Evaluation of Prototype Solutions for Optimizing Maternal Health Behaviors

Maternal Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907720
• Other study ID #: IRB00024473
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2023
• Est. completion date: October 2026

Study information

• Verified date: November 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Rajiv Rimal, PhD
• Phone: 410-502-4076
• Email: rimal[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1504
• Est. completion date: October 2026
• Est. primary completion date: July 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Maternal Behavior

Intervention

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.

Locations

Country	Name	City	State
Ethiopia	Center for Communication Programs	Addis Ababa
Ethiopia	Center for Communication Programs	Addis Ababa

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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