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

NCT02044107 | Unknown

• 1 other identifier: CeSSIAM_01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea.; Pneumonia.

Keywords

Diarrhea,; Pneumonia,; Zinc treatment,; Patient Compliance.

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Improved Provision of Care for Treatment of Diarrhea and Pneumonia

  6 months

Study Arms (2)

Co-packaging and counseling messages

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Co-packaging and counseling messages BEHAVIORAL

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.

Also known as: The physical co-packaging is called the "bolsita salva-vida"

Co-packaging and counseling messages

Eligibility Criteria

• Age: 2 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Unwillingness to sign consent form.

Sponsors & Collaborators

• Center for Studies of Sensory Impairment, Aging and Metabolism: lead
• Micronutrient Initiative: collaborator

Study Sites (1)

Guatemala: Ministry of Public Health and Social Assistance

San Marcos, Departamento de San Marcos, 012001, Guatemala

Location

MeSH Terms

Conditions

Diarrhea; Pneumonia; Patient Compliance

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marion Roche, PhD

  Micronutrient Initiative

  STUDY DIRECTOR

• María del Rosario García Meza, MA

  Center for Studies of Sensory Impairment, Aging and Metabolism

  PRINCIPAL INVESTIGATOR

• Noel W Solomons, MD

  Center for Studies of Sensory Impairment, Aging and Metabolism

  STUDY CHAIR

• Marieke Vossenaar, PhD

  Center for Studies of Sensory Impairment, Aging and Metabolism

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marieke Vossenaar, phD

CONTACT

50259000045; mvossenaar@hotmail.com

María del Rosario García Meza, MA

CONTACT

50254147956; marosgarcia@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Program Leader for Diet and Health

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

GU (1)