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.: PACTR202401521630856 Date of Registration: 12/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Heat adaptation benefits for vulnerable groups in Africa
Official scientific title HABVIA: Heat adaptation benefits for vulnerable groups in Africa
Brief summary describing the background and objectives of the trial Robust evaluation of the environmental, health and socio-economic outcomes of heat adaptations are limited for Africa, especially in real-world settings, despite high vulnerability to heat-related health risk. HABVIA aims to address the paucity of data, including quantitative health measurements, from well-designed heat adaptation intervention trials in real-world high vulnerability settings in sub-Saharan Africa (and indeed most world regions). The project will do this by co-producing and implementing heat adaptation interventions in four heat-vulnerable communities in South Africa and Ghana, in two settings: i) low-income/informal housing and ii) manual labour. Health and social outcomes of the heat adaptations will be assessed, using high-quality cohort data on the human physiological and mental health response to heat, alongside climate, environmental and qualitative data. The cohorts build on well-established health-research partnerships.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HABVIA
Disease(s) or condition(s) being studied Non-communicable disease risk, mental health, dehydration, heat-related conditions,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Heat adaptation intervention
Anticipated trial start date 01/12/2023
Actual trial start date 01/12/2023
Anticipated date of last follow up 31/03/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants)
Recruitment status 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 Permuted block randomization 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
Experimental Group Heat adaptation N/A The intervention will take place over two consecutive hot seasons (2 years, 24 months). Including baseline data, data collection will take place over three consecutive hot seasons (3 measurement cycles in 3 years, 36 months). The intervention will be co-developed with the four communities (2 in Ghana, 2 in South Africa), and will therefore be tailored to be appropriate for each site. The heat adaptation interventions will focus on where/how people live, and where/how people work. Interventions addressing these two areas will fall into four categories: i) Behaviour (such as work-rest cycles); ii) Education (such as awareness about the health impacts of heat); iii) Physical cooling (such as cooling sprays), and iv) other (such as subsidy support). The development of the intervention will be use a social-ecological approach, with interventions aimed at the individual, the community, and macro-level policies (such as early warning heat systems). Thirty (30) participants at each of the four sites will receive the intervention (total n =120). 120
Control Group Control N/A Three annual measurement cycles over three consecutive hot seasons (3 years, 36 months) The control group will undergo the same physiological and environmental data collection procedures as the intervention group but will not receive the intervention (untreated). Thirty (30) participants will be allocated to the control group at each of the four sites (total n=120) 120 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Already a research participant in one of the following studies: i) METS-Microbiome Study-being conducted in Nkwantakese, Ghana, and Khayelitsha, South Africa; ii) Heat, Health and Violence Study in Mphego Village, Thoyondou, South Africa; iii) Urban Health and Poverty Study and the Tsui Anaa Project in Ga Mashie, Ghana. 2. Between the ages of 18-65 years of age 3. Living in one of the designated study communities 1. Individuals with current symptoms of infectious disease (eg fever) 2. Pregnant or lactating women. 3. Persons with conditions preventing normal physical activities, e.g., lower extremity disability. 4. Persons unwilling to implement the co-produced adaptation interventions Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
Prospective participants will be recruited from ongoing research activities in the study sites and must: 1.Already have been a research participant in one of the following studies: - METS-Microbiome Study-being conducted in Nkwantakese, Ghana, and Khayelitsha, South Africa. - Heat, Health and Violence Study in Mphego Village, Thoyondou, South Africa. - Urban Health and Poverty Study and the Tsui Anaa Project in Ga Mashie, Ghana. 2. Be between the ages of 18-65 years of age 3. Live in one of the designated study communities 1. Individuals with current symptoms of infectious disease (eg fever) 2. Pregnant or lactating women. 3. Persons with conditions preventing normal physical activities, e.g., lower extremity disability. 4. Persons unwilling to implement the co-produced adaptation interventions. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 01/08/2023 University of Cape Town HREC
Ethics Committee Address
Street address City Postal code Country
Room 45 E-52-E-Floor Old Main Building, Groote Schuur Hospital Cape Town 7925 South Africa
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 23/08/2023 Kwame Nkrumah University of Science and Technology Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
Block L, School of Medicine and Dentistry, KNUST, University Post Office, Kumasi Kumasi KNUST Ghana
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 06/09/2023 Noguchi Memorial Institute for Medical Research Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
S Legon Drive, Accra, Ghana Accra NMIMR Ghana
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 28/11/2023 SAMRC Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl Drive, Parowvallei Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Body composition, anthropometrics - bioelectrical impedance analysis (BIA), weight, height, waist circumference, BMI. Measurement cycle 1 - 3 times, measurement cycle 2 - 3 times, measurement cycle 3 - 3 times
Primary Outcome Blood pressure - Omron Automatic Digital Blood Pressure Monitor Measurement cycle 1 - 3 times, measurement cycle 2 - 3 times, measurement cycle 3 - 3 times
Primary Outcome Fasting blood glucose - point of care capillary fasting blood glucose Measurement cycle 1 - 3 times, measurement cycle 2 - 3 times, measurement cycle 3 - 3 times
Primary Outcome Core body temperature - continuous monitoring device using a CORE sensor Measurement cycle 1 - 3 times, measurement cycle 2 - 3 times, measurement cycle 3 - 3 times
Primary Outcome Physical activity - objectively measured using Actical accelerometer, and by questionnaire. Measurement cycle 1 - 3 times, measurement cycle 2 - 3 times, measurement cycle 3 - 3 times
Primary Outcome Sleep - bedtime, sleep onset, sleep offset, sleep duration (total number of minutes scored as sleep), and mid-sleep time - objectively measured using Actiwatch, and by questionnaire Measurement cycle 1 - 3 times, measurement cycle 2 - 3 times, measurement cycle 3 - 3 times
Primary Outcome Hydration status - urine specific gravity and Albumin-to-creatinine ratios using a point of care urinalysis analyzer, Clinitek Status Analyzer. Measurement cycle 1 - 3 times, measurement cycle 2 - 3 times, measurement cycle 3 - 3 times
Secondary Outcome Mental health, personal impact, and thermal comfort - Center for epidemiologic studies depression scale, positive and negative affect scale, and ASHRAE, a 7-point thermal sensation scale Measurement cycle 1 - 3 times, measurement cycle 2 - 3 times, measurement cycle 3 - 3 times
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
METS Microbiome Study Khayelitsha David Flude Methodist Church, Site B, Khayelitsha Cape Town South Africa
METS Microbiome Study Nkwantakese Nkwantakese-Afigya Kwabre North District, Ashanti Region, Ghana Kumasi Ghana
Heat Health and Violence Study Mphego Village Mphego Village, Thohoyandou, Limpopo Province, South Africa Thohoyandou South Africa
Regional Institute for Population Studies Urban Health and Poverty Study GaMashie Ga-Mashie, Accra, Ghana Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust Gibbs Building, 215 Euston Road London NW12BE United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Rondebosch Cape Town 7700 South Africa University
Secondary Sponsor University of Ghana Legon Boundary Accra Ghana University
Secondary Sponsor Kwame Nkrumah University of Science and Technology Accra Rd Kumasi Ghana University
Secondary Sponsor South African Medical Research Council Francie van Zijl Dr Cape Town 7501 South Africa Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr. Thandi Kapwata Environment and Health Research Unit, South African Medical Research Council Johannesburg South Africa
Prof. Ama DeGraft Aikins Regional Institute for Population Studies, University of Ghana Accra Ghana
Prof. Guy Howard University of Bristol, Cabot Institute for the Environment, Royal Fort House, Bristol Bristol United Kingdom
Prof. Christopher Gordon Institute for Environmenta and Sanitation Studies, University of Ghana Accra Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lara Dugas lara.dugas@uct.ac.za +27214066300 School of Public Health Faculty of Health Sciences, University of Cape Town, Anzio Rd, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Professor of Epidemiology and AXA Research Chair in Non Communicable Disease Epidemiology at University of Cape Town
Role Name Email Phone Street address
Principal Investigator Mark New mark.new@uct.ac.za +27216505598 University of Cape Town Upper Campus Geological Sciences Building, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Director of the African Climate and Development Initiative at the University of Cape Town and Professor of International Development at the University of East Anglia UK
Role Name Email Phone Street address
Public Enquiries Machaela Deglon michaela.deglon@uct.ac.za +27216505598 University of Cape Town Upper Campus Geological Sciences Building, Rondebosch
City Postal code Country Position/Affiliation
Cape Town South Africa Project Coordinator
Role Name Email Phone Street address
Scientific Enquiries Lara Dugas lara.dugas@uct.ac.za +27214066300 School of Public Health Faculty of Health Sciences University of Cape Town, Anzio Rd, Observatory
City Postal code Country Position/Affiliation
Cape Town South Africa Professor of Epidemiology
Role Name Email Phone Street address
Scientific Enquiries Kweku Bedu Addo kbeduaddo.sms@knust.edu.gh +233322063621 Department of Physiology, School of Medicine and Dentistry, College of Health Sciences, Kwame Nkrumah University of Science and Technology
City Postal code Country Position/Affiliation
Kumasi Ghana Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Ama de Graft Aikins adaikins@ug.edu.gh +233302906800 Legon Boundary, Accra
City Postal code Country Position/Affiliation
Accra Ghana Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Project data (individual participant data collected during the trial, after deidentification) will be available on request as soon as the data is deposited, provided the request does not compete with analysis planned by the project team. All data will be stored on the University of Cape Town’s open data platform, ZivaHub (https://zivahub.uct.ac.za), which is driven by Figshare. All data are easily locatable by searching within the platform, and through general internet searches. All datasets will have a persistent DOI which will be used to identify associated publications, raise awareness of the availability of the data, and facilitate searching. Our data-sharing policy will be included on the project website (once established), and highlighted at research talks. In the final year of the project, the HABVIA team will publish a short article, describing the dataset in Wellcome Open Research to help researchers discover, access, and reference the resource. Statistical Analysis Plan,Study Protocol Project data will be available on request as soon as the data is deposited, provided the request does not compete with analysis planned by the project team. After the project is complete, data will be freely available for use (CC-BY licence), except where there is ongoing analysis of the data for a specific output by the project team. All data will be fully accessible 12 months after the project completion, once all publications have been submitted, with no end date. We will make the data and associated documentation available to external users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed
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