Introduction of MMS to Antenatal Care in Bamako, Mali

NCT05312242 | Completed

• 1 other identifier: IRB00017475
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Medication

Keywords

Multiple Micronutrient Supplements (MMS); Adherence; Acceptability; Implementation Research; Antenatal Care

Outcome Measures

Primary Outcomes (16)

• Adherence to the Antenatal Supplement Intervention (pill count)

  Adherence assessment (pill count report)

  4 weeks post-enrollment (ANC-2)

• Adherence to the Antenatal Supplement Intervention (pill count)

  Adherence assessment (pill count report)

  ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2

• Adherence to the Antenatal Supplement Intervention (pill count)

  Adherence assessment (pill count report)

  ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3

• Adherence to the Antenatal Supplement Intervention (pill count)

  Adherence assessment (pill count report)

  ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4

• Adherence to the Antenatal Supplement Intervention (pill count)

  Adherence assessment (pill count report)

  ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5

• Adherence to the Antenatal Supplement Intervention (pill count)

  Adherence assessment (pill count report)

  ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6

• Adherence to the Antenatal Supplement Intervention (pill count)

  Adherence assessment (pill count report)

  ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7

• Adherence to the Antenatal Supplement Intervention (pill count)

  Adherence assessment (pill count report)

  Postnatal visit (6 weeks after delivery of infant)

• Adherence to Antenatal Supplement Intervention (self report)

  Interviewer administered retrospective self report

  4 weeks post-enrollment (ANC-2)

• Adherence to Antenatal Supplement Intervention (self report)

  Interviewer administered retrospective self report

  ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2

• Adherence to Antenatal Supplement Intervention (self report)

  Interviewer administered retrospective self report

  ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3

• Adherence to Antenatal Supplement Intervention (self report)

  Interviewer administered retrospective self report

  ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4

• Adherence to Antenatal Supplement Intervention (self report)

  Interviewer administered retrospective self report

  ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5

• Adherence to Antenatal Supplement Intervention (self report)

  Interviewer administered retrospective self report

  ANC follow-up visit (ANC-7) - approximately 4-6 weeks after ANC-6

• Adherence to Antenatal Supplement Intervention (self report)

  Interviewer administered retrospective self report

  ANC follow-up visit (ANC-8) - approximately 4-6 weeks after ANC-7

• Adherence to Antenatal Supplement Intervention (self report)

  Interviewer administered retrospective self report

  Postnatal visit (6 weeks after delivery of infant)

Secondary Outcomes (22)

• Acceptability of Antenatal Supplement (i.e., pregnant women)

  At 4 weeks post-enrollment (ANC-2)

• Acceptability of Antenatal Supplement (i.e., pregnant women)

  ANC follow-up visit (ANC-3) - approximately 4-6 weeks after ANC-2

• Acceptability of Antenatal Supplement (i.e., pregnant women)

  ANC follow-up visit (ANC-4) - approximately 4-6 weeks after ANC-3

• Acceptability of Antenatal Supplement (i.e., pregnant women)

  ANC follow-up visit (ANC-5) - approximately 4-6 weeks after ANC-4

• Acceptability of Antenatal Supplement (i.e., pregnant women)

  ANC follow-up visit (ANC-6) - approximately 4-6 weeks after ANC-5

Other Outcomes (3)

• Pregnancy Outcome - Maternal Hemoglobin (Exploratory outcomes)

  Collected at delivery via health record review

• Pregnancy Outcome - Gestational Age (Exploratory outcomes)

  Collected at delivery via health record review

• Birth outcome (Exploratory outcomes)

  Collected at delivery via health record review

Study Arms (3)

IFA + Standard of Care

ACTIVE COMPARATOR

Iron and Folic Acid (IFA) tablets dispensed 30 tablets at a time + standard of care \[Represents standard of care comparison\]

Dietary Supplement: Iron Folic Acid Supplement

MMS 30 + novel counseling

EXPERIMENTAL

MMS dispensed 30 tablets at a time (MMS 30) with novel counseling

Dietary Supplement: United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMS

MMS 180 + novel counseling

EXPERIMENTAL

MMS dispensed 180 tablets at a time (MMS 30) with novel counseling

Dietary Supplement: United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMS

Interventions

United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) MMS DIETARY_SUPPLEMENT

Introduction of UNIMMAP MMS along with novel counseling strategies to increase acceptability and adherence to prenatal supplementation

Also known as: novel counseling strategies

MMS 180 + novel counseling; MMS 30 + novel counseling

Iron Folic Acid Supplement DIETARY_SUPPLEMENT

Standard of Care Intervention

IFA + Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sample Group 1: Pregnant Women
• Age 18 years or older at screening.
• At time of enrollment, able and willing to comply with all study requirements and complete all study procedures.
• Able and willing to provide verbal informed consent to be screened for and to take part in the study.
• 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).
• Presenting for first ANC visit.
• Pregnant, as confirmed by at least one of the following:
• Uterine examination
• Urine human chorionic gonadotropin (HCG)
• Ultrasound
• Sample Group 2: Midwives
• Sample Group 3: Pharmacists
• Sample Group 4: Family Members

You may not qualify if:

• Sample Group 1: Pregnant Women
• Potential supplementation trial participants who meet any of the following criteria will be excluded from the study:
• 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
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Jhpiego: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Center for Vaccine Development - Mali: collaborator

Study Sites (1)

JPIEGO Mali

Bamako, Mali

Location

Related Publications (9)

• Bourassa MW, Osendarp SJM, Adu-Afarwuah S, Ahmed S, Ajello C, Bergeron G, Black R, Christian P, Cousens S, de Pee S, Dewey KG, Arifeen SE, Engle-Stone R, Fleet A, Gernand AD, Hoddinott J, Klemm R, Kraemer K, Kupka R, McLean E, Moore SE, Neufeld LM, Persson LA, Rasmussen KM, Shankar AH, Smith E, Sudfeld CR, Udomkesmalee E, Vosti SA. Review of the evidence regarding the use of antenatal multiple micronutrient supplementation in low- and middle-income countries. Ann N Y Acad Sci. 2019 May;1444(1):6-21. doi: 10.1111/nyas.14121. Epub 2019 May 27.

  PMID: 31134643 BACKGROUND

• Engle-Stone R, Kumordzie SM, Meinzen-Dick L, Vosti SA. Replacing iron-folic acid with multiple micronutrient supplements among pregnant women in Bangladesh and Burkina Faso: costs, impacts, and cost-effectiveness. Ann N Y Acad Sci. 2019 May;1444(1):35-51. doi: 10.1111/nyas.14132. Epub 2019 May 27.

  PMID: 31134641 BACKGROUND

• Demographic Health Survey Mali 2018. https://link.edgepilot.com/s/58ae5387/4L1KP3pdmU6VyyFqGxSdsQ?u=https://dhsprogram.com/methodology/survey/survey-display-517.cfm

  BACKGROUND

• Institut National de la Statistique - INSTAT, Cellule de Planification et de Statistique Secteur Santé-Développement Social et Promotion de la Famille CPS/SS-DS-PF et ICF. 2019. Enquête Démographique et de Santé au Mali 2018.Bamako, Mali et Rockville, Maryland, USA : INSTAT, CPS/SS-DS-PF et ICF.

  BACKGROUND

• Keats EC, Haider BA, Tam E, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2019 Mar 14;3(3):CD004905. doi: 10.1002/14651858.CD004905.pub6.

  PMID: 30873598 BACKGROUND

• Smith ER, Shankar AH, Wu LS, Aboud S, Adu-Afarwuah S, Ali H, Agustina R, Arifeen S, Ashorn P, Bhutta ZA, Christian P, Devakumar D, Dewey KG, Friis H, Gomo E, Gupta P, Kaestel P, Kolsteren P, Lanou H, Maleta K, Mamadoultaibou A, Msamanga G, Osrin D, Persson LA, Ramakrishnan U, Rivera JA, Rizvi A, Sachdev HPS, Urassa W, West KP Jr, Zagre N, Zeng L, Zhu Z, Fawzi WW, Sudfeld CR. Modifiers of the effect of maternal multiple micronutrient supplementation on stillbirth, birth outcomes, and infant mortality: a meta-analysis of individual patient data from 17 randomised trials in low-income and middle-income countries. Lancet Glob Health. 2017 Nov;5(11):e1090-e1100. doi: 10.1016/S2214-109X(17)30371-6.

  PMID: 29025632 BACKGROUND

• WHO antenatal care recommendations for a positive pregnancy experience: Nutritional interventions update: Multiple micronutrient supplements during pregnancy [Internet]. Geneva: World Health Organization; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK560384/

  PMID: 32783435 BACKGROUND

• United Nations Interagency Group for Child Mortality Estimation. Level and trend in child mortality report. 2017

  BACKGROUND

• Alkema L, Chou D, Hogan D, Zhang S, Moller AB, Gemmill A, Fat DM, Boerma T, Temmerman M, Mathers C, Say L; United Nations Maternal Mortality Estimation Inter-Agency Group collaborators and technical advisory group. Global, regional, and national levels and trends in maternal mortality between 1990 and 2015, with scenario-based projections to 2030: a systematic analysis by the UN Maternal Mortality Estimation Inter-Agency Group. Lancet. 2016 Jan 30;387(10017):462-74. doi: 10.1016/S0140-6736(15)00838-7. Epub 2015 Nov 13.

  PMID: 26584737 BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kristen M Hurley, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Lisa Noguchi, PhD

  Jhpiego

  STUDY DIRECTOR

• Samba Sow, MD

  Center for Vaccine Development - Mali

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To examine differences in acceptability and adherence across three different approaches to antenatal micronutrient supplementation within the context of ANC

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: April 5, 2022
• Study Start: February 10, 2022
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After data collection and analysis. The individual personal data (IPD) will be share after the data analysis for the described research questions (see above) is complete
• Access Criteria: The data will be collected and stored through the Synapse platform. The data will not be individually identifiable. Investigators will also adhere to JHBC's data sharing policies.

Locations

MA (1)