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Kilkari Impact Evaluation

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ClinicalTrials.gov Identifier: NCT03576157
Recruitment Status : Unknown
Verified October 2018 by Johns Hopkins Bloomberg School of Public Health.
Recruitment status was:  Recruiting
First Posted : July 3, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Oxford Policy Management
University of Cape Town
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:

British Broadcasting Corporation (BBC) Media Action is presently implementing two large scale mobile health (mHealth) initiatives in India: Kilkari and Mobile Academy. Kilkari is an outbound service that delivers weekly, time-appropriate audio messages about pregnancy, childbirth, and childcare directly to families on their mobile phones, starting from the second trimester of pregnancy until the child is one-year-old. Mobile Academy (MA) is an Interactive Voice Response (IVR) in-service audio training course for Accredited social health activists (ASHAs) in India designed to refresh their knowledge of life-saving preventative health behaviors and improve their interpersonal communications skills. Both programs were initiated in Bihar in 2012, and have been scaled widely in a number of states with support from Ministry of Health and Family Welfare (MOHFW) at the national level, National Health Missions (NHM) at the state level, and an alliance of donors (Gates Foundation, USAID, Barr Foundation, and UK Department for International Development (UKAid)).

The Johns Hopkins School of Public Health, Oxford Policy Management, and University of Cape Town are supporting BBC Media Action and the Ministry of Health and Family Welfare (MOHFW) are conducting an external evaluation of both Kilkari and Mobile Academy (MA). The evaluation spans through April 2020.


Condition or disease Intervention/treatment Phase
Breast Feeding Family Planning Essential Newborn Care Training of Frontline Health Workers Other: Kilkari Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Impact Evaluation of Maternal Health Information Messaging in India
Actual Study Start Date : July 7, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : April 30, 2020

Arm Intervention/treatment
Experimental: Kilkari
Pregnant and postpartum women randomized to the Kilkari arm will receive health information messages over their mobile phone during pregnancy and up to 1 year postpartum.
Other: Kilkari
Kilkari is an outbound service that delivers weekly, time-appropriate audio messages about pregnancy, childbirth, and childcare directly to families on their mobile phones, starting from the second trimester of pregnancy until the child is one-year-old.

No Intervention: Comparison
Existing standard of care; no new health messages



Primary Outcome Measures :
  1. Exclusive breastfeeding [ Time Frame: 0-6 months following delivery ]
    The study aims to detect a 5% change in the proportion of women who report practicing exclusive breastfeeding

  2. Immediate breastfeeding [ Time Frame: 1 hour following delivery ]
    The study aims to detect a 5% change in the proportion of women who report practicing immediate breastfeeding



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women 5-7 months pregnant
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

15-45 years 5-7 months pregnant Resident of study area Consents to participation Access to a mobile phone during morning and afternoon

Exclusion Criteria:

<15 years of age Not female Not a resident of study area <5 months and >8 months pregnant Not a Hindi speaker Access to a mobile phone only during the night


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): NCT03576157


Contacts
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Contact: Amnesty E LeFevre, PhD MHS +270767828704 aelefevre@gmail.com
Contact: Aarushi Bhatnagar, PhD +919654485696 aarushi.bhatnagar@btspmle.com

Locations
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India
N/A-- recruitment occurring at household / community level in 4 districts: Rewa, Rajgarh, Mandsaur, Hoshangabad Not yet recruiting
Rewa, Madhya Pradesh, India
Principal Investigator: Amnesty E LeFevre, PhD         
Principal Investigator: Aarushi Bhatnagar, PhD         
Principal Investigator: Alain Labrique, PhD         
Sub-Investigator: Diwakar Mohan, PhD MBBS         
Sub-Investigator: Kerry Scott, Phd         
Sub-Investigator: Neha Shah, MSPH         
Sub-Investigator: Rakesh Chandra, PhD         
Sub-Investigator: Aaditya Singh, PhD         
BBC Media Action Recruiting
Delhi, India
Contact: Sara Chamberlain       sara.chamberlain@in.bbcmediaaction.org   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Oxford Policy Management
University of Cape Town
Investigators
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Principal Investigator: Amnesty E LeFevre, PhD Johns Hopkins School of Public Health, University of Cape Town
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03576157    
Other Study ID Numbers: 90075552
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified data may be made available upon request to study investigators following the publication of study findings.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
mobile health, Pregnant and postpartum women, Frontline health workers, India