mHealth Intervention for Increasing COVID-19 Prevention Practices With Urban Refugee and Displaced Youth in Uganda
Primary Purpose
Knowledge, Attitudes, Practice, Covid19
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Kukaa Salama: mHealth intervention
Face Mask + Soap
Sponsored by

About this trial
This is an interventional prevention trial for Knowledge, Attitudes, Practice focused on measuring Uganda, Forcibly displaced youth, mHealth, Water, Sanitation and Hygiene, RANAS (Risks, Attitudes, Norms, Abilities, Self-Regulation), COVID-19
Eligibility Criteria
Inclusion Criteria:
- Enrolled within the Tushirikiane HIV-self Testing cluster randomized trial
- Live in one of the 5 slum/informal settlement sites (Kabalanga, Kasanga, Katwe, Nsambya Rubaga)
- Identify as a refugee/displaced person or have refugee parents
- Age 16-24 years
- Speak English, Luganda, French, Swahili, or Kinyarwanda
- Own or have access to a mobile phone for the duration of the study
Exclusion Criteria:
- Not currently enrolled in the Tushirikiane HIV-self Testing cluster randomized trial
- Lives outside of 5 selected study sites
- Does not identify as a refugee or does not have refugee parents
- Less than 16 or older than 24 years
- Does not speak English, Luganda, French, Swahili, or Kinyarwanda
- Does not have mobile phone
Sites / Locations
- Factor-Inwentash Faculty of Social Work, University of Toronto
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Kukaa Salama: mHealth intervention
Arm Description
This is a pre-test/post-test trial, therefore all participants will receive the Kukaa Salama mHealth intervention and will be offered a COVID-19 prevention parcel.
Outcomes
Primary Outcome Measures
Changes in COVID-19 Prevention Practices
To assess changes in COVID-19 prevention practices, participants are asked to report on their self-efficacy (i.e. ability, confidence, adherence) to practice hand and respiratory hygiene (i.e. hand washing with soap, face mask usage) and physical distancing.
Secondary Outcome Measures
Changes in COVID-19 Risk Awareness
To assess changes in COVID-19 risk awareness, participants are asked to report on their perceived risk and vulnerabilites to COVID-19 as well as as their knowledge of symptoms and severity.
Changes in Attitude towards COVID-19
To assess changes in attitudes towards COVID-19, participants are asked to report on their attitude (i.e. feelings, costs/benefits) towards prevention practices as well as towards COVID-19 testing and potential vaccines.
Changes in COVID-19 Norms
To assess changes in COVID-19 norms, participants are asked to report on the percieved behaviours approved by others (i.e. social pressues) towards COVID-19 prevention practices, transmission, and stigma.
Changes in COVID-19 Self-Regulation
To assess changes in COVID-19 self-regulation, participants are asked about their action plan for implementing COVID-19 prevention practices.
Changes in Depression
Depression outcomes will be assessed using the Patient Health Questionnaire -9 item (PHQ-9). Higher scores mean a worse outcome. Range 0-27.
Sexual and Reproductive Health
To assess changes in sexual and reproductive health, participants are asked to report on personal experiences (e.g. intimate partner violence) as well as perceived changes in the community (e.g. violence, access to sexual and reproductive health services).
Food and Water insecurity
To assess changes in food and water insecurity, participants are asked to report on frequency of insufficient food (i.e. going to bed hungry) and inadequate clean water.
Full Information
NCT ID
NCT04631367
First Posted
November 13, 2020
Last Updated
December 23, 2021
Sponsor
University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04631367
Brief Title
mHealth Intervention for Increasing COVID-19 Prevention Practices With Urban Refugee and Displaced Youth in Uganda
Official Title
Kukaa Salama (Staying Safe): A Pre-Post Trial of a mHealth Social Group for Increasing COVID-19 Prevention Practices With Urban Refugee and Displaced Youth in Kampala, Uganda
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Uganda hosts 1.4 million refugees, making it Sub-Saharan Africa's largest refugee host community and the third largest globally. Adolescents and young people (AYP) comprise half of the world's 70.8 million forcibly displaced persons, yet they are understudied in pandemics, including in COVID-19. Poverty, overcrowded living conditions, and poor sanitation likely elevate forcibly displaced persons' COVID-19 risks by limiting their ability to practice mitigation strategies. There continue to be significant knowledge gaps regarding the implementation and effectiveness of behaviour change interventions on improving COVID-19 prevention practices (i.e. hand and respiratory hygiene, physical distancing). mHealth (healthcare delivered by mobile phones) is cost-effective, aligned with how youth learn and socialize, vital for physical distancing, and has been used for COVID-19 messaging in other low- and middle-income countries. Nested within an ongoing HIV self-testing cluster-randomized trial, this study aims to develop, implement, and evaluate the effectiveness of an mHealth intervention in increasing COVID-19 prevention practices with displaced/refugee AYP aged 16-24 in Kampala, Uganda. Participants will be enrolled in a 8-week mHealth social group intervention program that is informed by the RANAS (Risks, Attitudes, Norms, Abilities, and Self-Regulation) approach to Water, Sanitation, and Hygiene. Using a pre-test/post-test design, this study will assess changes in participants' self-efficacy (e.g. ability, confidence, adherence) in COVID-19 prevention practices.
Detailed Description
Background & Objectives: The proposed study will be nested within an ongoing cluster-randomized HIV self-testing trial (Tushirikiane) in Kampala, Uganda. Using a pre-test/post-test design, the proposed study aims to evaluate the effectiveness of a RANAS-informed mHealth intervention on increasing self-efficacy of COVID-19 prevention practices with displaced/refugee youth aged 16-24 in Kampala, Uganda. This research will be conducted in 5 informal settlements ('slums') grouped into 3 clusters based on proximity (1: Kabalanga and Kasanga, 2: Katwe and Nsambya, 3: Rubaga) where most displaced/refugee persons in Kampala live.
Kukaa Salama Intervention: Participants will be invited to take part in a 8-week COVID-19 prevention program; this will involve receiving 1 SMS/week on COVID-19 prevention messaging, delivered using the WelTel secure platform. All SMS will be delivered in participants' language of choice including English, French, Swahili, Luganda, or Kinyarwanda. Participants will also be invited to take part in a weekly group discussion (15 persons/group) using a secure group conversation integration with WelTel. Each week the group discussions will discuss barriers and facilitators and brainstorm solutions to advance COVID-19 prevention. Participants can also ask the research assistant questions by SMS about COVID-19 during Monday-Friday business hours 9 am-5 pm and can also receive psychosocial support from a counselor from Interaid collaborating with the team and YARID. Regardless of participation in the survey or interview, all participants of the parent trial (Tushirikiane) will also be offered a parcel that contains a face mask, a bar of soap, and a small parcel of food from the partner agency YARID.
Participant Recruitment and Retention: Tushirikiane participants will be invited to take part in the COVID-19 supplement of voluntary questions related to COVID-19 (i.e., about knowledge and prevention) and subsequent Kukaa Salama intervention. The participants will be informed the COVID-19 survey and Kukaa Salama intervention is voluntary and will not affect their participation in the larger Tushirikiane study. Community collaborators will facilitate recruitment and retention; peer navigators will use multiple study reminder strategies (e.g. social media, texts) to maintain engagement, and we will utilize existing outreach and services by MARPI, YARID, and community partners.
Research Team Training: This research involves collaborations with the Ministry of Health's Most At Risk Population Initiative (MARPI) clinics and YARID's urban refugee youth empowerment centres in Kampala.
mHealth Training: This research involves a collaboration with WelTel's non-profit agency for the supportive SMS intervention. WelTel will develop an integration to include discussion groups in the SMS communication platform: SMS surveys, COVID-19 updates, and discussion content will be delivered via WelTel's secure platform. WelTel will support consolidated communication capture and streamlined data visualization to support ongoing analysis. Weekly COVID-19 informational SMS will inform the moderated discussion focus. Multiple 'chat' methods are planned, including: 'scenarios' mimicking real-life situations; a 'question box'; sharing COVID-19 mitigation photos; short movies/GIFs (6-8 seconds); 'memes'; songs; and motivational drivers. The peer navigators and research coordinator will review group discussions weekly to publish top responses to incentivize engagement. WelTel staff has already conducted training with the research team and peer navigators as part of the larger trial.
COVID-19 Prevention Practices: Participants will be surveyed at 3 time points (time 1: baseline; time 2: 8 weeks; time 3: 16 weeks). At baseline (time 1), participants will complete a RANAS-informed questionnaire adapted to COVID-19 (i.e., about knowledge and prevention practices). These COVID-19 related questions will be delivered by a research assistant who will enter the survey responses directly into a tablet (survey will be on the Survey CTO secure platform that runs online and offline). Following the 8-week Kukaa Salama intervention, participants will be asked to complete the same survey (time 2) and again at a 4-month follow up (time 3) to examine changes in COVID-19 knowledge, prevention, and impacts after the intervention and over time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knowledge, Attitudes, Practice, Covid19
Keywords
Uganda, Forcibly displaced youth, mHealth, Water, Sanitation and Hygiene, RANAS (Risks, Attitudes, Norms, Abilities, Self-Regulation), COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single arm, pre-test/post-test trial design will be used to evaluate the effectiveness of a RANAS-informed WhatsApp Social Group intervention on uptake of COVID-19 prevention practices (i.e. hand and respiratory hygiene, physical distancing) with displaced/refugee youth in Kampala, Uganda. A control group design is intentionally not used based on recommendations regarding ethical concerns over the potential withholding of any intervention benefits from a vulnerable group (refugee youth living in informal settlements) in the midst of a pandemic.
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kukaa Salama: mHealth intervention
Arm Type
Experimental
Arm Description
This is a pre-test/post-test trial, therefore all participants will receive the Kukaa Salama mHealth intervention and will be offered a COVID-19 prevention parcel.
Intervention Type
Behavioral
Intervention Name(s)
Kukaa Salama: mHealth intervention
Intervention Description
Kukaa Salama is a 8-week social group program of COVID-19 prevention messaging, which includes sending informational SMS once per week and holding secure group discussions on COVID-19 prevention. Weekly SMS messages will focus on COVID-19 knowledge, including information about transmission, hand washing, respiratory hygiene (coughing and sneezing in ways that won't spread germs), face masks, and physical distancing. Participants can also respond to the SMS with any questions about COVID-19, and the study team will respond with further information and/or additional resources. Weekly group chats will be administered using the customized WelTel platform, and will focus on discussions of how participants can apply and practice the information on COVID-19 prevention in their daily lives. Each group chat will be composed of 15-20 participants, and will be facilitated by a research assistant in Kampala as well as a peer navigator.
Intervention Type
Device
Intervention Name(s)
Face Mask + Soap
Intervention Description
Participants will be offered the opportunity to pick up a parcel that contains a face mask, bar of soap, and a small parcel of food from the partner agency YARID.
Primary Outcome Measure Information:
Title
Changes in COVID-19 Prevention Practices
Description
To assess changes in COVID-19 prevention practices, participants are asked to report on their self-efficacy (i.e. ability, confidence, adherence) to practice hand and respiratory hygiene (i.e. hand washing with soap, face mask usage) and physical distancing.
Time Frame
Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Secondary Outcome Measure Information:
Title
Changes in COVID-19 Risk Awareness
Description
To assess changes in COVID-19 risk awareness, participants are asked to report on their perceived risk and vulnerabilites to COVID-19 as well as as their knowledge of symptoms and severity.
Time Frame
Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Title
Changes in Attitude towards COVID-19
Description
To assess changes in attitudes towards COVID-19, participants are asked to report on their attitude (i.e. feelings, costs/benefits) towards prevention practices as well as towards COVID-19 testing and potential vaccines.
Time Frame
Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Title
Changes in COVID-19 Norms
Description
To assess changes in COVID-19 norms, participants are asked to report on the percieved behaviours approved by others (i.e. social pressues) towards COVID-19 prevention practices, transmission, and stigma.
Time Frame
Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Title
Changes in COVID-19 Self-Regulation
Description
To assess changes in COVID-19 self-regulation, participants are asked about their action plan for implementing COVID-19 prevention practices.
Time Frame
Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Title
Changes in Depression
Description
Depression outcomes will be assessed using the Patient Health Questionnaire -9 item (PHQ-9). Higher scores mean a worse outcome. Range 0-27.
Time Frame
Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Title
Sexual and Reproductive Health
Description
To assess changes in sexual and reproductive health, participants are asked to report on personal experiences (e.g. intimate partner violence) as well as perceived changes in the community (e.g. violence, access to sexual and reproductive health services).
Time Frame
Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Title
Food and Water insecurity
Description
To assess changes in food and water insecurity, participants are asked to report on frequency of insufficient food (i.e. going to bed hungry) and inadequate clean water.
Time Frame
Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Enrolled within the Tushirikiane HIV-self Testing cluster randomized trial
Live in one of the 5 slum/informal settlement sites (Kabalanga, Kasanga, Katwe, Nsambya Rubaga)
Identify as a refugee/displaced person or have refugee parents
Age 16-24 years
Speak English, Luganda, French, Swahili, or Kinyarwanda
Own or have access to a mobile phone for the duration of the study
Exclusion Criteria:
Not currently enrolled in the Tushirikiane HIV-self Testing cluster randomized trial
Lives outside of 5 selected study sites
Does not identify as a refugee or does not have refugee parents
Less than 16 or older than 24 years
Does not speak English, Luganda, French, Swahili, or Kinyarwanda
Does not have mobile phone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen H Logie, PhD
Organizational Affiliation
University of Toronto, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Factor-Inwentash Faculty of Social Work, University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S1V4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data collected during this study will not be made publicly available due to the possibility of identifying participants using a combination of common demographic and response characteristics. The data may be made available from the corresponding author on reasonable request and upon completing suitable data sharing agreements.
Citations:
PubMed Identifier
34810193
Citation
Logie CH, Okumu M, Berry I, Hakiza R, Kibuuka Musoke D, Kyambadde P, Mwima S, Lester RT, Perez-Brumer AG, Baral S, Mbuagbaw L. Kukaa Salama (Staying Safe): study protocol for a pre/post-trial of an interactive mHealth intervention for increasing COVID-19 prevention practices with urban refugee youth in Kampala, Uganda. BMJ Open. 2021 Nov 22;11(11):e055530. doi: 10.1136/bmjopen-2021-055530.
Results Reference
derived
Learn more about this trial
mHealth Intervention for Increasing COVID-19 Prevention Practices With Urban Refugee and Displaced Youth in Uganda
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