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Clinical Trials/NCT05703373
NCT05703373
Enrolling By Invitation
Not Applicable

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

University of Pennsylvania13 sites in 1 country1,200 target enrollmentJuly 9, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
University of Pennsylvania
Enrollment
1200
Locations
13
Primary Endpoint
Proportion with first supplement filled by MMS
Status
Enrolling By Invitation
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 9, 2024
End Date
July 1, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ellen Caniglia

Assistant Professor of Epidemiology in Biostatistics and Epidemiology

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Proportion with first supplement filled by MMS

Time Frame: 6-month intervention period

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).

Secondary Outcomes

  • Implementation: Proportion for which first and second supplement filled by MMS(6-month intervention period)
  • Implementation: Proportion for which MMS is filled(6-month intervention period)
  • Clinical: Number of Pregnant Women with an Adverse Birth Outcome(6-months)
  • Clinical: Weight Gain in Pregnancy(6-months)
  • Clinical: Number of mothers diagnosed with Maternal Anemia(6-months)
  • Implementation: Feasibility(8 months)

Study Sites (13)

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