TY - JOUR
T1 - The effectiveness of non-pyrethroid insecticide-treated durable wall lining to control malaria in rural Tanzania
T2 - Study protocol for a two-armed cluster randomized trial
AU - Mtove, George
AU - Mugasa, Joseph P.
AU - Messenger, Louisa A.
AU - Malima, Robert C.
AU - Mangesho, Peter
AU - Magogo, Franklin
AU - Plucinski, Mateusz
AU - Hashimu, Ramadhan
AU - Matowo, Johnson
AU - Shepard, Donald
AU - Batengana, Bernard
AU - Cook, Jackie
AU - Emidi, Basiliana
AU - Halasa, Yara
AU - Kaaya, Robert
AU - Kihombo, Aggrey
AU - Lindblade, Kimberly A.
AU - Makenga, Geofrey
AU - Mpangala, Robert
AU - Mwambuli, Abraham
AU - Mzava, Ruth
AU - Mziray, Abubakary
AU - Olang, George
AU - Oxborough, Richard M.
AU - Seif, Mohammed
AU - Sambu, Edward
AU - Samuels, Aaron
AU - Sudi, Wema
AU - Thomas, John
AU - Weston, Sophie
AU - Alilio, Martin
AU - Binkin, Nancy
AU - Gimnig, John
AU - Kleinschmidt, Immo
AU - McElroy, Peter
AU - Moulton, Lawrence H.
AU - Norris, Laura
AU - Ruebush, Trenton
AU - Venkatesan, Meera
AU - Rowland, Mark
AU - Mosha, Franklin W.
AU - Kisinza, William N.
N1 - Funding Information:
Funding for this project was provided by the US President’s Malaria Initiative (PMI) managed by University Research Co., LLC (URC) (Cooperative Agreement No. GHS-A-00-09-00015-00).
Publisher Copyright:
© 2016 The Author(s).
PY - 2016/7/25
Y1 - 2016/7/25
N2 - Background: Despite considerable reductions in malaria achieved by scaling-up long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS), maintaining sustained community protection remains operationally challenging. Increasing insecticide resistance also threatens to jeopardize the future of both strategies. Non-pyrethroid insecticide-treated wall lining (ITWL) may represent an alternate or complementary control method and a potential tool to manage insecticide resistance. To date no study has demonstrated whether ITWL can reduce malaria transmission nor provide additional protection beyond the current best practice of universal coverage (UC) of LLINs and prompt case management. Methods/design: A two-arm cluster randomized controlled trial will be conducted in rural Tanzania to assess whether non-pyrethroid ITWL and UC of LLINs provide added protection against malaria infection in children, compared to UC of LLINs alone. Stratified randomization based on malaria prevalence will be used to select 22 village clusters per arm. All 44 clusters will receive LLINs and half will also have ITWL installed on interior house walls. Study children, aged 6 months to 11 years old, will be enrolled from each cluster and followed monthly to estimate cumulative incidence of malaria parasitaemia (primary endpoint), time to first malaria episode and prevalence of anaemia before and after intervention. Entomological inoculation rate will be estimated using indoor CDC light traps and outdoor tent traps followed by detection of Anopheles gambiae species, sporozoite infection, insecticide resistance and blood meal source. ITWL bioefficacy and durability will be monitored using WHO cone bioassays and household surveys, respectively. Social and cultural factors influencing community and household ITWL acceptability will be explored through focus-group discussions and in-depth interviews. Cost-effectiveness, compared between study arms, will be estimated per malaria case averted. Discussion: This protocol describes the large-scale evaluation of a novel vector control product, designed to overcome some of the known limitations of existing methods. If ITWL is proven to be effective and durable under field conditions, it may warrant consideration for programmatic implementation, particularly in areas with long transmission seasons and where pyrethroid-resistant vectors predominate. Trial findings will provide crucial information for policy makers in Tanzania and other malaria-endemic countries to guide resource allocations for future control efforts. Trial registration: NCT02533336 registered on 13 July 2014.
AB - Background: Despite considerable reductions in malaria achieved by scaling-up long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS), maintaining sustained community protection remains operationally challenging. Increasing insecticide resistance also threatens to jeopardize the future of both strategies. Non-pyrethroid insecticide-treated wall lining (ITWL) may represent an alternate or complementary control method and a potential tool to manage insecticide resistance. To date no study has demonstrated whether ITWL can reduce malaria transmission nor provide additional protection beyond the current best practice of universal coverage (UC) of LLINs and prompt case management. Methods/design: A two-arm cluster randomized controlled trial will be conducted in rural Tanzania to assess whether non-pyrethroid ITWL and UC of LLINs provide added protection against malaria infection in children, compared to UC of LLINs alone. Stratified randomization based on malaria prevalence will be used to select 22 village clusters per arm. All 44 clusters will receive LLINs and half will also have ITWL installed on interior house walls. Study children, aged 6 months to 11 years old, will be enrolled from each cluster and followed monthly to estimate cumulative incidence of malaria parasitaemia (primary endpoint), time to first malaria episode and prevalence of anaemia before and after intervention. Entomological inoculation rate will be estimated using indoor CDC light traps and outdoor tent traps followed by detection of Anopheles gambiae species, sporozoite infection, insecticide resistance and blood meal source. ITWL bioefficacy and durability will be monitored using WHO cone bioassays and household surveys, respectively. Social and cultural factors influencing community and household ITWL acceptability will be explored through focus-group discussions and in-depth interviews. Cost-effectiveness, compared between study arms, will be estimated per malaria case averted. Discussion: This protocol describes the large-scale evaluation of a novel vector control product, designed to overcome some of the known limitations of existing methods. If ITWL is proven to be effective and durable under field conditions, it may warrant consideration for programmatic implementation, particularly in areas with long transmission seasons and where pyrethroid-resistant vectors predominate. Trial findings will provide crucial information for policy makers in Tanzania and other malaria-endemic countries to guide resource allocations for future control efforts. Trial registration: NCT02533336 registered on 13 July 2014.
KW - Cluster randomized controlled trial
KW - Entomological inoculation rate
KW - Insecticide resistance management
KW - Insecticide-treated wall lining
KW - Long-lasting insecticidal nets
KW - Malaria control
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U2 - 10.1186/s12889-016-3287-3
DO - 10.1186/s12889-016-3287-3
M3 - Article
C2 - 27456339
AN - SCOPUS:84979587779
SN - 1471-2458
VL - 16
JO - BMC public health
JF - BMC public health
IS - 1
M1 - 633
ER -