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The Effectiveness of Co-packaging With Zinc to Improve Treatment of Diarrhea and Pneumonia in Guatemala (Zinc10)

Primary Purpose

Diarrhea., Pneumonia.

Status
Unknown status
Phase
Not Applicable
Locations
Guatemala
Study Type
Interventional
Intervention
Co-packaging and counseling messages
Sponsored by
Center for Studies of Sensory Impairment, Aging and Metabolism
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea. focused on measuring Diarrhea,, Pneumonia,, Zinc treatment,, Patient Compliance.

Eligibility Criteria

2 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Guatemala: Ministry of Public Health and Social Assistance

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Co-packaging and counseling messages

Control group

Arm Description

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

Current standard care at public health center (zinc & ORS for treatment of diarrhea and zinc & antibiotics for treatment of of pneumonia).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2014
Last Updated
January 23, 2014
Sponsor
Center for Studies of Sensory Impairment, Aging and Metabolism
Collaborators
Micronutrient Initiative
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1. Study Identification

Unique Protocol Identification Number
NCT02044107
Brief Title
The Effectiveness of Co-packaging With Zinc to Improve Treatment of Diarrhea and Pneumonia in Guatemala
Acronym
Zinc10
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Center for Studies of Sensory Impairment, Aging and Metabolism
Collaborators
Micronutrient Initiative

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea., Pneumonia.
Keywords
Diarrhea,, Pneumonia,, Zinc treatment,, Patient Compliance.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Co-packaging and counseling messages
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Current standard care at public health center (zinc & ORS for treatment of diarrhea and zinc & antibiotics for treatment of of pneumonia).
Intervention Type
Behavioral
Intervention Name(s)
Co-packaging and counseling messages
Other Intervention Name(s)
The physical co-packaging is called the "bolsita salva-vida"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of caregivers who administer zinc to child for at least 8 days.
Description
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.
Time Frame
10 days
Title
Percentage of caregivers who report giving zinc to child for at least 8 days.
Description
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.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Improved Provision of Care for Treatment of Diarrhea and Pneumonia
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marieke Vossenaar, phD
Phone
50259000045
Email
mvossenaar@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
María del Rosario García Meza, MA
Phone
50254147956
Email
marosgarcia@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Roche, PhD
Organizational Affiliation
Micronutrient Initiative
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
María del Rosario García Meza, MA
Organizational Affiliation
Center for Studies of Sensory Impairment, Aging and Metabolism
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noel W Solomons, MD
Organizational Affiliation
Center for Studies of Sensory Impairment, Aging and Metabolism
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marieke Vossenaar, PhD
Organizational Affiliation
Center for Studies of Sensory Impairment, Aging and Metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guatemala: Ministry of Public Health and Social Assistance
City
San Marcos
ZIP/Postal Code
012001
Country
Guatemala
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marieke Vossenaar, PhD
Phone
50259000045
Email
mvossenaar@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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