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

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ClinicalTrials.gov Identifier: NCT04335877
Recruitment Status : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Daniel Lopez de Romana, Nutrition International

Brief 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.

Condition or disease Intervention/treatment Phase
Diarrhea, Infantile Other: Private sector component + modified BCC Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2785 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Private sector component + modified BCC
Private sector component + modified BCC + current standard of care
Other: Private sector component + modified BCC
Intervention group will be exposed to the private sector component + modified BCC and will receive current standard care

No Intervention: Control
Current standard of care + standard BCC



Primary Outcome Measures :
  1. Treatment of uncomplicated diarrhea [ Time Frame: 12 months ]
    change in % of caregivers who use zinc and LO-ORS co-pack to treat uncomplicated childhood diarrhea at 12 months

  2. Care-seeking in the private sector [ Time Frame: 12 months ]
    Change in % of caregivers seek care for uncomplicated childhood diarrhea in the private sector at 12 months

  3. Availability of zinc and LO-ORS co-pack in the private sector [ Time Frame: 12 months ]
    Change in % of private retailers who have stock of zinc and LO-ORS co-pack at time of visit at 12 months

  4. Acceptability of private sector [ Time Frame: 1 month ]
    % private retailers who express intention to stock co-packs after sensitization and training.

  5. Acceptability of caregivers [ Time Frame: 12 months ]
    % caregivers who indicate preferred treatment for uncomplicated childhood diarrhea is co-pack.at 12 months

  6. Adoption by private sector at month 1 [ Time Frame: 1 month ]
    % private retailers who stock co-pack after 1 month

  7. Adoption by private sector at month 2 [ Time Frame: 2 months ]
    % private retailers who stock co-pack after 2 months

  8. Adoption by private sector at month 3 [ Time Frame: 3 months ]
    % private retailers who stock co-pack after 3 months

  9. Adoption by private sector at month 4 [ Time Frame: 4 months ]
    % private retailers who stock co-pack after 4 months

  10. Adoption by private sector at month 5 [ Time Frame: 5 months ]
    % private retailers who stock co-pack after 5 months

  11. Adoption by private sector at month 6 [ Time Frame: 6 months ]
    % private retailers who stock co-pack after 6 months

  12. Adoption by private sector at month 7 [ Time Frame: 7 months ]
    % private retailers who stock co-pack after 7 months

  13. Adoption by private sector at month 8 [ Time Frame: 8 months ]
    % private retailers who stock co-pack after 8 months

  14. Adoption by private sector at month 9 [ Time Frame: 9 months ]
    % private retailers who stock co-pack after 9 months

  15. Adoption by private sector at month 10 [ Time Frame: 10 months ]
    % private retailers who stock co-pack after 10 months

  16. Adoption by private sector at month 11 [ Time Frame: 11 months ]
    % private retailers who stock co-pack after 11 months

  17. Adoption by private sector at month 12 [ Time Frame: 12 months ]
    % private retailers who stock co-pack after 12 months

  18. Adoption by caregivers [ Time Frame: 12 months ]
    % caregivers who indicate having co-pack in house

  19. Feasibility of intervention at month 1 [ Time Frame: 1 month ]
    % private retailers who indicate that they can purchase/procure co-packs with ease after 1 month

  20. Feasibility of intervention at month 2 [ Time Frame: 2 months ]
    % private retailers who indicate that they can purchase/procure co-packs with ease after 2 months

  21. Feasibility of intervention at month 3 [ Time Frame: 3 months ]
    % private retailers who indicate that they can purchase/procure co-packs with ease after 3 months

  22. Feasibility of intervention at month 4 [ Time Frame: 4 months ]
    % private retailers who indicate that they can purchase/procure co-packs with ease after 4 months

  23. Feasibility of intervention at month 5 [ Time Frame: 5 months ]
    % private retailers who indicate that they can purchase/procure co-packs with ease after 5 months

  24. Feasibility of intervention at month 6 [ Time Frame: 6 months ]
    % private retailers who indicate that they can purchase/procure co-packs with ease after 6 months

  25. Feasibility of intervention at month 7 [ Time Frame: 7 months ]
    % private retailers who indicate that they can purchase/procure co-packs with ease after 7 months

  26. Feasibility of intervention at month 8 [ Time Frame: 8 months ]
    % private retailers who indicate that they can purchase/procure co-packs with ease after 8 months

  27. Feasibility of intervention at month 9 [ Time Frame: 9 months ]
    % private retailers who indicate that they can purchase/procure co-packs with ease after 9 months

  28. Feasibility of intervention at month 10 [ Time Frame: 10 months ]
    % private retailers who indicate that they can purchase/procure co-packs with ease after 10 months

  29. Feasibility of intervention at month 11 [ Time Frame: 11 months ]
    % private retailers who indicate that they can purchase/procure co-packs with ease after 11 months

  30. Feasibility of intervention at month 12 [ Time Frame: 12 months ]
    % private retailers who indicate that they can purchase/procure co-packs with ease after 12 months


Secondary Outcome Measures :
  1. Care-seeking to all sources [ Time Frame: 12 months ]
    Change in % of caregivers who seek care for childhood diarrhea outside the home at month 12

  2. Prompt treatment of uncomplicated childhood diarrhoea with zinc and LO-ORS co-pack [ Time Frame: 12 months ]
    Change in % of caregivers who use zinc and LO-ORS co-pack to treat uncomplicated childhood diarrhea within 24-h of the onset of the episode of diarrhea at 12 months

  3. Caregivers receive information from private retailers [ Time Frame: 12 months ]
    Change in % caregivers who indicate received information from private retailers about zinc and LO-ORS to treat uncomplicated childhood diarrhea at 12 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • All children under 5 years of age who live in the selected areas to be included in the study are eligible to participate. All children in area selected for the intervention will be exposed to the private sector component and the modified BCC.
  • In addition, all private sites (shops, kiosks, chemists) in the intervention area will be eligible to participate in the study.

Exclusion criteria:

- None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335877


Contacts
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Contact: Daniel V Lopez de Romana, PhD +16136121242 dlopezderomana@nutritionintl.org
Contact: Jacqueline K Kung'u, PhD +254 709 638 000 jkungu@nutritionintl.org

Sponsors and Collaborators
Nutrition International
Investigators
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Principal Investigator: Daniel V Lopez de Romana, PhD Nutrition International

Publications:
United Nations Inter-agency Group for Child Mortality Estimation (UN IGME), 'Levels & Trends in Child Mortality: Report 2019, Estimates developed by the United Nations Inter-agency Group for Child Mortality Estimation', United Nations Children's Fund, New York, 2019
UNICEF. Diarrhoeal disease - UNICEF DATA. 2018. Available from: https://data.unicef.org/topic/child-health/diarrhoeal-disease. (Accessed 24 Sept 2019)
KDHS, Kenya Demographic and Health Survey. Kenya National Bureau of Statistics, the National AIDS Control Council (NACC), the National Council for Population and Development (NCPD), and the Kenya Medical Research Institute (KEMRI), ICF International. 2014.
International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. Pneumonia and Diarrhoea Progress Report 2015: Sustainable Progress in the Post-2015 Era. 2015.
World Health Organization. Clinical Management of acute diarrhoea: WHO/UNICEF joint statement. 2004. Available: http://www.who.int/iris/handle/10665/68627. Accessed: 24 September 2019
International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health. Pneumonia and Diarrhea Progress Report 2017: Pushing Progress through Investment & Action; 2017. Available from: https://www.jhsph.edu/research/centers-and-institutes/ivac/resources/IVAC-2017-Pneumonia-Diarrhea-Progress-Report.pdf. Accessed: 23 Sept 2019.
Bradley, Sarah E. K., Lauren Rosapep, and Tess Shiras. 2018. Sources for Sick Child Care in Kenya. Brief. Rockville, MD: Sustaining Health Outcomes through the Private Sector Plus Project, Abt Associates
ACTwatch Group. (2015). ACTwatch Outlet Surveys 2013‐2014 - ORS and Zinc Availability Findings from 9 Countries. Washington DC: PSI.
Goh N, Pollak K. Progress over a decade of zinc and ORS scale-up: Best practices and lessons learned. 2016. Available: https://www.defeatdd.org/reports/progress-over-decade-zinc-and-ors-scale. Accessed: 25 September 2019
Data on policies, systems and financing. Countdown 2030 Master Databases (December 2017 Country Profiles). Countdown to 2030, Women's, Children's and Adolescents' Health. Available from: http://countdown2030.org/country-and-regional-networks/country-profiles/countdown-2030-master-databases-january-2018-country-profiles. Accessed: 23 September 2019
Ministry of Public Health and Sanitation (2010). Policy Guidelines on control and Management of Diarrhoeal disease in Children below five years in Kenya. Nairobi.
Ministry of Medical Services and Ministry of Public Health & Sanitation, (2010).Kenya Essential Medicines List 2010. Available at: http://apps.who.int/medicinedocs/documents/s18694en/s18694en.pdf. Accessed: 24 September 2019.
Ministry of Health - Government of Kenya. (2016). Kenya Reproductive Maternal Newborn Child and Adolescent Health (RMNCHA) Investment Framework. Nairobi: Ministry of Health - Government of Kenya
Ministry of Medical Services and Ministry of Public Health & Sanitation, (2016).Kenya Essential Medicines List 2016. Available at: http://apps.who.int/medicinedocs/documents/s23035en/s23035en.pdf. Accessed 24 Sept 2019.
Every Women Every Child. 2012. UN Commission on life-savig commodities for women and children: commisioners' report. Available at: https://www.unicef.org/media/files/UN_Commission_Report_September_2012_Final.pdf. Accessed 24 Sept 2019
Ahs J. Perceptions, Management and Barriers to Care-seeking for Childhood Diarrhea, Malaria, and Pneumonia: Uganda, Kenya, Nigeria, Ethiopia, Niger. 2012. North Carolina. USA
ICF, 2012. The DHS Program STATcompiler. Funded by USAID. Available at: http://www.statcompiler.com. Accessed 24 Sept 2019.
NCAPD, MOMS, MOPHS, KNBS, ICF Macro. (2011). Kenya Service Provision Assessment Survey 2010. Nairobi, Kenya: National Coordinating Agency for Population and Development, Ministry of Medical Services, Ministry of Public Health and Sanitation, Kenya National Bureau of Statistics, and ICF Macro.
UNICEF Supply Division. Oral Rehydration Salts and Zinc: UNICEF Suppliers and Product Range. February 2016. Availabel at: https://www.unicef.org/supply/files/ORS_and_Zinc_Supply_Update_1_-_with_warning_banner.pdf. Accessed: 24 Sept 2019.
SHOPS. Increasing the Use of ORS and Zinc through the Private Sector. 2018. Available at: https://www.shopsplusproject.org/sites/default/files/resources/Zinc_Final_.pdf. Accessed 24 Sept 2019.

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Responsible Party: Daniel Lopez de Romana, Technical Advisor, Nutrition International
ClinicalTrials.gov Identifier: NCT04335877    
Other Study ID Numbers: NI-2006-2020-001
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diarrhea
Diarrhea, Infantile
Signs and Symptoms, Digestive
Signs and Symptoms