Malaria, FalciparumNCT02448745
Liberia Insecticide Treated Durable Wall Linings Study: Protocol for a Cluster Randomised Trial (DL)
A study testing Insecticide treated wall lining in people with Malaria, Falciparum and Anemia, run by The Mentor Initiative at 1 site in Liberia.
Trial summary
A cluster-randomized control trial will study the effect of insecticide-treated wall lining on malaria transmission in Bomi County, Liberia. Half of the villages enrolled in the study will receive insecticide-treated wall lining covering their walls and ceilings in addition to long-lasting insecticidal nets, while the… Read more about this study
- Who is it for?
- Ages 2 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum, Anemia
- What is being tested?
- Insecticide treated wall lining
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,317 participants
- Where
- 1 siteLiberia
- Study dates
- 1 Mar 2014to 1 Apr 2017
- 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 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child resides in village
- Child presents with parent or guardian
Who cannot join
- Child or guardian has history of Ebola exposure
- Child has 3 symptoms of Ebola
Trial locations and contacts
1 site in 1 country.
About this study
A cluster-randomized control trial will study the effect of insecticide-treated wall lining on malaria transmission in Bomi County, Liberia. Half of the villages enrolled in the study will receive insecticide-treated wall lining covering their walls and ceilings in addition to long-lasting insecticidal nets, while the other half will be protected by existing long-lasting insecticidal nets.
Read the detailed description
Long-lasting insecticidal nets (LLINs) are the established vector control product for malaria control. In Bomi County Liberia, LLINs have been distributed but malaria prevalence in children under 5 remains high, with prevalence in study villages found to be 42% in April 2014. The major malaria vector species are resistant to pyrethroid insecticides approved for use in LLINs, and new control measures with non-pyrethroid active ingredients may protect the population.
- Conditions
- Malaria, Falciparum, Anemia
- Being tested
- Insecticide treated wall lining
- Medical subject headings
- Malaria, Falciparum, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insecticide treated wall liningDevice
Also called Durable wall lining, PermaNet Lining
Polypropylene non-woven fabric.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 21 clusters composed of one or more villages with a total number of 30 to 70 children under 5 years old. Routine distribution of long-lasting insecticidal nets is the only malaria control intervention. |
| Intervention | Experimental | 21 clusters composed of one or more villages with a total of 30 to 70 children under 5 years old. Routine distribution of long-lasting insecticidal nets is available and in addition insecticide treated wall lining is installed in all sleeping areas with homeowner consent. All 4 walls and the ceiling are covered with lining. Receives: Device: Insecticide treated wall lining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria Prevalence
Tested by mRDT and PCR
Measured: 6 months
Secondary outcomes (3)
Hemoglobin
Hemoglobin measured by Hemocue 301
Measured: 6 months
Fever
Number of participants with Fever, defined as tympanic temperature above 37.5C
Measured: 6 months
Mosquito biting rate.
Mosquitoes trapped indoors and outdoors using light traps and exit traps.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study start1 Mar 2014
- Primary completion1 Jun 2016
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malaria, FalciparumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,317 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Mentor Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Liberia
- Responsible party
- Sponsor
- Investigators
- David J Giesbrecht, MSc, Principal investigator, Study Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448745
- Sponsor's protocol ID
- LiberiaDL
- Status last verified
- Apr 2018
- First submitted
- 15 May 2015
- Last updated
- 1 May 2018
- Results posted
- No
Publications
Giesbrecht D, Belleh TG, Pontarollo J, Hinneh VS, Pratt O, Kamal S, Allan R. Durable wall lining for malaria control in Liberia: results of a cluster randomized trial. Malar J. 2023 Jan 12;22(1):15. doi: 10.1186/s12936-022-04429-7.
PubMed 36635660
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberia Insecticide Treated Durable Wall Linings Study: Protocol for a Cluster Randomised Trial (DL)
- ClinicalTrials.gov ID
- NCT02448745
- Acronym / sponsor ID
- LiberiaDL
- Conditions
- Malaria, Falciparum, Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,317 participants (actual)
- Lead sponsor
- The Mentor InitiativeUniversity, hospital or other
- Collaborators
- Ministry of Health, Liberia
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 19 May 2015 (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.
A cluster-randomized control trial will study the effect of insecticide-treated wall lining on malaria transmission in Bomi County, Liberia. Half of the villages enrolled in the study will receive insecticide-treated wall lining covering their walls and ceilings in addition to long-lasting insecticidal nets, while the other half will be protected by existing long-lasting insecticidal nets.
Detailed description
Long-lasting insecticidal nets (LLINs) are the established vector control product for malaria control. In Bomi County Liberia, LLINs have been distributed but malaria prevalence in children under 5 remains high, with prevalence in study villages found to be 42% in April 2014. The major malaria vector species are resistant to pyrethroid insecticides approved for use in LLINs, and new control measures with non-pyrethroid active ingredients may protect the population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –21 clusters composed of one or more villages with a total number of 30 to 70 children under 5 years old. Routine distribution of long-lasting insecticidal nets is the only malaria control intervention. |
| Intervention | Experimental | Device: Insecticide treated wall lining21 clusters composed of one or more villages with a total of 30 to 70 children under 5 years old. Routine distribution of long-lasting insecticidal nets is available and in addition insecticide treated wall lining is installed in all sleeping areas with homeowner consent. All 4 walls and the ceiling are covered with lining. |
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Child resides in village
- Child presents with parent or guardian
Key exclusion criteria (2 listed)
- Child or guardian has history of Ebola exposure
- Child has 3 symptoms of Ebola
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 wall liningAlso: Durable wall lining, PermaNet LiningPolypropylene non-woven fabric. | Device | Intervention |
Primary outcome
Malaria Prevalence
Time frame: 6 months
Tested by mRDT and PCR
3 secondary outcomes
Hemoglobin
Time frame: 6 months
Fever
Time frame: 6 months
Mosquito biting rate.
Time frame: 2 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 1 May 2018.
- Derived from this study: PubMed 36635660Giesbrecht D, Belleh TG, Pontarollo J, Hinneh VS, Pratt O, Kamal S, Allan R. Durable wall lining for malaria control in Liberia: results of a cluster randomized trial. Malar J. 2023 Jan 12;22(1):15. doi: 10.1186/s12936-022-04429-7.
- The MENTOR InitiativeLink 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.
David J Giesbrecht, MSc principal investigator
Study Coordinator
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 wall lining in people with Malaria, Falciparum and Anemia, run by The Mentor Initiative at 1 site in Liberia.
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 2 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 1 May 2018. 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 Liberia. 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?
Malaria Prevalence (time frame: 6 months). 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 NCT02448745, which also lists 1 linked publication.
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 1 May 2018.