Diarrhea. Clinical Trial
— Zinc10Official 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
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.
| Status | Not yet recruiting |
| Enrollment | 320 |
| Est. completion date | June 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 2 Months to 59 Months |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Guatemala | Guatemala: Ministry of Public Health and Social Assistance | San Marcos |
| Lead Sponsor | Collaborator |
|---|---|
| Center for Studies of Sensory Impairment, Aging and Metabolism | Micronutrient Initiative |
Guatemala,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Secondary | Improved Provision of Care for Treatment of Diarrhea and Pneumonia | 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 | No |