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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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:
Participants will include providers in intervention clinics and pregnant women attending intervention and control clinics for antenatal care (ANC):
The design to meet the study objectives is as follows:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Pregnant women:
Health providers in intervention sites:
Exclusion Criteria:
Pregnant women
Health providers in intervention sites:
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| Name | Affiliation | Role |
|---|---|---|
| Maria-Elena Figueroa, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Four regions in Ethiopia: South Ethiopia, Central Ethiopia, South-West Ethiopia, Sidama | Awasa | Ethiopia |
Following the donor's 2025 Open Access Policy, "underlying data supporting Funded Manuscripts will be made accessible immediately and as open as possible upon availability of the Funded Manuscripts, subject to any applicable ethical, legal, or regulatory requirements or restrictions." For this purpose, the investigators may deposit the survey data into an existing data repository like the Johns Hopkins University (JHU) Data Archive. Only fully de-identified datasets will be shared.
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Three to six months after a manuscript is completed.
The investigators will follow Johns Hopkins University data archive criteria and will include additional criteria when needed.
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| 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. |
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