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

NCT02044107 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2014-01-24

No results posted yet for this study

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.

Interventions

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.

Sponsors & Collaborators

  • Micronutrient Initiative

    collaborator OTHER
  • Center for Studies of Sensory Impairment, Aging and Metabolism

    lead OTHER

Principal Investigators

  • Marion Roche, PhD · Micronutrient Initiative

  • María del Rosario García Meza, MA · Center for Studies of Sensory Impairment, Aging and Metabolism

  • Noel W Solomons, MD · Center for Studies of Sensory Impairment, Aging and Metabolism

  • Marieke Vossenaar, PhD · Center for Studies of Sensory Impairment, Aging and Metabolism

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-05-31
Completion
2014-06-30

Countries

  • Guatemala

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02044107 on ClinicalTrials.gov