Knowledge, Attitudes, PracticeNCT04631367
mHealth Intervention for Increasing COVID-19 Prevention Practices With Urban Refugee and Displaced Youth in Uganda
A study testing Kukaa Salama: mHealth intervention and Face Mask + Soap in people with Knowledge, Attitudes, Practice and Covid19, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice, Covid19
- What is being tested?
- Kukaa Salama: mHealth intervention and Face Mask + Soap
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Factor-Inwentash Faculty of Social Work, University of Toronto
Toronto, Ontario, M5S1V4
About this study
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
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.
Read the 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.
- Conditions
- Knowledge, Attitudes, Practice, Covid19
- Being tested
- Kukaa Salama: mHealth intervention, Face Mask + Soap
- Keywords
- Uganda, Forcibly displaced youth, mHealth, Water, Sanitation and Hygiene, RANAS (Risks, Attitudes, Norms, Abilities, Self-Regulation), COVID-19
- Medical subject headings
- Behavior, COVID-19, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kukaa Salama: mHealth interventionBehavioural
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.
Face Mask + SoapDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Kukaa Salama: mHealth intervention | Experimental | 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. Receives: Behavioral: Kukaa Salama: mHealth intervention; Device: Face Mask + Soap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Secondary outcomes (7)
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.
Measured: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
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.
Measured: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
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.
Measured: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
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.
Measured: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
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.
Measured: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
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).
Measured: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
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.
Measured: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Feb 2021
- Primary completion20 Aug 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Logie, MSW, PhD, University of Toronto
- Investigators
- Carmen H Logie, PhD, Principal investigator, University of Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631367
- Sponsor's protocol ID
- idrc_covid
- Status last verified
- Dec 2021
- First submitted
- 13 Nov 2020
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Logie CH, Okumu M, Berry I, McAlpine A, Musoke DK, Hakiza R, Perez-Brumer A, Baral S, Kyambadde P. Multi-method findings on COVID-19 vaccine acceptability among urban refugee adolescents and youth in Kampala, Uganda. Glob Public Health. 2023 Jan;18(1):2185800. doi: 10.1080/17441692.2023.2185800.
PubMed 36883681Logie 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.
PubMed 34810193
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04631367
- Acronym / sponsor ID
- idrc_covid
- Conditions
- Knowledge, Attitudes, Practice, Covid19
- Keywords
- Uganda, Forcibly displaced youth, mHealth, Water, Sanitation and Hygiene, RANAS (Risks, Attitudes, Norms, Abilities, Self-Regulation), COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Kukaa Salama: mHealth intervention | Experimental | Behavioral: Kukaa Salama: mHealth intervention, Device: Face Mask + SoapThis 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. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kukaa Salama: mHealth interventionKukaa 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. | Behavioural | Kukaa Salama: mHealth intervention |
| Face Mask + SoapParticipants 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. | Device | Kukaa Salama: mHealth intervention |
Primary outcome
Changes in COVID-19 Prevention Practices
Time frame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
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.
7 secondary outcomes
Changes in COVID-19 Risk Awareness
Time frame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Changes in Attitude towards COVID-19
Time frame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Changes in COVID-19 Norms
Time frame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Changes in COVID-19 Self-Regulation
Time frame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Changes in Depression
Time frame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Sexual and Reproductive Health
Time frame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Food and Water insecurity
Time frame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Derived from this study: PubMed 36883681Logie CH, Okumu M, Berry I, McAlpine A, Musoke DK, Hakiza R, Perez-Brumer A, Baral S, Kyambadde P. Multi-method findings on COVID-19 vaccine acceptability among urban refugee adolescents and youth in Kampala, Uganda. Glob Public Health. 2023 Jan;18(1):2185800. doi: 10.1080/17441692.2023.2185800.
- Derived from this study: PubMed 34810193Logie 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen H Logie, PhD principal investigator
University of Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kukaa Salama: mHealth intervention and Face Mask + Soap in people with Knowledge, Attitudes, Practice and Covid19, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in COVID-19 Prevention Practices (time frame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04631367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.