AnemiaTIPS-CambodiaNCT07400796
Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia
An observational study of Anemia and Pregnancy, run by University of British Columbia at 1 site in Cambodia.
Trial summary
Malnutrition among pregnant women in low- and middle-income countries (LMICs) can cause micronutrient deficiencies that result in adverse maternal and neonatal health outcomes. The World Health Organization has recently recommended antenatal multiple micronutrient supplementation (MMS) that includes iron and folic… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Pregnancy, Micronutrients
- What is being tested?
- Multiple micronutrient supplement (MMS) for pregnancy
- Type of treatment
- Pill or oral medicine
- How many people
- 710 participants
- Where
- 1 siteCambodia
- Study dates
- 1 Dec 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 630 individuals will be enrolled in the pregnancy cohort regardless of gestational age to evaluate acceptability and adherence patterns across different pregnancy stages and reflect the real-world setting.
Who may be able to join
- Current pregnant
- At least 18 years of age
- Have attended at least one ANC visit at a health center or hospital in Takeo during the study period
- Can provide a functioning phone number for follow-up contact
- Willingness to participate and provide consent
Who cannot join
- Individuals with diagnosed anemia who require iron and folic acid (IFA) supplementation instead of MMS
- Individuals unable to communicate via telephone,;(3) individuals who withdraw consent at any point
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meng Sokchea Program Manager, Helen Keller International, MD contact
Cambodia1 site, 1 recruiting
- Recruiting
Takeo province
Phnom Penh
Meng Sokchea Program Manager, Helen Keller International, MD, +855 023 213 217, MSokchea@hki.org
About this study
Official title: Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia: A Mixed-Methods Assessment
Malnutrition among pregnant women in low- and middle-income countries (LMICs) can cause micronutrient deficiencies that result in adverse maternal and neonatal health outcomes. The World Health Organization has recently recommended antenatal multiple micronutrient supplementation (MMS) that includes iron and folic acid (IFA) to improve maternal and neonatal health outcomes. MMS likely provides additional antenatal benefits over IFA supplementation alone. The Cambodian government, in partnership with Helen Keller International, is piloting MMS implementation in Takeo Province, which will inform nationwide scale-up of MMS.
Study Purpose: The Takeo implementation must be evaluated to understand context-specific implementation of MMS and health system readiness for scale-up. This study assesses system readiness through four domains from the Intervention Scalability Assessment Tool (ISAT): (1) fidelity and adaptation, (2) reach and acceptability, (3) delivery setting and workforce capacity, and (4) implementation infrastructure.
Read more
Population: The pilot involves transitioning to MMS from IFA across all 86 health centers, all 6 referral hospitals, and the provincial hospital in Takeo province. This study includes pregnant women receiving antenatal care, antenatal healthcare providers and facilities, and hospital managers in Takeo. The study also includes national governing bodies for MMS delivery.
Methods: This mixed-methods study uses ISAT as a framework for developing data collection methods. Sampling strategies emphasize urban and rural representation across all operational districts in Takeo and diverse stakeholder perspectives at multiple levels of the health system. Data collection includes:
- 12 focus group discussions (FGDs) with health center providers to assess provider adherence to MMS delivery guidelines, perspectives on the transition to MMS, and additional resources needed for MMS delivery
- Workload assessment surveys at FGDs to quantify any burden on providers and resource gaps to deliver MMS
- MMS stockout monitoring at 18 health centers and 7 hospitals to assess supply chain reliability
- 15 key informant interviews with hospital managers to assess perspectives on the integration of MMS into antenatal services and facility readiness for MMS delivery
- Phone surveys with 630 pregnant women to assess acceptability and adherence to MMS at 90- and 180-days after MMS distribution
- One FGD with national-level stakeholders to assess national-level readiness, economic planning, and resource planning for sustainable MMS implementation and scale-up
- Rapid economic evaluation to estimate the cost of nationwide scale-up Potential Impact: This study will generate insights into real-world implementation of MMS in Cambodia. It will identify context-specific adaptations, implementation gaps, and resource planning frameworks needed for nationwide scale-up of MMS. Successful scale-up is anticipated to improve maternal and neonatal health in Cambodia. Findings can also be used to guide other LMICs seeking to transition to and sustainably implement MMS.
- Conditions
- Anemia, Pregnancy, Micronutrients, Supplement, Health Systems, Supply Chain Vulnerabilities
- Being tested
- Multiple micronutrient supplement (MMS) for pregnancy
- Keywords
- anemia, nutrition, micronutrient, supplement, dietary supplement, Cambodia, policy
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple micronutrient supplement (MMS) for pregnancyDietary supplement
Standard of care MMS during pregnancy (180 tablets total)
| Study group | Role | What they receive |
|---|---|---|
| Focus group discussions (FGD) with health centre providers | 15 FGD (5 individuals each) | |
| Key informant interviews with hospital managers | 17 hospital managers | |
| Surveys with pregnant individuals who are consuming MMS | 630 pregnant individuals consuming MMS Receives: Dietary Supplement: Multiple micronutrient supplement (MMS) for pregnancy | |
| Focus group discussion (FGD) with national-level stakeholders in Cambodia | 1 FGD with 5 national-level stakeholders in Cambodia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perspectives on the transition to MMS
12 FGD with health care providers
Measured: 4 months
Secondary outcomes (6)
Additional resources needed for successful MMS delivery
12 FGD with health care providers
Measured: 4 months
Provider adherence to MMS delivery guidelines
12 FGD with health care providers
Measured: 4 months
Adherence of pregnant individuals to MMS supplementation
Adherence, %, of the total 180 tablets prescribed
Measured: 6 months
Perspectives on the integration of MMS into antenatal services and facility readiness for MMS delivery
FGD with hospital managers (key informant interviews)
Measured: 4 months
National-level readiness, economic planning, and resource planning for sustainable MMS implementation and scale-up
FGD with national-level stakeholders
Measured: 4 months
Quantification of any burden on providers and resource gaps to deliver MMS
Workload assessment surveys among the 15 FGD with health center providers
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Dec 2025
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal Karakochuk, University of British Columbia
- Investigators
- Hou Kroeun, MPH, Study director, Helen Keller InternationalCrystal Karakochuk, PHD, Principal investigator, University of British ColumbiaMai Hoang, MPH, Study director, Helen Keller International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400796
- Sponsor's protocol ID
- TIPSCambodia2026
- Acronym
- TIPS-Cambodia
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia: A Mixed-Methods Assessment
- ClinicalTrials.gov ID
- NCT07400796
- Acronym / sponsor ID
- TIPS-Cambodia / TIPSCambodia2026
- Conditions
- Anemia, Pregnancy, Micronutrients, Supplement, Health Systems, Supply Chain Vulnerabilities
- Keywords
- anemia, nutrition, micronutrient, supplement, dietary supplement, Cambodia, policy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Feb 2026 (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.
Malnutrition among pregnant women in low- and middle-income countries (LMICs) can cause micronutrient deficiencies that result in adverse maternal and neonatal health outcomes. The World Health Organization has recently recommended antenatal multiple micronutrient supplementation (MMS) that includes iron and folic acid (IFA) to improve maternal and neonatal health outcomes. MMS likely provides additional antenatal benefits over IFA supplementation alone. The Cambodian government, in partnership with Helen Keller International, is piloting MMS implementation in Takeo Province, which will inform nationwide scale-up of MMS.
Study Purpose: The Takeo implementation must be evaluated to understand context-specific implementation of MMS and health system readiness for scale-up. This study assesses system readiness through four domains from the Intervention Scalability Assessment Tool (ISAT): (1) fidelity and adaptation, (2) reach and acceptability, (3) delivery setting and workforce capacity, and (4) implementation infrastructure.
Population: The pilot involves transitioning to MMS from IFA across all 86 health centers, all 6 referral hospitals, and the provincial hospital in Takeo province. This study includes pregnant women receiving antenatal care, antenatal healthcare providers and facilities, and hospital managers in Takeo. The study also includes national governing bodies for MMS delivery.
Methods: This mixed-methods study uses ISAT as a framework for developing data collection methods. Sampling strategies emphasize urban and rural representation across all operational districts in Takeo and diverse stakeholder perspectives at multiple levels of the health system. Data collection includes:
- 12 focus group discussions (FGDs) with health center providers to assess provider adherence to MMS delivery guidelines, perspectives on the transition to MMS, and additional resources needed for MMS delivery
- Workload assessment surveys at FGDs to quantify any burden on providers and resource gaps to deliver MMS
- MMS stockout monitoring at 18 health centers and 7 hospitals to assess supply chain reliability
- 15 key informant interviews with hospital managers to assess perspectives on the integration of MMS into antenatal services and facility readiness for MMS delivery
- Phone surveys with 630 pregnant women to assess acceptability and adherence to MMS at 90- and 180-days after MMS distribution
- One FGD with national-level stakeholders to assess national-level readiness, economic planning, and resource planning for sustainable MMS implementation and scale-up
- Rapid economic evaluation to estimate the cost of nationwide scale-up Potential Impact: This study will generate insights into real-world implementation of MMS in Cambodia. It will identify context-specific adaptations, implementation gaps, and resource planning frameworks needed for nationwide scale-up of MMS. Successful scale-up is anticipated to improve maternal and neonatal health in Cambodia. Findings can also be used to guide other LMICs seeking to transition to and sustainably implement MMS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Focus group discussions (FGD) with health centre providers | – | –15 FGD (5 individuals each) |
| Key informant interviews with hospital managers | – | –17 hospital managers |
| Surveys with pregnant individuals who are consuming MMS | – | Dietary Supplement: Multiple micronutrient supplement (MMS) for pregnancy630 pregnant individuals consuming MMS |
| Focus group discussion (FGD) with national-level stakeholders in Cambodia | – | –1 FGD with 5 national-level stakeholders in Cambodia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 630 individuals will be enrolled in the pregnancy cohort regardless of gestational age to evaluate acceptability and adherence patterns across different pregnancy stages and reflect the real-world setting.
Key inclusion criteria (5 listed)
- Current pregnant
- At least 18 years of age
- Have attended at least one ANC visit at a health center or hospital in Takeo during the study period
- Can provide a functioning phone number for follow-up contact
- Willingness to participate and provide consent
Key exclusion criteria (2 listed)
- Individuals with diagnosed anemia who require iron and folic acid (IFA) supplementation instead of MMS
- Individuals unable to communicate via telephone,;(3) individuals who withdraw consent at any point
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 |
|---|---|---|
| Multiple micronutrient supplement (MMS) for pregnancyStandard of care MMS during pregnancy (180 tablets total) | Dietary supplement | Surveys with pregnant individuals who are consuming MMS |
Primary outcome
Perspectives on the transition to MMS
Time frame: 4 months
12 FGD with health care providers
6 secondary outcomes
Additional resources needed for successful MMS delivery
Time frame: 4 months
Provider adherence to MMS delivery guidelines
Time frame: 4 months
Adherence of pregnant individuals to MMS supplementation
Time frame: 6 months
Perspectives on the integration of MMS into antenatal services and facility readiness for MMS delivery
Time frame: 4 months
National-level readiness, economic planning, and resource planning for sustainable MMS implementation and scale-up
Time frame: 4 months
Quantification of any burden on providers and resource gaps to deliver MMS
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Meng Sokchea Program Manager, Helen Keller International, MD contact
Hou Kroeun, MPH study director
Helen Keller International
Crystal Karakochuk, PHD principal investigator
University of British Columbia
Mai Hoang, MPH study director
Helen Keller International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Pregnancy, run by University of British Columbia at 1 site in Cambodia.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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 Cambodia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Sokchea Program Manager, Helen Keller International, MD (+855 023 213 217, MSokchea@hki.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perspectives on the transition to MMS (time frame: 4 months). 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 17 Feb 2026.