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Insecticide Treated Polyethylene Sheeting for Prevention of Malaria in Emergencies

NCT ID: NCT01456858

Last Updated: 2011-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2004-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Child UPS Largo Camp

Children 4months-36months enrolled who resided in Largo refugee camp under Untreated plastic sheeting (interior wall and ceiling lining)

Group Type PLACEBO_COMPARATOR

Untreated Plastic Sheeting

Intervention Type OTHER

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.

Child ITPS Largo Camp

Children 4months-36months enrolled who resided in Largo refugee camp under Insecticide treated plastic sheeting (interior wall and ceiling lining)

Group Type EXPERIMENTAL

Insecticide Treated Polyethylene Sheeting

Intervention Type OTHER

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.

Child UPS Tobanda Camp

Children 4months-36months enrolled who resided in Tobanda refugee camp under Untreated plastic sheeting (ceiling and interior roof lining)

Group Type PLACEBO_COMPARATOR

Untreated Plastic Sheeting

Intervention Type OTHER

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.

Child ITPS Tobanda Camp

Children 4months-36months enrolled who resided in Tobanda refugee camp under Insecticide treated plastic sheeting (ceiling and interior roof lining)

Group Type EXPERIMENTAL

Insecticide Treated Polyethylene Sheeting

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Untreated Plastic Sheeting

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.

Intervention Type OTHER

Other Intervention Names

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Zerofly

Eligibility Criteria

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Inclusion Criteria

* Resident of LARGO or TOBANDA Refugee Camp, Sierra Leone, West Africa
* Child whose guardian has given informed consent for their child to be enrolled into monitoring
* Child aged 4 months to 3 years

Exclusion Criteria

* Residents who answer "Yes" to the question, "Do you anticipate/plan on moving out of this shelter or camp in the next 6-12 months?"
* Children who have a serious illness other than malaria, based on guardian report.
* Children who have experienced adverse reactions to Amodiaquine or Artesunate on a previous occasion.
* Guardians of children who answer "Yes" to the question, "Do you anticipate/plan on moving out of this shelter or camp in the next 12 months?"
Minimum Eligible Age

4 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ECHO

UNKNOWN

Sponsor Role collaborator

UNHCR Country Office Freetown

UNKNOWN

Sponsor Role collaborator

World Health Organization

OTHER

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

National Malaria Control Programme Sierra Leone

UNKNOWN

Sponsor Role collaborator

Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role collaborator

The Mentor Initiative

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew R Burns, BSc MSc PhD viva pending

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

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The Mentor Initiative

Freetown, , Sierra Leone

Site Status

Countries

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Sierra Leone

References

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Graham K, Mohammad N, Rehman H, Nazari A, Ahmad M, Kamal M, Skovmand O, Guillet P, Allan R, Zaim M, Yates A, Lines J, Rowland M. Insecticide-treated plastic tarpaulins for control of malaria vectors in refugee camps. Med Vet Entomol. 2002 Dec;16(4):404-8. doi: 10.1046/j.1365-2915.2002.00395.x.

Reference Type RESULT
PMID: 12510893 (View on PubMed)

Diabate A, Chandre F, Rowland M, N'guessan R, Duchon S, Dabire KR, Hougard JM. The indoor use of plastic sheeting pre-impregnated with insecticide for control of malaria vectors. Trop Med Int Health. 2006 May;11(5):597-603. doi: 10.1111/j.1365-3156.2006.01605.x.

Reference Type RESULT
PMID: 16640611 (View on PubMed)

Djenontin A, Chabi J, Baldet T, Irish S, Pennetier C, Hougard JM, Corbel V, Akogbeto M, Chandre F. Managing insecticide resistance in malaria vectors by combining carbamate-treated plastic wall sheeting and pyrethroid-treated bed nets. Malar J. 2009 Oct 20;8:233. doi: 10.1186/1475-2875-8-233.

Reference Type RESULT
PMID: 19843332 (View on PubMed)

Chandre F, Dabire RK, Hougard JM, Djogbenou LS, Irish SR, Rowland M, N'guessan R. Field efficacy of pyrethroid treated plastic sheeting (durable lining) in combination with long lasting insecticidal nets against malaria vectors. Parasit Vectors. 2010 Aug 3;3(1):65. doi: 10.1186/1756-3305-3-65.

Reference Type RESULT
PMID: 20682050 (View on PubMed)

Djenontin A, Chandre F, Dabire KR, Chabi J, N'guessan R, Baldet T, Akogbeto M, Corbel V. Indoor use of plastic sheeting impregnated with carbamate combined with long-lasting insecticidal mosquito nets for the control of pyrethroid-resistant malaria vectors. Am J Trop Med Hyg. 2010 Aug;83(2):266-70. doi: 10.4269/ajtmh.2010.10-0012.

Reference Type RESULT
PMID: 20682865 (View on PubMed)

Other Identifiers

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TPS_210_202_01033/01034/01035

Identifier Type: -

Identifier Source: org_study_id