Takeo province
Phnom Penh, Cambodia
Location status: Recruiting
Location contact
Meng Sokchea Program Manager, Helen Keller International, MD
CONTACT
NCT Number: NCT07400796
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Phnom Penh, Cambodia
Location status: Recruiting
Meng Sokchea Program Manager, Helen Keller International, MD
CONTACT
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
Exclusion criteria
Standard of care MMS during pregnancy (180 tablets total)
Time frame: 4 months
12 FGD with health care providers
Time frame: 4 months
12 FGD with health care providers
Time frame: 4 months
12 FGD with health care providers
Time frame: 6 months
Adherence, %, of the total 180 tablets prescribed
Time frame: 4 months
FGD with hospital managers (key informant interviews)
Time frame: 4 months
FGD with national-level stakeholders
Time frame: 4 months
Workload assessment surveys among the 15 FGD with health center providers
Contact information is provided by the study sponsor or research team.
Meng Sokchea Program Manager, Helen Keller International, MD
CONTACT
Vannary Hun, MPH
CONTACT
University of British Columbia
Other
Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia: A Mixed-Methods Assessment
Acronym: TIPS-Cambodia
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.
Published trials that share one or more normalized conditions with this study.
NCT00118027
Anemia, Hematologic Diseases
Mukono, Central Uganda, Uganda
View Trial DetailsNCT07725497
Anemia, Chronic Disease
Basking Ridge, New Jersey, United States
View Trial DetailsNCT07623161
Anemia, Bone Marrow Diseases
Glendale, California, United States
View Trial DetailsNCT07422480
Anemia, Bone Marrow Diseases
Gilbert, Arizona, United States
View Trial Details