NCT04631367

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

November 13, 2020

Last Update Submit

December 23, 2021

Conditions

Keywords

UgandaForcibly displaced youthmHealthWater, Sanitation and HygieneRANAS (Risks, Attitudes, Norms, Abilities, Self-Regulation)COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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.

    Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)

Secondary Outcomes (7)

  • Changes in COVID-19 Risk Awareness

    Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)

  • Changes in Attitude towards COVID-19

    Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)

  • Changes in COVID-19 Norms

    Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)

  • Changes in COVID-19 Self-Regulation

    Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)

  • Changes in Depression

    Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week)

  • +2 more secondary outcomes

Study Arms (1)

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.

Behavioral: Kukaa Salama: mHealth interventionDevice: Face Mask + Soap

Interventions

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.

Kukaa Salama: mHealth intervention

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.

Kukaa Salama: mHealth intervention

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Factor-Inwentash Faculty of Social Work, University of Toronto

Toronto, Ontario, M5S1V4, Canada

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

BehaviorCOVID-19Self-Control

Interventions

Masks

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSocial Behavior

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Carmen H Logie, PhD

    University of Toronto, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 17, 2020

Study Start

February 1, 2021

Primary Completion

August 20, 2021

Study Completion

October 31, 2021

Last Updated

December 28, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

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.

Locations