Clinical trial NCT05565196: Birth Companion Intervention in Ethiopia, Kenya and Nigeria
Official title: Implementing the Birth Companion Intervention Package in Ethiopia, Kenya and Nigeria: Feasibility, Acceptability, and Impact on Coverage of Facility Births Attended by a Companion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Care Patterns
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: Addis Continental Institute of Public Health
name: St Paul's Hospital Millennium Medical College
name: International Center for Reproductive Health Kenya
name: Bill and Melinda Gates Foundation
name: Maternal and Reproductive Health Research Collective
First posted: 2022-10-04
Enrollment: 10360
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Birth Companion Coverage
timeFrame: Between baseline and Endline survey (12 months after intervention is initiated).
Secondary outcomes:
measure: Choice of Birth Companion
timeFrame: Between baseline and Endline survey (12 months after intervention is initiated).
measure: Change in Experience of Care (Mothers'-Quantitative)
timeFrame: Between baseline and Endline survey (12 months after intervention is initiated).
measure: Experience of Care (Mothers'-Qualitative)
timeFrame: Quarterly after initiation of the intervention (for a period of 12 months).
measure: Feasibility (Unit managers and Providers-Quantitative)
timeFrame: Endline survey (12 months after intervention is initiated).
measure: Feasibility (Unit Managers-Qualitative)
timeFrame: Quarterly after the initiation of the intervention (for a period of 12 months).
measure: Acceptability (Mothers)
timeFrame: Quarterly after the initiation of the intervention (for a period of 12 months).
measure: Acceptability (Birth Companions)
timeFrame: Quarterly after the initiation of the intervention (for a period of 12 months).
measure: Acceptability (Providers)
timeFrame: Quarterly after the initiation of the intervention (for a period of 12 months).
measure: Acceptability (Unit Managers)
timeFrame: Quarterly after the initiation of the intervention (for a period of 12 months).
Other outcomes:
measure: Potential association between baseline facility readiness and intervention coverage
timeFrame: Endline survey (12 months after intervention is initiated)
measure: Cost
timeFrame: Endline survey (12 months after intervention is initiated)
Locations:
city: Addis Ababa
country: Ethiopia
facility: Saint Paul's Millennium College
city: Machakos
country: Kenya
facility: Machakos County Health Office
city: Murang'a
country: Kenya
facility: Murang'a County Health Office
city: Kano
country: Nigeria
facility: Kano State Health Office
city: Karu
country: Nigeria
facility: Nasarawa Sate Health Office
Study officials:
References: