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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Center for Studies of Sensory Impairment, Aging and Metabolism
Sponsor:
Collaborator:
Micronutrient Initiative
Information provided by (Responsible Party):
Marieke Vossenaar, Center for Studies of Sensory Impairment, Aging and Metabolism
ClinicalTrials.gov Identifier:
NCT02044107
First received: January 21, 2014
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.

Condition Intervention
Diarrhea.
Pneumonia.
Behavioral: Co-packaging and counseling messages

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Center for Studies of Sensory Impairment, Aging and Metabolism:

Primary Outcome Measures:
  • Percentage of caregivers who administer zinc to child for at least 8 days. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

    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. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 320
Study Start Date: February 2014
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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).

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   2 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044107

Contacts
Contact: Marieke Vossenaar, phD 50259000045 mvossenaar@hotmail.com
Contact: María del Rosario García Meza, MA 50254147956 marosgarcia@hotmail.com

Locations
Guatemala
Guatemala: Ministry of Public Health and Social Assistance Not yet recruiting
San Marcos, Guatemala, 012001
Contact: Marieke Vossenaar, PhD    50259000045    mvossenaar@hotmail.com   
Sponsors and Collaborators
Center for Studies of Sensory Impairment, Aging and Metabolism
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
  More Information

No publications provided

Responsible Party: Marieke Vossenaar, Senior Program Leader for Diet and Health, Center for Studies of Sensory Impairment, Aging and Metabolism
ClinicalTrials.gov Identifier: NCT02044107     History of Changes
Other Study ID Numbers: CeSSIAM_01
Study First Received: January 21, 2014
Last Updated: January 23, 2014
Health Authority: Guatemala: Ministry of Public Health and Social Assistance

Keywords provided by Center for Studies of Sensory Impairment, Aging and Metabolism:
Diarrhea,
Pneumonia,
Zinc treatment,
Patient Compliance.

Additional relevant MeSH terms:
Diarrhea
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Zinc
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014