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Working With Community Health Workers to Increase ORS Use in Uganda

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02870491
Enrollment
7949
Registered
2016-08-17
Start date
2016-08-31
Completion date
2019-01-31
Last updated
2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration, Diarrhea, Infantile Diarrhea

Keywords

Child Diarrhea, Cluster Randomized Controlled Trial, Oral Rehydration, ORS, Zinc, Brac, Community Health Workers, Uganda

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.

Interventions

BEHAVIORALFree Distribution

Caretakers of children under 5-years-old will have access to free ORS and zinc

BEHAVIORALPreemptive Delivery

Caretakers of children under 5-years-old will have ORS and zinc delivered to their home

Sponsors

Makerere University
CollaboratorOTHER
University of California, Berkeley
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 59 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Oral rehydration salt (ORS) useLast 4 weeksCaretaker-reported ORS use to treat a diarrhea episode in the last 4 weeks

Secondary

MeasureTime frameDescription
Oral rehydration salt (ORS) with Zinc useLast 4 weeksCaretaker-reported ORS + zinc use to treat a diarrhea episode in the last 4 weeks
Antibiotic useLast 4 weeksCaretaker-reported antibiotic use to treat a diarrhea episode in the last 4 weeks
Time to Oral rehydration salt (ORS) useLast 4 weeksCaretaker-reported time from diarrhea initiation to ORS use
Time to zinc useLast 4 weeksCaretaker-reported time from diarrhea initiation to zinc use

Other

MeasureTime frameDescription
Oral rehydration salt (ORS) useLast 7 daysCaretaker-reported ORS use to treat a diarrhea episode in the last 7 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026