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临床试验/NCT04631367
NCT04631367已完成不适用

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

University of Toronto2 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
330
试验地点
2
主要终点
Changes in COVID-19 Prevention Practices

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Changes in COVID-19 Prevention Practices

时间窗: 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.

次要结局

  • Food and Water insecurity(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))
  • Sexual and Reproductive Health(Time 1 (1 week), Time 2 (8 week), Time 3 (month 16 week))
  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carmen Logie, MSW, PhD

Associate Professor

University of Toronto

研究点 (2)

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