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RecruitingNCT07400796

Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
710 (estimated)
Sponsor
University of British Columbia · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTMultiple micronutrient supplement (MMS) for pregnancyStandard of care MMS during pregnancy (180 tablets total)

Timeline

Start date
2025-12-01
Primary completion
2026-05-31
Completion
2026-06-30
First posted
2026-02-10
Last updated
2026-02-17

Locations

1 site across 1 country: Cambodia

Source: ClinicalTrials.gov record NCT07400796. Inclusion in this directory is not an endorsement.

Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia (NCT07400796) · Clinical Trials Directory