The impact of improved water supply on cholera and diarrhoeal diseases in Uvira, Democratic Republic of the Congo: a protocol for a pragmatic stepped-wedge cluster randomised trial and economic evaluation-Reference-Cited by-同舟云学术

The impact of improved water supply on cholera and diarrhoeal diseases in Uvira, Democratic Republic of the Congo: a protocol for a pragmatic stepped-wedge cluster randomised trial and economic evaluation

Published:2021-06-21 Issue:1 Volume:22 Page:
ISSN:1745-6215
Container-title:Trials
language:en
Short-container-title:Trials

Author:

Gallandat Karin^ORCID,Jeandron Aurélie,Ross Ian,Mufitini Saidi Jaime,Bashige Rumedeka Baron,Lumami Kapepula Vercus,Cousens Simon,Allen Elizabeth,MacDougall Amy,Cumming Oliver

Abstract

Abstract Introduction Diarrhoeal disease remains a leading cause of mortality and morbidity worldwide. Cholera alone is estimated to cause 95,000 deaths per year, most of which occur in endemic settings with inadequate water access. Whilst a global strategy to eliminate cholera by 2030 calls for investment in improved drinking water services, there is limited rigorous evidence for the impact of improved water supply on endemic cholera transmission in low-income urban settings. Our protocol is designed to deliver a pragmatic health impact evaluation of a large-scale water supply intervention in Uvira (Democratic Republic of the Congo), a cholera transmission hotspot. Methods/design A stepped-wedge cluster randomised trial (SW-CRT) was designed to evaluate the impact of a large-scale drinking water supply intervention on cholera incidence among the 280,000 inhabitants of Uvira. The city was divided into 16 clusters, where new community and household taps will be installed following a randomised sequence over a transition period of up to 8 weeks in each cluster. The primary trial outcomes are the monthly incidence of “confirmed” cholera cases (patients testing positive by rapid detection kit) and of “suspected” cholera cases (patients admitted to the cholera treatment centre). Concurrent process and economic evaluations will provide further information on the context, costs, and efficiency of the intervention. Discussion In this protocol, we describe a pragmatic approach to conducting rigorous research to assess the impacts of a complex water supply intervention on severe diarrhoeal disease and cholera in an unstable, low-resource setting representative of cholera-affected areas. In particular, we discuss a series of pre-identified risks and linked mitigation strategies as well as the value of combining different data collection methods and preparation of multiple analysis scenarios to account for possible deviations from the protocol. The study described here has the potential to provide robust evidence to support more effective cholera control in challenging, high-burden settings. Trial registration This trial is registered on clinicaltrials.gov (NCT02928341, 10th October 2016) and has received ethics approval from the London School of Hygiene and Tropical Medicine (8913, 10603) and from the Ethics Committee from the School of Public Health, University of Kinshasa, Democratic Republic of the Congo (ESP/CE/088/2015).

Funder

Agence Française de Développement

Fondation Veolia Environnement

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Medicine (miscellaneous)

Link

https://link.springer.com/content/pdf/10.1186/s13063-021-05249-x.pdf

Reference63 articles.

1. Troeger C, Forouzanfar M, Rao PC, Khalil I, Brown A, Reiner RC, et al. Estimates of global, regional, and national morbidity, mortality, and aetiologies of diarrhoeal diseases: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Infect Dis. 2017;17(9):909–48. https://doi.org/10.1016/S1473-3099(17)30276-1.

2. Vos T, Abajobir AA, Abate KH, Abbafati C, Abbas KM, Abd-Allah F, Abdulkader RS, Abdulle AM, Abebo TA, Abera SF, Aboyans V, Abu-Raddad LJ, Ackerman IN, Adamu AA, Adetokunboh O, Afarideh M, Afshin A, Agarwal SK, Aggarwal R, Agrawal A, Agrawal S, Ahmadieh H, Ahmed MB, Aichour MTE, Aichour AN, Aichour I, Aiyar S, Akinyemi RO, Akseer N, al Lami FH, Alahdab F, al-Aly Z, Alam K, Alam N, Alam T, Alasfoor D, Alene KA, Ali R, Alizadeh-Navaei R, Alkerwi A, Alla F, Allebeck P, Allen C, al-Maskari F, al-Raddadi R, Alsharif U, Alsowaidi S, Altirkawi KA, Amare AT, Amini E, Ammar W, Amoako YA, Andersen HH, Antonio CAT, Anwari P, Ärnlöv J, Artaman A, Aryal KK, Asayesh H, Asgedom SW, Assadi R, Atey TM, Atnafu NT, Atre SR, Avila-Burgos L, Avokphako EFGA, Awasthi A, Bacha U, Badawi A, Balakrishnan K, Banerjee A, Bannick MS, Barac A, Barber RM, Barker-Collo SL, Bärnighausen T, Barquera S, Barregard L, Barrero LH, Basu S, Battista B, Battle KE, Baune BT, Bazargan-Hejazi S, Beardsley J, Bedi N, Beghi E, Béjot Y, Bekele BB, Bell ML, Bennett DA, Bensenor IM, Benson J, Berhane A, Berhe DF, Bernabé E, Betsu BD, Beuran M, Beyene AS, Bhala N, Bhansali A, Bhatt S, Bhutta ZA, Biadgilign S, Bicer BK, Bienhoff K, Bikbov B, Birungi C, Biryukov S, Bisanzio D, Bizuayehu HM, Boneya DJ, Boufous S, Bourne RRA, Brazinova A, Brugha TS, Buchbinder R, Bulto LNB, Bumgarner BR, Butt ZA, Cahuana-Hurtado L, Cameron E, Car M, Carabin H, Carapetis JR, Cárdenas R, Carpenter DO, Carrero JJ, Carter A, Carvalho F, Casey DC, Caso V, Castañeda-Orjuela CA, Castle CD, Catalá-López F, Chang HY, Chang JC, Charlson FJ, Chen H, Chibalabala M, Chibueze CE, Chisumpa VH, Chitheer AA, Christopher DJ, Ciobanu LG, Cirillo M, Colombara D, Cooper C, Cortesi PA, Criqui MH, Crump JA, Dadi AF, Dalal K, Dandona L, Dandona R, das Neves J, Davitoiu DV, de Courten B, de Leo DD, Defo BK, Degenhardt L, Deiparine S, Dellavalle RP, Deribe K, Des Jarlais DC, Dey S, Dharmaratne SD, Dhillon PK, Dicker D, Ding EL, Djalalinia S, Do HP, Dorsey ER, dos Santos KPB, Douwes-Schultz D, Doyle KE, Driscoll TR, Dubey M, Duncan BB, el-Khatib ZZ, Ellerstrand J, Enayati A, Endries AY, Ermakov SP, Erskine HE, Eshrati B, Eskandarieh S, Esteghamati A, Estep K, Fanuel FBB, Farinha CSES, Faro A, Farzadfar F, Fazeli MS, Feigin VL, Fereshtehnejad SM, Fernandes JC, Ferrari AJ, Feyissa TR, Filip I, Fischer F, Fitzmaurice C, Flaxman AD, Flor LS, Foigt N, Foreman KJ, Franklin RC, Fullman N, Fürst T, Furtado JM, Futran ND, Gakidou E, Ganji M, Garcia-Basteiro AL, Gebre T, Gebrehiwot TT, Geleto A, Gemechu BL, Gesesew HA, Gething PW, Ghajar A, Gibney KB, Gill PS, Gillum RF, Ginawi IAM, Giref AZ, Gishu MD, Giussani G, Godwin WW, Gold AL, Goldberg EM, Gona PN, Goodridge A, Gopalani SV, Goto A, Goulart AC, Griswold M, Gugnani HC, Gupta R, Gupta R, Gupta T, Gupta V, Hafezi-Nejad N, Hailu GB, Hailu AD, Hamadeh RR, Hamidi S, Handal AJ, Hankey GJ, Hanson SW, Hao Y, Harb HL, Hareri HA, Haro JM, Harvey J, Hassanvand MS, Havmoeller R, Hawley C, Hay SI, Hay RJ, Henry NJ, Heredia-Pi IB, Hernandez JM, Heydarpour P, Hoek HW, Hoffman HJ, Horita N, Hosgood HD, Hostiuc S, Hotez PJ, Hoy DG, Htet AS, Hu G, Huang H, Huynh C, Iburg KM, Igumbor EU, Ikeda C, Irvine CMS, Jacobsen KH, Jahanmehr N, Jakovljevic MB, Jassal SK, Javanbakht M, Jayaraman SP, Jeemon P, Jensen PN, Jha V, Jiang G, John D, Johnson SC, Johnson CO, Jonas JB, Jürisson M, Kabir Z, Kadel R, Kahsay A, Kamal R, Kan H, Karam NE, Karch A, Karema CK, Kasaeian A, Kassa GM, Kassaw NA, Kassebaum NJ, Kastor A, Katikireddi SV, Kaul A, Kawakami N, Keiyoro PN, Kengne AP, Keren A, Khader YS, Khalil IA, Khan EA, Khang YH, Khosravi A, Khubchandani J, Kiadaliri AA, Kieling C, Kim YJ, Kim D, Kim P, Kimokoti RW, Kinfu Y, Kisa A, Kissimova-Skarbek KA, Kivimaki M, Knudsen AK, Kokubo Y, Kolte D, Kopec JA, Kosen S, Koul PA, Koyanagi A, Kravchenko M, Krishnaswami S, Krohn KJ, Kumar GA, Kumar P, Kumar S, Kyu HH, Lal DK, Lalloo R, Lambert N, Lan Q, Larsson A, Lavados PM, Leasher JL, Lee PH, Lee JT, Leigh J, Leshargie CT, Leung J, Leung R, Levi M, Li Y, Li Y, Li Kappe D, Liang X, Liben ML, Lim SS, Linn S, Liu PY, Liu A, Liu S, Liu Y, Lodha R, Logroscino G, London SJ, Looker KJ, Lopez AD, Lorkowski S, Lotufo PA, Low N, Lozano R, Lucas TCD, Macarayan ERK, Magdy Abd el Razek H, Magdy Abd el Razek M, Mahdavi M, Majdan M, Majdzadeh R, Majeed A, Malekzadeh R, Malhotra R, Malta DC, Mamun AA, Manguerra H, Manhertz T, Mantilla A, Mantovani LG, Mapoma CC, Marczak LB, Martinez-Raga J, Martins-Melo FR, Martopullo I, März W, Mathur MR, Mazidi M, McAlinden C, McGaughey M, McGrath JJ, McKee M, McNellan C, Mehata S, Mehndiratta MM, Mekonnen TC, Memiah P, Memish ZA, Mendoza W, Mengistie MA, Mengistu DT, Mensah GA, Meretoja TJ, Meretoja A, Mezgebe HB, Micha R, Millear A, Miller TR, Mills EJ, Mirarefin M, Mirrakhimov EM, Misganaw A, Mishra SR, Mitchell PB, Mohammad KA, Mohammadi A, Mohammed KE, Mohammed S, Mohanty SK, Mokdad AH, Mollenkopf SK, Monasta L, Montico M, Moradi-Lakeh M, Moraga P, Mori R, Morozoff C, Morrison SD, Moses M, Mountjoy-Venning C, Mruts KB, Mueller UO, Muller K, Murdoch ME, Murthy GVS, Musa KI, Nachega JB, Nagel G, Naghavi M, Naheed A, Naidoo KS, Naldi L, Nangia V, Natarajan G, Negasa DE, Negoi RI, Negoi I, Newton CR, Ngunjiri JW, Nguyen TH, Nguyen QL, Nguyen CT, Nguyen G, Nguyen M, Nichols E, Ningrum DNA, Nolte S, Nong VM, Norrving B, Noubiap JJN, O'Donnell MJ, Ogbo FA, Oh IH, Okoro A, Oladimeji O, Olagunju TO, Olagunju AT, Olsen HE, Olusanya BO, Olusanya JO, Ong K, Opio JN, Oren E, Ortiz A, Osgood-Zimmerman A, Osman M, Owolabi MO, PA M, Pacella RE, Pana A, Panda BK, Papachristou C, Park EK, Parry CD, Parsaeian M, Patten SB, Patton GC, Paulson K, Pearce N, Pereira DM, Perico N, Pesudovs K, Peterson CB, Petzold M, Phillips MR, Pigott DM, Pillay JD, Pinho C, Plass D, Pletcher MA, Popova S, Poulton RG, Pourmalek F, Prabhakaran D, Prasad NM, Prasad N, Purcell C, Qorbani M, Quansah R, Quintanilla BPA, Rabiee RHS, Radfar A, Rafay A, Rahimi K, Rahimi-Movaghar A, Rahimi-Movaghar V, Rahman MHU, Rahman M, Rai RK, Rajsic S, Ram U, Ranabhat CL, Rankin Z, Rao PC, Rao PV, Rawaf S, Ray SE, Reiner RC, Reinig N, Reitsma MB, Remuzzi G, Renzaho AMN, Resnikoff S, Rezaei S, Ribeiro AL, Ronfani L, Roshandel G, Roth GA, Roy A, Rubagotti E, Ruhago GM, Saadat S, Sadat N, Safdarian M, Safi S, Safiri S, Sagar R, Sahathevan R, Salama J, Saleem HOB, Salomon JA, Salvi SS, Samy AM, Sanabria JR, Santomauro D, Santos IS, Santos JV, Santric Milicevic MM, Sartorius B, Satpathy M, Sawhney M, Saxena S, Schmidt MI, Schneider IJC, Schöttker B, Schwebel DC, Schwendicke F, Seedat S, Sepanlou SG, Servan-Mori EE, Setegn T, Shackelford KA, Shaheen A, Shaikh MA, Shamsipour M, Shariful Islam SM, Sharma J, Sharma R, She J, Shi P, Shields C, Shifa GT, Shigematsu M, Shinohara Y, Shiri R, Shirkoohi R, Shirude S, Shishani K, Shrime MG, Sibai AM, Sigfusdottir ID, Silva DAS, Silva JP, Silveira DGA, Singh JA, Singh NP, Sinha DN, Skiadaresi E, Skirbekk V, Slepak EL, Sligar A, Smith DL, Smith M, Sobaih BHA, Sobngwi E, Sorensen RJD, Sousa TCM, Sposato LA, Sreeramareddy CT, Srinivasan V, Stanaway JD, Stathopoulou V, Steel N, Stein MB, Stein DJ, Steiner TJ, Steiner C, Steinke S, Stokes MA, Stovner LJ, Strub B, Subart M, Sufiyan MB, Sunguya BF, Sur PJ, Swaminathan S, Sykes BL, Sylte DO, Tabarés-Seisdedos R, Taffere GR, Takala JS, Tandon N, Tavakkoli M, Taveira N, Taylor HR, Tehrani-Banihashemi A, Tekelab T, Terkawi AS, Tesfaye DJ, Tesssema B, Thamsuwan O, Thomas KE, Thrift AG, Tiruye TY, Tobe-Gai R, Tollanes MC, Tonelli M, Topor-Madry R, Tortajada M, Touvier M, Tran BX, Tripathi S, Troeger C, Truelsen T, Tsoi D, Tuem KB, Tuzcu EM, Tyrovolas S, Ukwaja KN, Undurraga EA, Uneke CJ, Updike R, Uthman OA, Uzochukwu BSC, van Boven JFM, Varughese S, Vasankari T, Venkatesh S, Venketasubramanian N, Vidavalur R, Violante FS, Vladimirov SK, Vlassov VV, Vollset SE, Wadilo F, Wakayo T, Wang YP, Weaver M, Weichenthal S, Weiderpass E, Weintraub RG, Werdecker A, Westerman R, Whiteford HA, Wijeratne T, Wiysonge CS, Wolfe CDA, Woodbrook R, Woolf AD, Workicho A, Xavier D, Xu G, Yadgir S, Yaghoubi M, Yakob B, Yan LL, Yano Y, Ye P, Yimam HH, Yip P, Yonemoto N, Yoon SJ, Yotebieng M, Younis MZ, Zaidi Z, Zaki MES, Zegeye EA, Zenebe ZM, Zhang X, Zhou M, Zipkin B, Zodpey S, Zuhlke LJ, Murray CJL. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the global burden of disease study 2016. Lancet. 2017;390(10100):1211–59. https://doi.org/10.1016/S0140-6736(17)32154-2.