Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201411000910192 Date of Approval: 13/10/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Triage Plus
Official scientific 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: A cluster level randomized controlled trial
Brief summary describing the background and objectives of the trial In developing countries like Malawi people with chronic cough are screened for tuberculosis but those who test negative for TB are generally not worked up further for possible diagnoses of chronic airways disease (CAD) because no established screening and diagnostic services exist for CAD. Referral systems at primary health care level are weak and patients often resort to seek health care and treatment from informal providers who do not have the necessary capacity to handle such conditions. Consequently, people with undiagnosed CAD experience debilitation and reduced quality of life. CAD are part of the non-communicable disease (NCD) spectrum yet have presentations that can overlap with TB particularly smear negative disease. A diagnosis for people with chronic or persistent cough is usually delayed because of individual and health system barriers that pose a big challenge particularly in Sub-Saharan Africa. Delayed diagnosis and treatment of TB facilitates further transmission of TB, severity of disease with complications like disability and mortality. There is a need for integrated guidelines for TB and CAD to enable early diagnosis and treatment of these diseases. The WHO developed the practical approach to lung health (PAL) strategy, a patient-centred approach to the diagnosis and treatment of common respiratory illnesses in primary health centre settings as a means of strengthening health systems to improve the quality of management of respiratory diseases. Community engagement in health service delivery is recognised as being important in most independent health interventions. It is not known if engaging community informal health providers would make any positive difference in the implementation of the PAL strategy. The proposed trial seeks to determine the effect of Informal Health Provider and PAL interventions on the detection and management of CAD and TB at primary care level in Malawi.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Triage Plus
Disease(s) or condition(s) being studied Chronic cough,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/01/2015
Actual trial start date
Anticipated date of last follow up 01/01/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 27000
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Computer-generated randomization schedule with stratification by size of cluster Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard of care n/a 12 months Routine care will be offered 9000 Active-Treatment of Control Group
Experimental Group Intervention arm 1 n/a 12 months Implementation of PAL guidelines; spirometry & provision of inhaler bronchodilators & corticosteroids 9000
Experimental Group Intervention arm II n/a 12 months 1) Implementation of PAL guidelines; spirometry & provision of inhaler bronchodilators & corticosteroids 2) Engagement of informal community health care providers for disease recognition, counselling and referral 9000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for health facilities 1. Health facilities that offer out-patient services only 2. Run by low low/middle level health care workers Exclusion criteria 1. Health facilities offering in-patient services 2. Health facilities run by qualified medical doctors 15 Year(s) 120 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/09/2013 College of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mahatma Gandhi Road Blantyre n/a Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/07/2014 Liverpool School of Tropical Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Pembroke Place Liverpool L3 5QA United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Proportion of the population with a chronic cough who have a diagnosis of TB or airway disease(s) recorded in their health passports 1 year
Secondary Outcome Proportion of the population with a chronic cough on salbutamol / corticosteroid inhaler indicated in their health passports 1 year
Secondary Outcome Proportion of the population with a chronic cough with a diagnosis of TB or airway disease among patients with chronic cough attending primary health care recorded in patient registers at intervention facilities. 1 years
Secondary Outcome Proportion of people with disabilities with a diagnosis of TB or airway disease recorded in their health passports in all arms of the study. 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Reach Trust Off Paul Kagame Road Lilongwe n/a Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Norwegian Heart and Lung Patient Association (LHL) International Tuberculosis Foundation (LHL International) and the Norwegian Government (NORAD) LHL Internationla Tuberculosis Foundation Oslo Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Liverpool School of Tropical Medicine Pembroke Place Liverpool United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Prof B Squire Liverpool School of Tropical Medicine, Pembroke Place Liverpool L3 5QA United Kingdom
Prof Moffatt Nyirenda Mahatma Ghandi Campus, Off Mahatma Ghandi Rd Blantyre Malawi
Dr Jason Mason University of Warwick Coventry CV4 7AL United Kingdom
Dr Beatrice Mwagomba Ministry of Health Headquarters, Capital Hill, PO Box 30377, Capital City, Lilongwe Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hastings Banda hastings@reachtrust.org +265888853976 Res for Equity Community Health Trust, Area 6, Plot 6/28,
City Postal code Country Position/Affiliation
Lilongwe Malawi
Role Name Email Phone Street address
Public Enquiries Hastings Banda hastings@reachtrust.org +2651753260 Research for Equity & Community Health Trust, Off Paul Kagame Rd, Area 6,Plot6/28
City Postal code Country Position/Affiliation
Lilongwe Malawi
Role Name Email Phone Street address
Scientific Enquiries Hastings Banda hastings@reachtrust.org +2651753260 Off Paul Kagame Rd, rea 6, Plot 6/28
City Postal code Country Position/Affiliation
Lilongwe Malawi
REPORTING
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