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Insecticide Treated Polyethylene Sheeting for Prevention of Malaria in Emergencies

Primary Purpose

Malaria

Status
Completed
Phase
Phase 3
Locations
Sierra Leone
Study Type
Interventional
Intervention
Insecticide Treated Polyethylene Sheeting
Untreated Plastic Sheeting
Sponsored by
The Mentor Initiative
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Malaria Prevention Refugee Emergency, Malaria, Falciparum C03.752.530.650

Eligibility Criteria

4 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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?"

Sites / Locations

  • The Mentor Initiative

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Child UPS Largo Camp

Child ITPS Largo Camp

Child UPS Tobanda Camp

Child ITPS Tobanda Camp

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 19, 2011
Last Updated
October 20, 2011
Sponsor
The Mentor Initiative
Collaborators
ECHO, UNHCR Country Office Freetown, World Health Organization, Wageningen University, London School of Hygiene and Tropical Medicine, National Malaria Control Programme Sierra Leone, Institut de Recherche pour le Developpement
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1. Study Identification

Unique Protocol Identification Number
NCT01456858
Brief Title
Insecticide Treated Polyethylene Sheeting for Prevention of Malaria in Emergencies
Official Title
Insecticide Treated Polyethylene Sheeting for Prevention of Malaria in Emergencies: an Observational Cohort Study in a Refugee Setting in Sierra Leone
Study Type
Interventional

2. Study Status

Record Verification Date
November 2003
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Mentor Initiative
Collaborators
ECHO, UNHCR Country Office Freetown, World Health Organization, Wageningen University, London School of Hygiene and Tropical Medicine, National Malaria Control Programme Sierra Leone, Institut de Recherche pour le Developpement

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria Prevention Refugee Emergency, Malaria, Falciparum C03.752.530.650

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child UPS Largo Camp
Arm Type
Placebo Comparator
Arm Description
Children 4months-36months enrolled who resided in Largo refugee camp under Untreated plastic sheeting (interior wall and ceiling lining)
Arm Title
Child ITPS Largo Camp
Arm Type
Experimental
Arm Description
Children 4months-36months enrolled who resided in Largo refugee camp under Insecticide treated plastic sheeting (interior wall and ceiling lining)
Arm Title
Child UPS Tobanda Camp
Arm Type
Placebo Comparator
Arm Description
Children 4months-36months enrolled who resided in Tobanda refugee camp under Untreated plastic sheeting (ceiling and interior roof lining)
Arm Title
Child ITPS Tobanda Camp
Arm Type
Experimental
Arm Description
Children 4months-36months enrolled who resided in Tobanda refugee camp under Insecticide treated plastic sheeting (ceiling and interior roof lining)
Intervention Type
Other
Intervention Name(s)
Insecticide Treated Polyethylene Sheeting
Other Intervention Name(s)
Zerofly
Intervention Description
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
Intervention Name(s)
Untreated Plastic Sheeting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Malaria Incidence
Description
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
Secondary Outcome Measure Information:
Title
Anaemia (From Haemoglobin levels)
Description
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
Title
Adverse Event to ITPS
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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?"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew R Burns, BSc MSc PhD viva pending
Organizational Affiliation
Wageningen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mentor Initiative
City
Freetown
Country
Sierra Leone

12. IPD Sharing Statement

Citations:
PubMed Identifier
12510893
Citation
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.
Results Reference
result
PubMed Identifier
16640611
Citation
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.
Results Reference
result
PubMed Identifier
19843332
Citation
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.
Results Reference
result
PubMed Identifier
20682050
Citation
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.
Results Reference
result
PubMed Identifier
20682865
Citation
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.
Results Reference
result

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Insecticide Treated Polyethylene Sheeting for Prevention of Malaria in Emergencies

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