 10.1136/bmjopen-2022-060748.

    PMID: 36123052DERIVED

  • Vanhuyse F, Stirrup O, Odhiambo A, Palmer T, Dickin S, Skordis J, Batura N, Haghparast-Bidgoli H, Mwaki A, Copas A. Effectiveness of conditional cash transfers (Afya credits incentive) to retain women in the continuum of care during pregnancy, birth and the postnatal period in Kenya: a cluster-randomised trial. BMJ Open. 2022 Jan 6;12(1):e055921. doi: 10.1136/bmjopen-2021-055921.

    PMID: 34992119DERIVED

  • Batura N, Skordis J, Palmer T, Odiambo A, Copas A, Vanhuyse F, Dickin S, Eleveld A, Mwaki A, Ochieng C, Haghparast-Bidgoli H. Cost-effectiveness of conditional cash transfers to retain women in the continuum of care during pregnancy, birth and the postnatal period: protocol for an economic evaluation of the Afya trial in Kenya. BMJ Open. 2019 Nov 6;9(11):e032161. doi: 10.1136/bmjopen-2019-032161.

    PMID: 31699743DERIVED

  • Ochieng CA, Haghparast-Bidgoli H, Batura N, Odhiambo A, Shannon G, Copas A, Palmer T, Dickin S, Noel S, Fielding M, Onyango S, Odera S, Eleveld A, Mwaki A, Vanhuyse F, Skordis J. 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. Trials. 2019 Mar 1;20(1):152. doi: 10.1186/s13063-019-3224-8.

    PMID: 30823886DERIVED

Study Officials

  • Caroline Ochieng, PhD

    Stockholm Environment Institute - Africa Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Onyango Sangoro, PhD

CONTACT

+254 721 816 804onyango.sangoro@sei-international.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co Principal Investigator

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 13, 2017

Study Start

January 1, 2017

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

January 13, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Locations

KE(1)