Increasing Access to Multiple Micronutrient Supplementation - A Pilot Intervention at up to 15 Clinics in Botswana

The purpose of this study is to pilot a clinic-level supplementation intervention at up to 15 antenatal clinics throughout Botswana. The overall objective of this study is to improve access to and uptake of MMS among pregnant women in Botswana. The investigators will evaluate both implementation outcomes (adoption, penetration, fidelity, and feasibility) and clinical outcomes (adverse birth outcomes, weight gain in pregnancy, and anemia) through linkage with the Tsepamo birth outcomes surveillance study.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy Related
• Intervention / Treatment: Dietary supplement: Multiple Micronutrient Supplement

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Botswana
  • Gaborone, Botswana
    • Gabarone West Clinic
  • Gaborone, Botswana
    • Lesirane Clinic
  • Gaborone, Botswana
    • Mahlaku Lekganyane (Mmopane Block 1)
  • Gaborone, Botswana
    • Nkoyaphiri Clinic
  • Gaborone, Botswana
    • Tlokweng Main Clinic
  • Molepolole, Botswana
    • Borakalalo
  • Molepolole, Botswana
    • Boribamo Clinic
  • Molepolole, Botswana
    • Boswelakoko-Borakalalo New Clinic
  • Molepolole, Botswana
    • Phuthadikobo Clinic
  • Palapye, Botswana
    • Kediretswe Clinic
  • Palapye, Botswana
    • Palapye Primary Hospital
  • Gaborone
    • Block 8, Gaborone, Botswana
      • Kgatelopele (Block 8)
  • Molepolole
    • Kopong, Molepolole, Botswana
      • Kopong Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pregnant women attending interventional antenatal clinics during the 6-month study

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multiple Micronutrient Supplement (MMS) supplied to clinic	Dietary supplement: Multiple Micronutrient Supplement; Multiple micronutrient supplementation (MMS) which includes iron, folic acid, and additional micronutrients,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion with first supplement filled by MMS	Among pregnant women presenting for their first antenatal visit during the 6-month intervention period at one of the intervention clinics who then deliver at one of the Tsepamo sites, the proportion for whom the first supplement filled during pregnancy is MMS. As comparators, we will use the 6-month pre-intervention period at the intervention clinics and the 6-month intervention period at non-intervention clinics (all non-intervention clinics as well as specific preselected control clinics).	6-month intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation: Proportion for which MMS is filled	This outcome will be evaluated using data from clinic logbooks and by subtracting the number of supplements remaining in the clinic at the end of the study from the number of supplements provided to the clinic	6-month intervention period
Implementation: Proportion for which first and second supplement filled by MMS	Among pregnant women presenting for their first antenatal visit during the 6-month intervention period at one of the intervention clinics who then deliver at one of the Tsepamo sites, the proportion for whom MMS is filled at the first and second antenatal visit. This outcome will be evaluated through linkage with the Tsepamo Study. As comparators, we will use the 6-month pre-intervention period at the intervention clinics and the 6-month intervention period at non-intervention clinics (all non-intervention clinics as well as specific preselected control clinics).	6-month intervention period
Implementation: Feasibility	Feasibility of the intervention will be measured via qualitative pre- and post- intervention surveys among staff at the intervention clinics. Questions will be asked using a Likert scale ranging from completely disagree to completely agree. We will report the mean/median response for each question as well as the mean/median change in score between the pre and post surveys. As this is a qualitative measure there is no predefined minimum or maximum value.	8 months
Clinical: Number of Pregnant Women with an Adverse Birth Outcome	1) Any adverse birth outcome, consisting of stillbirth, preterm birth, SGA, neonatal death (as well as individual birth outcomes) among those who deliver at one of the Tsepamo sites. . As comparators, we will use the 6-month pre-intervention period at the intervention clinics and the 6-month intervention period at non-intervention clinics (all non-intervention clinics as well as specific preselected control clinics).	6-months
Clinical: Weight Gain in Pregnancy	Weight gain in pregnancy among those who deliver at one of the Tsepamo sites. As comparators, we will use the 6-month pre-intervention period at the intervention clinics and the 6-month intervention period at non-intervention clinics (all non-intervention clinics as well as specific preselected control clinics).	6-months
Clinical: Number of mothers diagnosed with Maternal Anemia	Number of mothers diagnosed with Anemia during the six month intervention or percentage of mothers diagnosed with anemia during 6 months of intervention compared to the percentage of mothers diagnosed with anemia in the 6 months prior to the intervention or 6 months after the interventions was completed.	6-months

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: 852412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No