Clinical trial NCT05907720: Evaluation of Prototype Solutions for Optimizing Maternal Health Behaviors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Behavior
Keywords: Birth Setting
Prenatal Care
Dietary Supplements
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2023-06-18
Enrollment: 1024
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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. 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in institutional delivery rates assessed by the survey instrument
timeFrame: Baseline and 4 months
measure: Change in the number of antenatal care visits assessed by the survey instrument
timeFrame: Baseline and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Center for Communication Programs
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Rajiv Rimal, PhD
role: PRINCIPAL_INVESTIGATOR
References: