Clinical Trials Logo
  1. Home
  2. Diarrhea, Infantile
  3. NCT04335877

Effect of Prompting the Supply of Zinc/LO-ORS Co-packs in the Private Sector Plus BCI on Childhood Diarrhea Treatment

Diarrhea, Infantile Clinical Trial

Official title:
Effectiveness-Implementation Research to Assess the Effect of Prompting the Supply of Zinc/LO-ORS Co-packs Through the Private Sector Coupled With Behavior Change Intervention on the Treatment of Uncomplicated Childhood Diarrhoea in Kenya

Clinical Trial Summary

This study assesses whether prompting the supply of zinc and LO-ORS co-packs in the private sector coupled with behavior change communication (BCC) has an effect on the treatment of uncomplicated childhood diarrhea. In addition the study will evaluate the acceptability, adoption, feasibility and coverage of the intervention model. One group of children and caregivers will receive the current standard of care and will be exposed to standard BCC and the second group will be exposed to the private sector component and to a modified BCC.

Clinical Trial Description

Diarrhoea accounts for 7% of all under-five deaths in Kenya. Recent experiences in other countries show that the private health sector can be successfully harnessed to improve diarrhoea treatment coverage. This study assesses the effect of prompting the supply of zinc and low-osmolarity oral rehydration salts (LO-ORS) co-packs in the private sector coupled with increasing the demand for co-packs among caregivers on: 1) the treatment of uncomplicated childhood diarrhoea, 2) care-seeking in the private sector, and 3) availability of co-packs in the private sector. The target population will be children under five years of age and their caregivers in Vihiga County. The study will use a effectiveness-implementation hybrid design with two arms: 1) children and caregivers from areas that receive the current standard of care and will be exposed to standard BCC and 2) children and caregivers from areas where the private sector component will be implemented and that will be exposed to a modified BCC. Two of the five existing sub-counties in Vihiga will be selected by convenience to be assigned to one of the two study arms. The selection will take into account geographical distance between the two sub-counties (i.e. maximizing the distance between the two counties to minimize cross-pollination between the two study groups), rural vs urban population, and number of operational community units and CHV in each sub-county. All private sector retailers within each sub-county will be identified with assistance from wholesalers. Retailers will be invited to participate in the study via sensitization meetings. Baseline and endline assessments will be conducted at the household level to collect information on care-seeking practices, availability of the co-pack in the household, treatment of diarrhoea, and whether caregivers received information from shopkeepers on using the co-pack. Monitoring of process indicators will be conducted throughout the intervention period. The monitoring process will also be used to evaluate the adoption and feasibility of the implementation model. In addition, the endline survey will be used to evaluate the acceptability, adoption, and coverage of the implementation model. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04335877
Study type Interventional
Source Nutrition International
Contact
Status Completed
Phase N/A
Start date March 1, 2021
Completion date April 2, 2022
View Details
See also
  Status Clinical Trial Phase
Terminated NCT00732732 - A Controlled Trial of Plantain Powder in Infantile Diarrhea N/A
Not yet recruiting NCT03598010 - Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea N/A
Recruiting NCT04654832 - IVC Index in Patient With Diarrhea and Dehydration And How It Affects Its Management
Completed NCT04061538 - Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age N/A
Completed NCT05322655 - PAthogen Transmission and Health Outcome Models of Enteric Disease
Recruiting NCT02870751 - Human Challenge Model With ST-only Enterotoxigenic Escherichia Coli Phase 1
Completed NCT01345695 - Bihar Evaluation of Social Franchising and Telemedicine N/A
Recruiting NCT04528303 - Whole Genome Sequencing Versus Whole Exome Sequencing for Congenital Diarrhea and Enteropahty N/A
Active, not recruiting NCT03012048 - Effectiveness of Point-of-use Water Treatment Technologies to Prevent Stunting Among Children in South Africa N/A
Completed NCT04677296 - Efficacy and Safety of "VS002A" With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children N/A
Completed NCT04209751 - Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits (PE-DIA)
Completed NCT00447161 - Preventing Antibiotic-Associated DiarRhea Using Erceflora Phase 4
Recruiting NCT05766826 - Coupons for Safe Water Project N/A
Terminated NCT04628819 - Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children N/A
Completed NCT03473561 - Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea Phase 3