Infantile DiarrheaNCT02870491
Working With Community Health Workers to Increase ORS Use in Uganda
A study testing Free Distribution and Preemptive Delivery in people with Infantile Diarrhea and Diarrhea, run by University of California, Berkeley.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Infantile Diarrhea, Diarrhea, Dehydration
- What is being tested?
- Free Distribution and Preemptive Delivery
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,949 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jan 2019
- 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 Up to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 0-59 months that reside on a village recruited to participate in the study will be included in the intervention. Only children with a diarrhea episode 4-weeks prior to data collection will be included in the analysis.
Who cannot join
- Children without a diarrhea episode in the weeks prior to data collection will be excluded from the analysis.
About this study
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).
Read the detailed description
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.
- Conditions
- Infantile Diarrhea, Diarrhea, Dehydration
- Being tested
- Free Distribution, Preemptive Delivery
- Keywords
- Child Diarrhea, Cluster Randomized Controlled Trial, Oral Rehydration, ORS, Zinc, Brac, Community Health Workers, Uganda
- Medical subject headings
- Diarrhea, Infantile, Diarrhea, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free DistributionBehavioural
Caretakers of children under 5-years-old will have access to free ORS and zinc
Preemptive DeliveryBehavioural
Caretakers of children under 5-years-old will have ORS and zinc delivered to their home
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Existing standard of care. |
| Free Distribute+Preemptive Delivery | Experimental | Community health workers (CHWs) will deliver oral rehydration salts (ORS) and zinc for free to all households in their catchment area with a child under 5-years-old at the beginning of the study. Receives: Behavioral: Free Distribution; Behavioral: Preemptive Delivery |
| Cost Sharing + Preemptive Delivery | Experimental | CHWs will visit all households with a child under 5-years-old at the beginning of the study and offer to sell ORS and zinc to caretakers at the time of the visit for them to store in their homes. Receives: Behavioral: Preemptive Delivery |
| Free Distribution Upon Retrieval | Experimental | CHWs will visit all households with a child under 5-years-old at the beginning of the study and inform caretakers that they have ORS and zinc available for free that caretakers can retrieved from the CHWs home if needed. Receives: Behavioral: Free Distribution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral rehydration salt (ORS) use
Caretaker-reported ORS use to treat a diarrhea episode in the last 4 weeks
Measured: Last 4 weeks
Secondary outcomes (4)
Oral rehydration salt (ORS) with Zinc use
Caretaker-reported ORS + zinc use to treat a diarrhea episode in the last 4 weeks
Measured: Last 4 weeks
Antibiotic use
Caretaker-reported antibiotic use to treat a diarrhea episode in the last 4 weeks
Measured: Last 4 weeks
Time to Oral rehydration salt (ORS) use
Caretaker-reported time from diarrhea initiation to ORS use
Measured: Last 4 weeks
Time to zinc use
Caretaker-reported time from diarrhea initiation to zinc use
Measured: Last 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile DiarrheaStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,949 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870491
- Sponsor's protocol ID
- ZW-03-28-1983
- Status last verified
- Apr 2019
- First submitted
- 9 Aug 2016
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be made available to the public after the results are published
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02870491
- Acronym / sponsor ID
- ZW-03-28-1983
- Conditions
- Infantile Diarrhea, Diarrhea, Dehydration
- Keywords
- Child Diarrhea, Cluster Randomized Controlled Trial, Oral Rehydration, ORS, Zinc, Brac, Community Health Workers, Uganda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,949 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Makerere University
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 17 Aug 2016 (estimated)
- 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.
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).
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Existing standard of care. |
| Free Distribute+Preemptive Delivery | Experimental | Behavioral: Free Distribution, Behavioral: Preemptive DeliveryCommunity health workers (CHWs) will deliver oral rehydration salts (ORS) and zinc for free to all households in their catchment area with a child under 5-years-old at the beginning of the study. |
| Cost Sharing + Preemptive Delivery | Experimental | Behavioral: Preemptive DeliveryCHWs will visit all households with a child under 5-years-old at the beginning of the study and offer to sell ORS and zinc to caretakers at the time of the visit for them to store in their homes. |
| Free Distribution Upon Retrieval | Experimental | Behavioral: Free DistributionCHWs will visit all households with a child under 5-years-old at the beginning of the study and inform caretakers that they have ORS and zinc available for free that caretakers can retrieved from the CHWs home if needed. |
Who may qualify
- Ages
- Up to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 0-59 months that reside on a village recruited to participate in the study will be included in the intervention. Only children with a diarrhea episode 4-weeks prior to data collection will be included in the analysis.
Key exclusion criteria (1 listed)
- Children without a diarrhea episode in the weeks prior to data collection will be excluded from the analysis.
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 |
|---|---|---|
| Free DistributionCaretakers of children under 5-years-old will have access to free ORS and zinc | Behavioural | Free Distribute+Preemptive Delivery, Free Distribution Upon Retrieval |
| Preemptive DeliveryCaretakers of children under 5-years-old will have ORS and zinc delivered to their home | Behavioural | Cost Sharing + Preemptive Delivery, Free Distribute+Preemptive Delivery |
Primary outcome
Oral rehydration salt (ORS) use
Time frame: Last 4 weeks
Caretaker-reported ORS use to treat a diarrhea episode in the last 4 weeks
4 secondary outcomes
Oral rehydration salt (ORS) with Zinc use
Time frame: Last 4 weeks
Antibiotic use
Time frame: Last 4 weeks
Time to Oral rehydration salt (ORS) use
Time frame: Last 4 weeks
Time to zinc use
Time frame: Last 4 weeks
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 8 Apr 2019.
- Individual participant dataSharing planned: Yes. Data will be made available to the public after the results are published
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Free Distribution and Preemptive Delivery in people with Infantile Diarrhea and Diarrhea, run by University of California, Berkeley.
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 1 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 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Oral rehydration salt (ORS) use (time frame: Last 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2019.