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

January 23, 2014 updated by: Marieke Vossenaar, Center for Studies of Sensory Impairment, Aging and Metabolism

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guatemala
      • San Marcos, Guatemala, 012001
        • Guatemala: Ministry of Public Health and Social Assistance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: Co-packaging and counseling messages
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.
Other Names:
  • The physical co-packaging is called the "bolsita salva-vida"
No Intervention: Control group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of caregivers who administer zinc to child for at least 8 days.
Time Frame: 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.
10 days
Percentage of caregivers who report giving zinc to child for at least 8 days.
Time Frame: 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.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved Provision of Care for Treatment of Diarrhea and Pneumonia
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Studies of Sensory Impairment, Aging and Metabolism

Collaborators

Micronutrient Initiative

Investigators

  • Study Director: Marion Roche, PhD, Micronutrient Initiative
  • Principal Investigator: María del Rosario García Meza, MA, Center for Studies of Sensory Impairment, Aging and Metabolism
  • Study Chair: Noel W Solomons, MD, Center for Studies of Sensory Impairment, Aging and Metabolism
  • Principal Investigator: Marieke Vossenaar, PhD, Center for Studies of Sensory Impairment, Aging and Metabolism

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

January 24, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CeSSIAM_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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