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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy Related

Intervention / Treatment
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* Dietary Supplement: Multiple Micronutrient Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women attending interventional antenatal clinics during the 6-month study Exclusion Criteria: None
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple Micronutrient Supplement (MMS) supplied to clinic<br> | Dietary Supplement: Multiple Micronutrient Supplement<br>* Multiple micronutrient supplementation (MMS) which includes iron, folic acid, and additional micronutrients,<br>|

What is the study measuring?
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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 |