The Effectiveness of Co-packaging With Zinc to Improve Treatment of Diarrhea and Pneumonia in Guatemala

Study Overview
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Brief Summary
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This project applies a randomized community design to test the effectiveness of health center level co-packaging and counseling messages to improve provider and caregiver behavior in the treatment of diarrhea with zinc & oral rehydration salts (ORS) and treatment of pneumonia with zinc & antibiotics in children aged 2-59 mo old. We will evaluate the adherence of caregivers in 10 health posts in 5 municipalities randomly assigned to receive the health center level co-packaging and counseling messages in addition to current standard care, by comparing them with the caregivers in 10 health posts in 5 municipalities randomly assigned to the receive only the current standard of care. Cost-effectiveness of co-packaging at the health-center level, as a means of improving provider treatment and counseling practices and caregiver adherence, will be evaluated. The main objective is to establish the effectiveness of a facility level co-packaging and counseling messages for increasing the adherence by caregivers of children aged 2-59 mo old to the prescribed 10 day treatment with zinc to complement ORS for the treatment of diarrhea and zinc to complement the antibiotics for the treatment of pneumonia diagnosed and treated in public health posts. Specific Quantitative Objectives: • To determine if visible co-packaging with pre-tested counseling messages: Improves adherence of caregivers of children towards the prescribed zinc treatment. Improves knowledge, awareness or attitudes of caregivers of children and health providers at public health care centers towards the prescribed zinc treatment. Results in overall increase in health care-seeking for the treatment of diarrhea and pneumonia at public health care centers. Specific Qualitative Objectives: To establish the perception, attitudes and experiences of caregivers towards the visible co-packaging with pre-tested counseling messages to promote the prescribed zinc treatment. To establish the perception, attitudes and experiences of health providers at public health care centers towards the visible co-packaging with pre-tested counseling messages to promote the prescribed zinc treatment. To establish the perception, attitudes and experiences of children aged 4 to 5 years old towards the visible co-packaging with pre-tested counseling messages to promote the prescribed zinc treatment.

Detailed Description
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Please note that the study protocol is also available in Spanish.

Official Title
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Measuring the Effectiveness of Co-packaging to Improve Provider and Caregiver Behavior in the Treatment of Diarrhea With Zinc & ORS and Pneumonia With Zinc & Antibiotics for Children Under 5 Yrs From San Marcos, Guatemala

Conditions
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Diarrhea., Pneumonia.

Intervention / Treatment
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* Behavioral: Co-packaging and counseling messages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The child is aged between between 2 and 59 mo old (< 5 years old). The child is diagnosed with diarrhea or pneumonia at one of the selected public health care centers. The caregiver accompanying the child to the public health care centers must live in the same household. Exclusion Criteria: Unwillingness to sign consent form.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Co-packaging and counseling messages<br>Current standard care at public health center ( zinc ORS for treatment of diarrhea and antibiotics for treatment of of pneumonia). The intervention consists of health center level co-packaging and visual counseling messages (zinc & ORS packaged at health center for diarrhea, and zinc & antibiotics co-packaged at health center for pneumonia) Co-packaging is done in a plastic bag, which is covered with pre-tested zinc treatment messages - a distinct packaging has been designed for diarrhea and for pneumonia | Behavioral: Co-packaging and counseling messages<br>* The intervention involves co-packaging in 2 distinct packages: 1) for diarrhea treatment to package zinc & ORS for the treatment of diarrhea using a plastic bag with printed messages that were pre-tested in formative research; and 2) for pneumonia treatment to co-package zinc & antibiotics in a plastic bag with printed messages that were pre-tested in a formative research phase. Pre-tested zinc treatment messages will be on posters displayed in the intervention health centers. Orientation will be provided to health facility staff in control and intervention areas.<br>* Other names: The physical co-packaging is called the bolsita salva-vida;|
| No Intervention: Control group<br>Current standard care at public health center (zinc & ORS for treatment of diarrhea and zinc & antibiotics for treatment of of pneumonia). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of caregivers who administer zinc to child for at least 8 days. | Improved adherence to diarrhea or pneumonia treatment with zinc for the prescribed 10 days based on pill count in the home. Expressed as percentage of caregivers who administer zinc to child for at least 8 days. | 10 days | 
| Percentage of caregivers who report giving zinc to child for at least 8 days. | Improved adherence to diarrhea or pneumonia treatment with zinc for the prescribed 10 days based on self-reports. Expressed as percentage of caregivers who report administering zinc to child for at least 8 days. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Provision of Care for Treatment of Diarrhea and Pneumonia | Percentage of caregivers who receive zinc from the health post. Percentage of caregivers that reported receiving instructions on how to prepare zinc. Percentage of caregivers that report favorable experience with treatment from the health center. Percentage of caregivers that report favorable experience with packaging | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diarrhea,, Pneumonia,, Zinc treatment,, Patient Compliance.