Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia

NCT07400796 | Recruiting

• 1 other identifier: TIPSCambodia2026
• Study Type: observational
• Target: 710
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anemia; Pregnancy; Micronutrients; Supplement; Health Systems; Supply Chain Vulnerabilities; Adherence

Keywords

anemia; nutrition; micronutrient; supplement; dietary supplement; Cambodia; policy

Outcome Measures

Primary Outcomes (1)

• Perspectives on the transition to MMS

  12 FGD with health care providers

  4 months

Secondary Outcomes (6)

• Additional resources needed for successful MMS delivery

  4 months

• Provider adherence to MMS delivery guidelines

  4 months

• Adherence of pregnant individuals to MMS supplementation

  6 months

• Perspectives on the integration of MMS into antenatal services and facility readiness for MMS delivery

  4 months

• National-level readiness, economic planning, and resource planning for sustainable MMS implementation and scale-up

  4 months

Study Arms (4)

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

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

Interventions

Multiple micronutrient supplement (MMS) for pregnancy DIETARY_SUPPLEMENT

Standard of care MMS during pregnancy (180 tablets total)

Surveys with pregnant individuals who are consuming MMS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Takeo province

Phnom Penh, Cambodia

RECRUITING

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hou Kroeun, MPH

  Helen Keller International

  STUDY DIRECTOR

• Crystal Karakochuk, PHD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Mai Hoang, MPH

  Helen Keller International

  STUDY DIRECTOR

Central Study Contacts

Meng Sokchea Program Manager, Helen Keller International, MD

CONTACT

+855 023 213 217; MSokchea@hki.org

Vannary Hun, MPH

CONTACT

+855 12 612 912; vhun@hki.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Human Nutrition

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: December 1, 2025
• Primary Completion: May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CA (1)