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Afya Credit Incentives for Improved Maternal and Child Health Outcomes in Kenya (AFYA)

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ClinicalTrials.gov Identifier: NCT03021070
Recruitment Status : Not yet recruiting
First Posted : January 13, 2017
Last Update Posted : January 13, 2017
Sponsor:
Collaborators:
Safe Water and Aids Project, Kenya
University College, London
NaiLab, Kenya
Safaricom Limited, Kenya
Information provided by (Responsible Party):
Onyango Sangoro, Stockholm Environment Institute

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.


Condition or disease Intervention/treatment Phase
Maternal and Child Health Other: Conditional cash transfer Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Afya Credit Incentives for Improved Maternal and Child Health Outcomes in Kenya
Study Start Date : January 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cash transfer arm
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
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.

No Intervention: Non-cash transfer arm
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.



Primary Outcome Measures :
  1. Ante Natal visits honoured after recruitment [ Time Frame: up to 18 months ]
    The proportion of required ANC visits honoured after recruitment into the study in the intervention arm compared to the control arm

  2. Delivery at health facility [ Time Frame: up to 18 months ]
    The proportion of health facility deliveries made by pregnant women recruited in the study in the intervention arm compared to the control arm

  3. Post natal visits honoured after recruitment [ Time Frame: 1 year ]
    The proportion of required post natal visits honoured after recruitment into the study in the intervention arm compared to the control arm

  4. Immunization visits honoured by children recruited into the study [ Time Frame: 1 year ]
    The proportion of eligible immunization visits honoured by children after recruitment into the study in the intervention arm compared to the control arm

  5. Refferal visits honoured by study particpants [ Time Frame: up to 18 months ]
    The proportion of health referrals for ANC, PNC and (children) immunization honoured by study particpants


Secondary Outcome Measures :
  1. Maternal death 48 hours post partum [ Time Frame: up to 1 year ]
    The proportion of maternal deaths post partum in the intervention arm compared to the control arm

  2. Live birth and child survival 48-hours after birth [ Time Frame: up to 1 year ]
    The proportion of live birth and child survival 48-hours after birth in the intervention arm compared to the control arm

  3. Timeliness of health visits (summary across ANC, PNC, immunization as appropriate) [ Time Frame: up to 18 months ]
    The proportion of timely visits honoured in the intervention arm compared to the control arm

  4. Self rated wellness [ Time Frame: up to 1 year ]
    Self-rated health of mothers and infants at 2 weeks, 6 months and 12 months after delivery in the intervention arm compared to the control arm

  5. Exclusive breastfeeding [ Time Frame: Up to 1 year ]
    Proportion of women that breastfed exclusively from 0 to 6 months in the intervention arm compared to the control arm

  6. Contraceptive use [ Time Frame: up to 18 months ]
    Proportion of women that used family planning methods in the intervention arm compared to the control arm

  7. Infection screening [ Time Frame: up to 18 months ]
    Proportion of women that were screened for infections, and for fetus/baby during pregnancy and post natal period in the intervention arm compared to the control arm



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021070


Contacts
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Contact: Onyango Sangoro, PhD +254 721 816 804 onyango.sangoro@sei-international.org

Locations
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Kenya
Stockholm Environment Institute Not yet recruiting
Nairobi, Kenya, 00100
Contact: Onyango Sangoro, PhD    +254 721 816 804    onyango.sangoro@sei-international.org   
Contact: Stacey Noel, PhD       stacey.noel@sei-international.org   
Sponsors and Collaborators
Onyango Sangoro
Safe Water and Aids Project, Kenya
University College, London
NaiLab, Kenya
Safaricom Limited, Kenya
Investigators
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Principal Investigator: Caroline Ochieng, PhD Stockholm Environment Institute - Africa Centre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Onyango Sangoro, Co Principal Investigator, Stockholm Environment Institute
ClinicalTrials.gov Identifier: NCT03021070     History of Changes
Other Study ID Numbers: AFYA 41361
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Onyango Sangoro, Stockholm Environment Institute:
Ante natal visit
Facility delivery
Post natal visit
Continuum of care
Conditional cash transfer
Maternal and child health
Cluster randomized trial