Ethiopia Group Antenatal Care Study at the Health Post Level (ARC004)

Evaluation of the Feasibility, Acceptability and Impact of Group-based Antenatal Care at the Health Post Level on Continuation in Antenatal Care and Facility-based Delivery in Amhara, Ethiopia Using a Cluster Randomized Step-wedge Design

The purpose of this study is to determine the acceptability, feasibility, and effectiveness of a group antenatal care (G-ANC) model introduced at the health post level compared to usual antenatal care (ANC) among women who report intention to receive ANC at the health post level.

Study Overview

• Status: Terminated
• Conditions: Antenatal Care
• Intervention / Treatment: Behavioral: Group Antenatal Care

• Study Type: Interventional
• Enrollment (Actual): 540
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • North Mecha Woreda, West Gojam Zone, Amhara Region
    • Mecha, North Mecha Woreda, West Gojam Zone, Amhara Region, Ethiopia
      • Enashenifalen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Minimum age of 15 years at the time of enrollment; pregnant 15-17 year-olds will be treated as emancipated/mature as per local regulations
• Gestational age less than or equal to 20 weeks at the time of enrollment determined by last menstrual period (LMP), pelvic exam, fundal height, quickening, ultrasound, and/or timing of fetal heart tones and pregnancy test
• Pregnant women able and willing to provide adequate locator information
• Planning to reside at their current location for at least 10 months
• Agree to participate in the study and continue ANC at health post
• Willing to participate and consent to follow up for up to 6 weeks post-delivery
• Are willing to receive group antenatal care at the health post level (during the intervention period)

Exclusion Criteria:

• Women who plan to travel away from the study site for more than four consecutive weeks during ANC or after 6 weeks post-delivery
• Women who are unable provide consent
• Women who have any condition that in the opinion of the investigator or designee, would complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group ANC; Intervention period in stepped wedge design where women are receiving antenatal care in a group setting	Behavioral: Group Antenatal Care; Group ANC is an integrated approach that incorporates physical assessment, education and skill development, and peer support and takes a broader, more holistic, woman-centered approach to traditional antenatal care
No Intervention: Individual ANC (routine); Pre-intervention time period (control period) where the intervention is not being implemented yet (women are receiving individual antenatal care as is currently offered)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of G-ANC at the health post level	Satisfaction survey to understand satisfaction with G-ANC	Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
Feasibility of G-ANC at the health post level	Documentation of number of G-ANC sessions facilitated by by health extension workers to measure feasibility	Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
Effectiveness of G-ANC on continuation of ANC	Survey of self-reported number of ANC visits to document effectiveness of continuing ANC	Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of G-ANC on quality of care	Survey of self-reported quality of care elements received during ANC to understand role of G-ANC on improving elements of quality of care during ANC	Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery

Collaborators and Investigators

• Sponsor: Jhpiego
• Collaborators: Bill and Melinda Gates Foundation; Addis Continental Institute of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 23, 2021

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

• Keywords: Ethiopia; Health post; Group ANC
• Other Study ID Numbers: 14448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared with the Gates ARC partner, RTI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No