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

Not Applicable

• Conditions: Diarrhea.; Pneumonia.
• Interventions: Behavioral: Co-packaging and counseling messages

• Registration Number: NCT02044107
• Lead Sponsor: Center for Studies of Sensory Impairment, Aging and Metabolism

Brief Summary

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

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

Study Timeline

• Status Verified: 2014-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-24
• Study Start: 2014-02
• Primary Completion: 2014-05
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Co-packaging and counseling messages	Co-packaging and counseling messages	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

Primary Outcome Measures

Name	Time	Method
Percentage of caregivers who administer zinc to child for at least 8 days.	10 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.
Percentage of caregivers who report giving zinc to child for at least 8 days.	10 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.

Secondary Outcome Measures

Name	Time	Method
Improved Provision of Care for Treatment of Diarrhea and Pneumonia	6 months	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

Trial Locations

Locations (1)

Guatemala: Ministry of Public Health and Social Assistance; 🇬🇹 San Marcos, Guatemala