Implementing the Birth Companion Intervention Package in Ethiopia, Kenya and Nigeria: Feasibility, Acceptability, and Impact on Coverage of Facility Births Attended by a Companion.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Jhpiego
- Enrollment
- 10,360
- Locations
- 5
- Primary Endpoint
- Change in Birth Companion Coverage
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
6801
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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
- •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
- •Facility staff strike or other disturbance to routine care noted prior to randomization that would pose significant challenge(s) to achieving the study objectives
- •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
Arms & Interventions
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.
Intervention: Birth companions (Behavioral)
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.
Outcomes
Primary Outcomes
Change in Birth Companion Coverage
Time Frame: Between baseline and Endline survey (12 months after intervention is initiated).
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.
Secondary Outcomes
- Feasibility (Unit Managers-Qualitative)(Quarterly after the initiation of the intervention (for a period of 12 months).)
- Experience of Care (Mothers'-Qualitative)(Quarterly after initiation of the intervention (for a period of 12 months).)
- Feasibility (Unit managers and Providers-Quantitative)(Endline survey (12 months after intervention is initiated).)
- Acceptability (Providers)(Quarterly after the initiation of the intervention (for a period of 12 months).)
- Acceptability (Unit Managers)(Quarterly after the initiation of the intervention (for a period of 12 months).)
- Acceptability (Birth Companions)(Quarterly after the initiation of the intervention (for a period of 12 months).)
- Choice of Birth Companion(Between baseline and Endline survey (12 months after intervention is initiated).)
- Change in Experience of Care (Mothers'-Quantitative)(Between baseline and Endline survey (12 months after intervention is initiated).)
- Acceptability (Mothers)(Quarterly after the initiation of the intervention (for a period of 12 months).)
Investigators
Della Berhanu
Research lead
Jhpiego