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NCT Number: NCT07400796

Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Takeo province

Phnom Penh, Cambodia

Location status: Recruiting

Location contact

Meng Sokchea Program Manager, Helen Keller International, MD

CONTACT

[email protected]

+855 023 213 217

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For the cohort of pregnant individuals consuming MMS:

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Multiple micronutrient supplement (MMS) for pregnancy

Dietary Supplement

Standard of care MMS during pregnancy (180 tablets total)

Primary outcomes

  1. Perspectives on the transition to MMS

    Time frame: 4 months

    12 FGD with health care providers

Secondary outcomes

  1. Additional resources needed for successful MMS delivery

    Time frame: 4 months

    12 FGD with health care providers

  2. Provider adherence to MMS delivery guidelines

    Time frame: 4 months

    12 FGD with health care providers

  3. Adherence of pregnant individuals to MMS supplementation

    Time frame: 6 months

    Adherence, %, of the total 180 tablets prescribed

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

    Time frame: 4 months

    FGD with hospital managers (key informant interviews)

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

    Time frame: 4 months

    FGD with national-level stakeholders

  6. Quantification of any burden on providers and resource gaps to deliver MMS

    Time frame: 4 months

    Workload assessment surveys among the 15 FGD with health center providers

Study contacts

Contact information is provided by the study sponsor or research team.

Meng Sokchea Program Manager, Helen Keller International, MD

CONTACT

[email protected]

+855 023 213 217

Vannary Hun, MPH

CONTACT

[email protected]

+855 12 612 912

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia: A Mixed-Methods Assessment

Acronym: TIPS-Cambodia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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