Working With Community Health Workers to Increase ORS Use in Uganda

Diarrhea Clinical Trial

Official title:

Working With Community Health Workers to Increase Oral Rehydration Salt and Zinc Use to Treat Child Diarrhea in Uganda: A Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870491
• Other study ID #: ZW-03-28-1983
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 2019

Study information

• Verified date: April 2019
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess how free distribution and preemptive home delivery of oral rehydration salts (ORS) by community health workers affects ORS use. The investigators will measure the impact of the combination of the two interventions (free distribution + pre-emptive home delivery) as well as the impact of each intervention separately (free distribution without home delivery and pre-emptive home delivery without free distribution).

Description:

This research aims to test the impact of a novel preemptive home-delivery intervention aimed at increasing the use of oral rehydration salts (ORS) and zinc for child diarrhea in Uganda. The intervention aims to increase availability of ORS and zinc and reduce barriers to access by having community health workers (CHWs) deliver the products directly to households for free prior to a diarrhea episode. Under this set-up, the products will be readily available for free immediately after a child comes down with diarrhea. Moreover, the investigators will disentangle the mechanisms through which the intervention could change product use by using a multi-armed approach that tests for the impact of free distribution and preemptive home-delivery separately (i.e. preemptive delivery but not free and free but not preemptive delivery). The investigators will use a four-arm cluster randomized controlled trial designed to measure the impact of each of the three interventions on ORS and zinc use for treating child diarrhea relative to a control group. The investigators will enroll 120 CHWs (each located in a different village) and randomly assign each to 1 of 4 groups:

Group 1 — Control: No intervention will take place. Caretakers will have standard access to ORS and zinc at local health facilities and pharmacies. Some CHWs in control villages could make household visits, however offers to sell diarrhea treatment preemptively are rare and CHWs are generally not the source of diarrhea treatment.

Group 2 — Household Visit + Free Distribution + Preemptive Delivery: CHWs will be provided a small incentive to visit all of the households in their catchment area that contain a child under 5-years-old (roughly 100 households) at the beginning of the study. CHWs will train caretakers on the dangers of diarrhea and the importance of ORS and zinc use. CHWs will then offer to give ORS and zinc to caretakers for free to store in their homes.

Group 3 — Household Visit + Cost Sharing + Preemptive Delivery: CHWs will be provided a small incentive to visit all of the households in their catchment area that contain a child under 5-years-old at the beginning of the study. CHWs will train caretakers on the dangers of diarrhea and the importance of ORS and zinc use. CHWs will then offer to sell ORS and zinc to caretakers at their standard subsidized price (roughly USD$0.40 in total per treatment course) to store in their homes.

Group 4 - Household Visit + Free Distribution Upon Retrieval: CHWs will be provided a small incentive to visit all of the households in their catchment area that contain a child under 5-years-old at the beginning of the study. CHWs will train caretakers on the dangers of diarrhea and the importance of ORS and zinc use. CHWs will then inform caretakers that they have ORS and zinc available for free that caretakers can retrieved from the CHWs home if needed. The average distance to the CHWs household is about 15 minutes.

Groups 2-4 compared to Group 1 measures the impact of each of the different ways of arranging the program. Group 3 compared to Group 2 measures the price effect. Group 4 compared to Group 2 measures the distance/convenience effect. Group 2 compared to Group 1 measures the combination of the price and distance/convenience effect.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7949
• Est. completion date: January 2019
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 59 Months

Eligibility

Inclusion Criteria:

• Children aged 0-59 months that reside on a village recruited to participate in the study will be included in the intervention. Only children with a diarrhea episode 4-weeks prior to data collection will be included in the analysis.

Exclusion Criteria:

• Children without a diarrhea episode in the weeks prior to data collection will be excluded from the analysis.

Related Conditions & MeSH terms

• Dehydration
• Diarrhea
• Diarrhea, Infantile
• Infantile Diarrhea

Intervention

Behavioral:
• Free Distribution
Caretakers of children under 5-years-old will have access to free ORS and zinc
• Preemptive Delivery
Caretakers of children under 5-years-old will have ORS and zinc delivered to their home

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	Makerere University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oral rehydration salt (ORS) use	Caretaker-reported ORS use to treat a diarrhea episode in the last 7 days	Last 7 days
Other	Oral rehydration salt (ORS) use	Caretaker-reported ORS use to treat a current diarrhea episode	current diarrhea episode up to 4 weeks
Primary	Oral rehydration salt (ORS) use	Caretaker-reported ORS use to treat a diarrhea episode in the last 4 weeks	Last 4 weeks
Secondary	Oral rehydration salt (ORS) with Zinc use	Caretaker-reported ORS + zinc use to treat a diarrhea episode in the last 4 weeks	Last 4 weeks
Secondary	Antibiotic use	Caretaker-reported antibiotic use to treat a diarrhea episode in the last 4 weeks	Last 4 weeks
Secondary	Time to Oral rehydration salt (ORS) use	Caretaker-reported time from diarrhea initiation to ORS use	Last 4 weeks
Secondary	Time to zinc use	Caretaker-reported time from diarrhea initiation to zinc use	Last 4 weeks