Evaluation of Prototype Solutions for Optimizing Maternal Health Behaviors

NCT05907720 | Recruiting

• 1 other identifier: IRB00024473
• Study Type: interventional
• Target: 1,024
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a three-year implementation research project that aims to develop and test the effectiveness and acceptability of interventions to promote three outcomes: institutional delivery, antenatal care, and iron-folic acid supplementation among pregnant women in Ethiopia. The project applies a Human-Centered-Design (HCD) to develop prototype solutions that optimize the uptake and adherence to maternal and child health services by pregnant women. The evaluation of high-fidelity prototype solutions that come out from a sprint workshop (rapid HCD) and an extended HCD process will take place across two phases.

Conditions

Maternal Behavior

Keywords

Birth Setting; Prenatal Care; Dietary Supplements

Outcome Measures

Primary Outcomes (2)

• Change in institutional delivery rates assessed by the survey instrument

  Institutional delivery will be measured using a question that asks about a place of child birth in most recent pregnancy

  Baseline and 4 months

• Change in the number of antenatal care visits assessed by the survey instrument

  The outcome will be measured using a question that asks about the number of antenatal care visits women had during current pregnancy.

  Baseline and 4 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The intervention arm will receive a package of behavioral interventions in addition to usual care in health facilities.

Behavioral: Human-centered design prototype solutions for vulnerable pregnant women

Control Arm

NO INTERVENTION

The control arm will not receive any intervention other than usual care.

Interventions

Human-centered design prototype solutions for vulnerable pregnant women BEHAVIORAL

The intervention package will include various social and behavior change programs derived from a human-centered design approach. The intervention will be tailored to vulnerable pregnant women's needs and contexts. It may include but is not limited to health communication campaigns, including radio and print media.

Intervention Arm

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant 5+ months
• to 49 years
• moderate to high vulnerability

You may not qualify if:

• Pregnant less than 5 months
• non-reproductive age
• low vulnerability

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Center for Communication Programs

Addis Ababa, Ethiopia

RECRUITING

Study Officials

• Rajiv Rimal, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajiv Rimal, PhD

CONTACT

410-502-4076; rimal@jhu.edu

Bee-Ah Kang, MSPH

CONTACT

646-991-6939; beeah.kang@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: July 18, 2023
• Primary Completion: October 24, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.

Locations

ET (1)