NCT07400796 Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia
| NCT ID | NCT07400796 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Anemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 710 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 710 participants in total. It began in 2025-12-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Hou Kroeun, MPH
STUDY DIRECTOR
Helen Keller International
Frequently Asked Questions
Who can join the NCT07400796 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07400796 currently recruiting?
Yes, NCT07400796 is actively recruiting participants. Contact the research team at MSokchea@hki.org for enrollment information.
Where is the NCT07400796 trial being conducted?
This trial is being conducted at Phnom Penh, Cambodia.
Who is sponsoring the NCT07400796 clinical trial?
NCT07400796 is sponsored by University of British Columbia. The principal investigator is Hou Kroeun, MPH at Helen Keller International. The trial plans to enroll 710 participants.