The effectiveness of non-pyrethroid insecticide-treated durable wall lining to control malaria in rural Tanzania: Study protocol for a two-armed cluster randomized trial

George Mtove, Joseph P. Mugasa, Louisa A. Messenger, Robert C. Malima, Peter Mangesho, Franklin Magogo, Mateusz Plucinski, Ramadhan Hashimu, Johnson Matowo, Donald Shepard, Bernard Batengana, Jackie Cook, Basiliana Emidi, Yara Halasa, Robert Kaaya, Aggrey Kihombo, Kimberly A. Lindblade, Geofrey Makenga, Robert Mpangala, Abraham MwambuliRuth Mzava, Abubakary Mziray, George Olang, Richard M. Oxborough, Mohammed Seif, Edward Sambu, Aaron Samuels, Wema Sudi, John Thomas, Sophie Weston, Martin Alilio, Nancy Binkin, John Gimnig, Immo Kleinschmidt, Peter McElroy, Lawrence Hale Moulton, Laura Norris, Trenton Ruebush, Meera Venkatesan, Mark Rowland, Franklin W. Mosha, William N. Kisinza

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Article number633
JournalBMC Public Health
Volume16
Issue number1
DOIs
StatePublished - Jul 25 2016

Fingerprint

Tanzania
Insecticides
Malaria
Universal Coverage
Insecticide Resistance
Anopheles gambiae
Sporozoites
Pyrethrins
Parasitemia
Resource Allocation
Case Management
Centers for Disease Control and Prevention (U.S.)
Random Allocation
Infection
Focus Groups
Administrative Personnel
Practice Guidelines
Biological Assay
Cost-Benefit Analysis
Meals

Keywords

  • Cluster randomized controlled trial
  • Entomological inoculation rate
  • Insecticide resistance management
  • Insecticide-treated wall lining
  • Long-lasting insecticidal nets
  • Malaria control

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

The effectiveness of non-pyrethroid insecticide-treated durable wall lining to control malaria in rural Tanzania : Study protocol for a two-armed cluster randomized trial. / Mtove, George; Mugasa, Joseph P.; Messenger, Louisa A.; Malima, Robert C.; Mangesho, Peter; Magogo, Franklin; Plucinski, Mateusz; Hashimu, Ramadhan; Matowo, Johnson; Shepard, Donald; Batengana, Bernard; Cook, Jackie; Emidi, Basiliana; Halasa, Yara; Kaaya, Robert; Kihombo, Aggrey; Lindblade, Kimberly A.; Makenga, Geofrey; Mpangala, Robert; Mwambuli, Abraham; Mzava, Ruth; Mziray, Abubakary; Olang, George; Oxborough, Richard M.; Seif, Mohammed; Sambu, Edward; Samuels, Aaron; Sudi, Wema; Thomas, John; Weston, Sophie; Alilio, Martin; Binkin, Nancy; Gimnig, John; Kleinschmidt, Immo; McElroy, Peter; Moulton, Lawrence Hale; Norris, Laura; Ruebush, Trenton; Venkatesan, Meera; Rowland, Mark; Mosha, Franklin W.; Kisinza, William N.

In: BMC Public Health, Vol. 16, No. 1, 633, 25.07.2016.

Research output: Contribution to journalArticle

Mtove, G, Mugasa, JP, Messenger, LA, Malima, RC, Mangesho, P, Magogo, F, Plucinski, M, Hashimu, R, Matowo, J, Shepard, D, Batengana, B, Cook, J, Emidi, B, Halasa, Y, Kaaya, R, Kihombo, A, Lindblade, KA, Makenga, G, Mpangala, R, Mwambuli, A, Mzava, R, Mziray, A, Olang, G, Oxborough, RM, Seif, M, Sambu, E, Samuels, A, Sudi, W, Thomas, J, Weston, S, Alilio, M, Binkin, N, Gimnig, J, Kleinschmidt, I, McElroy, P, Moulton, LH, Norris, L, Ruebush, T, Venkatesan, M, Rowland, M, Mosha, FW & Kisinza, WN 2016, 'The effectiveness of non-pyrethroid insecticide-treated durable wall lining to control malaria in rural Tanzania: Study protocol for a two-armed cluster randomized trial', BMC Public Health, vol. 16, no. 1, 633. https://doi.org/10.1186/s12889-016-3287-3
Mtove, George ; Mugasa, Joseph P. ; Messenger, Louisa A. ; Malima, Robert C. ; Mangesho, Peter ; Magogo, Franklin ; Plucinski, Mateusz ; Hashimu, Ramadhan ; Matowo, Johnson ; Shepard, Donald ; Batengana, Bernard ; Cook, Jackie ; Emidi, Basiliana ; Halasa, Yara ; Kaaya, Robert ; Kihombo, Aggrey ; Lindblade, Kimberly A. ; Makenga, Geofrey ; Mpangala, Robert ; Mwambuli, Abraham ; Mzava, Ruth ; Mziray, Abubakary ; Olang, George ; Oxborough, Richard M. ; Seif, Mohammed ; Sambu, Edward ; Samuels, Aaron ; Sudi, Wema ; Thomas, John ; Weston, Sophie ; Alilio, Martin ; Binkin, Nancy ; Gimnig, John ; Kleinschmidt, Immo ; McElroy, Peter ; Moulton, Lawrence Hale ; Norris, Laura ; Ruebush, Trenton ; Venkatesan, Meera ; Rowland, Mark ; Mosha, Franklin W. ; Kisinza, William N. / The effectiveness of non-pyrethroid insecticide-treated durable wall lining to control malaria in rural Tanzania : Study protocol for a two-armed cluster randomized trial. In: BMC Public Health. 2016 ; Vol. 16, No. 1.
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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 Hale

AU - Norris, Laura

AU - Ruebush, Trenton

AU - Venkatesan, Meera

AU - Rowland, Mark

AU - Mosha, Franklin W.

AU - Kisinza, William N.

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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