Clinical trial NCT01456858: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: Malaria Prevention Refugee Emergency
Malaria, Falciparum C03.752.530.650
Lead sponsor: The Mentor Initiative
Sponsor class: OTHER
Collaborators: name: ECHO
name: UNHCR Country Office Freetown
name: World Health Organization
name: Wageningen University
name: London School of Hygiene and Tropical Medicine
name: National Malaria Control Programme Sierra Leone
name: Institut de Recherche pour le Developpement
First posted: 2011-10-21
Enrollment: 222
Sex: ALL
Minimum age (years): 4
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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?"

Primary outcomes:
measure: Malaria Incidence
timeFrame: 8 months
Secondary outcomes:
measure: Anaemia (From Haemoglobin levels)
timeFrame: 8 months
measure: Adverse Event to ITPS
timeFrame: 8 Months
Other outcomes:
Locations:
city: Freetown
country: Sierra Leone
facility: The Mentor Initiative
Study officials:
affiliation: Wageningen University
name: Matthew R Burns, BSc MSc PhD viva pending
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.