Clinical trial NCT02044107: The Effectiveness of Co-packaging With Zinc to Improve Treatment of Diarrhea and Pneumonia in Guatemala
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
Overall status: UNKNOWN
Phase: NA
Conditions: Diarrhea.
Pneumonia.
Keywords: Diarrhea,
Pneumonia,
Zinc treatment,
Patient Compliance.
Lead sponsor: Center for Studies of Sensory Impairment, Aging and Metabolism
Sponsor class: OTHER
Collaborators: name: Micronutrient Initiative
First posted: 2014-01-23
Enrollment: 320
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of caregivers who administer zinc to child for at least 8 days.
timeFrame: 10 days
measure: Percentage of caregivers who report giving zinc to child for at least 8 days.
timeFrame: 10 days
Secondary outcomes:
measure: Improved Provision of Care for Treatment of Diarrhea and Pneumonia
timeFrame: 6 months
Other outcomes:
Locations:
city: San Marcos
country: Guatemala
facility: Guatemala: Ministry of Public Health and Social Assistance
Study officials:
affiliation: Micronutrient Initiative
name: Marion Roche, PhD
role: STUDY_DIRECTOR
affiliation: Center for Studies of Sensory Impairment, Aging and Metabolism
name: María del Rosario García Meza, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Studies of Sensory Impairment, Aging and Metabolism
name: Noel W Solomons, MD
role: STUDY_CHAIR
affiliation: Center for Studies of Sensory Impairment, Aging and Metabolism
name: Marieke Vossenaar, PhD
role: PRINCIPAL_INVESTIGATOR
References: