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.: PACTR202010729372570 Date of Approval: 01/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The COVID-19 Community Engagement Study
Official scientific title Owning our future through community engagement: enhancing uptake of COVID-19 prevention and mitigation measures
Brief summary describing the background and objectives of the trial Faced with the coronavirus pandemic, the government of Uganda, like many countries, has employed a topic down approach to the implementation of public health and mitigation measures. As such there has been minimal, if any engagement of communities to understand the pandemic and implement the necessary mitigation measures. The paucity of meaningful engagement between researchers/scientists and the public has denied the public an opportunity to appreciate basic health science facts, impedes critical thinking and reasoning and has far-reaching public health consequences. Uninformed, poorly informed or misinformed communities are at risk of making inappropriate health choices and the risk of misinformation is especially higher in this era of fast, versatile and globally-reaching communication platforms. This proof of concept trial will evaluate the effects of a community-owned risk communication intervention on the adoption of public health and social mitigation measures for COVID-19, in addition to evaluating the impact of the pandemic. Specific objectives 1. Ascertain the: a) Prevailing attitudes and perceptions towards COVID-19 mitigation measures and community response and adaptation (behaviours, practices) to the “new social norms” imposed by the emergency response; b) Short-term socioeconomic impact and community coping mechanisms 2. Develop and implement a community engagement intervention for enhancing uptake of the recommended COVID-19 public health and social mitigation measures. 3. Evaluate the effects of the intervention developed in 2 above on acceptance and uptake of the COVID-19 prevention and mitigation measures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Risk communication and community engagement intervention
Anticipated trial start date 05/10/2020
Actual trial start date
Anticipated date of last follow up 31/01/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 800
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 Simple randomization using a randomization table created by a computer software program 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 A community owned risk communication intervention We will have have household conversations on risk and mitigation measures lasting about 1 hour at at least two time points. 4 months This will be a community-owned risk communication intervention. The intervention will be designed in collaboration with communities. We will have context appropriate messages about risks of COVID-19 communicated through household conversations. These messages will be prepared in collaboration with members of the community. 400
Control Group No intervention. Treatment as usual. N/A 4 months Treatment as usual. Public health messaging from government 400 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
We will include villages if: 1. They have a mix of planned, semi-planned, and unplanned housing 2. Administrative authorities (e.g. LC1) agreeable, supportive and cooperative We will exclude villages if: 1. Overwhelming majority of structures are for commercial purposes 2. Overwhelming majority of residences are slum dwellings 3. Overwhelming majority of residences are for the well-to-do 4. A majority of residents / occupants are too mobile in ways that would make it difficult to follow them up 5. Perceived to be generally insecure 6. Too difficult to navigate or would require strenuous logistical arrangements 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) 12 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 04/09/2020 School of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Makerere University College of Health Sciences, Mulago hospital and complex. Mulago Hill Road Kampala 7072 Kla Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Proportion of participants reporting using face masks correctly and consistently 2. Proportion of participants reporting practicing social distancing correctly and consistently 3. Proportion of participants reporting washing or sanitizing hands correctly and consistently Two time points: at the baseline and at the end of the study follow-up period
Secondary Outcome 1. Risk perception regarding COVID-19 infection 2. Beliefs regarding COVID-19 infection 3. Understanding of personal disease prevention and management practices 4. Understanding of transmission dynamics for the pandemic 5. Understanding of population level mitigation measures 6. Attitudes towards government mitigation measures 7. Behaviours regarding mitigation measures 8. Likelihood of acceptance of a potential vaccine At two time points: at baseline and at the end of the study follow-up period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Makerere University College of Health Sciences Mulago Hill Road Kampala 7072 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Makerere University Makerere Hill Road Kampala 7072 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Government of Uganda and Makerere University Research and Innovations Fund Makerere University. Makerere Hill Road Kampala 7072 Uganda Government of Uganda in collaboration with Makerere University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nelson Sewankambo sewankam@infocom.com +256782366751 Makerere University College of Health Sciences, Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 7072 Uganda Professor of Medicine
Role Name Email Phone Street address
Scientific Enquiries Daniel Semakula semakuladaniel@gmail.com +256705543000 Makerere University College of Health Sciences. Mulago Hospital and Complex. Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 30906 Uganda Innovations and Knowledge Translation Officer
Role Name Email Phone Street address
Public Enquiries Daniel Semakula semakuladaniel@gmail.com +256705543000 Makerere University College of Health Sciences. Mulago Hospital and Complex
City Postal code Country Position/Affiliation
Kampala 30906 Uganda Innovations and Knowledge Translation Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the data upon request, and in addition submit them at publication, after deidentification. The trial report and the data will be published in an open access journal. Clinical Study Report,Informed Consent Form,Study Protocol 10 months after study completion All individuals who would like to access the data will have access.
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