title: Informal Health Provider and Practical Approach to Lung Health interventions to improve the detection of chronic airways disease and tuberculosis at primary care level in Malawi: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  In developing countries like Malawi, further investigation is rare after patients with chronic cough test negative for tuberculosis. Chronic airways disease has presentations that overlap with tuberculosis. However, chronic airways disease is often unrecognised due to a lack of diagnostic services. Within developing countries, referral systems at primary health care level are weak and patients turn to unskilled informal health providers to seek health care. Delayed diagnosis and treatment of these diseases facilitates increased severity and tuberculosis transmission. The World Health Organisation developed the Practical Approach to Lung Health strategy which has been shown to improve the management of both tuberculosis and chronic airways disease. The guidelines address the need for integrated guidelines for tuberculosis and chronic airways disease. Engaging with informal health providers has been shown to be effective in improving health services uptake. However, it is not known whether engaging community informal health providers would have a positive impact in the implementation of the Practical Approach to Lung Health strategy. We will use a cluster randomised controlled trial to determine the effect of using the two interventions to improve case detection and treatment of patients with tuberculosis and chronic airways disease.
  
  
  METHODS
  A three-arm cluster randomised trial design will be used. A primary health centre catchment population will form a cluster, which will be randomly allocated to one of the arms. The first arm personnel will receive the Practical Approach to Lung Health strategy intervention. In addition to this strategy, the second arm personnel will receive training of informal health providers. The third arm is the control. The effect of interventions will be evaluated by community surveys. Data regarding the diagnosis and management of chronic cough will be gathered from primary health centres.
  
  
  CONCLUSIONS
  This trial seeks to determine the effect of Informal Health Provider and Practical Approach to Lung Health interventions on the detection and management of chronic airways disease and tuberculosis at primary care level in Malawi.
  
  
  BACKGROUND
  The unique identification number for the registry is PACTR201411000910192--21 November 2014.
authors.affiliation: Research for Equity and Community Health Trust, ᅟ, Malawi. hastings@reachtrust.org.
authors.forename: Hastings T
authors.initials: HT
authors.lastname: Banda
authors.affiliation: Liverpool School of Tropical Medicine, Liverpool, UK. kevin.mortomer@lstmed.ac.uk.
authors.forename: Kevin
authors.initials: K
authors.lastname: Mortimer
authors.affiliation: Research for Equity and Community Health Trust, ᅟ, Malawi. gafbello@yahoo.co.uk.
authors.forename: George A F
authors.initials: GA
authors.lastname: Bello
authors.affiliation: Research for Equity and Community Health Trust, ᅟ, Malawi. grace@reachtrust.org.
authors.forename: Grace B
authors.initials: GB
authors.lastname: Mbera
authors.affiliation: Research for Equity and Community Health Trust, ᅟ, Malawi. ireen@reachtrust.org.
authors.forename: Ireen
authors.initials: I
authors.lastname: Namakhoma
authors.affiliation: Liverpool School of Tropical Medicine, Liverpool, UK. Rachael.Thomson@lstmed.ac.uk.
authors.forename: Rachael
authors.initials: R
authors.lastname: Thomson
authors.affiliation: College of Medicine, Mahatma Gandhi, Blantyre, Malawi. moffat.nyirenda@lshtm.ac.uk.
authors.forename: Moffat J
authors.initials: MJ
authors.lastname: Nyirenda
authors.affiliation: Liverpool School of Tropical Medicine, Liverpool, UK. brian.faragher@lstmed.ac.uk.
authors.forename: Brian
authors.initials: B
authors.lastname: Faragher
authors.affiliation: Warwick University, Coventry, CV4 7AL, UK. J.J.Madan@warwick.ac.uk.
authors.forename: Jason
authors.initials: J
authors.lastname: Madan
authors.affiliation: LHL International, Grensen 3, 0159, Oslo, Norway. rasmus.malmborg@lhl.no.
authors.forename: Rasmus
authors.initials: R
authors.lastname: Malmborg
authors.affiliation: LHL International, Grensen 3, 0159, Oslo, Norway. Berthe.Stenberg@lhl.no.
authors.forename: Berthe
authors.initials: B
authors.lastname: Stenberg
authors.affiliation: Ministry of Health, 30377, Capital City, Lilongwe 3, Malawi. jmpunga@ntpmalawi.org.
authors.forename: James
authors.initials: J
authors.lastname: Mpunga
authors.affiliation: Ministry of Health, 30377, Capital City, Lilongwe 3, Malawi. mwagombabeatrice@yahoo.com.
authors.forename: Beatrice
authors.initials: B
authors.lastname: Mwagomba
authors.affiliation: Liverpool School of Tropical Medicine, Liverpool, UK. elvis.gama@lstmed.ac.uk.
authors.forename: Elvis
authors.initials: E
authors.lastname: Gama
authors.affiliation: Liverpool School of Tropical Medicine, Liverpool, UK. kpiddock@doctors.org.uk.
authors.forename: Katherine
authors.initials: K
authors.lastname: Piddock
authors.affiliation: Liverpool School of Tropical Medicine, Liverpool, UK.
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Squire
mesh_terms: D002908:Chronic Disease; D003153:Community Health Services / Q000592:standards; D003371:Cough / Q000175:diagnosis* / Q000628:therapy; D019091:Critical Pathways; D057210:Delayed Diagnosis; D019033:Delivery of Health Care, Integrated; D003906:Developing Countries; D006282:Health Personnel / Q000592:standards; D006801:Humans; D008171:Lung Diseases / Q000175:diagnosis* / Q000628:therapy; D008295:Malawi; D005791:Patient Care / Q000592:standards; D017410:Practice Guidelines as Topic; D011237:Predictive Value of Tests; D011320:Primary Health Care / Q000592:standards; D011379:Prognosis; D058996:Quality Improvement; D012107:Research Design; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000628:therapy / Q000635:transmission; D000078329:Workforce