Evaluation of Prototype Solutions for Optimizing Maternal Health Behaviors

Evaluation of Prototype Solutions in Improving Uptake and Adherence to Institutional Delivery, ANC, and IFA Supplementation Services Among Pregnant Women in Selected Woredas of Ethiopia

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.

Study Overview

• Status: Recruiting
• Conditions: Maternal Behavior
• Intervention / Treatment: Behavioral: Human-centered design prototype solutions for vulnerable pregnant women

Detailed Description

With funding and support from the Bill and Melinda Gate Foundation (BMGF), a three-year implementation research project will be conducted to develop and test the effectiveness and acceptability of interventions to promote three outcomes: institutional delivery, antenatal care (ANC) and iron folic acid (IFA) supplementation among pregnant women. The project applies a Human-Centered-Design (HCD) to develop prototype solutions that optimize the uptake of and adherence to maternal and child health services by pregnant women. Initial and high-fidelity prototype solutions that come out from a sprint workshop (rapid HCD) and an extended HCD process will be implemented in two phases.

Phase 1: The investigators will conduct a design sprint workshop and develop prototype solutions focusing on ANC and institutional delivery and the high-fidelity prototypes will be implemented for six months. The prototype solutions may include but are not limited to social and behavior change communication campaigns, including print media, mass media, social media, and community-based educational events. Specific content and format of the prototypes will be determined based on participant needs and preferences identified from the workshop. Baseline and midline assessments will be conducted to evaluate the effectiveness of the prototypes.

Phase 2: The investigators will conduct extended HCD to develop prototype solutions for IFA supplementation and identify design challenges around ANC and institutional delivery that are not addressed by the design sprint. The prototype solutions may include but are not limited to social and behavior change communication campaigns, including print media, mass media, social media, and community-based educational events. Specific content and format of the prototypes will be determined based on participant needs and preferences identified from the workshops in Phases 1 and 2. High-fidelity prototypes designed in the two phases will be implemented in the two intervention Woredas (geographical areas in Ethiopia roughly equivalent to counties in the US) for another six months. Another round of baseline and end-line evaluations will be conducted to evaluate the effectiveness of the prototypes.

Hence, the following four research activities will occur throughout the study: (1) baseline in Year 1 and (2) midline in Year 1, possibly bleeding into Year 2. These two waves will involve the same pregnant women recruited at baseline. (3) Baseline and (4) end-line in Year 2 and Year 3; these two waves will recruit and retain the same women from the Year 2 baseline. Both rounds of evaluations (four data waves in total) have the objective of assessing the effectiveness of the intervention in improving (a) institutional delivery, (b) uptake of ANC services, and (c) consumption of IFA supplements. In addition, qualitative interviews will assess psychosocial and intermediate outcomes among pregnant women as well as implementation research outcomes of the intervention.

• Study Type: Interventional
• Enrollment (Estimated): 1504
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rajiv Rimal, PhD; Phone Number: 410-502-4076; Email: rimal@jhu.edu
• Study Contact Backup: Name: Bee-Ah Kang, MSPH; Phone Number: 646-991-6939; Email: beeah.kang@jhu.edu

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • Not yet recruiting
    • Center for Communication Programs
    • Contact: Habtamu Tamene
  • Addis Ababa, Ethiopia
    • Recruiting
    • Center for Communication Programs
    • Contact: Habtamu Tamene; Email: habtamut@jhu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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; 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.
No Intervention: Control Arm; The control arm will not receive any intervention other than usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 6 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 6 months
Change in the number of iron folic acid tablets consumed assessed by the survey instrument	The outcome will be measured using a question that asks about pregnant women's IFA intake in the last one month, breaking down to 1, 2, and 4 weeks.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Bill and Melinda Gates Foundation
• Investigators: Principal Investigator: Rajiv Rimal, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2023
• Primary Completion (Estimated): July 17, 2024
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Prenatal Care; Dietary Supplements; Birth Setting
• Other Study ID Numbers: IRB00024473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in a publication will be shared after deidentification. The data will be shared with researchers whose proposed use of the data has been approved by an independent review committee for individual participant data meta-analysis.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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