Adherence, PatientNCT06479109
Evaluation of a Behavioral Intervention to Optimize Supplement Adherence in Ethiopia
A study testing Motivational materials for pregnant women attending antenatal care visits to improve supplement adherence and Providers in people with Adherence, Patient, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ethiopia.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 49 years
- Conditions the study is for
- Adherence, Patient
- What is being tested?
- Motivational materials for pregnant women attending antenatal care visits to improve supplement adherence and Providers
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,930 participants
- Where
- 1 siteEthiopia
- Study dates
- 22 Aug 2024to 4 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Four regions in Ethiopia: South Ethiopia, Central Ethiopia, South-West Ethiopia, Sidama
Awasa
About this study
Official title: Evaluation of Prototype Solutions for Optimizing IFA or MMS Adherence Among Pregnant Women and Adolescent Girls in Ethiopia
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.
Read more
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.
Read the detailed description
The design to meet the study objectives is as follows:
- 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).
- 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.
- 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
- Being tested
- Motivational materials for pregnant women attending antenatal care visits to improve supplement adherence, Providers
- Keywords
- IFAS adherence, MMS adherence
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational materials for pregnant women attending antenatal care visits to improve supplement adherenceBehavioural
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.
ProvidersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start22 Aug 2024
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,930 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Maria-Elena Figueroa, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479109
- Sponsor's protocol ID
- IRB00024717
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prototype Solutions for Optimizing IFA or MMS Adherence Among Pregnant Women and Adolescent Girls in Ethiopia
- ClinicalTrials.gov ID
- NCT06479109
- Acronym / sponsor ID
- IRB00024717
- Conditions
- Adherence, Patient
- Keywords
- IFAS adherence, MMS adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,930 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Providers use a job aid (information sheet) during ANC counseling about supplement adherence. | Other | Other: ProvidersProviders in intervention sites use an information sheet that serves as a job aid to counsel women about the benefits of the supplements. |
| Pregnant women receive a behavioral intervention in IFAS or MMS sites during antenatal care visits. | Other | Behavioral: Motivational materials for pregnant women attending antenatal care visits to improve supplement adherencePregnant women in intervention clinics will receive antenatal care counseling assisted with an information sheet for providers to use. |
| 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Pregnant women:
- Health providers in intervention sites:
Key exclusion criteria (7 listed)
- Pregnant women
- Health providers in intervention sites:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational materials for pregnant women attending antenatal care visits to improve supplement adherenceDuring 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. | Behavioural | Pregnant women receive a behavioral intervention in IFAS or MMS sites during antenatal care visits. |
| ProvidersProviders 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. | Other | Providers use a job aid (information sheet) during ANC counseling about supplement adherence. |
Primary outcome
Percentage of pregnant women who report consuming five or more [ 80 percent] IFA/MMS tablets in the past week
Time frame: Baseline and 4 weeks afterwards
Numerator: Number of days women reported consuming a pill in the last 7 days. Denominator: 7 days
Percentage of pregnant women who report consuming 24 or more [80 percent] IFA/MMS tablets in the last 30 days [past month]
Time frame: Baseline and 4 weeks afterwards
Numerator: Number of days women reported consuming a pill in the last 30 days. Denominator: 30 days
Percentage of pregnant women who report consuming 90 or more IFA/MMS tablets during the entire pregnancy
Time frame: Baseline and 4 weeks afterwards
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.
Percent of pregnant women who consumed (65%, 70%, 80%) or more pills during the exposure days
Time frame: Baseline and 4 weeks afterwards
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria-Elena Figueroa, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational materials for pregnant women attending antenatal care visits to improve supplement adherence and Providers in people with Adherence, Patient, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of pregnant women who report consuming five or more [ 80 percent] IFA/MMS tablets in the past week (time frame: Baseline and 4 weeks afterwards). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.