- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07400796
Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia (TIPS-Cambodia)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Meng Sokchea Program Manager, Helen Keller International, MD
- Phone Number: +855 023 213 217
- Email: MSokchea@hki.org
Study Contact Backup
- Name: Vannary Hun, MPH
- Phone Number: +855 12 612 912
- Email: vhun@hki.org
Study Locations
-
-
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Phnom Penh, Cambodia
- Recruiting
- Takeo province
-
Contact:
- Meng Sokchea Program Manager, Helen Keller International, MD
- Phone Number: +855 023 213 217
- Email: MSokchea@hki.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Standard of care MMS during pregnancy (180 tablets total)
|
|
Focus group discussion (FGD) with national-level stakeholders in Cambodia
1 FGD with 5 national-level stakeholders in Cambodia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perspectives on the transition to MMS
Time Frame: 4 months
|
12 FGD with health care providers
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Additional resources needed for successful MMS delivery
Time Frame: 4 months
|
12 FGD with health care providers
|
4 months
|
|
Provider adherence to MMS delivery guidelines
Time Frame: 4 months
|
12 FGD with health care providers
|
4 months
|
|
Adherence of pregnant individuals to MMS supplementation
Time Frame: 6 months
|
Adherence, %, of the total 180 tablets prescribed
|
6 months
|
|
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)
|
4 months
|
|
National-level readiness, economic planning, and resource planning for sustainable MMS implementation and scale-up
Time Frame: 4 months
|
FGD with national-level stakeholders
|
4 months
|
|
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
|
4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Crystal Karakochuk, PhD, University of British Columbia
- Study Director: Hou Kroeun, MPH, Helen Keller International
- Study Director: Mai Hoang, MPH, Helen Keller International
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TIPSCambodia2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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