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Evaluation of a Behavioral Intervention to Optimize Supplement Adherence in Ethiopia

NCT06479109 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4930

Last updated 2025-07-03

No results posted yet for this study

Summary

This trial aims to learn if a set of behavioral materials designed to be used by providers and pregnant women increases supplement adherence among pregnant women in Ethiopia. The main questions the study aims to answer are:

* Do the behavioral materials increase adherence to iron and folic acid supplements (IFAS) or multiple micronutrient supplements (MMS) among women attending antenatal care visits?
* Are the materials relevant, easy to use, acceptable, and scalable? During the analysis, researchers will compare supplement adherence between women exposed to the behavioral materials and women not exposed to the behavioral materials. Researchers will also compare supplement adherence before and after the behavioral intervention, ensuring a comprehensive evaluation.

Participants will include providers in intervention clinics and pregnant women attending intervention and control clinics for antenatal care (ANC):

* A total of 28 clinics will receive the behavioral intervention, and another 28 will serve as controls providing the standard antenatal care counseling.
* Pregnant women attending intervention clinics for ANC will receive behavioral materials to use at home as a reminder to take ther supplements (IFAS or MMS).
* Pregnant women attending control clinics will receive the standard ANC counseling.

Conditions

  • Adherence, Patient

Interventions

BEHAVIORAL

Motivational materials for pregnant women attending antenatal care visits to improve supplement adherence

During the antenatal care visit, pregnant women will receive the information sheet used by the provider and a dangler/poster to hang in a visible location in the participant's house. This will serve as a reminder for her and her family to take the daily pill.

OTHER

Providers

Providers in intervention sites use an information sheet that serves as a job aid to counsel women about the benefits of the supplements. The sheet also includes adherence tips, such as involving family to increase adherence. The information sheet is provided to the woman to take home. Antenatal care providers will use an information sheet describing the supplement's benefits and adherence tips to help pregnant women take IFAS or MMS.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Maria-Elena Figueroa, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-22
Primary Completion
2025-06-04
Completion
2025-06-04

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06479109 on ClinicalTrials.gov