Evaluation of a Behavioral Intervention to Optimize Supplement Adherence in Ethiopia

NCT06479109 | Completed

• 1 other identifier: IRB00024717
• Study Type: interventional
• Target: 4,930
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

IFAS adherence; MMS adherence

Outcome Measures

Primary Outcomes (4)

• Percentage of pregnant women who report consuming five or more [ 80 percent] IFA/MMS tablets in the past week

  Numerator: Number of days women reported consuming a pill in the last 7 days. Denominator: 7 days

  Baseline and 4 weeks afterwards

• Percentage of pregnant women who report consuming 24 or more [80 percent] IFA/MMS tablets in the last 30 days [past month]

  Numerator: Number of days women reported consuming a pill in the last 30 days. Denominator: 30 days

  Baseline and 4 weeks afterwards

• Percentage of pregnant women who report consuming 90 or more IFA/MMS tablets during the entire pregnancy

  Numerator: Number of days women reported consuming a pill since first received in this pregnancy. Denominator: Eligible days to consume the pills. Computed as date of interview minus date when woman reported first started consuming the pills for this pregnancy.

  Baseline and 4 weeks afterwards

• Percent of pregnant women who consumed (65%, 70%, 80%) or more pills during the exposure days

  Numerator: Total number of pills estimated as received during the last ANC minus the number of pills remaining from the pill count (at the end of the interview). Denominator: Expected number of days to consume the pills since last ANC. Computed as date of interview minus date when received IFAS/MMS.

  Baseline and 4 weeks afterwards

Study Arms (3)

Providers use a job aid (information sheet) during ANC counseling about supplement adherence.

OTHER

Providers in intervention sites use an information sheet that serves as a job aid to counsel women about the benefits of the supplements.

Other: Providers

Pregnant women receive a behavioral intervention in IFAS or MMS sites during antenatal care visits.

OTHER

Pregnant women in intervention clinics will receive antenatal care counseling assisted with an information sheet for providers to use.

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

Pregnant women receive standard antenatal care visits in IFAS or MMS sites

NO INTERVENTION

Pregnant women in control clinics will receive standard counseling from health providers during the antenatal care visits.

Interventions

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

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.

Pregnant women receive a behavioral intervention in IFAS or MMS sites during antenatal care visits.

Providers OTHER

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.

Providers use a job aid (information sheet) during ANC counseling about supplement adherence.

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women:
• Between 15 and 49 years of age.
• Have had at least one ANC visit and received IFAS or MMS in the prior four months.
• For unmarried 15-18 years of age: agree for her parent/guardian to be contacted.
• Women in Intervention sites: Have received and used the intervention materials for at least one month.
• Health providers in intervention sites:
• Provide antenatal care and/or coordinate IFAS/MMS service provision at the clinic or post level.
• Health volunteers working in health extension services are 19 years or older and actively engaged in the implementation of the intervention

You may not qualify if:

• Pregnant women
• Receiving IFAS supplementation for the treatment of anemia.
• For unmarried 15-18 years of age: her parent/guardian lives outside the study woreda/district.
• For Intervention sites: Has not attended ANC visits in the prior 4-6 months and did not receive the intervention materials.
• Health providers in intervention sites:
• Have worked for less than six months in the health center or the health post at the intervention sites.
• Health volunteers working in health extension services are younger than 19 years old and not involved in house visits.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Four regions in Ethiopia: South Ethiopia, Central Ethiopia, South-West Ethiopia, Sidama

Awasa, Ethiopia

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Maria-Elena Figueroa, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 27, 2024
• Study Start: August 22, 2024
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Three to six months after a manuscript is completed.
• Access Criteria: The investigators will follow Johns Hopkins University data archive criteria and will include additional criteria when needed.

Locations

ET (1)