Evaluation of Prototype Solutions for Optimizing Maternal Health Behaviors
NCT ID: NCT05907720
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1024 participants
INTERVENTIONAL
2023-07-18
2026-06-30
Brief Summary
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Detailed Description
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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 four 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 refine prototype solutions for 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 four months. A post-intervention cross-sectional assessment 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) end-line in Year 3; this last assessment will recruit newly pregnant women to compare with the recruited panel at baseline. All rounds of evaluations (three data waves in total) have the objective of assessing the effectiveness of the intervention in improving (a) institutional delivery and (b) uptake of ANC services. In addition, qualitative interviews will assess psychosocial and intermediate outcomes among pregnant women as well as implementation research outcomes of the intervention.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intervention Arm
The intervention arm will receive a package of behavioral interventions in addition to usual care in health facilities.
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.
Control Arm
The control arm will not receive any intervention other than usual care.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 15 to 49 years
* moderate to high vulnerability
Exclusion Criteria
* non-reproductive age
* low vulnerability
15 Years
49 Years
FEMALE
Yes
Sponsors
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Bill and Melinda Gates Foundation
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Rajiv Rimal, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
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Center for Communication Programs
Addis Ababa, , Ethiopia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00024473
Identifier Type: -
Identifier Source: org_study_id
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