MalariaOutgrowersNCT01397851
Stimulating Private Sector Malaria Control
A study testing Insecticide-treated net (BASF Incerceptor) in people with Malaria, run by PATH at 1 site in Zambia.
Trial summary
Preliminary evidence from ongoing research provides strong indications that protecting farmers from malaria would be profitable for outgrowing agribusinesses in sub-Saharan Africa. The study team invests in experimental research to investigate this conjecture in more detail. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Insecticide-treated net (BASF Incerceptor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81,597 participants
- Where
- 1 siteZambia
- Study dates
- Dec 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Farmers who contracted with the participating cotton outgrowing company in the 2010-2011 season
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stimulating Private Sector Malaria Control: The Outgrower Opportunity
Preliminary evidence from ongoing research provides strong indications that protecting farmers from malaria would be profitable for outgrowing agribusinesses in sub-Saharan Africa. The study team invests in experimental research to investigate this conjecture in more detail.
Read the detailed description
The study evaluates whether the sourcing of insecticide-treated nets and their distribution to smallholder farmers for free would be a profitable investment for a cotton outgrowing agribusiness in Zambia.
The study therefore carries out a major net distribution through the existing distribution channels of a cotton outgrowing agribusiness, evaluates the impact of this distribution on smallholder cotton yields, and values the profitability implications for the outgrowing agribusiness.
- Conditions
- Malaria
- Being tested
- Insecticide-treated net (BASF Incerceptor)
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insecticide-treated net (BASF Incerceptor)Device
One per farmer, once during the 2010-2011 season
| Study group | Role | What they receive |
|---|---|---|
| Treatment: Insecticide-treated net | Experimental | Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net Receives: Device: Insecticide-treated net (BASF Incerceptor) |
| Control | No intervention | Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cotton Yields
Farmer's cotton yields (kg delivered per household), as defined in the routine data collection system of the participating cotton outgrowing agribusiness
Measured: 2010-2011 season (up to 1 year)
Secondary outcomes (3)
Contract Defaults
Defaults on input loans, as defined in the routine data collection system of the participating cotton outgrowing agribusiness. Odds ratios calculated in accordance with NIH guidance: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/
Measured: 2010-2011 season (up to 1 year)
Increase in Maize Productivity
Increase in self-reported maize productivity (yield on maize plots divided by size of maize plots), collected through validation survey; calculated as maize productivity 2010-11 minus maize productivity 2009-10, measured in bags (ordinarily 50kg bags; however, kg measure not specified)
Measured: 2009-2010 and 2010-2011 seasons (up to 2 years)
Self-reported Malaria Prevalence
Over two weeks before interview, collected through validation survey. Odds ratio calculated in accordance with NIH guidance http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/
Measured: 2010-2011 season (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MalariaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81,597 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Trias, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397851
- Sponsor's protocol ID
- PATH Outgrowers
- Acronym
- Outgrowers
- Status last verified
- Nov 2023
- First submitted
- 21 Jun 2011
- Last updated
- 15 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating Private Sector Malaria Control: The Outgrower Opportunity
- ClinicalTrials.gov ID
- NCT01397851
- Acronym / sponsor ID
- Outgrowers / PATH Outgrowers
- Conditions
- Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81,597 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Posted 15 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preliminary evidence from ongoing research provides strong indications that protecting farmers from malaria would be profitable for outgrowing agribusinesses in sub-Saharan Africa. The study team invests in experimental research to investigate this conjecture in more detail.
Detailed description
The study evaluates whether the sourcing of insecticide-treated nets and their distribution to smallholder farmers for free would be a profitable investment for a cotton outgrowing agribusiness in Zambia.
The study therefore carries out a major net distribution through the existing distribution channels of a cotton outgrowing agribusiness, evaluates the impact of this distribution on smallholder cotton yields, and values the profitability implications for the outgrowing agribusiness.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment: Insecticide-treated net | Experimental | Device: Insecticide-treated net (BASF Incerceptor)Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net |
| Control | No intervention | –Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Farmers who contracted with the participating cotton outgrowing company in the 2010-2011 season
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Insecticide-treated net (BASF Incerceptor)One per farmer, once during the 2010-2011 season | Device | Treatment: Insecticide-treated net |
Primary outcome
Cotton Yields
Time frame: 2010-2011 season (up to 1 year)
Farmer's cotton yields (kg delivered per household), as defined in the routine data collection system of the participating cotton outgrowing agribusiness
3 secondary outcomes
Contract Defaults
Time frame: 2010-2011 season (up to 1 year)
Increase in Maize Productivity
Time frame: 2009-2010 and 2010-2011 seasons (up to 2 years)
Self-reported Malaria Prevalence
Time frame: 2010-2011 season (up to 1 year)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- status update as of 2 April 2013Link provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insecticide-treated net (BASF Incerceptor) in people with Malaria, run by PATH at 1 site in Zambia.
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 0 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 15 Dec 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 Zambia. 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?
Yes. Results are posted in the registry (first posted 15 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cotton Yields (time frame: 2010-2011 season (up to 1 year)). 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 15 Dec 2023.