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

NCT04335877 | Completed

• 1 other identifier: NI-01-2006-ZNIR
• Study Type: interventional
• Target: 1,245
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea, Infantile

Outcome Measures

Primary Outcomes (30)

• Treatment of uncomplicated diarrhea

  change in % of caregivers who use zinc and LO-ORS co-pack to treat uncomplicated childhood diarrhea at 12 months

  12 months

• Care-seeking in the private sector

  Change in % of caregivers seek care for uncomplicated childhood diarrhea in the private sector at 12 months

  12 months

• Availability of zinc and LO-ORS co-pack in the private sector

  Change in % of private retailers who have stock of zinc and LO-ORS co-pack at time of visit at 12 months

  12 months

• Acceptability of private sector

  % private retailers who express intention to stock co-packs after sensitization and training.

  1 month

• Acceptability of caregivers

  % caregivers who indicate preferred treatment for uncomplicated childhood diarrhea is co-pack.at 12 months

  12 months

• Adoption by private sector at month 1

  % private retailers who stock co-pack after 1 month

  1 month

• Adoption by private sector at month 2

  % private retailers who stock co-pack after 2 months

  2 months

• Adoption by private sector at month 3

  % private retailers who stock co-pack after 3 months

  3 months

• Adoption by private sector at month 4

  % private retailers who stock co-pack after 4 months

  4 months

• Adoption by private sector at month 5

  % private retailers who stock co-pack after 5 months

  5 months

• Adoption by private sector at month 6

  % private retailers who stock co-pack after 6 months

  6 months

• Adoption by private sector at month 7

  % private retailers who stock co-pack after 7 months

  7 months

• Adoption by private sector at month 8

  % private retailers who stock co-pack after 8 months

  8 months

• Adoption by private sector at month 9

  % private retailers who stock co-pack after 9 months

  9 months

• Adoption by private sector at month 10

  % private retailers who stock co-pack after 10 months

  10 months

• Adoption by private sector at month 11

  % private retailers who stock co-pack after 11 months

  11 months

• Adoption by private sector at month 12

  % private retailers who stock co-pack after 12 months

  12 months

• Adoption by caregivers

  % caregivers who indicate having co-pack in house

  12 months

• Feasibility of intervention at month 1

  % private retailers who indicate that they can purchase/procure co-packs with ease after 1 month

  1 month

• Feasibility of intervention at month 2

  % private retailers who indicate that they can purchase/procure co-packs with ease after 2 months

  2 months

• Feasibility of intervention at month 3

  % private retailers who indicate that they can purchase/procure co-packs with ease after 3 months

  3 months

• Feasibility of intervention at month 4

  % private retailers who indicate that they can purchase/procure co-packs with ease after 4 months

  4 months

• Feasibility of intervention at month 5

  % private retailers who indicate that they can purchase/procure co-packs with ease after 5 months

  5 months

• Feasibility of intervention at month 6

  % private retailers who indicate that they can purchase/procure co-packs with ease after 6 months

  6 months

• Feasibility of intervention at month 7

  % private retailers who indicate that they can purchase/procure co-packs with ease after 7 months

  7 months

• Feasibility of intervention at month 8

  % private retailers who indicate that they can purchase/procure co-packs with ease after 8 months

  8 months

• Feasibility of intervention at month 9

  % private retailers who indicate that they can purchase/procure co-packs with ease after 9 months

  9 months

• Feasibility of intervention at month 10

  % private retailers who indicate that they can purchase/procure co-packs with ease after 10 months

  10 months

• Feasibility of intervention at month 11

  % private retailers who indicate that they can purchase/procure co-packs with ease after 11 months

  11 months

• Feasibility of intervention at month 12

  % private retailers who indicate that they can purchase/procure co-packs with ease after 12 months

  12 months

Secondary Outcomes (3)

• Care-seeking to all sources

  12 months

• Prompt treatment of uncomplicated childhood diarrhoea with zinc and LO-ORS co-pack

  12 months

• Caregivers receive information from private retailers

  12 months

Study Arms (2)

Private sector component + modified BCC

EXPERIMENTAL

Private sector component + modified BCC + current standard of care

Other: Private sector component + modified BCC

Control

NO INTERVENTION

Current standard of care + standard BCC

Interventions

Private sector component + modified BCC OTHER

Intervention group will be exposed to the private sector component + modified BCC and will receive current standard care

Private sector component + modified BCC

Eligibility Criteria

• Age: 2 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- None

Sponsors & Collaborators

• Nutrition International: lead

Study Sites (1)

Nutrition International - Kenya

Nairobi, Kenya

Location

Related Publications (32)

• 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

  BACKGROUND

• GBD 2016 Diarrhoeal Disease Collaborators. Estimates of the global, regional, and national morbidity, mortality, and aetiologies of diarrhoea in 195 countries: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Infect Dis. 2018 Nov;18(11):1211-1228. doi: 10.1016/S1473-3099(18)30362-1. Epub 2018 Sep 19.

  PMID: 30243583 BACKGROUND

• UNICEF. Diarrhoeal disease - UNICEF DATA. 2018. Available from: https://data.unicef.org/topic/child-health/diarrhoeal-disease. (Accessed 24 Sept 2019)

  BACKGROUND

• 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.

  BACKGROUND

• Walker CL, Black RE. Zinc for the treatment of diarrhoea: effect on diarrhoea morbidity, mortality and incidence of future episodes. Int J Epidemiol. 2010 Apr;39 Suppl 1(Suppl 1):i63-9. doi: 10.1093/ije/dyq023.

  PMID: 20348128 BACKGROUND

• Munos MK, Walker CL, Black RE. The effect of oral rehydration solution and recommended home fluids on diarrhoea mortality. Int J Epidemiol. 2010 Apr;39 Suppl 1(Suppl 1):i75-87. doi: 10.1093/ije/dyq025.

  PMID: 20348131 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• ACTwatch Group. (2015). ACTwatch Outlet Surveys 2013-2014 - ORS and Zinc Availability Findings from 9 Countries. Washington DC: PSI.

  BACKGROUND

• Kim Y, Hahn S, Garner P. Reduced osmolarity oral rehydration solution for treating dehydration caused by acute diarrhoea in children. Cochrane Database Syst Rev. 2001;2002(2):CD002847. doi: 10.1002/14651858.CD002847.

  PMID: 11406049 BACKGROUND

• Lazzerini M, Wanzira H. Oral zinc for treating diarrhoea in children. Cochrane Database Syst Rev. 2016 Dec 20;12(12):CD005436. doi: 10.1002/14651858.CD005436.pub5.

  PMID: 27996088 BACKGROUND

• Lamberti LM, Fischer Walker CL, Taneja S, Mazumder S, Black RE. The Association between Provider Practice and Knowledge of ORS and Zinc Supplementation for the Treatment of Childhood Diarrhea in Bihar, Gujarat and Uttar Pradesh, India: A Multi-Site Cross-Sectional Study. PLoS One. 2015 Jun 22;10(6):e0130845. doi: 10.1371/journal.pone.0130845. eCollection 2015.

  PMID: 26098305 BACKGROUND

• Carter E, Bryce J, Perin J, Newby H. Harmful practices in the management of childhood diarrhea in low- and middle-income countries: a systematic review. BMC Public Health. 2015 Aug 18;15:788. doi: 10.1186/s12889-015-2127-1.

  PMID: 26282400 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Ministry of Public Health and Sanitation (2010). Policy Guidelines on control and Management of Diarrhoeal disease in Children below five years in Kenya. Nairobi.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• Bedford KJ, Sharkey AB. Local barriers and solutions to improve care-seeking for childhood pneumonia, diarrhoea and malaria in Kenya, Nigeria and Niger: a qualitative study. PLoS One. 2014 Jun 27;9(6):e100038. doi: 10.1371/journal.pone.0100038. eCollection 2014.

  PMID: 24971642 BACKGROUND

• Ahs J. Perceptions, Management and Barriers to Care-seeking for Childhood Diarrhea, Malaria, and Pneumonia: Uganda, Kenya, Nigeria, Ethiopia, Niger. 2012. North Carolina. USA

  BACKGROUND

• ICF, 2012. The DHS Program STATcompiler. Funded by USAID. Available at: http://www.statcompiler.com. Accessed 24 Sept 2019.

  BACKGROUND

• Kruger C, Heinzel-Gutenbrunner M, Ali M. Adherence to the integrated management of childhood illness guidelines in Namibia, Kenya, Tanzania and Uganda: evidence from the national service provision assessment surveys. BMC Health Serv Res. 2017 Dec 13;17(1):822. doi: 10.1186/s12913-017-2781-3.

  PMID: 29237494 BACKGROUND

• Ross-Degnan D, Soumerai SB, Goel PK, Bates J, Makhulo J, Dondi N, Sutoto, Adi D, Ferraz-Tabor L, Hogan R. The impact of face-to-face educational outreach on diarrhoea treatment in pharmacies. Health Policy Plan. 1996 Sep;11(3):308-18. doi: 10.1093/heapol/11.3.308.

  PMID: 10160376 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Larson CP, Saha UR, Nazrul H. Impact monitoring of the national scale up of zinc treatment for childhood diarrhea in Bangladesh: repeat ecologic surveys. PLoS Med. 2009 Nov;6(11):e1000175. doi: 10.1371/journal.pmed.1000175. Epub 2009 Nov 3.

  PMID: 19888335 BACKGROUND

• Larson CP, Koehlmoos TP, Sack DA; Scaling Up of Zinc for Young Children (SUZY) Project Team. Scaling up zinc treatment of childhood diarrhoea in Bangladesh: theoretical and practical considerations guiding the SUZY Project. Health Policy Plan. 2012 Mar;27(2):102-14. doi: 10.1093/heapol/czr015. Epub 2011 Feb 22.

  PMID: 21343236 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Diarrhea, Infantile

Condition Hierarchy (Ancestors)

Diarrhea; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elijah Mbiti, MSc

  Nutrition International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Program Officer

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 6, 2020
• Study Start: March 1, 2021
• Primary Completion: April 2, 2022
• Study Completion: April 2, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)