Clinical Trial: Working With Community Health Workers to Increase ORS Use in Uganda

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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
Sponsor: University of California, Berkeley

Current Primary Outcome: Oral rehydration salt (ORS) use [ Time Frame: Last 4 weeks ]

Caretaker-reported ORS use to treat a diarrhea episode in the last 4 weeks


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Oral rehydration salt (ORS) with Zinc use [ Time Frame: Last 4 weeks ]
    Caretaker-reported ORS + zinc use to treat a diarrhea episode in the last 4 weeks
  • Antibiotic use [ Time Frame: Last 4 weeks ]
    Caretaker-reported antibiotic use to treat a diarrhea episode in the last 4 weeks
  • Time to Oral rehydration salt (ORS) use [ Time Frame: Last 4 weeks ]
    Caretaker-reported time from diarrhea initiation to ORS use
  • Time to zinc use [ Time Frame: Last 4 weeks ]
    Caretaker-reported time from diarrhea initiation to zinc use


Original Secondary Outcome:

  • Zinc use [ Time Frame: Last 4 weeks ]
    Caretaker-reported zinc use to treat a diarrhea episode in the last 4 weeks
  • Antibiotic use [ Time Frame: Last 4 weeks ]
    Caretaker-reported antibiotic use to treat a diarrhea episode in the last 4 weeks
  • Time to Oral rehydration salt (ORS) use [ Time Frame: Last 4 weeks ]
    Caretaker-reported time from diarrhea initiation to ORS use
  • Time to zinc use [ Time Frame: Last 4 weeks ]
    Caretaker-reported time from diarrhea initiation to zinc use


Information By: University of California, Berkeley

Dates:
Date Received: August 9, 2016
Date Started: August 2016
Date Completion: December 2017
Last Updated: November 17, 2016
Last Verified: November 2016