Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05907720 |
| Other study ID # |
IRB00024473 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
