Clinical trial NCT02870491: Working With Community Health Workers to Increase ORS Use in Uganda
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Diarrhea
Diarrhea
Dehydration
Keywords: Child Diarrhea
Cluster Randomized Controlled Trial
Oral Rehydration
ORS
Zinc
Brac
Community Health Workers
Uganda
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Makerere University
First posted: 2016-08-17
Enrollment: 7949
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oral rehydration salt (ORS) use
timeFrame: Last 4 weeks
Secondary outcomes:
measure: Oral rehydration salt (ORS) with Zinc use
timeFrame: Last 4 weeks
measure: Antibiotic use
timeFrame: Last 4 weeks
measure: Time to Oral rehydration salt (ORS) use
timeFrame: Last 4 weeks
measure: Time to zinc use
timeFrame: Last 4 weeks
Other outcomes:
measure: Oral rehydration salt (ORS) use
timeFrame: Last 7 days
measure: Oral rehydration salt (ORS) use
timeFrame: current diarrhea episode up to 4 weeks
Locations:
Study officials:
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