NCT06479109

Evaluation of a Behavioral Intervention to Optimize Supplement Adherence in Ethiopia

Evaluation of Prototype Solutions for Optimizing IFA or MMS Adherence Among Pregnant Women and Adolescent Girls in Ethiopia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,930 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 15 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The design to meet the study objectives is as follows: 1. A cross-section baseline and endline design with a nonequivalent control group will be used to assess the effect of the behavioral intervention (materials for pregnant women and ANC providers). Pregnant women in intervention and control sites will be interviewed using a structured questionnaire to assess adherence to IFAS or MMS. These women will be interviewed before the start of the intervention at the selected clinics (baseline). Four to six months (4-6mo) after the intervention, another sample of women who attended ANC visits and received IFAS or MMS will be invited for an interview (endline). 2. Key informant interviews (KIIs) with service providers will be used to explore the relevance, usability, acceptability, scalability, and other factors related to the intervention. Interviews will be conducted with the woreda/district-level maternal, newborn, and child health/Maternal Child Health (MCH) coordinator, the Primary Health Care Unit (PHCU) director, midwives/nurses from health clinics, and Health Extension Workers (HEWs) and Health Development Army volunteers from health posts. 3. In-depth interviews (IDIs) with pregnant women who received the intervention will be conducted to learn about the experiences with the materials. The study will be implemented in sixteen districts (woredas) within four regions of Ethiopia - South Ethiopia, Central Ethiopia, South-West Ethiopia, and Sidama; four woredas/districts in each region. Per the direction of the Ministry of Health, two regions (South-West and Sidama) will continue to receive the standard of care (IFAS), and the other two will receive MMS.

Conditions

• Adherence, Patient

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-22
• Primary completion: 2025-06-04
• Completion: 2025-06-04
• First posted: 2024-06-27
• Last updated: 2025-07-03

Locations

1 site across 1 country: Ethiopia