Evaluation of Prototype Solutions for Optimizing Maternal Health Behaviors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Maternal Behavior

Intervention / Treatment
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* Behavioral: Human-centered design prototype solutions for vulnerable pregnant women


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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<br>* 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.<br>|
| No Intervention: Control Arm<br>The control arm will not receive any intervention other than usual care. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Birth Setting, Prenatal Care, Dietary Supplements