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
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).
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06283784 -
Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients
|
N/A | |
| Recruiting |
NCT03851835 -
Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis
|
Phase 3 | |
| Completed |
NCT04003181 -
The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
|
N/A | |
| Completed |
NCT03596827 -
The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection
|
N/A | |
| Recruiting |
NCT05372068 -
Cement flooRs AnD chiLd hEalth (CRADLE)
|
N/A | |
| Completed |
NCT03972618 -
Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic
|
N/A | |
| Completed |
NCT05207618 -
Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant
|
N/A | |
| Not yet recruiting |
NCT05052489 -
Registry and Clinical Observation of Children With Diarrhoeal Disease
|
||
| Completed |
NCT02541695 -
Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
|
N/A | |
| Completed |
NCT02428647 -
Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation
|
N/A | |
| Completed |
NCT02197780 -
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
|
N/A | |
| Completed |
NCT01739231 -
Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults
|
Phase 1/Phase 2 | |
| Completed |
NCT01968408 -
Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children
|
Phase 3 | |
| Completed |
NCT01438645 -
ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy
|
N/A | |
| Terminated |
NCT01472211 -
Water-based Zinc Intervention Trial in Zinc Deficient Children
|
Phase 0 | |
| Terminated |
NCT01048567 -
Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly
|
Phase 2 | |
| Not yet recruiting |
NCT01382199 -
Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
|
Phase 3 | |
| Completed |
NCT01371656 -
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
|
Phase 3 | |
| Completed |
NCT00914225 -
Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya
|
N/A | |
| Completed |
NCT00760851 -
Yogurt Study in Children 2-4 Years Old Attending Daycare
|
Phase 3 |