Birth Companion Intervention in Ethiopia, Kenya and Nigeria

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

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.

Study Overview

• Status: Recruiting
• Conditions: Maternal Care Patterns
• Intervention / Treatment: Behavioral: Birth companions

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 4200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Della Berhanu, PhD; Phone Number: +251026783038; Email: della.berhanu@jhpiego.org
• Study Contact Backup: Name: Lisa Noguchi, PhD, CNM; Phone Number: +1202-664-2721; Email: Lisa.noguchi@jhpiego.org

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • Recruiting
    • Saint Paul's Millennium College
    • Contact: Felagot Taddese, MD; Phone Number: +251913056809; Email: felagot1989@yahoo.com
• Kenya
  • Machakos, Kenya
    • Recruiting
    • Machakos County Health Office
    • Contact: Halima Aden Ahmed; Phone Number: +254720835338; Email: halimaliha14@gmail.com
  • Murang'a, Kenya
    • Recruiting
    • Murang'a County Health Office
    • Contact: Caroline Mucio Macharia; Phone Number: +254721904960; Email: cm433841@gmail.com
• Nigeria
  • Kano, Nigeria
    • Not yet recruiting
    • Kano State Health Office
    • Contact: Bashir Sunusi
    • Contact: Phone Number: +234 8034037072; Email: Mbs966@yahoo.com
  • Karu, Nigeria
    • Not yet recruiting
    • Nasarawa Sate Health Office
    • Contact: Ibrahim Adamu Alhassan
    • Contact: Phone Number: +234 8036018579; Email: Ibrahima57@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Birth companion intervention arm; 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; 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.
No Intervention: Standard of care arm; 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?

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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential association between baseline facility readiness and intervention coverage	In intervention facilities, investigators will measure score on facility readiness to change (at baseline) to explore potential association with coverage of the intervention at endline. The tool used for facility staff has scale with 19 items and the score ranges from 0 to 57. The tool used for facility leaders has a scale with 34 items and a score ranging from 0 to 100. Low score means better outcome.	Endline survey (12 months after intervention is initiated)
Cost	In intervention facilities investigators will collect data on facility-level costs for updates to physical environment of care and other implementation costs.	Endline survey (12 months after intervention is initiated)

Collaborators and Investigators

• Sponsor: Jhpiego
• Collaborators: Bill and Melinda Gates Foundation; Addis Continental Institute of Public Health; St Paul's Hospital Millennium Medical College; International Center for Reproductive Health Kenya; Maternal and Reproductive Health Research Collective

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): January 15, 2025

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB00021183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Per current Bill & Melinda Gates Foundation policy for study data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No