Clinical trial NCT04631367: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Covid19
Keywords: Uganda
Forcibly displaced youth
mHealth
Water, Sanitation and Hygiene
RANAS (Risks, Attitudes, Norms, Abilities, Self-Regulation)
COVID-19
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 330
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in COVID-19 Prevention Practices
timeFrame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Secondary outcomes:
measure: Changes in COVID-19 Risk Awareness
timeFrame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
measure: Changes in Attitude towards COVID-19
timeFrame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
measure: Changes in COVID-19 Norms
timeFrame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
measure: Changes in COVID-19 Self-Regulation
timeFrame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
measure: Changes in Depression
timeFrame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
measure: Sexual and Reproductive Health
timeFrame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
measure: Food and Water insecurity
timeFrame: Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Factor-Inwentash Faculty of Social Work, University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto, Canada
name: Carmen H Logie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.