Maternal BehaviorNCT05907720
Evaluation of Prototype Solutions for Optimizing Maternal Health Behaviors
A study testing Human-centered design prototype solutions for vulnerable pregnant women in people with Maternal Behavior, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Behavior
- What is being tested?
- Human-centered design prototype solutions for vulnerable pregnant women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,468 participants
- Where
- 1 siteEthiopia
- Study dates
- 18 Jul 2023to 24 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant 5+ months
- 15 to 49 years
- moderate to high vulnerability
Who cannot join
- Pregnant less than 5 months
- non-reproductive age
- low vulnerability
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 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
- Maternal Behavior
- Being tested
- Human-centered design prototype solutions for vulnerable pregnant women
- Keywords
- Birth Setting, Prenatal Care, Dietary Supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human-centered design prototype solutions for vulnerable pregnant womenBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The intervention arm will receive a package of behavioral interventions in addition to usual care in health facilities. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start18 Jul 2023
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Rajiv Rimal, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907720
- Sponsor's protocol ID
- IRB00024473
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05907720
- Acronym / sponsor ID
- IRB00024473
- Conditions
- Maternal Behavior
- Keywords
- Birth Setting, Prenatal Care, Dietary Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,468 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Human-centered design prototype solutions for vulnerable pregnant womenThe intervention arm will receive a package of behavioral interventions in addition to usual care in health facilities. |
| Control Arm | No intervention | –The control arm will not receive any intervention other than usual care. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pregnant 5+ months
- 15 to 49 years
- moderate to high vulnerability
Key exclusion criteria (3 listed)
- Pregnant less than 5 months
- non-reproductive age
- low vulnerability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human-centered design prototype solutions for vulnerable pregnant womenThe 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. | Behavioural | Intervention Arm |
Primary outcome
Change in institutional delivery rates assessed by the survey instrument
Time frame: Baseline and 4 months
Institutional delivery will be measured using a question that asks about a place of child birth in most recent pregnancy
Change in the number of antenatal care visits assessed by the survey instrument
Time frame: Baseline and 4 months
The outcome will be measured using a question that asks about the number of antenatal care visits women had during current pregnancy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajiv Rimal, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human-centered design prototype solutions for vulnerable pregnant women in people with Maternal Behavior, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in institutional delivery rates assessed by the survey instrument (time frame: Baseline and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.