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

NCT05703373 | Enrolling By Invitation

• 1 other identifier: 852412
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Implementation: Proportion for which MMS is filled

  6-month intervention period

• Implementation: Proportion for which first and second supplement filled by MMS

  6-month intervention period

• Implementation: Feasibility

  8 months

• Clinical: Number of Pregnant Women with an Adverse Birth Outcome

  6-months

• Clinical: Weight Gain in Pregnancy

  6-months

Study Arms (1)

Multiple Micronutrient Supplement (MMS) supplied to clinic

EXPERIMENTAL

Dietary Supplement: Multiple Micronutrient Supplement

Interventions

Multiple Micronutrient Supplement DIETARY_SUPPLEMENT

Multiple micronutrient supplementation (MMS) which includes iron, folic acid, and additional micronutrients,

Multiple Micronutrient Supplement (MMS) supplied to clinic

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (13)

Kgatelopele (Block 8)

Block 8, Gaborone, Botswana

Location

Gabarone West Clinic

Gaborone, Gaborone, Botswana

Location

Lesirane Clinic

Gaborone, Gaborone, Botswana

Location

Mahlaku Lekganyane (Mmopane Block 1)

Gaborone, Gaborone, Botswana

Location

Nkoyaphiri Clinic

Gaborone, Gaborone, Botswana

Location

Tlokweng Main Clinic

Gaborone, Gaborone, Botswana

Location

Kopong Clinic

Kopong, Molepolole, Botswana

Location

Borakalalo

Molepolole, Molepolole, Botswana

Location

Boribamo Clinic

Molepolole, Molepolole, Botswana

Location

Boswelakoko-Borakalalo New Clinic

Molepolole, Molepolole, Botswana

Location

Phuthadikobo Clinic

Molepolole, Molepolole, Botswana

Location

Kediretswe Clinic

Palapye, Palapye, Botswana

Location

Palapye Primary Hospital

Palapye, Botswana

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology in Biostatistics and Epidemiology

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 30, 2023
• Study Start: July 9, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

BO (13)