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.: PACTR201911498556907 Date of Approval: 22/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Housing, Air Quality and Health Study (HeALTH Study)
Official scientific title Housing, Air Quality and Health Study (HeALTH Study)
Brief summary describing the background and objectives of the trial To assess the human health impacts of air quality household interventions in a low-income community on the South African Highveld
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HeALTH Study
Disease(s) or condition(s) being studied Cardiovascular, mental health,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Household intervention to improve indoor and ambient air quality
Anticipated trial start date 01/07/2019
Actual trial start date 01/07/2019
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants)
Recruitment status Completed
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Household air quality interventions Each eligible household in the intervention community receives an intervention suite. The control community only receives the intervention suite after the study has been completed. The interventions are meant to be taken up into the households for permanent use. Installation of ceiling in households in low-income communities in Mpumalanga, South Africa. Replacement of coal stoves with clean hybrid (electrical and gas) stoves and gas heaters. 500
Control Group No intervention in the control community None The control community will receive the interventions after the intervention study has been completed. No interventions will be received by the control community 500 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To qualify, households must meet following criteria: o Community must be impacted on by emissions stemming from coal fired power stations o Air Quality in community must be in non-compliance with National Ambient Air Quality Standards o Household must be a formal structure o Household must be making use of a coal stove for heating and/or cooking purposes o Household must accept the household intervention Informal households 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 01/07/2019 SAMRC Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl Drive, Parovallei, 7505, Cape Town, South Africa Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Improved well-being socio-economic implications After intervention implementation
Primary Outcome Improved indoor air quality and health After intervention implementation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KwaZamokuhle and Emzinoni towns on the Mpumalanga Highveld are the communities from which households are selected. KwaZamokuhle is the intervenion site and Emzinoni is the control site. None KwaZamokuhle South Africa
KwaZamokuhle and Emzinoni towns on the Mpumalanga Highveld are the communities from which households are selected. KwaZamokuhle is the intervenion site and Emzinoni is the control site. None Emzinoni South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Eskom Holdings SOC Ltd Maxwell Drive, Sunninghill Johannesbug South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Eskom Holdings SOC Ltd Maxwell Drive Johannesburg Johanesburg 2191 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
University of KwaZulu Natal and The NOVA Institute 238 Mazisi Kunene Rd and 13 Beuke Place Durban and Pretoria South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Caradee Wright Caradee.Wright@mrc.ac.za +27123398543 1 Soutpansberg Rd
City Postal code Country Position/Affiliation
Pretoria South Africa Senior Specialist Scientist in Environment and Health Research Unit in the South African Medical Research Council
Role Name Email Phone Street address
Public Enquiries Pierre Boshoff Pierre.Boshoff@mrc.ac.za +27219380685 Francie van Zijl Drive, Parow Valley
City Postal code Country Position/Affiliation
Cape Town South Africa Project Management and Accounting Office in the South African Medical Research Council
Role Name Email Phone Street address
Scientific Enquiries Angela Mathhee Angie.Mathee@mrc.ac.za +27123398539 Cnr Beit and Sherwell
City Postal code Country Position/Affiliation
Johannesburg South Africa Director of Environment and Health Research Unit SAMRC
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Only information excluding individual participant data will be made available. Informed Consent Form,Statistical Analysis Plan,Study Protocol 5 years (duration of study) Any access to information will be controlled by the SAMRC and the funder.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information