A Phase 3 interventional study of Insecticide Treated Polyethylene Sheeting and Untreated Plastic Sheeting in Malaria, sponsored by The Mentor Initiative. Completed at 1 site in Sierra Leone. Open to participants aged 4 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-21.
Sponsored by The Mentor Initiative · Phase 3, Interventional, and Prevention
A Phase III malaria prevention trial was conducted in two camps of Liberian refugees in Sierra Leone using Insecticide Treated Polyethylene Sheeting (ITPS) or untreated polyethylene sheeting (UPS) randomly deployed to defined sectors of each camp. The ITPS was impregnated with pyrethroid insecticide during manufacture. In Largo camp the ITPS or UPS was attached to inner walls and ceilings of shelters, while in Tobanda the ITPS or UPS was used to line the ceiling and roof only. Cohorts of children up to 3 years of age were cleared of malaria parasites and monitored for up to 8 months post construction for possible malaria re-infection. Installation teams and refugee groups were blinded as to whether the sheeting was insecticide treated or not.
During the last decade public and private sector organisations, under the leadership of the Roll Back Malaria (RBM) Initiative, have recognised the need to work together to bring complementary expertise to the task of identifying and developing vector control tools appropriate to humanitarian crises. Insecticide Treated Polyethylene Sheeting (ITPS), is one such tool emerging from this process and is being produced commercially. ITPS is based on the standard polyethylene sheeting that is issued routinely as temporary shelter for people affected by emergencies. During manufacture the pyrethroid insecticide, deltamethrin, is extruded with the polyethylene into three-ply laminated sheets, comprising an inner low-density laminate and two, outer high-density laminates. The insecticide release characteristics enable the deltamethrin to diffuse slowly to the outer surfaces and to become available for pick-up by any insect that lands on the surface. Consequently ITPS has dual purpose: to provide shelter but with vector-control potential. Deployment and erection of ITPS is done in the same way as standard tarpaulin shelters.
Until now evaluation of ITPS has been limited to small scale entomological testing in scientifically controlled environment 'entomological platforms' in Asian and 'experimental huts' in rural African settings (Refer to Citation Section). Before any novel control tool can go forward for recommendation by the WHO, or be used routinely in humanitarian crises, clear demonstration of impact on malaria morbidity in emergency refugee settings is essential. A Phase III field evaluation was therefore conducted to evaluate the impact of ITPS on malaria incidence in young children in an area of intense transmission. A unique feature of this trial was its setting - a true emergency - in two newly built refugee camps for Liberian refugees displaced to Sierra Leone. The findings offer insight into the effectiveness of ITPS when used in a scenario for which it was purposefully designed.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 222 is below the median of 252 across 937 interventional studies indexed under Malaria.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children 4months-36months enrolled who resided in Largo refugee camp under Untreated plastic sheeting (interior wall and ceiling lining)
Other: Untreated Plastic Sheeting
Children 4months-36months enrolled who resided in Largo refugee camp under Insecticide treated plastic sheeting (interior wall and ceiling lining)
Other: Insecticide Treated Polyethylene Sheeting
Children 4months-36months enrolled who resided in Tobanda refugee camp under Untreated plastic sheeting (ceiling and interior roof lining)
Other: Untreated Plastic Sheeting
Children 4months-36months enrolled who resided in Tobanda refugee camp under Insecticide treated plastic sheeting (ceiling and interior roof lining)
Other: Insecticide Treated Polyethylene Sheeting
Insecticide Treated Polyethylene Sheeting is based on the standard polyethylene sheeting that is issued routinely as temporary shelter for people affected by emergencies. During manufacture the pyrethroid insecticide, deltamethrin, is extruded with the polyethylene into three-ply laminated sheets, comprising an inner low-density laminate and two, outer high-density laminates. The insecticide release characteristics enable the deltamethrin to diffuse slowly to the outer surfaces and to become available for pick-up by any insect that lands on the surface.
Also known as: Zerofly
Standard polyethylene sheeting that is issued routinely as temporary shelter for people affected by emergencies. Standard untreated plastic sheeting is Identical to ITPS but without the incorporation of insecticide.
Malaria Incidence
The primary outcome was the malaria incidence rate between children in each study arm (ITPS V's UPS) in each refugee camp. Between Dec 2003 and July 2004, daily monitoring of children in both camps was conducted from health screening points. Any child presenting with fever or reported fever in the last 24 hours was administered a clinical questionnaire based on the Integrated Management of Childhood Illness (IMCI), after which a RDT was taken to confirm malaria positivity. Malaria incidence rate was estimated as the total number of malaria episodes per person year over the course of the trial.
Time frame: 8 months
Anaemia (From Haemoglobin levels)
In each study cohort (ITPS V's UPS arms in two camps) haemoglobin levels were monitored at 3 monthly intervals (three times during the 8 month monitoring period) using a HemoCue® photometer that was calibrated daily when used.
Time frame: 8 months
Adverse Event to ITPS
Symptoms or conditions considered to be potential adverse events related to ITPS usage (dizziness, inflamed/watery eyes, mucosal irritation, muscle cramps/tremors, nausea, runny nose, skin burning, skin itching, skin paraesthesia, skin rash, skin redness, sneezing and tachycardia (pulse rate \>150)) were recorded during the monitoring period in both ITPS and UPS intervention arms in each camp. A symptom listed repeatedly within a seven day period for each child was considered to be the same adverse event as was any child having more than one of the symptoms present on a single day.
Time frame: 8 Months
This study is completed, as verified in Nov 2003. You cannot join it, but the record below documents what was studied.
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