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

Not Applicable

• Conditions: Pregnancy Related
• Interventions: Dietary Supplement: Multiple Micronutrient Supplement

• Registration Number: NCT05703373
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-01-30
• Status Verified: 2024-07
• Study Start: 2024-07-09
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multiple Micronutrient Supplement (MMS) supplied to clinic	Multiple Micronutrient Supplement	-

Primary Outcome Measures

Name	Time	Method
Proportion with first supplement filled by MMS	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 Outcome Measures

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

Trial Locations

Locations (13)

Mahlaku Lekganyane (Mmopane Block 1); 🇧🇼 Gaborone, Botswana

Gabarone West Clinic; 🇧🇼 Gaborone, Botswana

Nkoyaphiri Clinic; 🇧🇼 Gaborone, Botswana

Boribamo Clinic; 🇧🇼 Molepolole, Botswana

Kopong Clinic; 🇧🇼 Kopong, Molepolole, Botswana

Lesirane Clinic; 🇧🇼 Gaborone, Botswana

Tlokweng Main Clinic; 🇧🇼 Gaborone, Botswana

Palapye Primary Hospital; 🇧🇼 Palapye, Botswana

Borakalalo; 🇧🇼 Molepolole, Botswana

Boswelakoko-Borakalalo New Clinic; 🇧🇼 Molepolole, Botswana

Kediretswe Clinic; 🇧🇼 Palapye, Botswana

Kgatelopele (Block 8); 🇧🇼 Block 8, Gaborone, Botswana

Phuthadikobo Clinic; 🇧🇼 Molepolole, Botswana