Clinical trial NCT05312242: Introduction of MMS to Antenatal Care in Bamako, Mali
Official title: Introduction of Multiple Micronutrient Supplementation to Antenatal Care in Bamako, Mali
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Medication
Keywords: Multiple Micronutrient Supplements (MMS)
Adherence
Acceptability
Implementation Research
Antenatal Care
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Jhpiego
name: Bill and Melinda Gates Foundation
name: Center for Vaccine Development - Mali
First posted: 2022-04-05
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To examine differences in acceptability and adherence across three different approaches to antenatal micronutrient supplementation within the context of ANC
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this implementation research is to compare how different implementation strategies influence the acceptability and adherence to antenatal supplement use in pregnancy.

Detailed description: In the past several decades, the République du Mali (Mali) has achieved reductions in both maternal mortality ratio and neonatal mortality rate. However, with an estimated 562 maternal deaths per 100,000 live births and 65.8 infant deaths per 1,000 births, substantial changes to maternal child health services will likely need to be implemented to realize the benefits of universal healthcare for mothers and children and recover from the damaging impacts of colonialism and conflict. The prevalence of low birth weight (\<2.5 kg) among children whose birth weights are known is estimated to be approximately 16%, but is likely underestimated. The Malian decentralized health system places antenatal care (ANC) at Centre de Santé Communautaire (CSCOM), a type of community-based health center. Approximately 36% of women in Mali access ANC in the first trimester. Within the context of ANC, the current national policy in Mali recommends that pregnant women take daily IFA supplements that contain 60 mg of iron and 400 μg of folic acid starting at the first ANC contact and ending three months after delivery. However, recent DHS data indicates that coverage of iron for pregnant women for at least 90 days has remained sub-optimal, and may be decreasing, with only 28% of women taking iron tablets for at least 90 days during their last pregnancy.

While IFA supplements have been a component of the "gold standard" of antenatal nutritional care for decades, there is clear and consistent evidence from clinical trials that MMS provide additional benefits over IFA in reducing adverse pregnancy outcomes. As compared to IFA, MMS performs better in reducing the occurrence of small for gestational age (SGA), low birth weight (LBW), preterm birth, and stillbirth. MMS performs even better than IFA with respect to pregnancy outcomes and infant survival when used by pregnant women who are anemic or underweight. Further, MMS has been demonstrated to be safe, cost-effective, and possible to produce at price parity with IFA. In 2020, the WHO released updated ANC guidelines recommending the use of MMS containing iron and folic acid in the context of rigorous research, including implementation research (IR) to establish the impact of switching from IFA supplements to MMS, including evaluation of uptake, acceptability, adherence, and cost-effectiveness.

This implementation research study design will facilitate answering the following questions, all of which were deemed to be of importance when considering the potential switch from supplementation with iron and folic acid (IFA) to multiple micronutrient supplementation (MMS) in the Malian context:

1. How does adherence to antenatal supplement use compare across study arms?
2. How does acceptability of antenatal supplements compare across study arms for both ANC clients and midwives?
3. What level of acceptability is associated with a novel counseling package for MMS?
4. What is the cost-effectiveness of switching from IFA to MMS in the Malian context?

Eligibility criteria: INCLUSION CRITERIA:

Sample Group 1: Pregnant Women

Potential supplementation trial participants must meet all the following criteria to be eligible for inclusion in the study:

1. Age 18 years or older at screening.
2. At time of enrollment, able and willing to comply with all study requirements and complete all study procedures.
3. Able and willing to provide verbal informed consent to be screened for and to take part in the study.
4. Intention to stay within study catchment area for study duration and willingness to give adequate locator information, as defined in site standard operating procedures (SOPs).
5. Presenting for first ANC visit.
6. Pregnant, as confirmed by at least one of the following:

   1. Uterine examination
   2. Urine human chorionic gonadotropin (HCG)
   3. Ultrasound

Sample Group 2: Midwives

Midwives who participated in delivery of the intervention will be recruited from the six health center study sites. Inclusion criteria includes the provision of verbal informed consent.

Sample Group 3: Pharmacists

Pharmacists who participated in delivery of the intervention will be recruited from the six health center study sites. Inclusion criteria includes the provision of verbal informed consent.

Sample Group 4: Family Members

Family members (e.g., male partners and mothers/mothers-in-law) will be recruited based on participation of their female family member in the study protocol. Inclusion criteria includes the provision of verbal informed consent.

EXCLUSION CRITERIA:

Sample Group 1: Pregnant Women

Potential supplementation trial participants who meet any of the following criteria will be excluded from the study:

1. At time of enrollment, evidence of gestational age greater than 26 0/7 weeks, using one or more of the following methods: a) Uterine examination, b) First day of last normal menstrual period, and c) Ultrasound
2. As determined by the site investigator, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder, or infectious disease. Note: examples of uncontrolled conditions include but are not limited to the following: HIV not virally suppressed, COVID-19 infection, symptomatic malaria infection.
3. Has any other condition that, in the opinion of the site investigator, would preclude verbal informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
4. At time of enrollment, any known condition requiring routine antenatal care to take place at a location other than the study site CSCOM, e.g., Rh- negative status.
5. At enrollment, reports either of the following: a) Participation in any research study involving drugs, vaccines, or medical devices during the current pregnancy, b) Expected to participate in other research studies involving drugs, vaccines, or medical devices for the duration of study participation

Sample Group 2: Midwives

Potential participants who do not provide verbal informed consent will not be included.

Sample Group 3: Pharmacists

Potential participants who do not provide verbal informed consent will not be included.

Sample Group 4: Family Members

Potential participants who do not provide verbal informed consent will not be included.

Primary outcomes:
measure: Adherence to the Antenatal Supplement Intervention (pill count)
timeFrame: 4 weeks post-enrollment (ANC-2)
measure: Adherence to the Antenatal Supplement Intervention (pill count)
timeFrame: ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2
measure: Adherence to the Antenatal Supplement Intervention (pill count)
timeFrame: ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3
measure: Adherence to the Antenatal Supplement Intervention (pill count)
timeFrame: ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4
measure: Adherence to the Antenatal Supplement Intervention (pill count)
timeFrame: ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5
measure: Adherence to the Antenatal Supplement Intervention (pill count)
timeFrame: ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6
measure: Adherence to the Antenatal Supplement Intervention (pill count)
timeFrame: ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7
measure: Adherence to the Antenatal Supplement Intervention (pill count)
timeFrame: Postnatal visit (6 weeks after delivery of infant)
measure: Adherence to Antenatal Supplement Intervention (self report)
timeFrame: 4 weeks post-enrollment (ANC-2)
measure: Adherence to Antenatal Supplement Intervention (self report)
timeFrame: ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2
measure: Adherence to Antenatal Supplement Intervention (self report)
timeFrame: ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3
measure: Adherence to Antenatal Supplement Intervention (self report)
timeFrame: ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4
measure: Adherence to Antenatal Supplement Intervention (self report)
timeFrame: ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5
measure: Adherence to Antenatal Supplement Intervention (self report)
timeFrame: ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6
measure: Adherence to Antenatal Supplement Intervention (self report)
timeFrame: ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7
measure: Adherence to Antenatal Supplement Intervention (self report)
timeFrame: Postnatal visit (6 weeks after delivery of infant)
Secondary outcomes:
measure: Acceptability of Antenatal Supplement (i.e., pregnant women)
timeFrame: At 4 weeks post-enrollment (ANC-2)
measure: Acceptability of Antenatal Supplement (i.e., pregnant women)
timeFrame: ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2
measure: Acceptability of Antenatal Supplement (i.e., pregnant women)
timeFrame: ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3
measure: Acceptability of Antenatal Supplement (i.e., pregnant women)
timeFrame: ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4
measure: Acceptability of Antenatal Supplement (i.e., pregnant women)
timeFrame: ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5
measure: Acceptability of Antenatal Supplement (i.e., pregnant women)
timeFrame: ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6
measure: Acceptability of Antenatal Supplement (i.e., pregnant women)
timeFrame: ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7
measure: Acceptability of Antenatal Supplement (i.e., pregnant women)
timeFrame: Postnatal visit (6 weeks after delivery of infant)
measure: Acceptability of Antenatal Counseling (i.e., pregnant women)
timeFrame: At 4 weeks post-enrollment (ANC-2)
measure: Acceptability of Antenatal Counseling (i.e., pregnant women)
timeFrame: ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2
measure: Acceptability of Antenatal Counseling (i.e., pregnant women)
timeFrame: ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3
measure: Acceptability of Antenatal Counseling (i.e., pregnant women)
timeFrame: ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4
measure: Acceptability of Antenatal Counseling (i.e., pregnant women)
timeFrame: ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5
measure: Acceptability of Antenatal Counseling (i.e., pregnant women)
timeFrame: ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6
measure: Acceptability of Antenatal Counseling (i.e., pregnant women)
timeFrame: ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7
measure: Acceptability of Antenatal Counseling (i.e., pregnant women)
timeFrame: Postnatal visit (6 weeks after delivery of infant)
measure: Acceptability of Antenatal Supplement (i.e., midwives) - Global Acceptability Assessment Form (supplement) and Focus Group Discussion Guide
timeFrame: Within 2 months of study completion
measure: Acceptability of Antenatal Supplement (i.e., pharmacists) - Global Acceptability Assessment Form (supplement) and Focus Group Discussion Guide
timeFrame: Within 2 months of study completion
measure: Acceptability of Antenatal Supplement (i.e., family members) - Global Acceptability Assessment Form (supplement) and Focus Group Discussion Guide
timeFrame: Within 2 months of study completion
measure: Acceptability of Antenatal Counseling (i.e., midwives) - Global Acceptability Assessment Form (counseling) and Focus Group Discussion Guide
timeFrame: Within 2 months of study completion
measure: Acceptability of Antenatal Counseling (i.e., pharmacists) - Global Acceptability Assessment Form (counseling) and Focus Group Discussion Guide
timeFrame: Within 2 months of study completion
measure: Acceptability of Antenatal Counseling (i.e., family members) - Global Acceptability Assessment Form (counseling) and Focus Group Discussion Guide
timeFrame: Within 2 months of study completion
Other outcomes:
measure: Pregnancy Outcome - Maternal Hemoglobin (Exploratory outcomes)
timeFrame: Collected at delivery via health record review
measure: Pregnancy Outcome - Gestational Age (Exploratory outcomes)
timeFrame: Collected at delivery via health record review
measure: Birth outcome (Exploratory outcomes)
timeFrame: Collected at delivery via health record review
Locations:
city: Bamako
country: Mali
facility: JPIEGO Mali
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Kristen M Hurley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jhpiego
name: Lisa Noguchi, PhD
role: STUDY_DIRECTOR
affiliation: Center for Vaccine Development - Mali
name: Samba Sow, MD
role: STUDY_DIRECTOR
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