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

Study Protocol

Yara Halasa¹  Jackie Cook²  Sophie Weston²  Louisa A. Messenger²  Immo Kleinschmidt²  Mark Rowland²  Lawrence H. Moulton³  Johnson Matowo⁴  Franklin W. Mosha⁴  Robert Kaaya⁴  Basiliana Emidi⁵  Aaron Samuels⁶  Kimberly A. Lindblade⁶  John Gimnig⁶  Joseph P. Mugasa⁷  Bernard Batengana⁷  Ruth Mzava⁷  George Olang⁷  Ramadhan Hashimu⁷  Robert C. Malima⁷  Abraham Mwambuli⁷  Peter Mangesho⁷  Mohammed Seif⁷  Edward Sambu⁷  George Mtove⁷  Robert Mpangala⁷  Wema Sudi⁷  Geofrey Makenga⁷  William N. Kisinza⁷  Aggrey Kihombo⁷  Abubakary Mziray⁷  Franklin Magogo⁷  Donald Shepard⁸  Richard M. Oxborough⁹  John Thomas^1,10  Meera Venkatesan^1,11  Laura Norris^1,11  Martin Alilio^1,11  Trenton Ruebush^1,12  Nancy Binkin^1,12  Mateusz Plucinski^1,13  Peter McElroy^1,13 

[1] Brandeis University, Heller School, Waltham, Massachusetts, USA;Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK;Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA;Kilimanjaro Christian Medical College, Moshi, Tanzania;Kilimanjaro Christian Medical College, Moshi, Tanzania;National Institute for Medical Research, Headquarters, Dar es Salaam, Tanzania;Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA;National Institute for Medical Research, Amani Research Centre, Muheza, Tanzania;National Institute for Medical Research, Headquarters, Dar es Salaam, Tanzania;PMI Africa Indoor Residual Spraying Project, Abt Associates, London, UK;Phoenix Ordinary LLC, Bridgewater, New Jersey, USA;President’s Malaria Initiative, United States Agency for International Development, Washington DC, USA;Translating Research into Action Project (TRAction) University Research Co., LLC, Bethesda, Maryland, USA;US President’s Malaria Initiative, Atlanta, GA, USA;Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA;

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

DOI  :  10.1186/s12889-016-3287-3

 received in 2016-06-18, accepted in 2016-07-09,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundDespite 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 insecticide­treated 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/designA 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.DiscussionThis 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 registrationNCT02533336 registered on 13 July 2014.

【 授权许可】

CC BY   
© The Author(s). 2016