Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04631367 |
| Other study ID # |
idrc_covid |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
October 31, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
University of Toronto |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
