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Incentives for Postnatal Care Demand

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ClinicalTrials.gov Identifier: NCT02936869
Recruitment Status : Completed
First Posted : October 18, 2016
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Adanna Chukwuma, Harvard School of Public Health

Tracking Information
First Submitted Date  ICMJE October 14, 2016
First Posted Date  ICMJE October 18, 2016
Results First Submitted Date  ICMJE November 21, 2017
Results First Posted Date  ICMJE July 24, 2019
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
Maternal Postnatal Care Referral [ Time Frame: Within 48 hours of delivery ]
The proportion of delivery clients that are successfully referred by the traditional birth attendant for postnatal care within 48 hours of delivery. For each delivery client that the traditional birth attendant reported, we visited at least three days after delivery to ascertain if they had been asked to visit the postnatal clinic, clarify if they had visited the clinic within 48 hours of delivery, and what care they had received (if yes). The team visited traditional birth attendants every two weeks to identify new clients. Where a new client was not up to three days post-delivery, the interview was postponed until the next visit by the team to the community. This occurred repeatedly, over a five-month frame.
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
Maternal Postnatal Care Referral [ Time Frame: Five months ]
Proportion of delivery clients that are successfully referred by the traditional birth attendant for postnatal care within 48 hours of delivery
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
Neonatal Postnatal Care Referral [ Time Frame: Within 48 hours of delivery ]
Proportion of neonates delivered by the traditional birth attendant that are successfully referred for postnatal care within 48 hours of delivery
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
Neonatal Postnatal Care Referral [ Time Frame: Five months ]
Proportion of neonates delivered by the traditional birth attendant that are successfully referred for postnatal care within 48 hours of delivery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incentives for Postnatal Care Demand
Official Title  ICMJE Incentives for Postnatal Care Demand
Brief Summary The purpose of this study is to identify the causal impact of performance-based monetary incentives in increasing postnatal care (PNC) referrals by traditional birth attendants (TBAs), via a randomized controlled trial (RCT).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Maternal Death
  • Neonatal Death
Intervention  ICMJE Behavioral: Performance-based monetary incentives
Study Arms  ICMJE
  • No Intervention: Control arm
    Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.
  • Experimental: Referral incentive arm

    Traditional birth attendants will receive an offer of two-weekly payouts per reported delivery they take that is verified by client.

    Traditional birth attendants randomized to this arm will also receive an offer of two-weekly payouts per successful referral of delivery clients to postnatal care within 48 hours of delivery in a facility if verified.

    Intervention: Behavioral: Performance-based monetary incentives
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2019)
207
Original Actual Enrollment  ICMJE
 (submitted: October 14, 2016)
208
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • community-based providers of antenatal and/or delivery care, and who are non-formally trained
  • must be resident within the community
  • must not plan to relocate over the intervention duration
  • identified in partnership with community leadership
  • be willing to participate fully in the study, including having their clients contacted for verification

Exclusion Criteria:

  • plan to relocate over the intervention duration
  • refusal to provide informed consent for the entire study protocol including agreeing to have their delivery clients contacted for verification
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02936869
Other Study ID Numbers  ICMJE HU-052
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data for this study including all the variables used for the analysis are available for download on the Harvard Dataverse.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: The data on the Harvard Dataverse are available indefinitely as long as the website continues to host datasets.
Access Criteria: The data can be freely downloaded without permission.
Responsible Party Adanna Chukwuma, Harvard School of Public Health
Study Sponsor  ICMJE Harvard School of Public Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adanna Chukwuma, MBBS, MSc. Harvard School of Public Health
Principal Investigator: Margaret McConnell, PhD Harvard School of Public Health
Principal Investigator: Jessica Cohen, PhD Harvard School of Public Health
Principal Investigator: Chinyere Mbachu, MBBS, MPH Health Policy Research Group
PRS Account Harvard School of Public Health
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP