Diarrhea, InfantileNCT04335877
Effect of Prompting the Supply of Zinc/LO-ORS Co-packs in the Private Sector Plus BCI on Childhood Diarrhea Treatment
A study testing Private sector component + modified BCC in people with Diarrhea, Infantile, run by Nutrition International at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 2 to 60 months
- Conditions the study is for
- Diarrhea, Infantile
- What is being tested?
- Private sector component + modified BCC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,245 participants
- Where
- 1 siteKenya
- Study dates
- 1 Mar 2021to 2 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diarrhea, Infantile
- Being tested
- Private sector component + modified BCC
- Medical subject headings
- Diarrhea, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Private sector component + modified BCCOther
Intervention group will be exposed to the private sector component + modified BCC and will receive current standard care
| Study group | Role | What they receive |
|---|---|---|
| Private sector component + modified BCC | Experimental | Private sector component + modified BCC + current standard of care Receives: Other: Private sector component + modified BCC |
| Control | No intervention | Current standard of care + standard BCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of uncomplicated diarrhea
change in % of caregivers who use zinc and LO-ORS co-pack to treat uncomplicated childhood diarrhea at 12 months
Measured: 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
Measured: 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
Measured: 12 months
Acceptability of private sector
% private retailers who express intention to stock co-packs after sensitization and training.
Measured: 1 month
Acceptability of caregivers
% caregivers who indicate preferred treatment for uncomplicated childhood diarrhea is co-pack.at 12 months
Measured: 12 months
Adoption by private sector at month 1
% private retailers who stock co-pack after 1 month
Measured: 1 month
Adoption by private sector at month 2
% private retailers who stock co-pack after 2 months
Measured: 2 months
Adoption by private sector at month 3
% private retailers who stock co-pack after 3 months
Measured: 3 months
Adoption by private sector at month 4
% private retailers who stock co-pack after 4 months
Measured: 4 months
Adoption by private sector at month 5
% private retailers who stock co-pack after 5 months
Measured: 5 months
Adoption by private sector at month 6
% private retailers who stock co-pack after 6 months
Measured: 6 months
Adoption by private sector at month 7
% private retailers who stock co-pack after 7 months
Measured: 7 months
Adoption by private sector at month 8
% private retailers who stock co-pack after 8 months
Measured: 8 months
Adoption by private sector at month 9
% private retailers who stock co-pack after 9 months
Measured: 9 months
Adoption by private sector at month 10
% private retailers who stock co-pack after 10 months
Measured: 10 months
Adoption by private sector at month 11
% private retailers who stock co-pack after 11 months
Measured: 11 months
Adoption by private sector at month 12
% private retailers who stock co-pack after 12 months
Measured: 12 months
Adoption by caregivers
% caregivers who indicate having co-pack in house
Measured: 12 months
Feasibility of intervention at month 1
% private retailers who indicate that they can purchase/procure co-packs with ease after 1 month
Measured: 1 month
Feasibility of intervention at month 2
% private retailers who indicate that they can purchase/procure co-packs with ease after 2 months
Measured: 2 months
Feasibility of intervention at month 3
% private retailers who indicate that they can purchase/procure co-packs with ease after 3 months
Measured: 3 months
Feasibility of intervention at month 4
% private retailers who indicate that they can purchase/procure co-packs with ease after 4 months
Measured: 4 months
Feasibility of intervention at month 5
% private retailers who indicate that they can purchase/procure co-packs with ease after 5 months
Measured: 5 months
Feasibility of intervention at month 6
% private retailers who indicate that they can purchase/procure co-packs with ease after 6 months
Measured: 6 months
Feasibility of intervention at month 7
% private retailers who indicate that they can purchase/procure co-packs with ease after 7 months
Measured: 7 months
Feasibility of intervention at month 8
% private retailers who indicate that they can purchase/procure co-packs with ease after 8 months
Measured: 8 months
Feasibility of intervention at month 9
% private retailers who indicate that they can purchase/procure co-packs with ease after 9 months
Measured: 9 months
Feasibility of intervention at month 10
% private retailers who indicate that they can purchase/procure co-packs with ease after 10 months
Measured: 10 months
Feasibility of intervention at month 11
% private retailers who indicate that they can purchase/procure co-packs with ease after 11 months
Measured: 11 months
Feasibility of intervention at month 12
% private retailers who indicate that they can purchase/procure co-packs with ease after 12 months
Measured: 12 months
Secondary outcomes (3)
Care-seeking to all sources
Change in % of caregivers who seek care for childhood diarrhea outside the home at month 12
Measured: 12 months
Prompt treatment of uncomplicated childhood diarrhoea with zinc and LO-ORS co-pack
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
Measured: 12 months
Caregivers receive information from private retailers
Change in % caregivers who indicate received information from private retailers about zinc and LO-ORS to treat uncomplicated childhood diarrhea at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 Mar 2021
- Primary completion2 Apr 2022
- Study completion2 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Diarrhea, InfantileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutrition International
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elijah Mbiti, Nutrition International
- Investigators
- Elijah Mbiti, MSc, Principal investigator, Nutrition International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335877
- Sponsor's protocol ID
- NI-01-2006-ZNIR
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2020
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
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.
PubMed 30243583UNICEF. 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.
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.
PubMed 20348128Munos 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.
PubMed 20348131International 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.
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.
PubMed 11406049Lazzerini 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.
PubMed 27996088Lamberti 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.
PubMed 26098305Carter 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.
PubMed 26282400
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04335877
- Acronym / sponsor ID
- NI-01-2006-ZNIR
- Conditions
- Diarrhea, Infantile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,245 participants (actual)
- Lead sponsor
- Nutrition InternationalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 2 Apr 2022 (actual)
- Study completion
- 2 Apr 2022 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Private sector component + modified BCC | Experimental | Other: Private sector component + modified BCCPrivate sector component + modified BCC + current standard of care |
| Control | No intervention | –Current standard of care + standard BCC |
Who may qualify
- Ages
- 2 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Private sector component + modified BCCIntervention group will be exposed to the private sector component + modified BCC and will receive current standard care | Other | Private sector component + modified BCC |
Primary outcome
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
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
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
Acceptability of private sector
Time frame: 1 month
% private retailers who express intention to stock co-packs after sensitization and training.
Acceptability of caregivers
Time frame: 12 months
% caregivers who indicate preferred treatment for uncomplicated childhood diarrhea is co-pack.at 12 months
Adoption by private sector at month 1
Time frame: 1 month
% private retailers who stock co-pack after 1 month
Adoption by private sector at month 2
Time frame: 2 months
% private retailers who stock co-pack after 2 months
Adoption by private sector at month 3
Time frame: 3 months
% private retailers who stock co-pack after 3 months
Adoption by private sector at month 4
Time frame: 4 months
% private retailers who stock co-pack after 4 months
Adoption by private sector at month 5
Time frame: 5 months
% private retailers who stock co-pack after 5 months
Adoption by private sector at month 6
Time frame: 6 months
% private retailers who stock co-pack after 6 months
Adoption by private sector at month 7
Time frame: 7 months
% private retailers who stock co-pack after 7 months
Adoption by private sector at month 8
Time frame: 8 months
% private retailers who stock co-pack after 8 months
Adoption by private sector at month 9
Time frame: 9 months
% private retailers who stock co-pack after 9 months
Adoption by private sector at month 10
Time frame: 10 months
% private retailers who stock co-pack after 10 months
Adoption by private sector at month 11
Time frame: 11 months
% private retailers who stock co-pack after 11 months
Adoption by private sector at month 12
Time frame: 12 months
% private retailers who stock co-pack after 12 months
Adoption by caregivers
Time frame: 12 months
% caregivers who indicate having co-pack in house
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
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
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
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
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
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
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
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
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
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
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
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
3 secondary outcomes
Care-seeking to all sources
Time frame: 12 months
Prompt treatment of uncomplicated childhood diarrhoea with zinc and LO-ORS co-pack
Time frame: 12 months
Caregivers receive information from private retailers
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- BackgroundUnited 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: PubMed 30243583GBD 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.
- BackgroundUNICEF. Diarrhoeal disease - UNICEF DATA. 2018. Available from: https://data.unicef.org/topic/child-health/diarrhoeal-disease. (Accessed 24 Sept 2019)
- BackgroundKDHS, 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: PubMed 20348128Walker 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.
- Background: PubMed 20348131Munos 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.
- BackgroundInternational 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.
- BackgroundWorld 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
- BackgroundInternational 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.
- BackgroundBradley, 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
- BackgroundACTwatch Group. (2015). ACTwatch Outlet Surveys 2013-2014 - ORS and Zinc Availability Findings from 9 Countries. Washington DC: PSI.
- Background: PubMed 11406049Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elijah Mbiti, MSc principal investigator
Nutrition International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Private sector component + modified BCC in people with Diarrhea, Infantile, run by Nutrition International at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of uncomplicated diarrhea (time frame: 12 months). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04335877, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.