Birth Companion Intervention in Ethiopia, Kenya and Nigeria

Study Overview
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Brief Summary
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The study aims to assess the acceptability; feasibility; implementation cost; and penetration of the birth companion intervention introduced at health facilities. It is a multi-country study (Ethiopia, Kenya and Nigeria) with a two parallel arm cluster randomized controlled trial design. The study duration will approximately be 16 months.

Detailed Description
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The overall purpose of this study is to investigate how a birth companion (BC) intervention can be implemented to increase the proportion of women who are accompanied by a BC during labor, childbirth, and postpartum in Ethiopia, Kenya and Nigeria. After baseline data collection, facilities will be randomized in a 3:1 ratio; for every three facilities that receive the BC intervention, one facility will serve as a control facility. After randomization, over the course of two months, intervention facilities will start preparing to introduce the BC intervention to facilitate presence of BC during labor and delivery, while the control facilities will continue to provide the local standard of routine care. The intervention will have the following components: 1) Orient facilities and providers to benefits of BC; 2) Develop/update formal standard operating procedures (SOP) for implementing BC and develop plans to implement SOP; 3) Assess data required for implementation and an audit and feedback cycle for tracking coverage; 4) Assess and carry out modest structural changes in facilities to facilitate BC; 5) Use human centered design to develop materials/resources and a means to distinguish/recognize the BC, taking into account common barriers and misconceptions; 6) Prepare providers to integrate BC into care team; 7) Orient antenatal care (ANC) clients to BC rationale and selection; 8) Prepare BCs to support women; 9) Iterate model and track intervention/policies. Investigators will use a mixed methods approach to address the implementation research questions with exit interviews, health facility register data extraction, in-depth interviews, focus group discussions, and key informant interviews. Investigators will collect quarterly quantitative and qualitative data over the course of one week each, for a total of five data collection periods including baseline.

Official Title
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Implementing the Birth Companion Intervention Package in Ethiopia, Kenya and Nigeria: Feasibility, Acceptability, and Impact on Coverage of Facility Births Attended by a Companion.

Conditions
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Maternal Care Patterns

Intervention / Treatment
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* Behavioral: Birth companions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Facilities Prior to randomization, head of facility grants permission for facility to participate in the study Be willing to develop, adopt, and implement the BC standard operating procedures and other components of the BC intervention package Have more than 16 births per month during the past three months Be in the Addis Ababa and surrounding area, Ethiopia, in Muranga and Machakos County, Kenya or Nasarawa and Kano states, Nigeria Providers At the time of enrollment, providers need to work in ANC or labor and delivery ward(s) of the study facilities Able and willing to provide informed consent to participate in the study Mothers Per participant report, age 15 years or older Have vaginal birth Able and willing to provide informed consent to participate in the study Birth companions Per participant report, for emancipated minors, age 15 years or older. If not an emancipated minor, per participant report, 18 years or older Was present at labor and/or delivery Identified as a BC by the delivering mother Able and willing to provide informed consent to participate in the study Unit managers Involved in the implementation and management of the BC intervention Able and willing to provide informed consent to participate in the study Exclusion Criteria: Facilities Facility staff strike or other disturbance to routine care noted prior to randomization that would pose significant challenge(s) to achieving the study objectives Providers N/A Mothers Unable to participate in an interview due to their physical or emotional condition caused by an adverse delivery outcome. Unable to provide valid information because of mental or other serious health condition Birth companions Unable to provide valid information because of mental or other serious health condition Unit managers N/A

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Birth companion intervention arm<br>Women who deliver in facilities in the experimental arm will be exposed to a facility-based intervention designed to improve companionship in labor, childbirth, and postpartum periods. | Behavioral: Birth companions<br>* The intervention will have the following components: 1) Orient facilities and providers to benefits of BC; 2) Develop/update formal standard operating procedures (SOP) for implementing BC and develop plans to implement SOP; 3) Assess data required for implementation and an audit and feedback cycle for tracking coverage; 4) Assess and carry out modest structural changes in facilities to facilitate BC; 5) Use human centered design to develop materials/resources and a means to distinguish/recognize the BC, taking into account common barriers and misconceptions; 6) Prepare providers to integrate BC into care team; 7) Orient ANC clients to BC rationale and selection; 8) Prepare BCs to support women; 9) Iterate model and track intervention/policies.<br>|
| No Intervention: Standard of care arm<br>Women who deliver in facilities in the experimental arm will be exposed to the standard of care for labor, delivery, and the postpartum period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Birth Companion Coverage | Between baseline and endline surveys, the investigators will measure the change in the proportion of women who are accompanied by a birth companion during labor, childbirth, and postpartum. | Between baseline and Endline survey (12 months after intervention is initiated). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choice of Birth Companion | Between baseline and endline surveys, among women who report having a birth companion, the investigators will measure the change in the proportion who report that their birth companion was the one of their choice. | Between baseline and Endline survey (12 months after intervention is initiated). | 
| Change in Experience of Care (Mothers'-Quantitative) | Between baseline and endline surveys, the investigators will measure the change in mothers' score on Person-Centered Maternity Care scale. This scale has 33 items with a score ranging from 0-98. A low score signifies a better outcome. | Between baseline and Endline survey (12 months after intervention is initiated). | 
| Experience of Care (Mothers'-Qualitative) | In intervention facilities, among women who had birth companions investigators will use in-depth interviews to explore their perception of having a birth companion. | Quarterly after initiation of the intervention (for a period of 12 months). | 
| Feasibility (Unit managers and Providers-Quantitative) | In intervention facilities, investigators will measure the proportion of providers and unit managers who report the physical environment of care supports the presence of birth companions during labor, birth, and the postnatal period. | Endline survey (12 months after intervention is initiated). | 
| Feasibility (Unit Managers-Qualitative) | In intervention facilities, investigators will use key informant interviews to understand unit managers' perception on the feasibility of having birth companions. | Quarterly after the initiation of the intervention (for a period of 12 months). | 
| Acceptability (Mothers) | In intervention facilities, investigators will use in-depth interviews to understand mothers' perception on the acceptability of having birth companions. | Quarterly after the initiation of the intervention (for a period of 12 months). | 
| Acceptability (Birth Companions) | In intervention facilities, investigators will use in-depth interviews to understand birth companions' perception on the acceptability of being a birth companion. | Quarterly after the initiation of the intervention (for a period of 12 months). | 
| Acceptability (Providers) | In intervention facilities, investigators will use focus group discussions to understand providers' perception on the acceptability of having birth companions. | Quarterly after the initiation of the intervention (for a period of 12 months). | 
| Acceptability (Unit Managers) | In intervention facilities, investigators will use qualitative methods understand unit managers' perception on the acceptability of having birth companions. | Quarterly after the initiation of the intervention (for a period of 12 months). |